Head and neck cancer metastatic

In addition to cognitive benefit, pepinemab is believed to preserve vascular integrity in brain, a key consideration to avoid toxicity in Alzheimer’s diseaseROCHESTER, N.Y., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present promising new efficacy and safety data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference in Madrid, on October 31, 2024. Elizabeth Evans, PhD, Chief Operating Officer and Senior VP Discovery and Translational Medicine, will present results of the study in a podium presentation. Presentation title: Results of SIGNAL-AD, a randomized, phase 1b/2 trial to evaluate safety and efficacy of pepinemab, anti-SEMA4D antibody believed to block reactive astrogliosis, in patients with Mild Cognitive Impairment (MCI) and Mild Dementia due to AD Presenter: Elizabeth Evans, PhD Date: Thursday October 31, 2024, 2:55 PM Central European Time, 9:55 AM EDT. Venue: Madrid Marriott Auditorium Hotel and Conference Center What can we expect to learn from results of this study? Vaccinex scientists discovered and published that Semaphorin 4D (SEMA4D), a molecule that binds to high affinity plexin-B1 receptors expressed on astrocytes in the brain, is highly upregulated on stressed or damaged neurons during progression of Alzheimer’s Disease (AD)Astrocytes, which are key brain cells that support the health and function of neurons, undergo extensive changes in morphology and gene expression when SEMA4D binds to their receptors. They switch from normal supportive functions to neurotoxic inflammatory activity that is believed to aggravate and accelerate progression of AD.The Company’s hypothesis, which is being tested in the SIGNAL-AD study, is that treating with pepinemab antibody that binds SEMA4D can block signaling through astrocyte receptors and slow or prevent the damaging consequences of astrocyte activation.The Company has previously reported that antibody blockade of SEMA4D appears to protect healthy astrocyte functions and to slow disease progression in patients with Huntington’s disease.Key outcomes of the SIGNAL-AD study include the impact of pepinemab treatment on cognitive decline as well as biomarkers of disease progression.Deposition of Aβ amyloid in the brain is currently the earliest recognized event in the pathologic cascade leading to AD. Aggregates of Aβ are believed to trigger a series of subsequent events, including astrocyte reactivity and formation of toxic tau tangles in neurons, which are believed to be key drivers of neurodegeneration. Levels of soluble biomarkers, such as astrocyte protein glial fibrillary acidic protein and phosphorylated tau peptide (p-tau 217), are, therefore, key biomarkers of disease progression, and it is important to characterize expression of these biomarkers in relation to treatment effects.Some currently approved drugs have been reported to compromise the integrity of brain vasculature leading to inflammation and microhemorrhages. Vaccinex will report evidence from new preclinical models suggesting beneficial effects of pepinemab treatment on brain vasculature. The SIGNAL-AD study was funded in part by a grant from the Alzheimer’s Association as well as by investments from the Alzheimer’s Drug Discovery Foundation (ADDF). About PepinemabPepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of astrocytes and other glial cells in the brain and of dendritic cells in immune tissue. Pepinemab appears to have been well-tolerated with a favorable safety profile in multiple clinical trials in different neurological and cancer indications. About Vaccinex Inc. Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers damaging inflammation in chronic diseases of the brain and prevents infiltration and activation of immune cells in tumors. Pepinemab is being studied as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data in Huntington’s disease. Pepinemab could be an important contributor to combination therapy in AD. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma. Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer. Forward Looking StatementsTo the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about expectations and objectives with respect to the results and timing of the SIGNAL-AD clinical trial; expectations with respect to compliance with Nasdaq listing standards; our plans, expectations and objectives with respect to the results and timing of the SIGNAL-AD and KEYNOTE-B84 clinical trials; the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications; the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®; expectations with respect to the collaboration of Merck,; and other statements identified by words such as “anticipate,” “believe,” “plans,” “schedule,” “being,” “will,” “appears,” “expect,” “ongoing,” “potential,” “promising,” “suggest”, and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the possible delisting of our common stock from Nasdaq if the Company is unable to regain and sustain compliance with the Nasdaq listing standards, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission and the other risks and uncertainties described in the Company’s annual year-end Form 10-K and subsequent filings with the SEC. Investor ContactElizabeth Evans, PhDChief Operating Officer, Vaccinex, Inc.(585) 271-2700eevans@vaccinex.com

RT-NBTXR3 followed by anti-PD-1 demonstrated favorable safety profile, disease control and tumor response in patients both naïve and resistant to anti-PD-1, suggesting that NBTXR3 may prime the immune system before checkpoint therapySeveral clinical milestones expected over the next 12-18 months including updated data in pancreatic, and head and neck cancer, and initial data in esophageal and lung cancer€66.3 million in cash and cash equivalents as of June 30, 2024, with a cash runway extended into Q4 2025 PARIS and CAMBRIDGE, Mass., Sept. 18, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanoparticle-based approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress and announced its half year financial results for the six-month period ended June 30, 2024. “We continue to make strong progress advancing our nanoparticle-based therapeutic approach with lead candidate NBTXR3, which is part of our global licensing agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company. The agreement is designed to realize significant therapeutic and market opportunities in solid tumor cancers worldwide, starting with lung and head and neck. We also continue to establish additional expansion opportunities across multiple cancer settings as part of our ongoing collaboration with MD Anderson,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “The potential of NBTXR3 to prime immune activity before an anti-PD-1 inhibitor was further reinforced with new data from Study 1100 announced at the Annual Meeting of American Society for Clinical Oncology (ASCO) showing disease control and tumor response in patients with head and neck cancer that are naïve or resistant to prior anti-PD-1 therapy. We expect several clinical milestones over the next 12-18 months that, would further advance and broaden the potential patient population for NBTXR3 including updated data in pancreatic and head and neck cancer, and initial data in esophageal and lung cancer.” First Half 2024 Operational Highlights, Pipeline Status and Expected Milestones Strengthened Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy, and Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors. Achieved a NANORAY-312 operational milestone as part of global exclusive licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company, for the investigational, potential first-in-class radioenhancer NBTXR3 and subsequently received the $20 million payment. Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Local Control as Single Agent Activated by Radiotherapy (RT) NANORAY-312, a pivotal, global, randomized Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients ineligible for cisplatin chemotherapy Interim analysis to be reported after both the requisite number of events has occurred and the last patient is recruited, expected by 1H2026Ongoing transfer of the sponsorship to Janssen to facilitate preparations for potentially positive trial results and subsequent steps Study 102, a successfully completed Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 in patients ineligible for cisplatin chemotherapy or intolerant to cetuximab. Final results showed topline safety and efficacy data supporting robust anti-tumor activity and a well-tolerated profile in elderly patients with a high burden of comorbidity (n=56) Non-Small Cell Lung Cancer (NSCLC) Janssen-led randomized Phase 2 study evaluating NBTXR3 + chemoradiation followed by anti-PD-L1 for patients with inoperable, stage 3 NSCLC Study may proceed letter received from the Food and Drug Administration (FDA)First patient randomized is the next expected milestone Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Priming Immune Response Followed by an Anti-PD-1 Treatment: Study 1100, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 as a second-or-later line treatment in patients with advanced cancers Completed dose escalation part – ongoing dose expansion part. New data in R/M HNSCC Naïve or Resistant to Anti-PD-1 presented at ASCO: Favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; “ITT”)48% overall response rate (ORR) in evaluable anti-PD-1 naïve patients (n=25); 28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.176% disease control rate (DCR) in evaluable naïve patients; 68% DCR in evaluable resistant patients as per RECIST 1.1Preliminary review of survival data in ITT anti-PD-1 naïve patients (n=33) showed mPFS of 7.3 months and mOS of 26.2 monthsITT anti-PD-1 resistant patients (n=35) showed mPFS of 4.2 months and mOS of 7.8 months Initial data from immunotherapy resistant patients with multiple primary tumors expected in 2025Data supports further evaluation in randomized clinical trials which may include a potential registrational pathway for NBTXR3 in combination with an immunotherapy. Pancreatic, Lung and Others: Expanding NBTXR3 Opportunity Through a Strategic Collaboration with The University of Texas MD Anderson Cancer Center to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profiles Five ongoing clinical trials in advanced solid tumors: Advanced Solid Tumors with Lung or Liver Metastases: Phase 1/2 study (NCT05039632) of RT-activated NBTXR3 plus an anti-PD-1/L-1 immune checkpoint inhibitorRecurrent or Metastatic Head and Neck Cancer: Phase 2 study (NCT04862455) of RT-activated NBTXR3 in combination with anti-PD-1Inoperable Non-Small Cell Lung Cancer (NSCLC): Phase 1 study (NCT04505267) of single agent RT-activated NBTXR3 Dose escalation completed and dose expansion ongoing. Established RP2D after determination of injection feasibility and observation of a favorable safety profile. Esophageal Cancer: Phase 1 study (NCT04615013) of RT-activated NBTXR3 in combination with chemotherapy Pancreatic Cancer: Phase 1b study (NCT04484909) of RT-activated NBTXR3 after cytotoxic chemotherapy for patients with locally advanced pancreatic cancer (LAPC) Multiple expected clinical milestones: Updated Phase 1b dose escalation data in pancreatic cancer expected 2H2024Initial Phase 1 dose escalation data in inoperable, recurrent NSCLC amenable to re-irradiation expected 1H2025Completion of dose escalation in Phase 1b/2 trial in esophageal cancer expected in 2024, initiation of dose expansion part, and presentation of first data in 2025 Half Year 2024 Financial Results Revenue and Other Income: Revenue and other income has increased for the six months ended June 30, 2024, to €9.3 million, compared to €3.3 million for the six months ended June 30, 2023, primarily resulting from services and product supply revenue linked to the exclusive licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV executed on July 7, 2023. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2024, were €22.0 million, primarily driven by an increase of the clinical development activities in NANORAY-312, compared to €17.8 million for the six months ended June 30, 2023. Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. Total SG&A expenses for the six months ended June 30, 2024, were €10.8 million, compared to €10.9 million for the prior-year six-month period. Net loss: Net loss attributable to common shareholders for the six months ended June 30, 2024, was €21.9 million, or a €0.46 basic loss per share. This compares to a net loss attributable to common shareholders of €28.1 million, or €0.80 basic loss per share, for the same period in 2023. Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2024, were €66.3 million, compared to €75.3 million as of December 31, 2023. Based on the current operating plan and financial projections, we anticipate that the cash and cash equivalents of €66.3 million as of June 30, 2024, will now fund our operations into Q4 2025, compared to Q3 2025 in prior guidance. Availability of the Half Year 2024 Financial Reports The 2024 half-year financial report has been filed with the French financial market authority (Autorité des marchés financiers). It is available to the public on the Company’s website, www.nanobiotix.com. About NBTXR3 NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter DisclaimerThis press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18 2024, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts NanobiotixCommunications DepartmentBrandon OwensVP, Communications+1 (617) 852-4835contact@nanobiotix.comInvestor Relations DepartmentCraig WestSVP, Investor Relations+1 (617) 583-0211investors@nanobiotix.comMedia RelationsFR – Ulysse CommunicationLaurent Wormser+ 33 (0)6 13 12 04 04lwormser@ulysse-communication.comGlobal – LifeSci AdvisorsKevin Gardner+1 (617) 283-2856kgardner@lifesciadvisors.com Attachment 2024-09-18 -- NBTX -- 1H24 Financial Results -- FINAL

Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease New results show potential of RYBREVANT® beyond lung cancer BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI) demonstrated promising rapid and durable antitumor activity in patients with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC) who have not previously received anti-epidermal growth factor receptor (EGFR) therapy. These data were presented in a mini-oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress.1 "OrigAMI-1 is the first study to show RYBREVANT plus chemotherapy may provide clinically meaningful benefits to patients with metastatic colorectal cancer who have not received any EGFR-targeted treatments as their first or second line of therapy," said Filippo Pietrantonio, M.D., medical oncologist at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, and presenting author.* "Notably, we saw 21 percent of patients proceed to curative intent surgery, showing the promise of RYBREVANT in patients in this setting." In the study, patients receiving RYBREVANT® plus chemotherapy were either in their first (26 percent) or second line (74 percent) of treatment for mCRC and had not been treated with specific anti-EGFR therapies. Patients receiving FOLFOX were oxaliplatin-naïve and patients receiving FOLFIRI were irinotecan-naïve. Response was assessed by the investigator per RECIST v1.1.** Forty-three patients were treated with RYBREVANT® along with either FOLFOX (20 patients) or FOLFIRI (23 patients). The median follow-up period was 7.3 months for RYBREVANT® plus FOLFOX and RYBREVANT® plus FOLFIRI.1 Patients treated with RYBREVANT® plus chemotherapy achieved an overall response rate (ORR) of 49 percent (95 percent confidence interval [CI], 33-65), median duration of response of 7.4 months (95 percent CI, 5.6-not estimable [NE]) and median progression-free survival of 7.5 months (95 percent CI, 7.4‒NE). Disease control was observed in 88 percent of patients (95 percent CI, 75-96). Clinically meaningful intrahepatic antitumor activity was observed among patients with liver metastases treated with RYBREVANT® plus chemotherapy, demonstrating a significant reduction in liver tumors (ORR of 53 percent, disease control rate of 93 percent). Notably, nine (21 percent) patients were able to proceed to curative-intent surgery due to strong antitumor activity.1 The safety profile of RYBREVANT® plus FOLFOX/FOLFIRI was manageable and consistent with each of the individual components, without any additive toxicity. No new safety signals were observed. The most frequent treatment-emergent adverse events were neutropenia, rash, stomatitis, infusion-related reactions (IRRs) and diarrhea. All IRRs were Grade 1 or 2 and there were no Grade 3 or higher IRR events reported. Treatment-related discontinuations of RYBREVANT® were 10 percent for RYBREVANT® plus FOLFOX and nine percent for RYBREVANT® plus FOLFIRI.1 "Confirmation that RYBREVANT has activity beyond lung cancer, given its unique multi-targeted approach in inhibiting EGFR and MET, is a potentially important step forward for patients with EGFR inhibitor-naïve metastatic colorectal cancer," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. "Colorectal cancer is the third most common cancer globally, representing about 10 percent of all cancer cases and the second leading cause of cancer-related deaths. Our commitment to advancing cancer care drives us to evaluate every possibility to improve patient outcomes, and these findings highlight the potential of RYBREVANT to help even more patients with cancer." Pivotal Phase 3 registration trials evaluating RYBREVANT®-based regimens as first- and second-line treatment in colorectal cancer are planned. About the OrigAMI-1 Study OrigAMI-1 (NCT05379595) is an open-label Phase 1b/2 study assessing the efficacy and safety of RYBREVANT® plus mFOLFOX6 or FOLFIRI in anti-EGFR-naïve RAS/BRAF WT mCRC. Eligible patients were WT for KRAS, NRAS or BRAF genes based on circulating tumor DNA testing. Additionally, patients were required to have no amplification of the ERBB2/HER2 gene. In the RYBREVANT® and chemotherapy cohorts, patients were either treatment-naïve or had received at least one prior line in the metastatic setting (no EGFR inhibitor treatment). The primary endpoint of the combination cohorts was to characterize the safety and confirm the dose of RYBREVANT® plus mFOLFOX6 or FOLFIRI. Response was assessed by the investigator per RECIST v1.1.2 About RYBREVANT® RYBREVANT® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe, and in other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.3 RYBREVANT® is approved in the U.S., Europe, and in markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. RYBREVANT® is approved in the U.S. in combination with LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. A marketing authorization application (MAA) and type II extension of indication application were submitted to the European Medicines Agency (EMA) seeking approval of LAZCLUZE™ in combination with RYBREVANT® based on the MARIPOSA study. In November 2023, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for RYBREVANT® in combination with chemotherapy for the treatment of patients with EGFR-mutated NSCLC who progressed on or after osimertinib based on the MARIPOSA-2 study. This indication was approved in Europe in August 2024. In June 2024, Johnson & Johnson submitted a BLA to the U.S. FDA for the subcutaneous formulation of RYBREVANT® in combination with LAZCLUZE™ for all currently approved or submitted indications of intravenous (IV) RYBREVANT® in certain patients with NSCLC. A submission for the extension of the RYBREVANT® marketing authorization (line extension) was also submitted to the EMA seeking approval for this indication. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC§ prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Guidelines include: Amivantamab-vmjw (RYBREVANT®) plus lazertinib (LAZCLUZE™) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.4 †‡ Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NCSLC with EGFR exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.4 †‡ Amivantamab-vmjw (RYBREVANT®) plus carboplatin and pemetrexed as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive advanced NSCLC, or as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without immunotherapy and have EGFR exon 20 insertion mutation-positive advanced NSCLC.4 †‡ Amivantamab-vmjw (RYBREVANT®) as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC.4 †‡ In addition to the Phase 1b/2 OrigAMI-1 study, RYBREVANT® is being studied in multiple clinical trials, including: The Phase 3 MARIPOSA (NCT04487080) study assessing RYBREVANT® in combination with LAZCLUZE™ versus osimertinib and versus LAZCLUZE™ alone in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations.5 The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of RYBREVANT® (with or without LAZCLUZE™) carboplatin-pemetrexed versus carboplatin-pemetrexed alone in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC after disease progression on or after osimertinib.6 The Phase 3 PAPILLON (NCT04538664) study assessing RYBREVANT® in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.7 The Phase 3 PALOMA-3 (NCT05388669) study assessing LAZCLUZE™ with subcutaneous amivantamab compared to intravenous amivantamab in patients with EGFR-mutated advanced or metastatic NSCLC.8 The Phase 2 PALOMA-2 (NCT05498428) study assessing subcutaneous amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.9 The Phase 1 PALOMA (NCT04606381) study assessing the feasibility of subcutaneous administration of amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for amivantamab subcutaneous delivery.10 The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT® in patients with advanced NSCLC.11 The Phase 1/1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® in combination with LAZCLUZE™ and LAZCLUZE™ as a monotherapy in patients with advanced NSCLC with EGFR mutations.12 The Phase 1/2 METalmark (NCT05488314) study assessing RYBREVANT® and capmatinib combination therapy in locally advanced or metastatic NSCLC.13 The Phase 1/2 PolyDamas (NCT05908734) study assessing RYBREVANT® and cetrelimab combination therapy in locally advanced or metastatic NSCLC.14 The Phase 2 SKIPPirr study (NCT05663866) exploring how to decrease the incidence and/or severity of first-dose infusion-related reactions with RYBREVANT® in combination with LAZCLUZE™ in relapsed or refractory EGFR-mutated advanced or metastatic NSCLC.15 The Phase 1/2 swalloWTail (NCT06532032) study assessing RYBREVANT® and docetaxel combination therapy in patients with metastatic NSCLC.16 The Phase 1b/2 OrigAMI-4 (NCT06385080) study assessing RYBREVANT® monotherapy and in addition to standard-of-care therapeutic agents in patients with recurrent/metastatic head and neck squamous cell carcinoma.17 For more information, visit: . About Colorectal Cancer Colorectal cancer is the third most common cancer worldwide, accounting for approximately 10 percent of all cancer cases and is the second leading cause of cancer-related deaths worldwide.18 While it predominantly affects older individuals, recent research suggests that colorectal cancer is now being diagnosed in adults under the age of 50 at record rates.19 Left-sided colorectal cancer, which represents approximately 65 percent of cases, often has distinct characteristics that influence treatment strategies. Around half of colorectal cancer patients have mutations in the RAS genes, with KRAS being the most common mutation. While tumors with normal RAS and BRAF genes generally respond better to EGFR inhibitors, those with RAS and BRAF mutations – particularly on the left side – are associated with poorer outcomes.20 IMPORTANT SAFETY INFORMATION3,21 WARNINGS AND PRECAUTIONS Infusion-Related Reactions RYBREVANT® can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour. RYBREVANT® with LAZCLUZE™ RYBREVANT® in combination with LAZCLUZE™ can cause infusion-related reactions. In MARIPOSA (n=421), IRRs occurred in 63% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 5% and Grade 4 in 1% of patients. The incidence of infusion modifications due to IRR was 54% of patients, and IRRs leading to dose reduction of RYBREVANT® occurred in 0.7% of patients. Infusion-related reactions leading to permanent discontinuation of RYBREVANT® occurred in 4.5% of patients receiving RYBREVANT® in combination with LAZCLUZE™. RYBREVANT® with Carboplatin and Pemetrexed In PAPILLON (n=151), infusion-related reactions occurred in 42% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (1.3%) adverse reactions. The incidence of infusion modifications due to IRR was 40%, and 0.7% of patients permanently discontinued RYBREVANT®. RYBREVANT® as a Single Agent In CHRYSALIS (n=302), IRR occurred in 66% of patients treated with RYBREVANT®. Among patients receiving treatment on Week 1 Day 1, 65% experienced an IRR, while the incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. The incidence of infusion modifications due to IRR was 62% and 1.3% of patients permanently discontinued RYBREVANT® due to IRR. Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of infusion-related reactions. Monitor patients for signs and symptoms of infusion reactions during RYBREVANT® infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. Interstitial Lung Disease/Pneumonitis RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. RYBREVANT® with LAZCLUZE™ In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case (0.2%) of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE™ due to ILD/pneumonitis. RYBREVANT® with Carboplatin and Pemetrexed In PAPILLON, Grade 3 ILD/pneumonitis occurred in 2.6% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, all patients required permanent discontinuation. RYBREVANT® as a Single Agent In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT®, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) discontinued RYBREVANT® due to ILD/pneumonitis. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). For patients receiving RYBREVANT® in combination with LAZCLUZE™, immediately withhold both drugs in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, immediately withhold RYBREVANT® in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. Venous Thromboembolic (VTE) Events with Concomitant Use of RYBREVANT® and LAZCLUZE™ RYBREVANT® in combination with LAZCLUZE™ can cause serious and fatal venous thromboembolic (VTEs) events, including deep vein thrombosis and pulmonary embolism. The majority of these events occurred during the first four months of therapy. In MARIPOSA, VTEs occurred in 36% of patients receiving RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE™; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE™; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE™. The median time to onset of VTEs was 84 days (range: 6 to 777). Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT® and LAZCLUZE™ based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT® and LAZCLUZE™ at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT® and continue treatment with LAZCLUZE™ at the same dose level at the discretion of the healthcare provider. Dermatologic Adverse Reactions RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus, and dry skin. RYBREVANT® with LAZCLUZE™ In MARIPOSA, rash occurred in 86% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE™, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE™, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE™. RYBREVANT® with Carboplatin and Pemetrexed In PAPILLON, rash occurred in 89% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (19%) adverse reactions. Rash leading to dose reductions occurred in 19% of patients, and 2% permanently discontinued RYBREVANT® and 1.3% discontinued pemetrexed. RYBREVANT® as a Single Agent In CHRYSALIS, rash occurred in 74% of patients treated with RYBREVANT® as a single agent, including Grade 3 rash in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% of patients, and RYBREVANT® was permanently discontinued due to rash in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%) treated with RYBREVANT® as a single agent. Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT® or LAZCLUZE™ in combination with RYBREVANT®. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. Alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream is recommended for dry skin. When initiating RYBREVANT® treatment with or without LAZCLUZE™, administer alcohol-free emollient cream to reduce the risk of dermatologic adverse reactions. Consider prophylactic measures (e.g. use of oral antibiotics) to reduce the risk of dermatologic reactions. If skin reactions develop, start topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT® in combination with LAZCLUZE™, withhold, dose reduce or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT® based on severity. Ocular Toxicity RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus, and uveitis. RYBREVANT® with LAZCLUZE™ In MARIPOSA, ocular toxicity occurred in 16% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT® and continue LAZCLUZE™ based on severity. RYBREVANT® with Carboplatin and Pemetrexed In PAPILLON, ocular toxicity including blepharitis, dry eye, conjunctival redness, blurred vision, and eye pruritus occurred in 9%. All events were Grade 1-2. RYBREVANT® as a Single Agent In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients treated with RYBREVANT®. All events were Grade 1-2. Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT® based on severity. Embryo-Fetal Toxicity Based on its mechanism of action and findings from animal models, RYBREVANT® and LAZCLUZE™ can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT®. Advise females of reproductive potential to use effective contraception during treatment with LAZCLUZE™ and for 3 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LAZCLUZE™ and for 3 weeks after the last dose. Adverse Reactions RYBREVANT® with LAZCLUZE™ For the 421 patients in the MARIPOSA clinical trial who received RYBREVANT® in combination with LAZCLUZE™, the most common adverse reactions (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (RYBREVANT®, 63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), nausea (21%), and ocular toxicity (16%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%). Serious adverse reactions occurred in 49% of patients who received RYBREVANT® in combination with LAZCLUZE™. Serious adverse reactions occurring in ≥2% of patients included VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and infusion-related reaction (RYBREVANT®) (2.1% each). Fatal adverse reactions occurred in 7% of patients who received RYBREVANT® in combination with LAZCLUZE™ due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each). RYBREVANT® with Carboplatin and Pemetrexed For the 151 patients in the PAPILLON clinical trial who received RYBREVANT® in combination with carboplatin and pemetrexed, the most common adverse reactions (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), infusion-related reaction (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%). Serious adverse reactions occurred in 37% of patients who received RYBREVANT® in combination with carboplatin and pemetrexed. Serious adverse reactions in ≥2% of patients included rash, pneumonia, ILD, pulmonary embolism, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified. RYBREVANT® as a Single Agent For the 129 patients in the CHRYSALIS clinical trial who received RYBREVANT® as a single agent, the most common adverse reactions (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%). Serious adverse reactions occurred in 30% of patients who received RYBREVANT®. Serious adverse reactions in ≥2% of patients included pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death. LAZCLUZE™ Drug Interactions Avoid concomitant use of LAZCLUZE™ with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4. Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate. Please read full Prescribing Information for RYBREVANT®. Please read full Prescribing Information for LAZCLUZE™. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT® (amivantamab-vmjw). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. *Dr. Filippo Pietrantonio has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. **RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger. †See the NCCN Guidelines for detailed recommendations, including other treatment options. ‡The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories. §The NCCN Content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 1 Pietrantonio, et al. Amivantamab plus FOLFOX or FOLFIRI in metastatic colorectal cancer: Results from OrigAMI-1, a phase 1b/2 study. 2024 European Society for Medical Oncology. September 14, 2024. 2 ClinicalTrials.gov. A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (OrigAMI-1). . Accessed September 2024. 3 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 4 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.9.2024© National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed September 2024. 5 ClinicalTrials.gov. A Study of Amivantamab and LAZCLUZE™ Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). Available at: . Accessed September 2024. 6 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2). Available at: . Accessed September 2024. 7 ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON). Available at: . Accessed September 2024. 8 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). . Accessed September 2024. 9 ClinicalTrials.gov. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PALOMA-2). . Accessed September 2024. 10 ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (PALOMA). Available at: . Accessed September 2024. 11 ClinicalTrials.gov. A Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS). . Accessed September 2024. 12 ClinicalTrials.gov. A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (CHRYSALIS-2). . Accessed August 2024. 13 ClinicalTrials.gov. A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer (METalmark). . Accessed September 2024. 14 ClinicalTrials.gov. A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (PolyDamas). . Accessed September 2024. 15 ClinicalTrials.gov. Premedication to Reduce Amivantamab Associated Infusion Related Reactions (SKIPPirr). . Accessed September 2024. 16 ClinicalTrials.gov. A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer (swalloWTail). . Accessed September 2024. 17 ClinicalTrials.gov. A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/ Metastatic Head and Neck Cancer (OrigAMI-4). . Accessed September 2024. 18 World Health Organization. Colorectal Cancer. 2022. Available at: . Accessed: July 2024 19 Virostko J, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer, 2019;125: 3828-3835. 20 Christopher H. Lieu et al., Integrating Biomarkers and Targeted Therapy Into Colorectal Cancer Management. Am Soc Clin Oncol Educ Book 39, 207-215(2019). DOI:10.1200/EDBK_240839 21 LAZCLUZE™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED