Venetoclax

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Updated data from the pivotal phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant1 89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment1 Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease Results demonstrate potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option Basel, 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today two-year follow-up data from the phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) and OS was not reached, compared to 13.5 months for MabThera®/Rituxan® (rituximab) plus GemOx (R-GemOx).1 These updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit of this off-the-shelf, fixed-duration Columvi combination for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT).1 Data will be presented in an oral session at the 61st American Society of Clinical Oncology (ASCO), 30 May – 3 June 2025. “We are encouraged that the two-year follow-up data for Columvi reinforces its potential to extend the lives of many patients where prognosis has historically been poor,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “These findings demonstrate the potential lasting benefits of early and effective treatment initiation with a bispecific antibody for people with relapsed or refractory disease.” "When cancer comes back or doesn’t respond to treatment, it’s devastating for patients with DLBCL given the aggressive nature of the disease,” said Haifaa Abdulhaq, MD, Professor, University of California San Francisco (UCSF), Director of Hematology, UCSF Fresno. “In my community practice, I’ve seen the potential of this Columvi combination to help patients start treatment quickly - providing lasting remissions and more time without ongoing therapy.” The benefit across key secondary endpoints, including progression-free survival (PFS) and complete remission (CR), was maintained for patients treated with the Columvi combination.1 There was a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% confidence interval: 0.29–0.58) and more than twice as many patients sustained a CR (58.5% vs. 25.3%).1 Among patients with a CR at the end of the treatment period, 89% were alive and 82% had maintained remission one year after treatment.1 Safety of the combination remained unchanged from the previous analysis and was consistent with the known safety profiles of the individual medicines.1,2 Patients received a higher median number of cycles of the Columvi combination (11 versus 4), due to disease progression in the R-GemOx arm.1,2 A higher rate of adverse events (AEs) was observed with the Columvi regimen. One of the most common AEs was cytokine release syndrome, which was generally low grade.1 Given the wide adoption of global treatment guidelines in real-world clinical practice, there are no biological or clinical differences in DLBCL management worldwide.3-6 While second-line therapies have advanced, DLBCL can progress rapidly and many people are not candidates for, cannot tolerate, or do not have access to latest therapies.7,8 There is an urgent need for treatments that are rapidly available upon a diagnosis of relapse, that can manage the disease and improve long-term outcomes. Based on the STARGLO data, this Columvi combination is approved in more than 30 countries for people with R/R DLBCL who are not candidates for ASCT, including countries throughout the EU. Columvi in combination with GemOx was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as an NCCN category 1 preferred recommendation for the treatment of people with second-line DLBCL who are not intended to proceed to transplant.†3 Columvi monotherapy has been approved for use in R/R DLBCL after two or more prior lines of therapy in more than 60 countries worldwide. Columvi is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. Together with the clinical development of off-the-shelf allogeneic CAR T-therapies, Roche aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. The STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin) and MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study [GO44145; NCT06047080]. DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.9 Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions.9,10 Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide.3-6 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.7,11 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. †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. References [1] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. Presented at: ASCO Annual Meeting; 2025 May 30 - Jun 3. Abstract #7015. [2] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024; 404 (10466): 1940-1954. [3] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.1.2025. [4] Tilly H, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26:v116-25. [5] Zhu J, et al. Union for China Lymphoma Investigators of Chinese Society of Clinical Oncology. Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines for malignant lymphoma 2021 (English version). Chin J Cancer Res. 2021;30;33(3):289-301. [6] Wight J, et al. Diffuse large B-cell lymphoma: a consensus practice statement from the Australasian Lymphoma Alliance. Intern Med J. 2022;52(9):1609-1623. [7] Fabbri N, et al. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312. [8] Westin J, et al. CAR T cells as a second-line therapy for large B-cell lymphoma: A paradigm shift? Blood. 2022;139(18):2737–2746. [9] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited May 2025]. Available from: https://www-uptodate-com.libproxy1.nus.edu.sg/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-thebasics. [10] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited May 2025]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/34-nonhodgkin-lymphoma-fact-sheet.pdf. [11] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. The content above comes from the network. if any infringement, please contact us to modify.