Alectinib Hydrochloride

Group sales grew by 6%1 at constant exchange rates (CER; 7% in CHF), driven by high demand for newer medicines and diagnostic solutions.Pharmaceuticals Division sales rose by 8% (9% in CHF) on continued strong demand for a broad range of our medicines; top growth drivers were Phesgo (breast cancer), Vabysmo (severe eye diseases), Xolair (allergies) and Hemlibra (haemophilia A).Diagnostics Division sales remained stable with high demand across products and regions offsetting the impact of the recent healthcare pricing reforms in China.Highlights: US approval for Evrysdi tablet for spinal muscular atrophy and Susvimo for the leading cause of diabetes-related blindnessEU approval for Columvi combination with chemotherapy for people with relapsed or refractory diffuse large B-cell lymphomaUS acceptance of supplemental Biologics License Application for Gazyva/Gazyvaro for lupus nephritisTrontinemab for Alzheimer’s disease and NXT007 for haemophilia A to move into phase IIIExclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise amylin analogue as a stand-alone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388 for weight lossUnveiling of novel sequencing by expansion (SBX) technology, a new class of next-generation sequencingAnnouncement of plans to invest USD 50 billion in pharmaceuticals and diagnostics in the US in R&D and manufacturing over the next five yearsAnnouncement of plans to establish Roche Genentech Innovation Center Boston Outlook for 2025 confirmed Roche CEO Thomas Schinecker: “We had a good start to the year with Group sales increasing by 6% at constant exchange rates and we achieved a number of important milestones. Based on recent data, two potential new therapies – our investigational Brainshuttle bispecific antibody to treat Alzheimer’s and our investigational next-generation haemophilia A medicine – will move into phase III. Together with Zealand Pharma, we are developing amylin as a potential new stand-alone therapy for weight loss and as a fixed-dose combination with our incretin CT-388. In Diagnostics, we unveiled our breakthrough ‘sequencing by expansion’ technology, offering unparalleled speed, throughput and flexibility combined with high accuracy. We are expanding our already strong US footprint – with currently over 25,000 employees, 15 R&D and 13 manufacturing sites – by investing USD 50 billion, an important step to continue to meet patient needs in the US with highly innovative medicines and diagnostics. We are confident we will continue our positive momentum and confirm our full-year outlook.” Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Group 15,440 14,399 100.0 100.0 6 7 Pharmaceuticals Division 11,949 10,921 77.4 75.8 8 9 United States 6,224 5,692 40.3 39.5 6 9 Europe 2,320 2,200 15.0 15.3 5 5 Japan 671 649 4.3 4.5 3 3 International* 2,734 2,380 17.8 16.5 18 15 Diagnostics Division 3,491 3,478 22.6 24.2 0 0 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Outlook for 2025 confirmedRoche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Group salesIn the first three months of 2025, Roche achieved sales growth of 6% (7% in CHF) to CHF 15.4 billion. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the impact from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19), totalling CHF 0.2 billion, and the impact of the recent healthcare pricing reforms in China. Sales in the Pharmaceuticals Division increased by 8% (9% in CHF) to CHF 11.9 billion, with newer medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Vabysmo, Xolair, Hemlibra and Xofluza (influenza) – achieved total sales of CHF 3.6 billion. This represents a plus of CHF 0.7 billion at CER compared to the first quarter of 2024. Phesgo achieved sales of CHF 0.6 billion due to growing demand across regions, notably China and the US, while Vabysmo continued to witness strong uptake, generating sales of CHF 1.0 billion on increased demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 0.2 billion (CER) due to the impact of loss of exclusivity. In the United States, sales rose by 6%. Xolair, Phesgo, Vabysmo, Polivy (blood cancer) and Ocrevus (multiple sclerosis) were the main growth drivers. This growth more than compensated for the reduced sales of medicines with expired patents and the decline in sales of Tecentriq (cancer immunotherapy). Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra more than compensated for the decline in sales of medicines with expired patents and lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo. In Japan, sales increased by 3% due to growth in sales of Phesgo, Vabysmo, PiaSky (rare blood disorder), Tamiflu (influenza) and Alecensa (lung cancer). This growth more than compensated for the impact of price cuts as well as biosimilar erosion. Sales in the International region grew by 18%, led by China. In China, sales rose by 14%, driven by demand for Xofluza and Phesgo. The Diagnostics Division sales remained stable at CHF 3.5 billion as growth in demand, notably for immunodiagnostic products and pathology solutions, offset the impact of the recent healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 4% due to higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, sales rose by 7%, driven by growth across all customer areas. Sales in Asia-Pacific decreased by 15% due to the impact of the healthcare pricing reforms in China. Pharmaceuticals: key developments Compound Milestone Regulatory ColumviBlood cancer European Commission approves Columvi as the first bispecific antibody for diffuse large B-cell lymphoma (DLBCL) after initial therapy The approval is based on the phase III STARGLO study, where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy.DLBCL is an aggressive cancer with a high risk of progression, meaning urgent and effective treatments are needed for people who relapse or have refractory disease.This Columvi regimen offers a much needed off-the-shelf and fixed-duration treatment option for those ineligible for transplant. More information: Media Release, 14 April 2025 Gazyva/GazyvaroLupus nephritis FDA accepts supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of lupus nephritis Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit.The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis.Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years. More information: Media Release, 5 March 2025 ColumviBlood cancer CHMP recommends EU approval of Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Columvi plus chemotherapy showed a 41% reduction in the risk of death in the pivotal phase III STARGLO study.DLBCL – an aggressive disease with a high risk of progression – remains an area of high unmet need, especially for treatments that can be initiated soon after the cancer returns.If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse. More information: Media Release, 28 February 2025 EvrysdiSpinal muscular atrophy FDA approves Evrysdi tablet as first and only tablet for spinal muscular atrophy (SMA) Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries.Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution.New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration. More information: Media Release, 12 February 2025 SusvimoSevere eye diseases FDA approves Susvimo as the first and only continuous-delivery treatment for the leading cause of diabetes-related blindness Susvimo is the first and only continuous-delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME).With as few as two treatments per year, Susvimo may help people with DME maintain their vision.Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD). More information: Media Release, 4 February 2025 Phase III, pivotal and other key read-outs TrontinemabAlzheimer’s disease Roche presents novel therapeutic and diagnostic advancements in Alzheimer’s at AD/PD 2025 New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in phase Ib/IIa Brainshuttle AD study.Data on the Elecsys pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease.Roche will initiate a phase III programme for trontinemab later this year based on totality of data. More information: Media Release, 3 April 2025 OcrevusMultiple sclerosis Roche provides update on phase III Ocrevus high dose study in people with relapsing multiple sclerosis MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis.The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression.High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals observed. More information: Media Release, 2 April 2025 XolairAllergies Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies First-ever head-to-head trial comparing Xolair and oral immunotherapyResults were featured as late-breakers at the 2025 AAAAI Annual Meeting.Xolair is the only US FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies. More information: Media Release, 2 March 2025 Other US investment announcement Roche announces plans to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years USD 50 billion commitment includes new state-of-the-art research and development (R&D) sites, new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California and an additional site location to be announced soon.Investments will create more than 12,000 new jobs: 1,000 at Roche and more than 11,000 in support of new US manufacturing capabilities. Roche already has a significant existing US presence with more than 25,000 employees, 15 R&D centres and 13 manufacturing sites. More information: Media Release, 22 April 2025 Zealand Pharmaagreement Roche enters into an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed-dose combination with Roche’s lead incretin asset CT-388.Collaboration will complement Roche’s portfolio in the field of cardiovascular, renal and metabolic (CVRM) diseases.Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion people globally by 2035. More information: Media Release, 12 March 2025 Roche Genentech Innovation Center Roche announces launch of Roche Genentech Innovation Center Boston based at Harvard’s Enterprise Research Campus in Allston The new centre will be a hub for both Roche and Genentech, bringing together expertise in cardiovascular, renal and metabolic diseases, as well as for data science and AI specialists to drive innovation in drug discovery and development.Roche will be the first to join Harvard’s Enterprise Research Campus in Allston, taking a suite in the first phase of the project’s cutting-edge lab space.Starting with a lease of 30,000 square feet (approx. 2,800 square metres), Roche intends to invest over the coming years into a research and development presence with eventually up to 500 employees. More information: Media Release, 7 March 2025 Gazyva/GazyvaroLupus nephritis New England Journal of Medicine publishes new data for Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone.Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need.Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit, which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease. More information: Media Release, 7 February 2025 Enlarged Corporate Executive Committee change Change to the Roche Enlarged Corporate Executive Committee Wafaa Mamilli joins Roche as Chief Digital Technology Officer (CDTO), reporting to Group CEO Thomas Schinecker.She became a member of the Enlarged Corporate Executive Committee starting 10 February 2025. She is based at Genentech in South San Francisco. More information: Media Release, 29 January 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 11,949 10,921 100.0 100.0 8 9 United States 6,224 5,692 52.1 52.1 6 9 Europe 2,320 2,200 19.4 20.1 5 5 Japan 671 649 5.6 5.9 3 3 International 2,734 2,380 22.9 21.9 18 15 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 1,778 6 1,247 3 344 11 - - 187 16 HemlibraHaemophilia A 1,165 11 610 0 247 7 82 3 226 72 VabysmoEye diseases (nAMD, DME, RVO) 1,018 18 718 7 197 42 32 35 71 101 TecentriqCancer immunotherapy 870 0 411 -8 220 5 81 -5 158 21 Perjeta2Breast cancer 840 -10 342 -3 144 -16 18 -51 336 -9 Xolair2Asthma 645 26 645 26 - - - - - - Actemra/RoActemra2RA, COVID-19 619 -1 294 3 152 -19 71 5 102 26 PhesgoBreast cancer 593 52 179 38 199 18 40 115 175 142 Kadcyla2Breast cancer 506 5 201 5 135 -7 21 -3 149 21 EvrysdiSpinal muscular atrophy 420 18 160 15 145 6 20 0 95 56 AlecensaLung cancer 397 11 130 21 68 -6 49 12 150 12 PolivyBlood cancer 358 42 156 30 94 74 44 2 64 80 MabThera/Rituxan2Blood cancer, RA 298 -16 181 -14 35 -10 3 -17 79 -23 Activase/TNKase2Cardiac diseases 297 -2 285 -2 - - - - 12 -9 Herceptin2Breast and gastric cancer 292 -20 60 -12 77 0 2 -56 153 -29 Avastin2Various cancer types 274 -15 80 -21 14 -33 36 -30 144 -3 Gazyva/Gazyvaro2Blood cancer 249 15 131 27 60 -3 8 46 50 11 XofluzaInfluenza 159 234 14 239 - * - - 145 234 Pulmozyme2Cystic fibrosis 123 10 84 22 18 -9 - -26 21 -10 Tamiflu2Influenza 100 56 9 * 26 114 13 81 52 17 * Over 500%DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone SBX technology Roche unveils a new class of next-generation sequencing with its novel sequencing by expansion technology Roche’s innovative sequencing by expansion (SBX) technology represents a leap forward in next-generation sequencing (NGS), which is playing a vital role in decoding complex diseases like cancer, immune disorders and neurodegenerative conditions.Combined with an innovative, high-throughput sensor module, SBX uses expanded synthetic molecules to determine the DNA sequence of a target molecule, creating an ultra-rapid, scalable and flexible technology.Reducing the time from sample to genome from days to hours, this novel approach could significantly speed up genomic research, as well as translational and clinical applications in the years to come. More information: Media Release, 20 February 2025 PATHWAY HER2 (4B5) test Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU As seen in the DESTINY-Breast06 trial, approximately 20–25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow. These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment. More information: Media Release, 31 January 2025 Diagnostics sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Diagnostics Division 3,491 3,478 100.0 100.0 0 0 Customer areas3 Core Lab 1,904 1,926 54.5 55.4 -1 -1 Molecular Lab 634 611 18.2 17.6 2 4 Near Patient Care 536 569 15.4 16.3 -5 -6 Pathology Lab 417 372 11.9 10.7 11 12 Regions Europe, Middle East, Africa 1,236 1,188 35.4 34.2 4 4 North America 1,154 1,055 33.1 30.3 7 9 Asia-Pacific 853 992 24.4 28.5 -15 -14 Latin America 248 243 7.1 7.0 11 2 More information on Roche performance in the first quarter of 2025: Q1 2025 presentationAppendix with tables About Roche 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 Pharmaceuticals 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. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly. Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachments 25042025_Roche_Q1_2025_EN Communications appendix tables_Q1 2025 Sales

CAMBRIDGE, Mass., April 23, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced two "Trial in Progress" poster presentations for its novel ALK-selective inhibitor, neladalkib, and novel HER2-selective inhibitor, NVL-330, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 – June 5, 2025, in Chicago. Posters will be archived on the Nuvalent website at . The first "Trial in Progress" poster will include background and study design for ALKAZAR (NCT06765109), a global, randomized, controlled Phase 3 trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive non-small cell lung cancer (NSCLC). Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA® (alectinib) monotherapy. The company plans to initiate the ALKAZAR trial in the first half of 2025. The second poster will include background and study design for the ongoing HEROEX-1 Phase 1a/1b clinical trial (NCT06521554) evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. Details of the poster presentations are as follows: Title: Neladalkib (NVL-655), a highly selective anaplastic lymphoma kinase (ALK) inhibitor, compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer: The Phase 3 ALKAZAR study Authors: Sanjay Popat*1, Benjamin J. Solomon2, Thomas E. Stinchcombe3, Geoffrey Liu4, Gilberto Lopes5, Melissa Johnson6, Misako Nagasaka7, Ece Cali Daylan8, Christina Baik9, James D'Olimpio10, Tzu-Chuan Huang11, Alexander Spira12, Daniel Haggstrom13, Benjamin Creelan14, Tina Kehrig15, Junwu Shen15, Rachel DeLaRosa15, Viola W. Zhu15, Alexander Drilon16, Alice T. Shaw17 Abstract Number: TPS8666 Session Title: Lung Cancer—Non-Small Cell Metastatic Session Date and Time: May 31, 2025, from 1:30 p.m.– 4:30 p.m. CDT Poster Board Number: 136b *Presenter, corresponding author; 1Royal Marsden Hospital NHS Foundation Trust and The Institute of Cancer Research, London, UK; 2Peter MacCallum Cancer Centre, Melbourne, Australia; 3Duke Cancer Center, Durham, NC, USA; 4Princess Margaret Hospital, Toronto, ON, Canada; 5Sylvester Comprehensive Cancer Center, Miami, FL, USA; 6Sarah Cannon Research Institute Oncology Partners, Nashville, TN, USA; 7University of California Irvine School of Medicine, Orange, CA, USA; 8Washington University School of Medicine, St. Louis, MO, USA; 9Fred Hutchinson Cancer Center, Seattle, WA, USA; 10Clinical Research Alliance Inc., Westbury, NY, USA; 11University Cancer and Blood Center, LLC, Athens, GA, USA; 12Virginia Cancer Specialists (Fairfax) - USOR, Fairfax, VA, USA; 13Carolinas Medical Center, Charlotte, NC, USA; 14H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA; 15Nuvalent, Inc., Cambridge, MA, USA; 16Memorial Sloan Kettering Cancer Center, New York, NY, USA; 17Dana-Farber Cancer Institute, Boston, MA, USA Title: NVL-330, a selective HER2 tyrosine kinase inhibitor, in patients with advanced or metastatic HER2-altered non-small cell lung cancer: The Phase 1 HEROEX-1 study Authors: Xiuning Le*1, Zofia Piotrowska2, Alexander Spira3, Christina Baik4, Maria Q. Baggstrom5, Gerald Falchook6, Joel Neal7, Shirish Gadgeel8, Gilberto Lopes9, Melissa Johnson10, Jonathan W. Riess11, Danny Nguyen12, Lisa Morelli13, Danieska Sandino13, Steven Margossian13, Vivek Upadhyay13, Fernando C. Santini14 Abstract Number: TPS8665 Session Title: Lung Cancer—Non-Small Cell Metastatic Session Date and Time: May 31, 2025, from 1:30 p.m.– 4:30 p.m. CDT Poster Board Number: 136a *Presenter, corresponding author; 1University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2Massachusetts General Hospital, Boston, MA, USA; 3NEXT Oncology, Fairfax, VA, USA; 4Fred Hutchinson Cancer Center, Seattle, WA, USA; 5Washington University School of Medicine, St. Louis, MO, USA; 6Sarah Cannon Research Institute at HealthONE, Denver, CO, USA; 7Stanford Cancer Institute, Stanford, CA, USA; 8Henry Ford Cancer Institute, Detroit, MI, USA; 9Sylvester Comprehensive Cancer Center, Miami, FL, USA; 10Sarah Cannon Research Institute Oncology Partners, Nashville, TN, USA; 11University of California Davis, Davis Comprehensive Cancer Center, Sacramento CA, USA; 12City of Hope-Lennar, Irvine, CA, USA; 13Nuvalent, Inc., Cambridge, MA, USA; 14Memorial Sloan Kettering Cancer Center, New York, NY, USA About Neladalkib Neladalkib is a novel brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC. About NVL-330 NVL-330 is a novel brain-penetrant HER2-selective tyrosine kinase inhibitor designed to address the combined medical need of treating HER2-mutant tumors, including those with HER2 exon 20 insertion mutations, avoiding treatment related adverse events due to off-target inhibition of wild-type EGFR, and treating brain metastases. About Nuvalent Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of presentations; the potential benefits and effects of Nuvalent's product development candidates; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib and NVL-330; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our product candidates; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED