Encorafenib

ASCO press program to feature overall survival and progression-free survival data for BRAFTOVI ® (encorafenib) combination regimen in first-line BRAF V600E -mutant metastatic colorectal cancer and progression-free survival data from VERITAC-2 study of vepdegestrant in metastatic breast cancer NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) will showcase data across its portfolio of potential breakthrough cancer medicines at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 30 to June 3 in Chicago. Data from more than 60 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 9 oral presentations and 6 rapid oral presentations, will be presented across Pfizer’s key tumor areas, including breast, genitourinary, hematologic, and thoracic cancers, as well as colorectal cancer. “This has already been a significant year for Pfizer’s Oncology pipeline, with multiple Phase 3 data readouts and regulatory approvals, and the initiation of pivotal registrational programs across our major tumor areas of focus,” said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research & Development, Pfizer. “The depth and diversity of our data presentations at ASCO are building on that momentum to bring us closer to our goal of delivering eight breakthrough cancer medicines by 2030.” Pfizer will have two late-breaking oral presentations featured in ASCO’s embargoed pre-meeting press briefing on May 27. These include the primary analysis of the pivotal overall survival (OS) and progression-free survival (PFS) results from the Phase 3 BREAKWATER study investigating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer,* as well as the first presentation of the PFS results from the Phase 3 VERITAC-2 study of vepdegestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (a/mBC) in partnership with Arvinas.** Pfizer will share additional updates from key late-stage programs, including five-year survival data from the Phase 3 ARCHES study of XTANDI® (enzalutamide) in combination with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer (mHPSC),*** and the first combination data for ELREXFIO® (elranatamab) + daratumumab + lenalidomide from the ongoing MagnetisMM-6 study in patients with transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM). Pfizer will also share new findings highlighting the company’s strategy to explore novel vedotin antibody-drug conjugates (ADCs) in combination with immune checkpoint inhibitors to potentially enhance anti-tumor activity. For the first time, Pfizer will present encouraging Phase 1 data on two novel investigational ADCs in combination with pembrolizumab in thoracic cancers: sigvotatug vedotin (SV), an integrin beta-6 (IB6)-directed ADC, in lung cancer and head and neck cancers, and PDL1V (PF-08046054), a PD-L1 directed ADC, in head and neck cancers. Additionally, new exploratory analyses will be presented from the pivotal EV-302 trial with PADCEV® (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).**** Several presentations will highlight updated results from ongoing Phase 1 studies that inform the dosing strategy in registrational programs for two molecules targeting epigenetic regulators: mevrometostat, an investigational EZH2 inhibitor being evaluated in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC); and PF-07248144, a potential first-in-class KAT6 inhibitor for ER+/HER2- metastatic breast cancer (mBC). “Our data at ASCO this year reflect how we are strategically progressing our deep pipeline of next generation cancer medicines while simultaneously extending the impact of our foundational therapies to reach more people living with cancer,” said Megan O’Meara, Head of Early-Stage Development and Interim Head of Late-Stage Development, Pfizer Oncology. “Important early-stage updates highlight our extensive pipeline and depth within our core cancer types, as we advance up to nine new pivotal Phase 3 trials this year.” Key ASCO Presentations Colorectal Cancers BRAFTOVI : A late-breaking session will detail PFS and OS results from the Phase 3 BREAKWATER study of BRAFTOVI in combination with cetuximab and mFOLFOX6 chemotherapy in BRAF V600E -mutant metastatic colorectal cancer, further establishing the benefit of the BRAFTOVI combination regimen following its FDA accelerated approval in late 2024. These pivotal study results follow the topline results announcement for PFS and OS and the objective response rate (ORR) results presented at ASCO GI . These new data will also be featured in the ASCO press program. Breast Cancer Vepdegestrant : In a late-breaking session, PFS data will be presented for the first time from the Phase 3 VERITAC-2 study of vepdegestrant, a PROTAC ER degrader, in ER+/HER2− a/mBC. These detailed data follow the topline results from VERITAC-2 announced earlier this year and will also be featured in the ASCO press program. PF-07248144 (KAT6 inhibitor) : A rapid oral presentation will highlight dose optimization data from an ongoing Phase 1 study for PF-07248144, a potential first-in-class KAT6 inhibitor, in patients with ER+/HER2− mBC. These results support the recommended dosing for PF-07248144 ahead of the Phase 3 trial initiation in second-line mBC planned for 2H 2025. IBRANCE ® (palbociclib) : Roche will present detailed results from the OS analysis of the Phase 3 INAVO120 study investigating ITOVEBI™ (inavolisib) in combination with IBRANCE and fulvestrant in patients with PIK3CA -mutated, HR+/HER2-, endocrine-resistant, locally a/mBC. This presentation will be featured in ASCO’s embargoed pre-meeting press briefing on May 21. Genitourinary Cancers XTANDI : Five-year follow-up overall survival data from the ARCHES study of XTANDI in combination with androgen deprivation therapy in patients with mHSPC will be featured in an oral presentation. In addition, updates from the Astellas-supported, investigator-sponsored ENZAMET Phase 3 research study, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by the University of Sydney, will also be presented, including 8 year-outcomes in men with mHSPC. These presentations further underscore the value of XTANDI across approved indications. Mevrometostat : A poster presentation will highlight pharmacokinetic and safety data from the ongoing Phase 1 study for mevrometostat, an investigational EZH2 inhibitor, in combination with XTANDI. These updated data further inform the dosing strategy for mevrometostat in a robust registrational program that includes two Phase 3 trials in mCRPC, and a third trial in metastatic castration-sensitive prostate cancer (mCSPC) that is planned to start in 1H 2025. PADCEV : Additional updates from the Phase 3 EV-302 study of PADCEV in combination with KEYTRUDA in previously untreated la/mUC will be presented, including an oral presentation with exploratory analysis of responders. Hematologic Cancers ELREXFIO : Initial safety and efficacy results from Part 1 of the ongoing MagnetisMM-6 study of ELREXFIO in combination with daratumumab and lenalidomide in patients with newly diagnosed MM that are not eligible for transplant will be presented as an oral presentation. Part 1 of the ongoing MagnetisMM-6 study evaluates the optimal dose of the ELREXFIO combination regimen in patients with RRMM or NDMM to determine the recommended phase 3 dose for part 2. Thoracic Cancers Sigvotatug vedotin (SV): Phase 1 results for SV, an IB6-directed vedotin ADC, in combination with pembrolizumab in non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) will be featured in a rapid oral presentation. This initial combination data for SV with pembrolizumab support a Phase 3 study in first line PD-L1-High NSCLC, initiated this year. The data also support the overall SV trial program that includes an ongoing Phase 3 monotherapy trial in second line+ NSCLC. PDL1V (PF-08046054) : Two poster presentations will highlight interim Phase 1 results for PDL1V, a PD-L1 directed vedotin ADC, as monotherapy in NSCLC and initial safety and efficacy data in combination with pembrolizumab in patients with first-line recurrent or metastatic (r/m) HNSCC. These data provide additional support for the initiation of the two pivotal Phase 3 trials planned for PDL1V in 2025 in second line+ NSCLC and first line r/mHNSCC. Additional information on key Pfizer-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting May 22, 2025. COLORECTAL CANCERS Oral Presentation (Abstract LBA3500) Friday, May 30, 2:45-5:45 PM CDT First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): progression-free survival and updated overall survival analyses Elez et al BREAST CANCER Rapid Oral Presentation (Abstract 1020) Friday, May 30, 2:45-4:15 PM CDT Dose optimization of PF-07248144, a first-in-class KAT6 inhibitor, in patients (pts) with ER+/HER2− metastatic breast cancer (mBC): Results from phase 1 study to support the recommended phase 3 dose (RP3D) LoRusso et al Oral Presentation (Abstract LBA1000) Saturday, May 31, 1:15-4:15 PM CDT Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study Hamilton et al GENITOURINARY CANCERS Oral Presentation (Abstract 4502) Sunday, June 1, 9:45 AM-12:45 PM CDT Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) Gupta et al Oral Presentation (Abstract 5005) Tuesday, June 3, 9:45 AM-12:45 PM CDT ARCHES 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) Armstrong et al Poster Presentation (Abstract 4571) Monday, June 2, 9:00 AM-12:00 PM CDT EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) Bedke et al Poster Presentation (Abstract 5046) Monday, June 2, 9:00 AM-12:00 PM CDT Safety and pharmacokinetics of mevrometostat (M) in combination with enzalutamide (E) in patients with metastatic castration-resistant prostate cancer (mCRPC) Matsubara et al HEMATOLOGIC CANCERS Oral Presentation (Abstract 7504) Tuesday, June 3, 9:45 AM-12:45 PM CDT Elranatamab in combination with daratumumab and lenalidomide (EDR) in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant: Initial results from MagnetisMM-6 part 1 Quach et al THORACIC CANCERS Rapid Oral Presentation (Abstract 3010) Monday, June 2, 8:00-9:30 AM CDT Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001) Sehgal et al Poster Presentation (Abstract 6033) Monday, June 2, 9:00 AM-12:00 PM CDT Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC Gillison et al Poster Presentation (Abstract 8611) Saturday, May 31, 1:30-4:30 PM CDT Interim results of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in patients with NSCLC in a phase 1 trial Fontana et al *The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company. **Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant. ***XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. ****Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI®. Please see full Prescribing Information, including BOXED WARNING, for ELREXFIO™ (elranatamab-bcmm). Please see full Prescribing Information for IBRANCE® (palbociclib) tablets and IBRANCE® (palbociclib) capsules. Please see full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin). Please see full Prescribing Information for XTANDI® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. 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昨天分享了一些肺癌靶向用药中，三代EGFR-TKI药物的相关数据（这个赛道，能容下这么多新药吗？），今天补充一下其他靶向用药的国内市场销售数据。1、EGFR突变最常见突变，占比最大，用药最多。一代、二代TKI基本被淘汰。全球市场基本被淘汰。国内市场吉非替尼、厄洛替尼国采后，价格大幅下降，市场销售大幅下降，基本被淘汰。国产新药埃克替尼凭借独家优势，以及贝达的推广能力，仍有较大市场规模。但面临更多的国产三代TKI冲击。三代TKI是核心一线方案。三代药物可以克服T790M耐药，能更好的穿透血脑屏障，对合并脑转移患者更有优势。国内已上市1个进口，6个国产三代TKI。奥希替尼最早上市，获批适应症最多，证据最充分。国产三代新药结构、适应症、疗效指标相似，竞争激烈。三代TKI国内医院市场年销售额约100亿元，原研进口的奥希替尼销售额稳定。早先获批的阿美替尼、伏美替尼销售大幅增长，份额不断增加。来源：摩熵医药未来的新一线方案。最有潜力的是强生的埃万妥单抗联合兰泽替尼。在全球多中心III期MARIPOSA临床中，一线方案头对头击败奥希替。埃万妥单抗显著延长患者的 PFS（23.7vs16.6 个月，HR=0.70）。2024年8月该疗法已获FDA批准，未来可能改写一线治疗方案。埃万妥单抗皮下注射剂型，显示出更好的疗效和安全性。PALOMA-3试验数据显示，皮下注射剂型组在mDOR（11.2vs8.3），mPFS（6.1vs4.3），mOS（HR=0.62）等终点中均占据优势，相关不良反应发生率更低（13%vs66%）。浙江通源的三代氘代 EGFR-TKI TY-9591是也开展头对头奥希替尼的大型临床研究。治疗三代EGFR-TKI耐药，是新药的发力方向。重点药物类型包括：抗体耦联药物（ADC)、 PD-1/PD-L1、MET靶向药。ADC药物：科伦博泰的药物SKB264（TROP2 ADC），百利天恒的BL-B01D1（HER3 ADC）。第一三共/阿斯利康德达博妥单抗（Dato-DXd）用于EGFR突变NSCLC患者（EGFR-TKI和铂类化疗后进展），2025年1月获FDA优先审评资格。PD-1/PD-L1：康方的PD-1/VEGF 双抗依沃西单抗，2024年5月在国内获批联合化疗治疗经 EGFR TKI（包括一二代）治疗后进展的 nsq-NSCLC患者。信迪利单抗(PD-1)联合贝伐珠单抗+含铂化疗，用于三代TKI治疗后患者适应症获批。MET靶向药：埃万妥单抗联合化疗或靶向药物，已在美国、欧盟获批用于奥希替尼耐药患者，并已在中国提交进口上市申请。2、ALK重排NSCLC中占比3-7%，钻石突变，靶向治疗效果好，治疗后长期生存率高。ALK抑制剂历经三次迭代。一代：克唑替尼。最早上市，从2020年开始，销售额就大幅下降。复星万邦首仿已经获批。二代：阿来替尼、布格替尼、恩沙替尼、依奉阿克、伊鲁阿克。阿来替尼上市多年，国内销售表现强劲，年销18亿元。齐鲁的伊鲁阿克，在一线和二线方案的临床数据表现，最为出色。但二代产品的同质化竞争依然严重。正大天晴的依奉阿克也是强劲对手。三代：洛拉替尼。由辉瑞研发，全球首个获批的第三代ALK。与前两代相比，洛拉替尼具备更强的血脑屏障穿透能力，对颅内肿瘤也有较好的控制效果，在基线伴随脑转移的患者中更具优势。洛拉替尼对一代、二代 ALK 抑制剂耐药的患者仍然有效， 目前临床上常使用二代TK 耐药后再序贯三代TKI的“2+3 模式”。国内上市时间不长，但增长很快，去年半年销售额超过2亿。3、METc-MET 抑制剂有望用于多种肿瘤的治疗。国内已获批5个药品：和黄的赛沃替尼、中美冠科的伯瑞替尼、上海海和的谷美替尼、诺华的卡马替尼、默克的特泊替尼。首发适应症均为外显子14跳变的NSCLC，各产品的临床数据结果差距相当。和黄的赛沃替尼具有先发优势，年销超2亿，又拓展了EGFR TKI耐药适应症，潜力较大。4、KRAS最常见的突变基因之一，一直是肿瘤新药热门方向，其中，G12C是常见类型，但已获批的药物较少。全球仅有3款，BMS的阿达格拉西、安进的索托拉西布还未获批进口。信达/劲方的氟泽雷塞2024年8月抢到国内首个获批，正大天晴的格索雷塞第二家上市，加思科的格来雷塞上市申请还在审批中。还没有销售数据。但此类药物单药效果并不明显，BMS和安进的产品卖的都不好。各企业的临床开发路线，选择抱大腿：和PD1等其他药物联用。5、ROS1占比较少，药物不多，主要都是进口产品。再鼎与BMS联合开发的瑞普替尼，信达的他雷替尼，临床结果数据略有优势。暂无销售数据。6、HER2重点是HER2 ADC，第一三共的德曲妥珠单抗在2022年获FDA批准，拓展经治HER2突变的转移性NSCLC适应症， 肺癌领域首个获批HER2靶向治疗方案，完成概念验证。这个适应症在国内刚刚获批。国产恒瑞的SHR-A1811进展最快，2024年9月已提交上市申请。其他有多个企业参与，但进度较慢。7、BRAF药物很少，全球已上市两款，分别是诺华的达拉非尼，2019年就获批进口，国内医院市场销售额约3亿元。辉瑞的恩考芬尼还未进口。这两个产品都需要和其他药物联用。国内企业布局较少。8、RET全球仅两个产品，分布是基石药业引进的普拉替尼，信达引进的塞普替尼，国内卖的不多。9、NTRK突变发生率很低，只有0.23%。NTRK 抑制剂多为多靶点抑制剂，共四个产品获批上市：拉罗替尼、恩曲替尼、瑞普替尼、他雷替尼。除罗氏的恩曲替尼外，其他产品上市时间不长，还没有销售数据。用摩熵药筛小程序，快速查询产品申报进展！