Enfortumab Vedotin-ejfv

24 年已接近尾声。Insight 「医药交易」数据库显示，在今年（截至 12 月 9 日）已经发生的 101 起国产药品/技术 License Out 中， ADC 和化药的交易数量有 20 个，并列榜二，成为外资扫货的 TOP 级别热门药物。 数据来源：Insight 数据库 在 BD 交易中，药物是否具有突破性疗效是买方评估项目的一个主要维度。获得监管机构突破性疗法称号的药物往往具有治疗优势和潜力，是交易时可以参考的指标之一。 此前，我们已介绍了三款具有出海潜力的突破性国产 ADC 药物（点击链接查看）。今天我们将介绍来自恒瑞的 3 款在研 ADC，它们都在今年获得了 NMPA 的（拟）突破性疗法称号，且至今尚未对外授权。 HER2 ADC：瑞康曲妥珠单抗 瑞康曲妥珠单抗（SHR-A1811）今年有两项适应症申请被纳入突破性治疗，加上此前的，该药共计已有 6 项申请获得 NMPA 突破性治疗认定。 在研发进度上，瑞康曲妥珠单抗处于领先地位。今年 9 月，该药申报了首个 NDA（HER2 突变 NSCLC 二线治疗），并被 CDE 纳入优先审评。在 HER2 ADC 的 HER2 突变 NSCLC 赛道，无论是全球还是中国，此前仅有德曲妥珠单抗（第一三共/AZ）获批，恒瑞是全球第 2 个报产的。 在纳入突破性疗法的其它适应症方面，除了 HER2 阳性的复发或转移性乳腺癌竞争较为激烈外，其它赛道，瑞康曲妥珠单抗在同类产品中大都处于相对靠前的梯队，例如： 在HER2 阳性结直肠癌领域，全球尚无 HER2  ADC 获批，恒瑞在同类产品中的进度第一，正在国内开展 Ⅲ 期临床。 在HER2 阳性晚期胃癌或胃食管结合部腺癌领域，目前有两款产品获批（德曲妥珠单抗、维迪西妥单抗），恒瑞进度第三，正在开展 Ⅲ 期临床。 在HER2 低表达复发或转移性乳腺癌领域，国内目前仅有德曲妥珠单抗获批，恒瑞正在开展 Ⅲ 期临床； 在HER2 阳性不可切除或转移性胆道癌领域，全球尚无 HER2  ADC 获批。同类产品中，德曲妥珠单抗进度最快，正在开展 Ⅲ 期临床，恒瑞正在国内开展 Ⅱ 期临床。 国内 HER2  ADC 项目研究进度概览图数据来源：Insight 数据库 SHR-A1921：TROP2 ADC 今年 5 月， SHR-A1921 首次被 CDE 纳入突破性治疗，治疗铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌。此前，该药还获得 FDA 授予快速通道资格，用于治疗铂耐药复发上皮性卵巢癌。 虽然国内此前已有两款 TROP2 ADC 获批上市，但它们的适应症都是三阴性乳腺癌。在卵巢癌领域，全球尚无 TROP2 ADC 获批。恒瑞的 SHR-A1921 是首个在卵巢上皮癌适应症上进入 Ⅲ 期临床的 TROP2  ADC。 国内  TROP2   ADC 项目研究进度概览图数据来源：Insight 数据库 今年 ESMO 大会上，恒瑞以口头报告形式首次公布了 SHR-A1921 治疗铂耐药卵巢癌的首次人体试验 I 期研究结果。数据显示， SHR-A1921 在这类患者中显示出了非常好的潜力：ORR 为 42.3%，DCR 为 100%，mDoR 为 9.9 个月，mPFS 为 7.9 个月，中位 OS 未达到，6 个月 OS 率为 91.9%。 虽然国内尚无 TROP2 ADC 获批治疗卵巢癌，但卵巢癌患者已在今年 11 月迎来了首款获批的 ADC 药物——华东医药引进的「索米妥昔单抗」。它是首款 FRα ADC，获批用于治疗既往接受过 1-3 种系统治疗的 FRα阳性的铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。索米妥昔单抗治疗这类患者的 ORR 为 31.4%，3 个月 PFS 率为 73.5%。  SHR-A2102：Nectin-4 ADC 12 月 4 日， SHR-A2102 被 CDE 纳入拟突破性治疗，适应症为单药治疗既往含铂化疗和 PD-(L)1 抑制剂治疗失败的局部晚期或转移性尿路上皮癌。此前，该药已获得 FDA 授予的快速通道资格，用于治疗晚期尿路上皮癌。 Insight 数据库显示，在 Nectin-4 ADC 赛道，全球目前只有维恩妥尤单抗（辉瑞/安斯泰来）一款产品获批。在研产品中，迈威生物的 9MW2821 进度最快，正在开展尿路上皮癌和宫颈癌 III 期临床。恒瑞的 SHR-A2102 进度其次，正在开展 HR+/HER2-乳腺癌、三阴性乳腺癌的 Ⅱ 期临床，以及治疗尿路上皮癌的 I/II 期临床。 国内  Nectin-4   ADC 项目研究进度概览图 数据来源：Insight 数据库 结 语 ADC 类药物是恒瑞新药管线布局的重点方向之一。Insight 数据库显示（截至 12 月 5 日），恒瑞的 ADC 矩阵拥有 19 款产品（仅统计活跃状态），其中 NDA 阶段的有 1 款，Ⅲ 期临床阶段的有 3 款 ，Ⅰ 期和 Ⅱ 期阶段的有 6 款。此外，还有多款 ADC 项目处于临床前研究阶段。 从靶点布局来看，除了 HER2、TROP2、CLDN18.2 、c-MET 等常见靶点之外，恒瑞也有布局一些市场相对空白的靶点，例如 ：PSMA ADC，国内尚无产品获批临床，全球也仅有 2 款在早期临床阶段；LIV-1 ADC，国内仅有 1 款进入临床，全球也只有 2 款在开展早期临床；DLL3 ADC，全球仅有 4 款在 Ⅰ 期临床，且都来自国内企业。这些产品的竞争格局目前都非常良好。 恒瑞 ADC 靶点分布数据来源：Insight 数据库 23 年1 月，恒瑞医药成立了 BD 团队，并任命前基石药业 CEO 江宁军博士担任首席战略官，负责创新药的临床研究和商务拓展工作。最近一年多来，恒瑞的 BD 交易动作确实有所加快，不过 License Out 出去的产品中，ADC 并不多。 Insight 「医药交易」数据库显示，2015 年以来，恒瑞一共达成了 14 项  License Out 合作，药物类型最多的是化药和单抗。在 ADC 领域，恒瑞仅有 1 款产品实现对外授权，即 Claudin 18.2 ADC SHR-A1904 。SHR-A1904 目前正在国内开展胃癌 Ⅲ 期临床，其海外权益在去年 10 月授权给了德国默克，这也是恒瑞首次与大型跨国药企达成合作。  恒瑞 License Out 产品成分类别分布 数据来源：Insight 数据库 目前，恒瑞对 BD 的态度已更加开放。对于前述三款获得突破性疗法的 ADC ，恒瑞也是很有可能会考虑对外授权的。这三款产品在对应的适应症赛道，整体都属于比较靠前的梯队。如果真要 License Out ，很有可能会卖个大价钱。 封面来源：站酷海洛题图 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验 点击阅读原文，立刻解锁！

KEYTRUDA ® (pembrolizumab) plus chemotherapy followed by maintenance with LYNPARZA ® (olaparib), with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone The study did not reach its secondary endpoint of overall survival RAHWAY, NJ, USA I December 09, 2024 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA ® (pembrolizumab) plus chemotherapy followed by maintenance with LYNPARZA ® (olaparib), with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival (PFS). At the final analysis conducted by an independent Data Monitoring Committee, the KEYTRUDA plus LYNPARZA regimen demonstrated a statistically significant and clinically meaningful improvement in PFS for these patients compared to chemotherapy alone. The study did not reach its secondary endpoint of overall survival (OS). The role of KEYTRUDA in the intention-to-treat population remains uncertain at this time. The safety profiles of KEYTRUDA and LYNPARZA were consistent with those observed in previously reported studies for the individual therapies. These results will be presented at an upcoming medical meeting and discussed with regulatory authorities. “For people living with ovarian cancer, there remains an unmet need for new treatment options that have the potential to improve outcomes,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “KEYLYNK-001 is the first positive Phase 3 trial for KEYTRUDA plus LYNPARZA, highlighting our commitment to research that may help address the global impact of women’s cancers.” In the U.S., LYNPARZA has three approved indications in ovarian cancer: for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy; in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability; and for the maintenance treatment of adult patients with deleterious or suspected deleterious g BRCA m or s BRCA m recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. For each of these indications, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. KEYTRUDA is not approved to treat ovarian cancer. See selected KEYTRUDA indications in the U.S. below. About KEYLYNK-001 KEYLYNK-001 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03740165 ) evaluating KEYTRUDA in combination with chemotherapy (paclitaxel and carboplatin) followed by KEYTRUDA with maintenance LYNPARZA, with or without bevacizumab, for the first-line treatment of BRCA non-mutated advanced epithelial ovarian cancer. The primary endpoints are PFS in patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10) and PFS in the intention-to-treat population. Secondary endpoints include OS and safety. The trial enrolled 1,367 patients who were randomized to receive: Patients who experience severe hypersensitivity reaction or an adverse event requiring discontinuation of paclitaxel may receive docetaxel plus carboplatin. Participants may also receive bevacizumab at the investigator’s discretion. About ovarian cancer Ovarian cancer often begins in the fallopian tubes or on the outer surface of the ovaries. It is the second most common gynecologic malignancy and seventh most common cancer in women worldwide. Globally, there were approximately 324,603 patients diagnosed with ovarian cancer and about 206,956 deaths from the disease in 2022. In the U.S., it is estimated there will be approximately 19,680 patients diagnosed with ovarian cancer and about 12,740 deaths from the disease in 2024. The primary aim of first-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission. About Merck’s research in women’s cancers Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecological cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to give patients facing these devastating diseases options. With more than 20 clinical trials in more than 18,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Merck is working to develop a portfolio and pipeline to address the impact of women’s cancers on patients, their families and communities globally. About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. About LYNPARZA ® (olaparib) LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR. LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types. Independently, Merck is developing LYNPARZA in combination with its anti-PD-1 therapy, KEYTRUDA. INDICATIONS LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: First-Line Maintenance BRCA m Advanced Ovarian Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Maintenance BRCA -mutated Recurrent Ovarian Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Adjuvant Treatment of g BRCA m, HER2-Negative, High-Risk Early Breast Cancer For the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. g BRCA m, HER2-Negative Metastatic Breast Cancer For the treatment of adult patients with deleterious or suspected deleterious g BRCA m, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. First-Line Maintenance g BRCA m Metastatic Pancreatic Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious g BRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. BRCA m Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone In combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Please see complete Prescribing Information , including Medication Guide . Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit www.merck.com/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter ), Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck