Pembrolizumab

– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union – – ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10). The European Commission decision on this indication is anticipated later in 2026. Metastatic TNBC is an aggressive form of breast cancer that is associated with rapid disease progression and poor prognosis. Approximately 40% of metastatic TNBC tumors are PD-L1 positive. These tumors are considered more aggressive and associated with shorter survival, creating urgency to initiate treatment with effective regimens as soon as possible. For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment. “People with metastatic triple-negative breast cancer need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1,” said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and Investigator of the ASCENT-04 study. “This positive opinion is welcome news for our patients and the entire clinical community. If authorized, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status.” The CHMP’s recommendation is based on data from the Phase 3 ASCENT-04 study/KEYNOTE-D19 which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy plus Keytruda versus the combination of standard of care chemotherapy plus Keytruda as a first-line treatment in PD-L1 positive patients. In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% reduced risk of disease progression or death in patients with PD-L1 positive metastatic TNBC. The ASCENT-04/KEYNOTE-D19 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. “Building on our established leadership in metastatic TNBC, this positive opinion reinforces our commitment to the breast cancer community,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “People with metastatic TNBC desperately need new options as early as possible. This positive opinion, coupled with the recent EMA approval of Trodelvy monotherapy, is an important step in changing outcomes for these patients.” The European Commission has approved the use of Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. The U.S. Food and Drug Administration (FDA) has approved Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC. Trodelvy is approved for: either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. KEYTRUDA® and KEYTRUDA QLEX™ are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC. Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is globally approved for use in certain patients with metastatic TNBC and pre-treated HR+HER2- metastatic breast cancer. Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression, including in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. The content above comes from the network. if any infringement, please contact us to modify.

7月23日，默沙东全球CEO Rob Davis公开对美国国会及政府部门喊话：如果切断或限制与中国药企的交易，美国可能丧失全球生物科技的领导地位。 “你可以用一半的成本，快两倍的速度，”Davis的这句话迅速在行业内传开，“不是因为他们走捷径，而是流程更高效、系统障碍更少。” 这番表态不是空穴来风。 在地球另一端的上海，默沙东全球高级副总裁兼中国区总裁唐凯宇（KyleTattle）正用一整年的实践，验证着这句判断的分量。 从2025年7月1日正式接棒至今，这位曾把默沙东日本从市场第8拉到第3的老将，正在中国市场书写一份更复杂的答卷。 01 “沉浸式”理解中国 2025年7月1日，KyleTattle有了一个响亮的中文名“唐凯宇”。 这位1998年便加入默沙东的“老兵”，在担任默沙东日本总裁的五年间，将日本市场排名从第8位提升至第3位，实现了超过10%的增长。 员工大会上，他留下了三个关键词：“早起、健身房、铁人三项”。 这不仅是一个人的自律标签，更像是对默沙东中国未来走向的隐喻，一场需要耐力的马拉松，而非短跑。 “从外部视角看中国与真正生活在这里，是完全不一样的体验。”履新不久后，唐凯宇在第八届进博会上这样对媒体说。 “近半年来，我花了大量时间与同事、客户、合作伙伴交流，努力理解中国医药产业的脉络与节奏。” 这种“沉浸式”的融入姿态，与他的前任们形成了微妙的分野。 此前常来中国出差的经历，远不如“在这里生活工作”来得真切。 唐凯宇显然明白，在中国做医药生意，光靠全球总部的指令远远不够，更需要读懂这个市场的呼吸节奏。 而他面对的，正是一个呼吸急促的市场。 02 “增长引擎”变“失血点” 正式接掌默沙东中国总裁帅印，唐凯宇接过的绝不是一个轻松的位置。 履新之际，默沙东中国正经历着前所未有的阵痛。 核心品种HPV疫苗佳达修，曾经是默沙东在中国最锋利的武器。 2023年全球销售额尚达67.1亿美元，到2025年已缩水至18.16亿美元，骤降超过三分之二。 2025年，默沙东甚至一度暂停向中国供应HPV疫苗。 有评论直言，默沙东中国已从昔日的“增长引擎”变为“失血点”。 这不是一个新人总裁乐于见到的开场白。但唐凯宇的履历恰恰说明，默沙东总部选中他，看中的正是他在逆境中破局的能力。 03 从“走进中国”到“融入中国” 唐凯宇对此了然于胸。 在进博会上，他展示的不仅是默沙东的产品线，更是一张与中国创新生态深度绑定的合作网络。 默沙东与科伦博泰的合作始于2022年，获得了多款ADC的独家权利，总交易金额超百亿美元。 2025年11月，默沙东甚至针对科伦博泰授权产品Sac-TMT启动专项融资，向黑石融资7亿美元用于全球开发。 与恒瑞医药的合作同样引人注目。 2025年3月，默沙东获得恒瑞心血管药物HRS-5346在大中华区以外的全球独家权利，支付2亿美元首付款，潜在里程碑付款最高可达17.7亿美元。 “我们希望通过这些合作，将中国创新带给世界，惠及中国和全球患者。”唐凯宇说。 这句话的潜台词是：默沙东不再仅仅是把全球药物“带进来”，更在把中国创新“带出去”。 04 40项新品的“进博速度” 唐凯宇为默沙东中国描绘的蓝图同样清晰：未来5年，预计将有40多项新产品和新适应证引入中国。 这不是空洞的口号。 第八届进博会上展示的多款在研药物，已在会后陆续获批上市。 这种高效的“进博速度”，正在成为默沙东中国加速奔跑的缩影。 在肿瘤领域，可瑞达（帕博利珠单抗）截至2025年8月已在中国获批32个适应证。 2026年，它又先后获批子宫内膜癌和铂耐药卵巢癌适应症，实现了对三大女性生殖系统恶性肿瘤的全面覆盖。 在罕见病领域，肺动脉高压对因治疗新药欣瑞来于2026年6月正式商业化上市。 在抗感染领域，RSV预防单抗克莱罗韦单抗也于2026年6月获批。 05 “耐力型转型”的考验 但挑战依然严峻。HPV疫苗留下的业绩缺口，短期内难以被新品完全填补。与此同时，地缘政治的阴影正在逼近。 2026年6月，美国众议院已对默沙东等五家美国头部药企启动国家安全调查，重点审查在华临床试验运营情况。 更早的4月，美国众议院拨款委员会已要求FDA在审评新药时不得采信来自中国临床试验中心的数据。 这正是Davis发出警告的直接诱因，也是唐凯宇必须直面的外部变量。 05 写在最后 回到那个“早起、健身房、铁人三项”的隐喻。 唐凯宇接手的默沙东中国，需要的正是一场耐力型转型。 既要填补HPV疫苗留下的巨大缺口，又要在中美医药合作的地缘政治博弈中寻找平衡点，还要在“中国创新走出去”与“全球创新引进来”之间搭建桥梁。 这位在默沙东体系内浸淫近三十年的“老兵”，能否用“一半的成本快两倍”的中国速度，跑赢这场耐力赛？ 答案或许就藏在唐凯宇那句看似朴素的话里：“默沙东将一如既往地坚守对中国市场的承诺。”在医药行业，承诺的分量，最终要靠产品来兑现。 而40多项新品的管线，就是他手中最硬的筹码。