Lurbinectedin

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study1 First and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC2 Regimen recommended in National Comprehensive Cancer Network® Guidelines for SCLC*3 3 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide (CE).4 This approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited. The U.S. National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®)* have been updated to include the regimen as a category 2A and preferred option for maintenance treatment of people with ES-SCLC, following induction therapy with Tecentriq and CE.3 “For people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse,” said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and haematology at Yale Cancer Center and Smilow Cancer Hospital. “The Tecentriq and Zepzelca combination provides a new option and a proactive approach in this setting shown to improve progression-free and overall survival in patients who haven't progressed after standard induction treatment with Tecentriq and chemotherapy. The approval may lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help to delay disease progression and extend survival.” “The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “We are proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals, as it reflects our abiding commitment to improving outcomes in the hardest-to-treat cancers.” The FDA approval is based on results from the phase III IMforte study, which showed that the Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Following 3.2 months of induction therapy, the median overall survival (OS) for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54; 95% CI: 0.43–0.67; p<0.0001). Safety was generally consistent with the known safety profiles of Tecentriq and lurbinectedin.1 Today’s approval builds on Tecentriq’s established role in ES-SCLC. In 2019, the FDA approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with ES-SCLC, based on the IMpower133 study, which at the time was the first new treatment option in two decades for this patient population.5 IMforte [NCT05091567] is a phase III, open-label, randomised trial evaluating the efficacy and safety of Tecentriq® (atezolizumab) plus lurbinectedin (Zepzelca®) versus Tecentriq alone as first-line maintenance therapy for adults (≥18 years) with extensive-stage small-cell lung cancer (ES-SCLC). Patients first received induction therapy with Tecentriq, carboplatin and etoposide for four 21-day cycles. Those without disease progression were then randomised 1:1 to receive maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone until disease progression or unacceptable toxicity. The study enrolled 660 patients in the induction phase and randomised 483 patients in the maintenance phase. The study’s primary endpoints were independent review facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS) from randomisation into the maintenance phase.1 Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS). 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. ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license. All trademarks used or mentioned in this release are protected by law. References [1] Paz-Ares L, et al. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. Presented at: ASCO Annual Meeting; 2025 May 30-Jun 03; Chicago, IL, USA. Abstract #8006. [2] Paz-Ares L, et al. Unmet Needs in Maintenance Therapy for Extensive Stage Small Cell Lung Cancer. Clinical Lung Cancer. 2025;26(3): 168-178. [3] National Comprehensive Cancer Network (NCCN). NCCN Guidelines® small cell lung cancer version 2.2026. [Internet; cited September 2025]. Available from: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1462. [4] TECENTRIQ Prescribing Information. Genentech, Inc. [5] F. Hoffman-La Roche Ltd. FDA approves Roche's Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer [Internet; cited September 2025]. Available from: https://www.roche.com/media/releases/med-cor-2019-03-19. The content above comes from the network. if any infringement, please contact us to modify.

今日（10月6日），绿叶制药及其合作伙伴PharmaMar宣布，美国食品药品监督管理局（FDA）已批准芦比替定联合阿替利珠单抗或阿替利珠单抗皮下制剂用于广泛期小细胞肺癌（ES-SCLC）成人患者的维持治疗，这些患者在接受阿替利珠单抗、卡铂和依托泊苷一线诱导治疗后未出现疾病进展。这也是当前首个获批用于ES-SCLC一线维持治疗的联合疗法。 芦比替定是一种选择性的致癌基因转录抑制剂，在抑制肿瘤基因转录、导致肿瘤细胞凋亡的同时，还可调节肿瘤微环境，进一步发挥抗肿瘤作用。该产品于2020年首次获得FDA的附条件批准，用于治疗含铂化疗中或化疗后疾病进展的转移性小细胞肺癌成人患者。绿叶制药获权在中国内地、香港及澳门地区开发和商业化芦比替定（英文商品名为Zepzelca®，中文商品名为赞必佳®），并已成功推动该产品在上述三地上市。 此次“芦比替定联合阿替利珠单抗用于ES-SCLC一线维持治疗”的新适应症在美国获得批准，基于一项Ⅲ期临床研究（IMforte研究）结果。该项研究显示： 与阿替利珠单抗单药维持治疗相比，芦比替定与阿替利珠单抗的联用方案将疾病进展或死亡的风险降低了46%，将死亡风险降低了27%； 经过4个周期的诱导治疗后，在随机分组的患者中，接受芦比替定与阿替利珠单抗联用方案维持治疗的中位总生存期（OS）为 13.2个月，而使用阿替利珠单抗单药的中位OS则为 10.6个月（分层风险比[HR]=0.73；95% CI：0.57–0.95；p=0.0174）； 此外，经独立评估的联用方案与单药维持治疗的中位无进展生存期（PFS）分别为5.4个月和2.1个月（分层HR=0.54；95% CI：0.43–0.67；p<0.0001）； 安全性方面：联用方案的安全性特征与该两种药物已知的安全性特征一致。 欢迎加入群聊