FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer
Roche (OTCQX: RHHBY) announced FDA approval on October 3, 2025 of Tecentriq (atezolizumab) plus lurbinectedin (Zepzelca) as the first‑line maintenance regimen for adults with extensive‑stage small cell lung cancer (ES‑SCLC) whose disease has not progressed after induction with Tecentriq (or Tecentriq Hybreza), carboplatin and etoposide.
The approval is based on phase III IMforte: the combination reduced risk of progression or death by 46% and risk of death by 27%. Median overall survival was 13.2 vs 10.6 months (HR=0.73; p=0.0174); median PFS was 5.4 vs 2.1 months (HR=0.54; p<0.0001). Safety matched known profiles. NCCN updated the regimen to category 2A preferred for maintenance after Tecentriq+CE.
Roche (OTCQX: RHHBY) ha annunciato l'approvazione FDA il 3 ottobre 2025 di Tecentriq (atezolizumab) più lurbinectedin (Zepzelca) come regime di mantenimento di prima linea per adulti con carcinoma polmonare a piccole cellule allo stadio esteso (ES-SCLC) la cui malattia non è progredita dopo induzione con Tecentriq (o Tecentriq Hybreza), carboplatino ed etoposide.
L'approvazione si basa sullo studio di fase III IMforte: la combinazione ha ridotto il rischio di progressione o morte del 46% e il rischio di morte del 27%. La sopravvivenza globale mediana è stata 13,2 vs 10,6 mesi (HR=0,73; p=0,0174); la PFS mediana è stata 5,4 vs 2,1 mesi (HR=0,54; p<0,0001). La sicurezza ha rispecchiato i profili noti. Il NCCN ha aggiornato il regime a categoria 2A preferita per il mantenimento dopo Tecentriq+CE.
Roche (OTCQX: RHHBY) anunció la aprobación de la FDA el 3 de octubre de 2025 de Tecentriq (atezolizumab) más lurbinectedin (Zepzelca) como régimen de mantenimiento de primera línea para adultos con cáncer de pulmón de células pequeñas en estadio extenso (ES-SCLC) cuyas enfermedad no ha progresado tras la inducción con Tecentriq (o Tecentriq Hybreza), carboplatino y etopósido.
La aprobación se basa en el estudio de fase III IMforte: la combinación redujo el riesgo de progresión o muerte en un 46% y el riesgo de muerte en un 27%. La supervivencia global mediana fue de 13,2 vs 10,6 meses (HR=0,73; p=0,0174); la mediana de PFS fue de 5,4 vs 2,1 meses (HR=0,54; p<0,0001). La seguridad coincidió con los perfiles conocidos. NCCN actualizó el régimen a categoría 2A preferida para el mantenimiento tras Tecentriq+CE.
Roche (OTCQX: RHHBY)는 Tecentriq(atezolizumab)와 lurbinectedin (Zepzelca)를 1차 유지요법으로 승인받았다고 발표했습니다. 이 승인은 확산형 소세포폐암(ES-SCLC)에서 Tecentriq(또는 Tecentriq Hybreza)로의 유도 치료, 카보플라틴 및 에토포시드 후 질병이 진행되지 않은 성인 환자를 대상으로 합니다.
승인은 III상 IMforte에基해 이 조합이 진행/사망 위험을 46% 감소시키고 사망 위험을 27% 감소시켰습니다. 중간 전체 생존기간은 13.2개월 대 10.6개월이며 (HR=0.73; p=0.0174); 중간 PFS는 5.4개월 대 2.1개월 (HR=0.54; p<0.0001)였습니다. 안전성은 알려진 프로파일과 일치했습니다. NCCN은 Tecentriq+CE 이후의 유지요법으로 이 요법을 2A 우선으로 업데이트했습니다.
Roche (OTCQX: RHHBY) a annoncé l'approbation par la FDA le 3 octobre 2025 de Tecentriq (atezolizumab) plus lurbinectedin (Zepzelca) comme régime d'entretien de première ligne pour les adultes atteints d'un cancer du poumon à petites cellules à un stade avancé (ES-SCLC) dont la maladie n'a pas progressé après une induction avec Tecentriq (ou Tecentriq Hybreza), le carboplatine et l'étoposide.
L'approbation est basée sur l'essai de phase III IMforte : la combinaison a réduit le risque de progression ou de décès de 46% et le risque de décès de 27%. La médiane de survie globale était de 13,2 vs 10,6 mois (HR=0,73; p=0,0174) ; la médiane de PFS était de 5,4 vs 2,1 mois (HR=0,54; p<0,0001). La sécurité correspondait aux profils connus. Le NCCN a mis à jour le régime en catégorie 2A privilégiée pour l'entretien après Tecentriq+CE.
Roche (OTCQX: RHHBY) gab am 3. Oktober 2025 die FDA-Zulassung für Tecentriq (atezolizumab) plus lurbinectedin (Zepzelca) als Erstlinien-Wartungsregime für Erwachsene mit weit fortgeschrittenem kleinen Zell-Lungenkrebs (ES-SCLC), dessen Krankheit nach Induktion mit Tecentriq (oder Tecentriq Hybreza), Carboplatin und Etoposid nicht fortgeschritten ist.
Die Zulassung basiert auf der Phase-III-IMforte-Studie: Die Kombination reduzierte das Risiko einer Progression oder eines Todes um 46% und das Risiko eines Todes um 27%. Das mediane Gesamtüberleben betrug 13,2 vs 10,6 Monate (HR=0,73; p=0,0174); das mediane PFS betrug 5,4 vs 2,1 Monate (HR=0,54; p<0,0001). Sicherheit entsprach den bekannten Profilen. Das NCCN hat das Regime für Wartung nach Tecentriq+CE auf Kategorie 2A bevorzugt aktualisiert.
ROCHE (OTCQX: RHHBY) أعلنت موافقة إدارة الغذاء والدواء الأمريكية في 3 أكتوبر 2025 على Tecentriq (atezolizumab) بالإضافة إلى lurbinectedin (Zepzelca) كنظام صيانة من الخط الأول للبالغين المصابين بسرطان الرئة صغير الخلايا في مراحله المتقدمة ES-SCLC، لم يتقدم مرضهم بعد التحريض بـ Tecentriq (أو Tecentriq Hybreza)، الكاربوبلاتين والايتيوبوسيد.
اعتمادها يعتمد على تجربة المرحلة الثالثة IMforte: أن الجمع خفض مخاطر التقدم أو الوفاة بنسبة 46% وخطر الوفاة بنسبة 27%. الوسيط العام للبقاء على قيد الحياة كان 13.2 مقابل 10.6 أشهر (HR=0.73؛ p=0.0174)؛ الوسيط للنمو دون تقدم المرض كان 5.4 مقابل 2.1 أشهر (HR=0.54؛ p<0.0001). السلامة مطابقة للملامح المعروفة. NCCN حدّث النظام إلى الفئة 2A المفضلة للصيانة بعد Tecentriq+CE.
Roche (OTCQX: RHHBY) 宣布美国 FDA 在 2025 年 10 月 3 日 批准将 Tecentriq（atezolizumab） 加上 lurbinectedin（Zepzelca） 作为第一线维持治疗方案，用于已扩展期的小细胞肺癌（ES-SCLC）成年患者，在以 Tecentriq（或 Tecentriq Hybreza）、卡铂和依托泊苷进行诱导治疗后未进展者。
该批准基于 III 期 IMforte 研究：联合方案将进展或死亡风险降低了 46%，死亡风险降低了 27%。中位总生存期为 13.2 个月对 10.6 个月（HR=0.73；p=0.0174），中位无进展生存期为 5.4 个月对 2.1 个月（HR=0.54；p<0.0001）。安全性符合已知特征。NCCN 将该方案更新为维持治疗的 优选类别 2A，用于 Tecentriq+CE 之后。
- Risk of progression or death reduced by 46%
- Risk of death reduced by 27%
- Median overall survival 13.2 vs 10.6 months
- Median progression‑free survival 5.4 vs 2.1 months
- NCCN guideline updated to category 2A preferred
- Absolute median OS gain only 2.6 months
- Approval limited to patients not progressed after Tecentriq+CE
- Safety described as consistent — potential class toxicities remain
- Combination reduced the risk of disease progression or death by
46% and risk of death by27% 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
Basel, 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
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
About the IMforte study
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
The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals.
About Tecentriq® (atezolizumab)
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).
About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy
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 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.
For more information, please visit www.roche.com.
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.
*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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.
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