SHERIDAN, WYOMING – June 16, 2025 – Roche has unveiled promising Phase III results for its immunotherapy Tecentriq® (atezolizumab) combined with lurbinectedin (Zepzelca®) in the treatment of extensive-stage small cell lung cancer (ES-SCLC), offering new hope for a patient population with few effective treatment options and historically poor survival outcomes.
The IMforte study demonstrated that this first-line maintenance regimen significantly improves both progression-free and overall survival compared to Tecentriq monotherapy. With a 46% reduction in the risk of disease progression or death and a 27% reduction in overall mortality, the trial marks a notable advancement in the treatment of this aggressive cancer.
Practice-Changing Potential for a Hard-to-Treat Cancer
Small cell lung cancer remains one of the most challenging oncology areas, with the majority of cases diagnosed at an advanced stage and limited life expectancy beyond two years. The IMforte data suggests a new treatment paradigm may be emerging.
"Small cell lung cancer is an aggressive and devastating disease. At the time of diagnosis, the large majority of patients have already progressed to extensive-stage disease and only one out of five survive longer than two years,” said Luis Paz-Ares, MD, PhD, Head of Medical Oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. “The IMforte results are very encouraging showing a potentially practice-changing option that could improve survival for patients with a very high unmet need.”
The study results were presented at the 2025 ASCO Annual Meeting and simultaneously published in The Lancet, reinforcing the clinical community’s recognition of the findings.
Key Findings from the IMforte Trial
The randomized Phase III IMforte study involved 660 patients in the induction phase and 483 in the maintenance phase. All patients initially received Tecentriq with chemotherapy (carboplatin and etoposide) before being randomized into maintenance arms.
- Overall survival: 13.2 months with Tecentriq + lurbinectedin vs. 10.6 months with Tecentriq alone (HR = 0.73; p = 0.0174)
- Progression-free survival: 5.4 months vs. 2.1 months, respectively (HR = 0.54; p < 0.0001)
- Safety: No new safety signals; consistent with existing profiles of both drugs
“In the IMforte study, the Tecentriq and lurbinectedin maintenance regimen significantly extended survival for people living with extensive-stage small cell lung cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This study builds on Tecentriq’s well-established safety and efficacy profile as the first immunotherapy for this cancer type and may provide another approach to help physicians and patients better manage this aggressive disease."
Strategic Implications for Oncology Innovation
The success of the IMforte trial underscores Roche’s continued leadership in immuno-oncology and its strategic commitment to expanding Tecentriq’s clinical utility across cancer types. As the first immunotherapy to demonstrate such a benefit in ES-SCLC maintenance, the results could inform updated clinical guidelines and influence payer and provider decisions globally.
The trial is co-funded by Jazz Pharmaceuticals and builds on Tecentriq’s broad regulatory footprint across other indications including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and triple-negative breast cancer (TNBC).
Looking Ahead: Innovation Backed by Scale
Founded in 1896, Roche remains the world’s largest biotech company with a strong focus on personalized healthcare and integrated diagnostics. The company continues to leverage its scientific expertise and global infrastructure to deliver next-generation therapies.
Roche also reaffirms its long-term commitment to sustainability, aiming for net zero emissions by 2045 through its alignment with the Science Based Targets initiative and the Sustainable Markets Initiative.
To explore Roche’s oncology pipeline and cancer immunotherapy research, visit www.roche.com.