CHMP backs Zepzelca plus Tecentriq in first-line ES-SCLC

Immedica said the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, has recommended expanding Zepzelca’s label to include use with Tecentriq as a first-line maintenance treatment for adults with extensive-stage small cell lung cancer whose disease has not progressed after induction therapy with atezolizumab, carboplatin, and etoposide. The recommendation builds on results from the phase 3 IMforte trial, which tested maintenance lurbinectedin plus atezolizumab against atezolizumab alone after four cycles of induction chemoimmunotherapy. In that study, the combination improved median overall survival from 10.6 months to 13.2 months and median progression-free survival from 2.1 months to 5.4 months, with no new safety signals reported. Tecentriq is already authorized in the EU with carboplatin and etoposide in first-line ES-SCLC, so the CHMP opinion would extend its role into the maintenance setting if the European Commission follows through. (ema.europa.eu)

Why it matters: For oncology teams, this is a meaningful regulatory step toward a new maintenance option in a disease with few durable gains. IMforte has been described in conference and industry coverage as the first phase 3 trial to show an overall survival benefit for first-line maintenance therapy in ES-SCLC, and the regimen has already reached the U.S. market, where the FDA approved it in October 2025. If the European Commission adopts the CHMP recommendation, clinicians in Europe would gain access to a regimen backed by randomized phase 3 data and aligned with a broader shift toward extending benefit after induction treatment in small cell lung cancer. (oncologynewscentral.com)

What to watch: The next step is a European Commission decision, which typically follows a positive CHMP opinion and would determine when the combo can launch across EU member states. (ema.europa.eu)