Presented at ASCO 2025, the IMforte study shows a significant improvement in survival with first-line maintenance therapy
A new hope for patients with extensive-stage small cell lung cancer
At the 2025 ASCO Annual Meeting, PharmaMar unveiled game-changing results from the Phase 3 IMforte study, showing that the combination of Zepzelca® (lurbinectedin) and Tecentriq® (atezolizumab) significantly improves overall survival (OS) and progression-free survival (PFS) as first-line maintenance therapy for patients with extensive-stage small cell lung cancer (ES-SCLC).
Longer survival, slower progression
The data speak volumes: median PFS reached 5.4 months with the combination versus just 2.1 months with atezolizumab alone. Median OS increased to 13.2 months from 10.6 months. That’s a 46% reduction in disease progression or death and a 27% drop in mortality risk.
A new standard of care
IMforte is the first global phase 3 trial to demonstrate statistically and clinically significant benefits in first-line maintenance for ES-SCLC. As emphasized by Dr. Filippo de Marinis, director of thoracic oncology at the IEO in Milan, the findings have the potential to “change clinical practice” for a disease that affects over 6,000 Italians each year.
A safe and tolerable therapy
No new or unexpected safety concerns emerged. The treatment duration with the combination therapy was doublecompared to the monotherapy arm, and adverse events were manageable, with serious ones occurring in less than 1%of patients.
From ASCO to The Lancet to the regulators
The study results were published in The Lancet and have already led to a Marketing Authorisation Application (MAA) with the EMA by PharmaMar and a supplemental New Drug Application (sNDA) with the FDA by Jazz Pharmaceuticals.
A game-changer for thousands across Europe
With 63,000–72,000 new SCLC cases diagnosed annually in Europe, introducing lurbinectedin earlier in the treatment pathway could significantly expand access and improve outcomes for a vulnerable population.
Expert webcast on June 12
PharmaMar will host a Key Opinion Leader webcast on June 12, featuring Dr. Martin Wermke (TU Dresden) and Dr. Nicolas Girard (Institut Curie), to discuss the data and future implications for ES-SCLC treatment.
Zepzelca’s unique marine origin
Zepzelca®, derived from a marine invertebrate, acts as a selective oncogenic transcription inhibitor, reducing both tumor cell growth and the production of pro-tumor cytokines in tumor-associated macrophages. A unique approach in a cancer type with few actionable targets.
FAQ
1. What is Zepzelca?
It’s a marine-derived anti-cancer drug indicated for small cell lung cancer.
2. What did the IMforte study show?
That combining Zepzelca and Tecentriq improves survival outcomes in ES-SCLC.
3. What were the survival benefits?
Median PFS was 5.4 months, and OS reached 13.2 months with the combo.
4. Who can benefit from this therapy?
Adults with ES-SCLC who didn’t progress after induction chemotherapy.
5. Is the treatment safe?
Yes, no unexpected safety signals were observed.
6. Where were the results presented?
At ASCO 2025 and published in The Lancet.
7. How does lurbinectedin work?
It inhibits oncogenic transcription and modulates the tumor microenvironment.
8. Has PharmaMar filed for approval?
Yes, with the EMA in Europe.
9. What is Jazz Pharmaceuticals’ role?
They submitted the sNDA to the U.S. FDA.
10. Where can I learn more?
Visit www.pharmamar.com or clinicaltrials.gov (NCT05091567).
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