AstraZeneca’s human monoclonal antibody Imfinzi (durvalumab) has improved overall survival in the Phase III CASPIAN trial in first-line extensive-stage small cell lung cancer (SCLC).
The trial showed positive overall survival (OS) results from the CASPIAN trial in SCLC, a disease with a significant unmet need and limited treatment options.
An Independent Data Monitoring Committee conducted a planned interim analysis and concluded that the trial met its primary endpoint.
The trial is being conducted at more than 200 centres across 22 countries, including the US, Europe, South America, Asia and the Middle East.
A statistically-significant and clinically-meaningful improvement was observed in OS in patients treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy options versus chemotherapy alone.
AstraZeneca Oncology R&D executive vice-president José Baselga said: “The Phase III CASPIAN results offer new hope for patients who are facing the devastating diagnosis of small cell lung cancer, and for whom new medicines are urgently needed.
“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options.”
The randomised, open-label, multi-centre, global, Phase III CASPIAN trial will continue to the final analysis of OS for the combination of dual immune checkpoint blockade with chemotherapy.
The combination includes anti-CTLA4 antibody tremelimumab, anti-PDL1 antibody Imfinzi, and chemotherapy.
AstraZeneca will also test Imfinzi following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.
At present, Imfinzi is approved for the treatment of unresectable, Stage III non-small cell lung cancer in more than 45 countries, including the US.