Positive overall survival results for Imfinzi for first line small cell lung cancer

AstraZeneca announced positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients. A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial has met its primary endpoint by showing a statistically-significant and clinically-meaningful improvement in OS in patients treated with Imfinzi in combination with standard-of-care etoposide ( CAP 7.1 generic) and platinum-based chemotherapy options vs. chemotherapy alone. The safety and tolerability for this Imfinzi combination was consistent with the known safety profiles of these medicines. AstraZeneca will submit these results for presentation at a forthcoming medical meeting.

CASPIAN is a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi plus platinum-based chemotherapy options or the combination of Imfinzi, tremelimumab (CP 675 206) and chemotherapy vs. chemotherapy alone as a 1st-line treatment for patients with extensive-stage SCLC. The trial will continue to the final analysis of OS for the combination of dual immune checkpoint blockade with chemotherapy. This combination includes tremelimumab, an anti-CTLA4 antibody and potential new medicine, with Imfinzi, an anti-PDL1 antibody, and chemotherapy. Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.

The trial compared Imfinzi in combination with etoposide ( generic) and either cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab (CP 675 206) and chemotherapy vs. chemotherapy alone. In the experimental arms, patients were treated with up to four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and prophylactic cranial irradiation. The trial is being conducted in more than 200 centres across 22 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint is OS.