AstraZeneca announced Thursday that a Phase III study of Imfinzi (durvalumab) as a first-line treatment in patients with extensive-stage small-cell lung cancer (SCLC) met its primary endpoint. In the CASPIAN trial, patients treated with the PD-L1 inhibitor in combination with standard-of-care etoposide and platinum-based chemotherapy options had a significant and clinically-meaningful improvement in overall survival (OS) compared to those who received chemotherapy alone.
"This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options," remarked José Baselga, executive vice president of oncology R&D. The study is investigating Imfinzi plus platinum-based chemotherapy options or the combination of Imfinzi, the anti-CTLA-4 antibody tremelimumab and chemotherapy versus chemotherapy alone as a first-line treatment for patients with extensive-stage SCLC.
AstraZeneca noted that following the planned interim analysis conducted by an Independent Data Monitoring Committee, the trial will continue to the final analysis of OS for the combination of dual immune checkpoint blockade with Imfinzi plus tremelimumab and chemotherapy. The company said it will submit the results for presentation at an upcoming medical meeting.
Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial. The drug is currently approved for unresectable, Stage III non-small-cell lung cancer in more than 45 countries, including the US, EU and Japan, based on the Phase III PACIFIC study.
In March, the FDA approved  Roche's PD-L1 inhibitor Tecentriq (atezolizumab), in combination with chemotherapy, as the first immunotherapy authorised for the first-line treatment of adults with extensive-stage SCLC. The clearance was based on results of the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone, with median OS in the two groups of 12.3 months and 10.3 months, respectively.