AstraZeneca's Phase III CASPIAN trial final analysis shows Imfinzi confirmed survival benefit for small cell lung cancer patients
Imfinzi confirmed a sustained overall survival benefit in the final analysis of the Phase III CASPIAN trial in 1st-line extensive-stage small cell lung cancer
Cambridge: High-level results from the final analysis of the Phase III CASPIAN trial showed AstraZeneca's Imfinzi (durvalumab) in combination with a choice of standard-of-care (SoC) chemotherapies confirmed a sustained, clinically meaningful overall survival (OS) benefit for patients with extensive-stage small-cell lung cancer (ES-SCLC) treated in the 1st-line setting.
In June 2019, the CASPIAN trial met one primary endpoint for Imfinzi plus SoC (etoposide and either carboplatin or cisplatin chemotherapy) by demonstrating a statistically significant and clinically meaningful improvement in OS versus SoC alone at a planned interim analysis.
The second experimental arm testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to Imfinzi and SoC did not meet its primary endpoint of demonstrating a statistically significant improvement in OS in this analysis.
José Baselga, Executive Vice President, Oncology R&D, said: "We are pleased to see the sustained and meaningful survival benefit of Imfinzi for patients with small-cell lung cancer after more than two years median follow up. We have already received the first global regulatory approval for Imfinzi with etoposide plus either carboplatin or cisplatin and remain on track for more approvals soon as we provide patients with an important new 1st-line treatment option."
The safety and tolerability for Imfinzi and tremelimumab were consistent with the known safety profiles of these medicines. The data will be presented at a forthcoming medical meeting.
Imfinzi in combination with etoposide and either carboplatin or cisplatin is currently under regulatory review for the treatment of ES-SCLC in the 1st-line setting based on the Phase III CASPIAN trial in the US, EU and Japan. The US Food and Drug Administration has granted a Priority Review with a Prescription Drug User Fee Act date set for the first quarter of 2020.
As part of a broad development programme, Imfinzi is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial with data anticipated in 2021.