Results of the phase II CASPIAN trial showed mixed results for patients with extensive-stage small-cell lung cancer as a first-line therapy.
The trial results met one primary endpoint for durvalumab plus a choice of standard-of-care of either etoposide and either carboplatin or cisplatin chemotherapy, according to a release from the manufacturer. The results showed a “statistically significant and clinically meaningful” improvement in overall survival versus standard of care alone, according to the release.
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A second arm of the trial did not meet its primary endpoint when tremelimumab, an anti-CTLA4 monoclonal antibody, was added to durvalumab and standard of care. That arm did not demonstrate a statistically significant improvement in overall survival.
The randomized trial included 805 patients at various centers around the world. Patients were treated with four cycles of chemotherapy in the experimental arms, while the control arm had patients on six cycles of chemotherapy as well as optional prophylactic cranial irradiation.
“We are pleased to see the sustained and meaningful survival benefit of imfinzi (durvalumab) for patients with small-cell lung cancer after more than two years median follow-up,” Jose Baselga, Executive Vice President, Oncology R&D said in the release.
Durvalumab in combination with etoposide and either carboplatin or cisplatin is under review for approval as a first-line treatment for ES-SCLC in the US, the EU, and Japan. It has been granted priority review by the FDA with a Prescription Drug User Fee Act date of the first quarter of 2020. It is also being tested after concurrent chemoradiation in patients with limited-stage SCLC in the ADRIATIC trial.
