FDA approves Imfinzi for extensive-stage small cell lung cancer
Click Here to Manage Email Alerts
The FDA approved durvalumab in combination with standard chemotherapy as first-line treatment of adults with extensive-stage small cell lung cancer.
The approval applies to use of durvalumab (Imfinzi, AstraZeneca) — a human monoclonal antibody that binds to PD-L1 — with etoposide plus either carboplatin or cisplatin.
“The U.S. approval of Imfinzi brings a new medicine to [patients with extensive-stage small cell lung cancer] in urgent need of new options,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in a company-issued press release. “Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease.”
The FDA based the approval on results of the randomized phase 3 CASPIAN trial, which included 805 patients with extensive-stage small cell lung cancer.
Researchers assigned patients to one of three regimens: durvalumab in combination with etoposide and either carboplatin or cisplatin; durvalumab and chemotherapy with the addition of the anti-CTLA-4 antibody tremelimumab (AstraZeneca); or chemotherapy alone.
Results showed patients who received durvalumab plus chemotherapy achieved significantly longer OS than those who received standard chemotherapy alone (median, 13 months vs. 10.3 months; HR = 0.73; 95% CI, 0.59-0.91). Researchers also reported a higher confirmed objective response rate in the durvalumab group (68% vs. 58%).
The addition of tremelimumab to durvalumab and chemotherapy did not confer an OS benefit.
The safety and tolerability of the durvalumab-chemotherapy combination appeared consistent with the known safety profiles of each therapy alone.
“Patients with extensive-stage small cell lung cancer continue to face a poor prognosis, and finding new medicines to improve outcomes in this setting has been a formidable challenge,” Jonathan Goldman, MD, associate professor of hematology and oncology at UCLA Medical Center and lead investigator of the CASPIAN trial, said in the release. “The CASPIAN trial enables clinicians to choose durvalumab in combination with etoposide and either carboplatin or cisplatin, making this an important new first-line treatment option for patients that is both effective and well-tolerated.”
The FDA previously approved durvalumab for treatment of patients with unresectable stage III non-small cell lung cancer who underwent chemoradiation, as well as for previously treated patients with advanced bladder cancer.