FDA Approves Durvalumab Plus Standard of Care for SCLC

The FDA approved durvalumab (Imfinzi) plus standard-of-care (SoC) chemotherapies etoposide with either carboplatin or cisplatin (platinum-etoposide) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC), according to AstraZeneca, the manufacturer of the PD-L1 inhibitor.

“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. The CASPIAN trial enables clinicians to choose durvalumab in combination with etoposide and either carboplatin or cisplatin, making this an important new 1st-line treatment option for patients that is both effective and well-tolerated,” Jonathan Goldman, MD, associate professor of hematology and oncology at UCLA Medical Center, said in a statement.

The approval was based on results from the phase III CASPIAN trial published in The Lancet, which showed that durvalumab plus SoC platinum-etoposide resulted in a statistically significant and clinically meaningful improvement in OS compared to SoC alone.

In CASPIAN, the drug combination reduced risk of death by 27% (HR 0.73; 95% CI 0.59-0.91; p=0.0047). Median overall survival (OS) for the durvalumab regimen was 13 months, compared to 10.3 months for SoC alone.

Durvalumab plus SoC also had a higher confirmed objective response rate compared to the other regimen (68% versus 58%, respectively).

Patients on the trial in the experiment arm received a 1500 mg fixed dose of durvalumab every 3 weeks for 4 cycles in combination with chemotherapy and then every 4 weeks until disease progression. There was a second experimental arm testing durvalumab plus tremelimumab, but it did not meet its primary endpoint.

The safety and tolerability of durvalumab plus SoC was consistent with the known profiles of each of the regimens.

“The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options. 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,” Dave Fredrickson, executive vice president, Oncology Business Unit at AstraZeneca said.