Imfinzi (durvalumab) has been approved by the FDA as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care chemotherapies, Astrazeneca reported.

The approval was based on positive results from a Phase III trial that showed Imfinzi plus platinum-etoposide (chemo) demonstrated a statistically significant and clinically meaningful improvement in overall survival versus chemotherapy alone.

Imfinzi (1500 mg) plus chemotherapy was associated with a 27% reduced risk of death, with median overall survival of 13.0 months versus 10.3 months for chemotherapy alone.

“Patients with ES-SCLC continue to face a poor prognosis, and finding new medicines to improve outcomes in this setting has been a formidable challenge,” said Ph3 lead investigator Jonathan Goldman, MD, associate professor of Hematology & Oncology, UCLA Medical Center. “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.”

The most common adverse reactions (≥20% of patients with extensive-stage SCLC) were nausea, fatigue/asthenia and alopecia.

“The US approval of Imfinzi brings a new medicine to ES-SCLC patients in urgent need of new options,” said Dave Fredrickson, executive VP, Astrazeneca. “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.”