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The drug, plus chemotherapy, shows a significant survival benefit.
A new drug to treat extensive-stage small cell lung cancer (ES-SCLC) is launching in the U.S.
AstraZeneca recently garnered FDA approval for durvalumab (Imfinzi) as a first-line treatment for adult patients with ES-SCLC in combination with standard-of-care (SoC) chemotherapies, etoposide and either carboplatin or cisplatin (platinum-etoposide).
SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy. 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,” AstraZeneca says in a press release.
FDA’s approval was based on the Phase 3 CASPIAN trial showing Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus SoC alone.
In the IMFINZI plus SoC arm, the risk of death was reduced by 27% with median overall survival of 13 months versus 10.3 months for SoC alone. There was also an increased confirmed objective response rate in the Imfinzi plus SoC arm (68% versus 58% for SoC 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. 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,” says Jonathan Goldman, MD, associate professor of hematology & oncology at UCLA Medical Center and a lead investigator in the CASPIAN trial.
The most common adverse reactions to Imfinzi were nausea, fatigue/asthenia and alopecia.