The approval by the US Food and Drug Administration was based on positive results from the Phase III 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.
SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “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.”
Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, UCLA Medical Center, Santa Monica, California and a lead investigator in the Phase III CASPIAN trial, said: “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.”
The Phase III CASPIAN trial had two primary endpoints comparing experimental arms to SoC. In the IMFINZI plus SoC arm, the risk of death was reduced by 27% (equal to a hazard ratio of 0.73; 95% CI 0.59-0.91; p=0.0047), with median OS of 13.0 months versus 10.3 months for SoC alone. Results also showed an increased confirmed objective response rate in the IMFINZI plus SoC arm (68% versus 58% for SoC alone). The safety and tolerability for IMFINZI plus SoC was consistent with the known safety profiles of these medicines. The IMFINZI plus SoC data from the CASPIAN trial were published in The Lancet.
The second experimental arm testing tremelimumab added to IMFINZI and SoC recently read out but did not meet the primary endpoint. Details will be presented at a forthcoming medical meeting.
The most common adverse reactions (≥20% of patients with extensive-stage SCLC) were nausea, fatigue/asthenia and alopecia.
The CASPIAN trial used a fixed dose of IMFINZI (1500 mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks until disease progression as a single medicine. As part of a broad development program, IMFINZI is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial with data anticipated in 2021.
IMFINZI received its first approval based on the Phase III CASPIAN trial in Singapore for patients with ES-SCLC in February 2020. IMFINZI in combination with etoposide and either carboplatin or cisplatin is currently under regulatory review for the treatment of ES-SCLC in the 1st-line setting based on the Phase III CASPIAN trial in the EU and Japan.
Source: Company Press Release