17th Mar 2020 09:14
(Alliance News) - AstraZeneca PLC said Tuesday Phase III results from its Caspian trial confirmed the sustained overall benefit of its key cancer treatment drug Imfinzi.
The pharma giant noted, however, a second immunotherapy, tremelimumab, added to Imfinzi - the brand name of durvalumab - did not meet its primary endpoint of overall survival.
"High-level results from the final analysis of the Phase III Caspian trial showed AstraZeneca's Imfinzi in combination with a choice of standard-of-care chemotherapies confirmed a sustained, clinically meaningful overall survival benefit for patients with extensive-stage small cell lung cancer treated in the 1st-line setting," Astra said.
Astra Oncology R&D Executive Vice President Jose Baselga added: "We are pleased to see the sustained and meaningful survival benefit of Imfinzi for patients with small cell lung cancer after more than two years median follow up. We have already received the first global regulatory approval for Imfinzi with etoposide plus either carboplatin or cisplatin and remain on track for more approvals soon as we provide patients an important new 1st-line treatment option."
Imfinzi in combination with etoposide and either carboplatin or cisplatin is currently under regulatory review for the treatment of small cell lung cancer in the 1st-line setting based on the Phase III Caspian trial in the US, EU and Japan. The US Food & Drug Administration has granted a Priority Review with a Prescription Drug User Fee Act date set for the first quarter of 2020.
Imfinzi is also being tested in patients with limited-stage small cell lung cancer in the Phase III Adriatic trial with data expected in 2021.
Shares in AstraZeneca were 3.9% higher in London Tuesday morning at 6,466.00 pence each.
By Paul McGowan; [email protected]
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