AstraZeneca scores Japanese approval for Imfinzi combo in extensive-stage small cell lung cancer
pharmafile | August 21, 2020 | News story | Medical Communications, Sales and Marketing | AstraZeneca, Imfinzi, Japan
AstraZeneca’s Imfinzi (durvalumab) has secured approval in Japan for the treatment of extensive-stage small cell lung cancer when combined with etoposide and either carboplatin or cisplatin platinum chemotherapy, it has emerged.
The Japanese Ministry of Health, Labour and Welfare awarded the authorisation based on Phase 3 data which showed that Imfinzi generated “statistically significant and clinically meaningful improvement” in overall survival (OS), meeting its primary endpoint back in June last year. Patients receiving the combo therapy were at a 27% lower risk of death compared to chemotherapy alone.
The combo also registered a median OS of 13 months versus 10.3 months with chemotherapy, and objective response rate rose to 68% with the combo versus 58% with chemo. After a two-year follow up, median OS stood at 12.9 months for the combo compared to 10.5 months with chemo.
“This approval of Imfinzi provides an important new immunotherapy option in Japan for patients with extensive-stage small cell lung cancer,” commented Dave Fredrickson, Executive Vice President, Oncology Business Unit at AstraZeneca. “These patients have an especially poor prognosis, with only 2% surviving beyond five years. Imfinzi, in combination with chemotherapy, delivers a sustained survival benefit and prolonged treatment response with a convenient dosing regimen given every four weeks during maintenance.”
Matt Fellows
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