Imfinzi is a human monoclonal antibody that targets and blocks the interaction of PD-L1 with PD-1 and CD80, to prevent the inhibition of immune responses
AstraZeneca has received Japanese regulatory approval for Imfinzi (durvalumab) in combination with etoposide plus platinum chemotherapy (carboplatin or cisplatin) to treat extensive-stage small-cell lung cancer (ES-SCLC).
Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC. SCLC is an aggressive and fast-growing type of lung cancer that usually reappears and advances rapidly, regardless of an initial response to chemotherapy.
Imfinzi is a human monoclonal antibody that targets and blocks the interaction of PD-L1 with PD-1 and CD80, to prevent the inhibition of immune responses by rackling the tumour’s immune-evading tactics.
The drug has been approved to treat Stage-3 NSCLC after chemoradiation therapy in the curative-intent setting, in the US, Japan, China, across the EU and other countries, and is also approved for patients with advanced bladder cancer in the US and a few other countries.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “This approval of Imfinzi provides an important new immunotherapy option in Japan for patients with extensive-stage small-cell lung cancer.
“These patients have an especially poor prognosis, with only two per cent 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.”
The Japanese regulatory approval for Imfinzi is supported by Phase 3 CASPIAN trial
The Japanese Ministry of Health, Labour and Welfare has approved the drug regimen based on results from the Phase 3 CASPIAN trial, which showed that Imfinzi plus chemotherapy significantly improved the overall survival (OS) compared to chemotherapy alone.
The clinical trial administered a fixed dose of Imfinzi (1,500mg) every three weeks for four cycles, while a combination of the drug with chemotherapy is administered for every four weeks until disease progression.
In the CASPIAN trial, the drug reduced 27% risk of death compared to chemotherapy alone, with 13.0 months median OS than 10.3 months for chemotherapy alone, in 805 patients with ES-SCLC.
The company said that the efficacy and safety results for Japanese patients in the clinical trial were consistent with the overall trial population in a prespecified analysis.
Furthermore, AstraZeneca has obtained the US FDA Priority Review for Imfinzi, for a new four-week, fixed-dose use to treat non-small cell lung cancer (NSCLC) and bladder cancer.
Phase 3 CASPIAN trial investigator Makoto Nishio said: “Patients with extensive-stage small-cell lung cancer in Japan are in urgent need of new options that can provide long-term tumour control and sustained improvements in overall survival.
“This approval of Imfinzi provides Japanese patients with a new, effective and well-tolerated 1st-line treatment option for this disease, and for the first time physicians have the opportunity to combine immunotherapy with cisplatin for these patients.”