The Japanese Ministry of Health, Labor, and Welfare approved AstraZeneca’s Imfinzi (durvalumab) for treating patients with extensive-stage small-cell lung cancer (ES-SCLC). The drug is administered in combination with etoposide plus platinum chemotherapy (either carboplatin or cisplatin).
The approval is based on the Phase 3 CASPIAN trial, which enrolled 805 patients. The trial demonstrated a statistically significant improvement in the overall survival compared to chemotherapy. Patients were randomized in 1:1:1 ratio, durvalumab plus platinum–etoposide; durvalumab plus tremelimumab plus platinum–etoposide; or platinum–etoposide alone. Overall survival is considered as the primary endpoint. Durvalumab plus platinum–etoposide showed statistical improvement in the overall survival; median overall survival was 13 months in the durvalumab plus platinum-etoposide arm compared to 10.3 months in the platinum-etoposide group. The CASPIAN is a multicenter trial conducted across 23 countries, which included several locations in Japan.
About small cell lung cancer:
Lung cancer is the leading cause of death; 119,000 people were diagnosed with lung cancer in 2018 in Japan. Fifteen percent of lung cancer is small cell lung cancer; 85% of the patients are categorised as non-small cell lung cancer. Only six percent of the patients alive five years after the initial diagnosis.
Imfinzi is a monoclonal antibody, acts by inhibiting PD-L1 with PD-1 and CD80. The drug was approved for NSCLC in the US, Japan, China, Europe, based on PACIFIC trial.
The drug is in Phase 3 trials for biliary cancer, bladder cancer, cervical cancer, endometrial cancer, fallopian cancer, head and neck cancer, liver cancer, ovarian cancer, and renal cancer.
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