AZ received one more approval in Japan, received approval of Imfinzi for SCLC
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.
For pipeline, market overview, SLRs, and market access reports (syndicate and customised) please write to firstname.lastname@example.org
For all syndicate reports: Click here