In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.
According to a press release dated July 19, 2021, AstraZeneca’s Imfinzi (durvalumab) has been approved by China’s National Medical Products Administration for the first-line treatment of adult patients in China with advanced small cell lung cancer (ES-SCLC) in combination with standard-therapy platinum chemotherapy ( Etoposide plus optionally carboplatin or cisplatin).
SCLC is an aggressive and rapidly growing type of lung cancer. Typically, despite an initial response to chemotherapy, it recurs and progresses rapidly. Approximately seven percent of all SCLC patients and three percent of those with ES-SCLC survive five years after diagnosis.
The CASPIAN phase III study found that Imfinzi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to chemotherapy alone. In June 2019, the CASPIAN phase III study reached the primary endpoint OS for Imfinzi plus chemotherapy. The risk of death was reduced by 27% compared to chemotherapy alone, with a median OS of 13.0 months versus 10.3 months with chemotherapy alone. These results were published in The Lancet in October 2019. In addition, the results from the Chinese patient cohort were consistent with the global results.
In the study, a fixed dose of Imfinzi (1500 mg) was given every three weeks for four cycles in combination with chemotherapy and then every four weeks as monotherapy until the disease got worse. Based on the results, Imfinzi has been approved as first-line therapy for ES-SCLC in combination with etoposide and either carboplatin or cisplatin in more than 55 countries, including the US, Japan and across the EU.