AstraZeneca PLC said that its Imfinzi immunotherapy treatment for extensive-stage small-cell lung cancer has been approved in China for first-line treatment of adult patients, in combination with chemotherapy.
The pharmaceutical company said the approval by China’s National Medical Products Administration was based on positive results from the Caspian Phase 3 trial. The trial showed Imfinzi, together with chemotherapy, demonstrated a significant and clinically meaningful improvement in overall survival when compared to just chemotherapy alone.
Small-cell lung cancer is an aggressive and fast-growing lung cancer that often recurs and progresses rapidly despite initial chemotherapy responses. Only 3% of patients with the extensive-stage disease will be alive five years after diagnosis.
The trial, conducted in more than 200 centers across 23 countries, met its primary endpoint of overall survival in June 2019 when it reduced the risk of death by 27% when compared to chemotherapy alone. An updated analysis showed sustained efficiency after more than two years on average.
The results also showed an increased confirmed objective response rate for Imfinzi and chemotherapy of 68%, compared with 58% for chemotherapy alone, and the combination delayed the time taken for disease symptoms to worsen.