The drugmaker said Monday that the FDA had approved Imfinzi, its PD-L1 inhibitor, for first-line extensive-stage small cell lung cancer, with platinum chemotherapy. The drug creates a new competitive threat to Roche's Tecentriq, which is approved for the same disease setting.
The FDA gave priority review to the British drugmaker's application for Imfinzi in first-line extensive-stage SCLC. Data published last month showed a statistically significant improvement in overall survival for the drug plus chemotherapy compared with chemotherapy alone.
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The company said Imfinzi and chemotherapy, with or without tremelimumab, extended progression-free survival in first-line non-small cell lung cancer versus chemotherapy, setting up Imfinzi as a potential competitor to Merck's Keytruda. Overall survival data are expected next year.
Data for AstraZeneca's Imfinzi showed an improvement in overall survival and duration of response in patients with first-line extensive-stage small-cell lung cancer. Roche's Tecentriq already has approval in that indication.
The company said Wednesday that the pairing of PD-L1 inhibitor Imfinzi and CTLA-4 inhibitor tremelimumab did not prolong overall survival in previously untreated metastatic non-small cell lung cancer. The Phase III results are the latest in a string of failures for the combination.
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The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche's Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases.
The studies - in lung and head and neck cancers - produced negative results late last year. Several Phase I Imfinzi and tremelimumab studies were also removed, but others were added to the company's pipeline.
The company pointed to better survival numbers in patients with high tumor mutational burden, in a presentation at the ESMO immuno-oncology congress in Geneva.
Results of the Phase III EAGLE study leave Merck's Keytruda and Bristol's Opdivo as the dominant players in the space of HNSCC after progression on platinum-based chemotherapy.
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