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.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche's Tecentriq.
The PD-L1 inhibitor is the first new drug for ES-SCLC in more than 20 years. Meanwhile, Merck is also running a Phase III study of its PD-1 inhibitor in first-line ES-SCLC.
The news closely followed that of the FDA approving the first immunotherapy drug for cancer, Roche's Tecentriq, in combination with Abraxane.
The drug received accelerated approval for combination with Celgene's Abraxane based on Phase III data. According to a study, PD-L1-positive patients account for 26 percent of TNBC patients overall.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.