AstraZeneca plc (NYSE: AZN) faced a clinical setback in a study evaluating a combo drug regimen in non-small cell lung cancer, or NSCLC.
AstraZeneca said a Phase 3 study dubbed NEPTUNE that evaluated its PD-LI inhibitor Imfinzi in combination with tremelimumab, an anti-CTLA4 antibody, versus platinum-based chemotherapy – the current standard-of-care- in previously untreated Stage IV NSCLC did not meet the primary endpoint of improving overall survival.
The company noted that the primary analysis population was patients with a high tumor mutational burden.
The safety and tolerability profile of the combo, however, was consistent with previous trials.
AstraZeneca said it intends to do a deep analysis of the vast clinical and biomarker data from the trial to gain further insights to improve Immuno-oncology approaches for patients with metastatic NSCLC. The company will submit the full results for presentation at a forthcoming medical meeting.
Imfinzi is also being tested as monotherapy in a Phase 3 trial, dubbed PEARL, and in combination with chemotherapy with or without tremelimumab in the Phase 3 trial, dubbed POSEIDON, as part of an extensive late-stage Immuno-oncology program in Stage IV NSCLC.
Notwithstanding the negative catalyst, AstraZeneca shares were up 1.1% to $45.13& Wednesday morning.
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