AstraZeneca's Imfinzi and tremelimumab combination fails to meet primary endpoint in Phase III lung cancer trial
AstraZeneca announced final overall survival results from the Phase III NEPTUNE trial, showing the combination of Imfinzi and tremelimumab did not meet its primary endpoint in previously untreated Stage IV non-small cell lung cancer.
AstraZeneca has announced the final overall survival (OS) results from its Phase III NEPTUNE trial involving patients with Stage IV non-small cell lung cancer (NSCLC).
The trial investigated the combination of Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody, compared to standard-of-care (SoC) platinum-based chemotherapy in patients with no prior treatment for metastatic NSCLC. In the primary analysis, which focused on patients with a high tumor mutational burden (TMB) of 20 or more mutations per megabase, the combination therapy did not achieve its primary endpoint of improving OS compared to SoC chemotherapy.
The safety and tolerability profile of the Imfinzi and tremelimumab combination was consistent with previous trials. AstraZeneca stated its commitment to a thorough analysis of the trial's clinical and biomarker data to gain further insights for improving immuno-oncology approaches in metastatic NSCLC.
Full results will be submitted for presentation at an upcoming medical meeting. Imfinzi is also being evaluated in other ongoing Phase III trials, PEARL and POSEIDON, as part of AstraZeneca's broader immuno-oncology program for Stage IV NSCLC.