AstraZeneca has announced that its combination of Imfinzi (durvalumab) and tremelimumab has failed to hit its key target in a late-stage trial assessing its potential in patients with late-stage lung cancer.
The drug giant reported that in the primary analysis population - patients with stage IV non-small cell lung cancer (NSCLC) whose blood TMB was 20 or more mutations per megabase - the combination did not meet the primary endpoint of improving overall survival (OS) compared to standard of care (SoC) chemotherapy.
On the plus side, the safety and tolerability profile for the combination of Imfinzi and tremelimumab was consistent with previous trials and AstraZeneca is set to submit the full results for presentation at a forthcoming medical meeting.
José Baselga, executive vice president, Oncology R&D said that the company are “fully committed to a deep analysis of the vast clinical and biomarker data from this trial to gain further insights to improve Immuno-Oncology approaches for patients with metastatic non-small cell lung cancer.”
The drug is also being tested as monotherapy in the Phase III PEARL trial, and in combination with chemotherapy with or without tremelimumab in the Phase III POSEIDON trial as part of an extensive late-stage Immuno-Oncology programme in Stage IV NSCLC.
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths. The disease is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.