A Phase III non-small cell lung cancer trial is the latest to fail to show that a two-drug immunotherapy combination can extend patients’ lives.
London-based AstraZeneca said Wednesday that the NEPTUNE study, combining the PD-L1 inhibitor Imfinzi (durvalumab) with the CTLA-4 inhibitor tremelimumab in patients with previously untreated metastatic non-small cell lung cancer, did not meet its primary endpoint of showing an improvement in overall survival for the combination over standard-of-care platinum chemotherapy. The company did not release further details of the data, but said it would submit them for presentation at a forthcoming medical meeting.
The news did not appear to affect AstraZeneca’s share price on the New York Stock Exchange.
“We 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,” said Jose Baselga, AstraZeneca’s executive vice president for oncology research and development, in a statement.
Imfinzi is approved as a monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma patients whose disease has progressed after certain existing treatments. Other trials testing the drug in metastatic NSCLC include PEARL, investigating it as a monotherapy, and POSEIDON, testing Imfinzi and chemotherapy with or without tremelimumab.
Currently, there is one CTLA-4 inhibitor on the market, Bristol-Myers Squibb’s Yervoy (ipilimumab). Yervoy and BMS’ PD-1 inhibitor, Opdivo (nivolumab), are approved as a combination for metastatic melanoma, certain patients with kidney cancer and also in metastatic colorectal cancer patients with microsatellite instability high or mismatch-repair deficiency biomarkers. Opdivo, Merck & Co. PD-1 inhibitor Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab) are all approved for various settings of NSCLC.
The news about NEPTUNE marks one of multiple failures for the Imfinzi-tremelimumab combination, which if successful would be a competitor to BMS’ Opdivo and Yervoy. In December of last year, AstraZeneca announced that the EAGLE study of Imfinzi and tremelimumab in second-line head and neck cancer had failed, a month after the failure of the MYSTIC study looking at the two-drug combination in first-line NSCLC. Prior to those studies, in April 2018, the company said Imfinzi-tremelimumab also failed to prolong survival in the Phase III ARCTIC trial in third-line NSCLC.
Photo: blueringmedia, Getty Images
