BMS and Nektar combination moving to phase III trials, despite questions over data.

In February, BMS signed a $3.6bn deal to pair NKTR-214 with Opdivo and its CTLA4 inhibitor Yervoy (ipilimumab) in a host of tumour types. Opdivo is still the biggest-selling drug in the PD’1/PD-L1 inhibitor category but has been losing ground to Merck & Co’s Keytruda (pembrolizumab).

The phase I/II PIVOT trial met the criteria necessary to move PD-1 inhibitor Opdivo (nivolumab) and CD122-biased agonist NKTR0214 into pivotal trials in melanoma, renal cell carcinoma and urothelial cancer, but a comparison of data from the trial reported last November showed a reduction in response rates. Nevertheless, BMS and Nektar are going ahead with the first phase III trials in melanoma in the third quarter, on what some believe is scant clinical evidence. Stage 1 of the trial is an initial assessment to monitor whether the combination has efficacy, and stage 2 involves the recruitment of additional patients to ascertain whether advancement into a full-blown phase III programme can be substantiated.

There are still questions to be answered over Opdivo/NKTR-214, and investors will be eagerly awaiting additional data from the PIVOT trials and a results update from Nektar at the Society for Immunotherapy of Cancer (SITC), which will be held in Washington DC in November.