Bristol-Myers Squibb, Nektar partner to assess combination of Opdivo, NKTR-214
Bristol-Myers Squibb and Nektar Therapeutics on Tuesday announced a collaboration to evaluate the combination of the former's Opdivo (nivolumab) and the latter's investigational medicine NKTR-214 for the treatment of five tumour types and seven potential indications. Bristol-Myers Squibb's head of oncology Fouad Namouni said "we believe that a combination regimen which utilises two different and complementary mechanisms designed to harness the body's own immune system to fight cancer has the potential to provide new treatment options for patients."
In the collaboration, the companies indicated that they will conduct Phase I/II studies to compare the efficacy and safety of Opdivo and NKTR-214 with the current standard of care in patients with melanoma, kidney cancer, colorectal cancer, bladder cancer or non-small-cell lung cancer. The drugmakers further noted that an initial dose-escalation study of the combination regimen has been initiated.
The companies will equally share the costs of the clinical studies, while Nektar will retain commercialisation rights to NKTR-214. Nektar chief scientific officer Steve Doberstein noted that Bristol-Myers Squibb will have the first right over the next two years to negotiate a licence for the therapy over a three-month period, as well as an option to match any other company's offer for the drug within 90 days until the end of September, 2018. Other financial terms of the collaboration were not disclosed.
Opdivo was initially approved in 2014 by Japanese regulators for the treatment of patients with unresectable melanoma. The PD-1 inhibitor was later granted accelerated approval for the treatment of patients with unresectable or metastatic melanoma in the US, where it has since been cleared for squamous and non-squamous non-small-cell lung cancer in patients who disease progressed during or after platinum-based therapy. The drug has also been approved in Europe for use in patients with advanced melanoma. (For some recent analysis on Opdivo, read ViewPoints: Aggressive development strategy with Opdivo comes back to bite Bristol-Myers Squibb.)
Meanwhile, the drugmakers indicated that a Phase I/II study of NKTR-214 as monotherapy in patients with cancer is ongoing.