Nektar Therapeutics (NASDAQ:NKTR) and Bristol-Myers Squibb Company (NYSE:BMY) announced today the companies have agreed to a new joint development plan to advance bempegaldesleukin (bempeg) plus Opdivo (nivolumab) into multiple new registrational trials.
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The revision to the strategic collaboration agreement includes a new joint development plan under which Nektar and Bristol-Myers Squibb will expand the active clinical development program for bempeg plus nivolumab from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and in muscle-invasive bladder cancer. In addition, a Phase 1/2 dose escalation and expansion study will be initiated to evaluate bempeg plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. The costs for these studies will be shared based upon the cost-sharing outlined in the terms of the original collaboration agreement. Also as part of the new strategic collaboration agreement, Bristol-Myers Squibb will independently conduct and fund a Phase 1/2 dose optimization and expansion study in first-line non-small-cell lung cancer with bempeg and nivolumab.
“Bristol-Myers Squibb and Nektar view bempeg as an important asset and IL-2 as an important target,” said Fouad Namouni, M.D., head of oncology development, Bristol-Myers Squibb. “We look forward to expanding the registrational program currently underway for bempeg and are committed to the development of potential new combination therapies to address the unmet needs of patients living with cancer.”
“We are pleased to move forward with this new set of registrational trials for bempeg, including the addition of an important Phase 3 study in adjuvant melanoma which builds on the existing metastatic melanoma study and our Breakthrough Therapy Designation,” said Nektar President & CEO Howard W. Robin. “We now have a comprehensive plan to target multiple indications and have the opportunity to continue to collaborate on development with other companies in indications outside of those in the BMS and Nektar joint development program.”