Nektar Therapeutics and Bristol-Myers Squibb Company have entered a revised strategic collaboration agreement to expand the clinical development programme for bempegaldesleukin (bempeg) plus Opdivo (nivolumab).
Under the revised agreement, the two companies will add two additional registrational trials of bempeg plus nivolumab in adjuvant melanoma and in muscle-invasive bladder cancer.
The programme already includes three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer, and first-line metastatic renal cell carcinoma (RCC).
Furthermore, the two companies agreed to begin a Phase I/II dose-escalation and expansion study to assess the combination with axitinib in first-line RCC.
Nektar and Bristol-Myers Squibb will share the cost of these trials as agreed in the original collaboration agreement.
The revised agreement also enables Bristol-Myers Squibb to carry out a Phase I/II dose optimisation and expansion study in first-line non-small-cell lung cancer with bempeg and nivolumab.
Nektar president and CEO Howard Robin said: “We are pleased to move forward with this new set of registrational trials for bempeg, including the addition of an important Phase III study in adjuvant melanoma which builds on the existing metastatic melanoma study and our breakthrough therapy designation.
“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 programme.”
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that utilises the body’s own immune system to combat multiple forms of cancer.
Bempeg is also an investigational anti-cancer drug candidate that supports the growth of cancer-killing immune cells called as CD8+ effector T cells and natural killer (NK) cells.