New Collaboration Will Evaluate Combination of Opdivo and NKTR-214

Regimen will target five tumor types and have seven indications

A new clinical collaboration will evaluate nivolumab (Opdivo, Bristol-Myers Squibb) in combination with the investigational medicine NKTR-214 (Nektar Therapeutics) as a potential treatment regimen in five tumor types and for seven potential indications.

Nivolumab is a programmed cell death-1 (PD-1) immune checkpoint inhibitor designed to overcome immune suppression. NKTR-214 is an investigational immunostimulatory therapy designed to expand specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor microenvironment and increase expression of PD-1 on these immune cells.

“We are excited to explore the potential benefits in multiple types of cancer of the combination of Opdivo with Nektar’s innovative cancer immunotherapy,” said Fouad Namouni, MD, Head of Oncology at Bristol-Myers Squibb. “We believe that a combination regimen which utilizes 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.”

The phase 1/2 clinical trials will evaluate the potential for the combination of nivolumab and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, colorectal, bladder, and non–small-cell lung cancer patients. An initial dose-escalation trial is under way with nivolumab and NKTR-214.

Bristol-Myers Squibb and Nektar will share costs of the combined therapy trials equally. Nektar will maintain its global commercial rights to NKTR-214.

“We’re very pleased to be collaborating with Bristol-Myers Squibb … in order to advance quickly the development of NKTR-214 with a PD-1 immune checkpoint inhibitor,” said Howard W. Robin, President and CEO of Nektar Therapeutics. “NKTR-214 is designed to grow tumor infiltrating lymphocytes (TILs) in vivo and replenish the immune system, which is critically important as many patients battling cancer lack sufficient TIL populations to benefit from approved checkpoint inhibitor therapies. The combination of checkpoint inhibition with T cell growth could lead to synergistic effects that may provide a new treatment option for patients.”

Nivolumab was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 54 countries including the United States, Japan, and in the European Union.

NKTR-214 is an experimental therapy designed to stimulate cancer-killing immune cells in the body by targeting CD122-specific receptors found on the surface of these immune cells, known as CD8+ effector T cells and NK cells. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor microenvironment. NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines. A phase 1/2 clinical study is ongoing to evaluate single-agent NKTR-214 in cancer patients.

Source: Bristol-Myers Squibb; September 27, 2016.