Bristol-Myers Squibb (BMS)’s Opdivo® (nivolumab) and Nektar Therapeutics’ NKTR-214 will be assessed in Phase I/II trials as a combination regimen in five tumor types and seven potential indications, the companies said today, through a collaboration whose value was not disclosed.
The trials will evaluate the ability of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above current standard of care in patients with melanoma, kidney, colorectal, bladder, and non-small-cell lung cancer, the companies said. An initial dose-escalation trial is underway.
“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,” Fouad Namouni, M.D., BMS’ head of oncology development, said in a statement.
BMS and Nektar have agreed to share costs of the trials equally, with Nektar maintaining global commercial rights to NKTR-214.
NKTR-214 is designed to stimulate cancer-killing immune cells by targeting CD122-specific receptors found on the surface of these immune cells, known as CD8+ effector T cells and natural killer (NK) cells, directly in tumors, thus increasing expression of programmed death 1 (PD-1) on these immune cells. Necktar has an ongoing Phase I/II study to evaluate single-agent NKTR-214 in cancer patients.
Opdivo is a marketed PD-1 immune checkpoint inhibitor designed to overcome immune suppression. Opdivo generated $1.544 billion in worldwide product revenue for BMS in the first half of this year and $942 million last year. Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 and now has regulatory approval in 54 countries including the U.S., the EU, and Japan.
Last month, BMS acknowledged that Opdivo failed a Phase III trial assessing its effectiveness as a monotherapy in patients with previously untreated advanced non-small-cell lung cancer (NSCLC). BMS said at the time that its development program for Opdivo would include numerous combination therapy trials, with CEO Giovanni Caforio telling Bloomberg: “The role of monotherapy might be limited to a very small subset of patients in the first-line setting, which makes our program now ideally suited to address the next question, which is: ‘What is the role of combination therapy?”