The hope is that the therapy, NKTR-214, can be used with the checkpoint inhibitors to treat more than 20 types of cancer.
Two combinations the companies plan to assess are NKTR-214 plus Opdivo (nivolumab) and NKTR-214 plus Opdivo and Yervoy (ipilimumab). They will also look at combinations of NKRT-214 and other cancer therapies that each is developing.
The combinations will be tested in melanoma, kidney cancer, non-small cell lung cancer, bladder cancer, triple negative breast cancer, and other malignancies. Pivotal clinical trials in patients with renal cell carcinoma and melanoma are expected to start in mid-2018.
“We are excited to bring our leading capabilities and expertise in developing cancer therapies, together with Nektar’s innovative science, to jointly develop and commercialize the investigative drug [NKRT-214] in combination with Opdivo and Opdivo plus Yervoy,” Dr. Giovanni Caforio, the chairman and CEO of Bristol-Myers Squibb, said in a press release.
“With this commitment to the development of NKTR-214, we now have a third validated [cancer immunotherapy] mechanism that has demonstrated a clinical benefit in patients, and holds significant potential to expand the benefits that these immuno-oncology agents can bring to patients with cancer,” Caforio added.
NKTR-214 targets CD122, a receptor found on the surface of tumor-killing immune cells, including T-cells and natural killer cells. Targeting the receptor leads to the rapid expansion and mobilization of these cells into tumors, where they eliminate cancer cells.
The drug also increases immune cells’ ability to go after PD-1, a protein associated with many cancers. This makes it as a promising therapy to be used in combination with immune checkpoint inhibitors, which can prevent cancer from evading immune cell detection.
Preliminary data from a Phase 1/2 trial (NCT02869295) showed that NKTR-214 shrank the solid tumors of 40 percent of the patients treated with it. It also stabilized the cancer of the other 60 percent, even when it had progressed with other treatments.
Bristol-Myers Squibb and Nektar are evaluating a combination of NKTR-214 and Opdivo in the Phase 1/2 PIVOT trial (NCT02983045). Researchers are recruiting 350 participants at 63 sites in the United States, Canada, and Europe. They will test the combo in advanced non-small cell lung cancer, kidney cancer, bladder cancer, melanoma, and triple negative breast cancer.
“Bristol-Myers Squibb, the global leader in immuno-oncology [cancer immunotherapy], is the ideal collaborator to enable us to establish NKTR-214 as a backbone immunotherapy in the treatment of cancer,” said Howard Robin, the president and CEO of Nektar. “This strategic collaboration allows us to very quickly develop NKTR-214 with the leading approved PD-1 immune checkpoint inhibitor in numerous registrational trials.”