Promising Early results with BEMPEG/Nivo in Melanoma

Updated results of an early-phase trial showing positive outcomes for melanoma patients treated with an investigational anti-cancer drug plus the checkpoint inhibitor nivolumab could be promising for kidney cancer patients too.

People diagnosed with renal cell carcinoma (RCC) are at increased risk for developing melanoma, and vice versa. The cancers share some genetic characteristics and respond to many of the same therapies, including nivolumab.

Researchers presented results from the phase 1/2 PIVOT-02 study during the recent Society for Immunotherapy of Cancer meeting. This study evaluated the safety and clinical activity of nivolumab plus bempegaldesleukin (also called BEMPEG or NKTR-214), which stimulates the immune system to fend off cancer cells by helping increase production of T cells and natural killer (NK) cells.

After 18 months of follow up, people enrolled in PIVOT-02 had a complete response rate of 34% – meaning no target lesions were detected – and over half saw a reduction in their tumor burden. The researchers were not yet able to determine median progression-free survival and the study is ongoing.

“These data demonstrate the potentially powerful anti-tumor effect of this combination,” said Dr. Brian Rini, a urologic oncologist, chief of Clinical Trials at Vanderbilt-Ingram Cancer Center, and a member of the KCA’s Medical Steering Committee.

“In RCC, the combination has shown activity although we need to see more RCC-specific data to know if this combination will advance our current options.”

This BEMPEG/nivolumab combination, produced by Nektar Therapeutics and Bristol-Myers Squibb, respectively, received breakthrough therapy designation earlier this year from the FDA for patients with metastatic melanoma, and there are a number of clinical trials open to test it in several types of cancer, including RCC.