Human melanoma. Credit: Dr Timothy Triche/National Cancer Institute.

Nektar Therapeutics and Bristol-Myers Squibb (BMS) have reported interim results from the Phase I/II PIVOT-02 trial of NKTR-214 in combination with Opdivo in patients suffering from stage IV melanoma, renal cell carcinoma and non-small cell lung cancer (NSCLC).

Opdivo is BMS’ PD-1 immune checkpoint inhibitor, while Nektar’s NKTR-214 is an immuno-stimulatory agent designed to directly expand and trigger specific cancer-fighting T-cells and natural killer (NK) cells in the tumour micro-environment and enhance cell-surface PD-1 expression on these immune cells.

The dose-escalation phase of the ongoing PIVOT trial included a total of 38 patients whose responses were measured per RECIST 1.1.

When treated with the investigational combination, 63% of subjects suffering from stage IV melanoma demonstrated responses with a disease control rate (DCR) of 91%, while 75% stage IV I-O naïve NSCLC showed responses and 75% DCR.

“These initial findings underscore the potential benefit of the combination of Opdivo and NKTR-214 across several tumour types.”

In 46% of stage IV renal cell carcinoma patients who showed responses, the DCR was 85%, and only 14% stage IV I-O naïve patients had a response with 100% DCR.

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Bristol-Myers Squibb Oncology Development head Fouad Namouni said: “These initial findings underscore the potential benefit of the combination of Opdivo and NKTR-214 across several tumour types.

“We believe that a combination regimen, which utilises two different, complementary, and non-overlapping mechanisms designed to harness the body’s own immune system to fight cancer has the potential to benefit patients and should be the subject of additional research.”

The results indicated no treatment discontinuations due to adverse events (AEs) or study deaths, with the common AEs being fatigue, flu-like symptoms, rash and pruritus.

PIVOT-02 established a recommended Phase II dose of NKTR-214 0.006mg/kg with Opdivo at 360mg, which is being assessed in more than ten patient groups with melanoma, renal cell carcinoma, NSCLC, bladder and triple-negative breast cancers.