Trial of combination for advanced melanoma fails to meet endpoints
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A phase 3 trial designed to assess the addition of bempegaldesleukin to nivolumab for previously untreated unresectable or metastatic melanoma failed to meet its primary endpoint, according to the agents’ manufacturers.
The combination failed to improve PFS or objective response rates as assessed by blinded central review, according to results from the first analysis of the phase 3 PIVOT IO-001 study.
In addition, the trial did not meet the third primary endpoint of improved OS at the first interim analysis.
Bempegaldesleukin (NKTR-214, Nektar Therapeutics) is an investigational CD122-preferential IL-2 pathway agonist. Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 immune checkpoint inhibitor that is approved in the United States for treatment of several cancers.
The PIVOT IO-001 study included 783 patients with previously untreated unresectable or metastatic melanoma. Researchers randomly assigned half of the patients to 0.006 mg/kg bempegaldesleukin and 360 mg nivolumab via IV every 3 weeks. The other half received nivolumab alone.
Treatment continued for up to 24 months, or until disease recurrence, unacceptable toxicity or consent withdrawal.
Due to the lack of additional benefit with the doublet therapy regimen, Nektar Therapeutics and Bristol Myers Squibb decided to unblind the trial. The companies will perform no additional OS analyses.
In addition, the companies discontinued enrollment in and unblinded the ongoing PIVOT-12 study, designed to evaluate the addition of bempegaldesleukin to nivolumab for patients with melanoma at high risk for recurrence after complete resection.
Four other ongoing studies evaluating bempegaldesleukin plus nivolumab for patients with renal cell carcinoma or bladder cancer will continue. Initial results from these trials are expected later this year.
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