Opdivo Combo Fails in the Phase 3

Nektar Therapeutics will make “significant adjustments” to its operations in the coming weeks as a result of “extremely disturbing” results indicating the medicine bempegaldesleukin failed a phase 3 study that was testing it in combination with Bristol Myers Squibb’s Opdivo. On Monday morning, Nektar CEO and President Howard Robin stated the biotech was “very startled” by the results of the failed late-stage study during an investor update.

According to Robin, the executive team at partner BMS was astounded by the results, stating that the trial failure was “unexpected for all of us.” Investors, too, were taken aback. Nektar’s stock plummeted 53 percent to $4.97 per share at 9:31 a.m. ET on the first day of trading. In patients with previously untreated unresectable or metastatic melanoma, the long-acting interleukin-2 medication, called bempeg for short, failed to meet all three primary objectives of the late-stage experiment.

That implies the medicine, which is an improved version of Clinigen’s Proleukin, failed to offer an objective response, maintain patients alive without disease progression, or result in a statistically significant improvement in overall survival. The PIVOT IO-001 research enrolled 783 patients who were given either the combination treatment or Opdivo by IV infusion every three weeks for up to 24 months.

Nektar will now make “significant changes” to lengthen the biotech’s runway, Robin said on the investor call, and will have more details on operational shifts in the coming weeks. According to the CEO, the company had roughly $800 million in cash by the end of 2021 and will be able to support itself until at least the end of 2024. The study has been tagged by William Blair analysts as having “the highest potential of success for the bempegaldesleukin franchise.”