Bristol Myers Squibb (NYSE: BMY) and Nektar Therapeutics (NASDAQ: NKTR) today announced an update following the first analysis of the Phase 3 PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma. Following a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers Squibb and Nektar were informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR). The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis.
Given there was no additional clinical benefit in the doublet therapy arm compared to the monotherapy arm for the primary endpoints of PFS and ORR, and based on the data reviewed by the DMC, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint. Additionally, based on the results from PIVOT IO-001, the companies have also made the decision to discontinue enrollment and unblind the ongoing PIVOT-12 study in adjuvant melanoma, which is evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo compared to Opdivo monotherapy in patients at high risk for recurrence after complete resection of melanoma. Patients in both studies will be counseled on their treatment options, and permitted to continue treatment if agreed to with their physician.
The companies will review the data and plan to share the results with the scientific community.
“As a leader in developing innovative therapies for patients with cancer, we have continued to explore novel strategies that may expand treatment benefits to more patients with advanced disease,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “We are disappointed with the results of this trial, which we had hoped would lead to a new therapeutic option to treat metastatic melanoma. We express our gratitude to the patients, caregivers and investigators who chose to participate in these trials.”
The other four studies ongoing for bempegaldesleukin plus Opdivo in renal cell carcinoma and bladder cancer are continuing.
“While we are surprised and deeply disappointed in these results for the melanoma study, we will continue to await initial results from our first two ongoing studies in renal cell carcinoma and urothelial cancer, which are currently expected in the first half of 2022,” said Jonathan Zalevsky, chief research and development officer of Nektar Therapeutics. “We look forward to collaborating with BMS to evaluate the data from these other studies to guide the future development of bempegaldesleukin. Nektar remains dedicated to the development of therapeutics to treat cancer and auto-immune disease.”
About PIVOT IO-001
PIVOT IO-001 is a randomized Phase 3 study evaluating the combination of bempegaldesleukin in combination with Opdivo versus Opdivo alone in patients with previously untreated unresectable or metastatic melanoma. The study is sponsored and conducted by Bristol-Myers Squibb. A total of 783 patients were randomized 1:1 to receive a combination of bempegaldesleukin 0.006 mg/kg and Opdivo 360 mg or Opdivo 360 mg by intravenous infusion every three weeks in an outpatient setting. Patients were treated until disease recurrence, unacceptable toxicity or withdrawal of consent for up to 24 months.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
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