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BMS/Nektar ends $3.6 billion Opdivo combination therapy partnership
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Bristol-Myers Squibb and Nektar Therapeutics announced on April 18 that they have decided to close a pre-planned analysis of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer. bempegaldesleukin joins Opdivo in global clinical development program.
At the same time, all other ongoing clinical trials in the therapy’s known research and collaborative programs will cease.
In the Phase 3 PIVOT-09 clinical trial in patients with previously untreated advanced or metastatic RCC, the final analytical review of in-trial objective response rate (ORR) adjudicated after an independent data monitoring committee assessment showed that the The combination of bempegaldesleukin and Opdivo did not meet prespecified criteria for statistical significance compared to the control group (TKI).
In addition, interim analyses of overall survival (OS) with combination therapy did not meet any of the prespecified ranges for statistical significance in this patient population.
Therefore, given that the combination arm did not provide sufficient clinical benefit compared to the TKI arm, the companies ultimately decided to unblind the trial and will not conduct additional outcome analyses for the OS endpoint in the future.
The companies also conducted a separate Phase 2 PIVOT-10 clinical trial of the dual-agent combination of bempegaldesleukin and Opdivo in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma, Independent Data Monitoring Committee The final ORR analysis after the evaluation showed that the combination of bempegaldesleukin and Opdivo failed to meet the efficacy threshold to support the continuation of the trial.
Bristol-Myers Squibb entered into a clinical collaboration with Nektar as early as September 2016. The two parties jointly developed Opdivo and bempeg for the treatment of various types of cancer.
Bristol-Myers Squibb paid $1 billion upfront to buy $850 million worth of Netkar shares at $102.60 per share, with a promise that it could continue to pay up to $1.8 billion in future milestones.
Bempegaldesleukin is a CD122-biased IL-2 pathway agonist that stimulates the proliferation of anti-cancer immune cells in patients by targeting CD122-specific receptors on the surface of NK cells, CD4+ T cells, and CD8+ T cells.
Despite announcing the termination of the collaboration, the two sides said they would further review the data from the two studies and plan to share relevant trial results.
Just last month, following a review of the efficacy and safety of the combination therapy Phase 3 PIVOT IO-001 melanoma study by an independent data monitoring committee, it was found that the trial did not achieve progression-free survival (PFS) and objective response rate (ORR). ) primary endpoint, followed by the companies’ decision to discontinue enrollment and unblind the ongoing PIVOT-12 study in adjuvant melanoma.
In addition, other ongoing pilot studies of Opdivo in combination with bempegaldesleukin include a pivotal study in muscle-invasive bladder cancer (CA045-009), a Phase 1/2 study of a dual-agent TKI in 1LRCC ( CA045-011) and a Phase 1/2 study in relapsed and/or refractory pediatric tumors (CA045-020), which will also be phased out in the future.
Nektar Therapeutics : and Bristol Myers Squibb Announce Update on Clinical Development Program for Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) – Form 8-K
Trial results missed expectations: BMS/Nektar ends $3.6 billion Opdivo combination therapy partnership
(source:internet, reference only)