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CompileDraven
Recently, Bristol Myers Squibb (Bristol-Myers Squibb, BMS) and Nektar Therapeutics (Nektar) announced the failure of the Phase 3 PIVOT IO-001 clinical trial and discontinued another Phase 3 PIVOT-12 open-label trial
Both trials tested the immunotherapy drug bempegaldesleukin (bempeg, NKTR-214) in combination with Opdivo (nivolumab) in unresectable or metastatic melanoma and in completely resected but high-risk melanoma, in combination with Opdivo (nivolumab).
The PIVOT IO-001 trial involved 783 patients receiving Opdivo or the Opdivo/bempeg combination intravenously every three weeks
The companies announced they would unblind the clinical trial due to the data, and said they planned to share the data with the scientific community for transparency and continuous improvement
The failure of these two melanoma trials could bode ill for the other four Opdivo studies currently underway
Last week, Opdivo was approved by the U.
Opdivo has previously shown promise in several of these studies
Jonathan Zalevsky, chief research and development officer at Nektar, said that he will continue to await preliminary results from the first two ongoing studies in renal cell carcinoma and urothelial carcinoma, which are currently expected to be completed in the first half of 2022, and look forward to working with BMS to evaluate these other studies.
Separately, last week Merck announced that its Keytruda drug showed significant improvement in patients in a phase 3 trial to remove melanoma
Reference source: Two Melanoma Trials Fall as BMS and Nektar Report Disappointing Results