Bristol-Myers Squibb said that the FDA placed a partial clinical hold on three studies investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma. The company noted that the regulator's decision affects the CheckMate-602, CheckMate-039 and CA204142 trials of the anti-PD-1 therapy, adding that it "will work closely with the FDA to address concerns."
Separately on Thursday, Celgene announced that the FDA placed a partial clinical hold on five studies and a full clinical hold on one trial investigating the anti-PD-L1 antibody Imfinzi (durvalumab) in combination with immunomodulatory and chemotherapy agents in blood cancers such as multiple myeloma, chronic lymphocytic leukaemia and lymphoma. Celgene entered into a deal in 2015 to develop AstraZeneca's Imfinzi for haematologic malignancies.
According to Bristol-Myers Squibb and Celgene, the FDA made the decision after earlier this year placing full clinical holds on combination trials of Merck & Co.'s similar therapy Keytruda (pembrolizumab) in patients with multiple myeloma. In the Keytruda studies, which include combinations with Celgene's Pomalyst (pomalidomide) and Revlimid (lenalidomide), more deaths were observed in patients who received the anti-PD-1 therapy. For related analysis, see ViewPoints: Loss of Merck & Co.'s Keytruda head start in MM not necessarily a win for competing anti-PD-(L)1 mAbs.
The FDA recently issued an update on the matter determining that based on current data, the risks of PD-1/PD-L1 treatment plus Pomalyst or Revlimid and possibly PD-1/PD-L1 treatments alone or with other combinations outweigh potential benefit for patients with multiple myeloma.
FirstWord reports in this therapy area - KOL Insight Multiple Myeloma: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Bristol-Myers Squibb indicated that the affected studies include one investigating Opdivo in combination with Empliciti (elotuzumab), Pomalyst and dexamethasone, as well as another in combination with Johnson & Johnson's Darzalex (daratumumab), with or without Pomalyst and dexamethasone, both in patients with relapsed or refractory multiple myeloma.
Meanwhile, Celgene said that the study placed on full clinical hold is investigating Imfinzi in combination with Revlimid with and without low-dose dexamethasone in patients with newly diagnosed multiple myeloma. Imfinzi studies placed on partial hold include one in combination with Darzalex in subjects with multiple myeloma, as well as another trial in combination with Revlimid and Roche and Biogen's Rituxan (rituximab) in patients with lymphoma or chronic lymphocytic leukaemia.
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