Bristol Stuck In Waiting Game As Opdivo TMB Gamble Fails To Pay Off
Withdrawal of filing of CheckMate 227 data in patients with high tumor mutational burden (TMB) means another delay for Opdivo in first-line lung cancer.
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Merck has secured FDA approval for Keytruda for use in tumors with high tumor mutational burden, something Bristol's Opdivo and AstraZeneca's Imfinzi were not able to do in lung cancer.
The Checkmate-227 results surprised with an OS benefit for Opdivo plus Yervoy in first-line NSCLC and a miss for the Opdivo-chemotherapy combination. Bristol reported a solid quarter, with growth for IO, Eliquis.
Updated data from PIVOT-02 at the ASCO GU meeting suggest a path for accelerated approval of the NKTR-214/Opdivo combination as first-line treatment of patients with PD-L1-negative urothelial cancers.