Bristol Claims A First With Opdivo In Neoadjuvant NSCLC
Co-Primary Endpoint Data May Support Early Approval
More lung cancer patients treated with neoadjuvant Opdivo plus chemotherapy had a pathologic complete response than those who received chemo alone. BMS will discuss the results with regulators.
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Opdivo gets approved by the US FDA for neoadjuvant non-small cell lung cancer, an important new early-stage indication for the anti-PD-1 agent that cleared the agency in roughly two months.
BMS reports event-free survival advantage, adding to earlier findings that Opdivo plus chemotherapy met statistical significance for pathologic complete response in the CheckMate-816 study.
iTeos presents early anti-TIGIT results, Affimed reports 100% response rate in Hodgkin lymphoma, Treovir will start a pivotal Phase II after Phase I pediatric glioma study, updates in KRAS-mutated cancers from Revolution Medicines and Cardiff Oncology, plus Opdivo plus chemo shows complete responses in neoadjuvant lung cancer and Lilly’s Retevmo is active in additional tumors.