Phase III CheckMate -816 study of Opdivo + chemo shows positive response in NSCLC.- BMS

Bristol Myers Squibb announced results from the phase III CheckMate -816 study, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). In the study, 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR, compared to 2.2% of patients treated with chemotherapy alone (Odds Ratio [OR] 13.94, 99% Confidence Interval [CI]: 3.49–55.75; p<0.0001), with pcr defined as no evidence of cancer cells in their resected tissue as assessed by a blinded independent pathology review. additionally, opdivo plus chemotherapy was well tolerated and showed consistent improvements in pcr regardless of pd-l1 expression levels, histologies or stages of disease. opdivo plus chemotherapy also demonstrated improvements in key secondary endpoints, including major pathological response (mpr). four times as many patients treated with opdivo plus chemotherapy vs. chemotherapy alone achieved mpr (36.9% vs 8.9%; or 5.70, 95% ci: 3.16-10.26), meaning 10% or less of their tumor cells remained after neoadjuvant therapy. three cycles of opdivo plus chemotherapy were associated with a tolerable safety profile, and no new safety signals were observed. further, in this trial, more patients who received neoadjuvant opdivo plus chemotherapy underwent surgery (83% vs. 75% with chemotherapy), showing that the addition of opdivo did not decrease the feasibility of performing surgery. in addition, the number of patients whose tumors were completely resected (r0) was higher with opdivo plus chemotherapy vs. chemotherapy (83% vs. 78%). rates of surgery-related adverse events were similar between the two treatment arms. checkmate -816 represents the first randomized phase iii study to show a significant improvement in pathological response with a neoadjuvant immunotherapy combination in patients with resectable nsclc. the first disclosure of these data will be featured in an oral presentation during the clinical trials plenary session (abstract #5218) at the american association for cancer research (aacr) annual meeting 2021 on saturday, april 10, 2021 from 12:30-12:45 p.m. edt.>