LBA2 Clinical outcomes with perioperative nivolumab (NIVO) in patients (PTS) with resectable NSCLC from the phase III CheckMate 77T study

In CheckMate 77T, perioperative NIVO demonstrated statistically significant and clinically meaningful EFS benefit vs neoadjuvant (neoadj) chemo followed by adjuvant (adj) placebo (PBO) in pts with resectable NSCLC (HR 0.58, 97.36% CI 0.42–0.81; P = 0.00025). pCR and MPR rates were also improved with perioperative NIVO. Here, we report clinical outcomes by number of neoadj treatment (tx) cycles. Adults with untreated, resectable stage IIA–IIIB NSCLC (AJCC 8th ed) were randomized 1:1 to NIVO 360 mg Q3W + chemo (4 cycles) followed by adj NIVO 480 mg Q4W (1 y) or PBO Q3W + chemo (4 cycles) followed by adj PBO Q4W (1 y). Primary endpoint: EFS. Exploratory analyses: pCR, MPR, EFS, TTDM, and safety by number of completed neoadj tx cycles (< 4 and 4); TTDM in randomized pts (prespecified) and by pathologic response. Of 461 randomized pts (median f/u 25.4 mo), 191 (83%; NIVO) and 205 (88%; chemo) completed 4 cycles of neoadj tx; the majority of pts who discontinued neoadj tx did so due to study drug toxicity. Baseline characteristics were similar for pts who completed < 4 or 4 cycles of neoadj tx in both tx arms, except that a higher proportion of pts who completed < 4 cycles were from Asia. In pts who completed < 4 cycles of neoadj tx (NIVO, 38; chemo, 27), pCR, MPR, and EFS favored NIVO vs chemo (table); 53% and 37% had surgery, respectively, and among these pts, pCR rates were 35% vs 0% and MPR rates were 40% vs 0%. In pts who completed 4 cycles of neoadj tx, pCR, MPR, and EFS were improved with NIVO vs chemo (table). TTDM favored NIVO vs chemo in all randomized pts (HR 0.62, 95% CI 0.44–0.85) and regardless of number of completed neoadj tx cycles or pCR/MPR status (data to be presented). No new safety signals were seen.Table: LBA2< 4 cycles4 cyclesNIVO (n = 38)chemo (n = 27)NIVO (n = 191)chemo (n = 205)pCR, % (95% CI)18.4 (7.7-34.3)0 (0-12.8)26.7 (20.6-33.6)5.4 (2.7-9.4)MPR, % (95% CI)21.1 (9.6-37.3)0 (0-12.8)38.2 (31.3-45.5)13.7 (9.3-19.1)Pts who received surgery, n (%)20 (53)10 (37)158 (83)168 (82) pCR, % (95% CI)35.0 (15.4–59.2)032.3 (25.1–40.2)6.5 (3.3–11.4) MPR, % (95% CI)40.0 (19.1–63.9)046.2 (38.2–54.3)16.7 (11.4–23.2)mEFS, mo (95% CI)NR (10.8–NR)7.8 (2.2–NR)NR (28.9–NR)19.8 (14.4–28.2) HR (95% CI)0.51 (0.23–1.11)0.57 (0.42–0.79) 12-mo EFS rate, %62367661mTTDM, mo (95% CI)NR (16.5–NR)10.9 (3.4–22.2)NR (NR–NR)38.8 (22.3–NR) HR (95% CI)0.46 (0.22–0.98)0.61 (0.42–0.88) Open table in a new tab In these exploratory analyses from CheckMate 77T, perioperative NIVO showed clinical benefit in pts with resectable NSCLC, including those who received < 4 cycles of neoadj NIVO + chemo, further supporting perioperative NIVO as a tx option for this pt population.