Perioperative Nivolumab in Resectable Lung Cancer

Author(s): Tina Cascone, M.D., Ph.D., Mark M. Awad, M.D., Ph.D., Jonathan D. Spicer, M.D., Ph.D., Jie He, M.D., Ph.D., Shun Lu, M.D., Ph.D., Boris Sepesi, M.D., Fumihiro Tanaka, M.D., Ph.D., Janis M. Taube, M.D., Robin Cornelissen, M.D., Ph.D. https://orcid.org/0000-0002-4289-3092, Libor Havel, M.D., Nina Karaseva, M.D., Jaroslaw Kuzdzal, M.D., Ph.D., Lubos B. Petruzelka, M.D., Ph.D., Lin Wu, M.D., Jean-Louis Pujol, M.D., Ph.D., Hiroyuki Ito, M.D., Ph.D., Tudor-Eliade Ciuleanu, M.D., Ph.D., Ludmila de Oliveira Muniz Koch, M.D., Annelies Janssens, M.D., Ph.D., Aurelia Alexandru, M.D., Sabine Bohnet, M.D., Fedor V. Moiseyenko, M.D., Ph.D., Yang Gao, M.D., Ph.D., Yasutaka Watanabe, M.D., Ph.D., Cinthya Coronado Erdmann, M.D., Padma Sathyanarayana, Ph.D., Stephanie Meadows-Shropshire, Ph.D., Steven I. Blum, M.B.A., M.A., and Mariano Provencio Pulla, M.D., Ph.D., for the CheckMate 77T Investigators†
Source: DOI: 10.1056/NEJMoa2311926
Anjan J Patel MD

Dr. Anjan Patel's Thoughts

Perioperative nivolumab (Nivo) showed a 20% 18-month EFPS improvement. This is another option to consider for your patients with stage IIA-IIIB NSCLC. Of note, the study arm received chemo + Nivo x 4 cycles preoperatively, then 12 months of Nivo therapy, and toxicities were as expected.

BACKGROUND

Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable non–small-cell lung cancer (NSCLC). Perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes.

METHODS

In this phase 3, randomized, double-blind trial, we assigned adults with resectable stage IIA to IIIB NSCLC to receive neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary outcome was event-free survival according to blinded independent review. Secondary outcomes were pathological complete response and major pathological response according to blinded independent review, overall survival, and safety.

RESULTS

At this prespecified interim analysis (median follow-up, 25.4 months), the percentage of patients with 18-month event-free survival was 70.2% in the nivolumab group and 50.0% in the chemotherapy group (hazard ratio for disease progression or recurrence, abandoned surgery, or death, 0.58; 97.36% confidence interval [CI], 0.42 to 0.81; P<0.001). A pathological complete response occurred in 25.3% of the patients in the nivolumab group and in 4.7% of those in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97); a major pathological response occurred in 35.4% and 12.1%, respectively (odds ratio, 4.01; 95% CI, 2.48 to 6.49). Grade 3 or 4 treatment-related adverse events occurred in 32.5% of the patients in the nivolumab group and in 25.2% of those in the chemotherapy group.

CONCLUSIONS

Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC. No new safety signals were observed. (Funded by Bristol Myers Squibb; CheckMate 77T ClinicalTrials.gov number, NCT04025879.)

Author Affiliations

From the University of Texas M.D. Anderson Cancer Center, Houston (T.C., B.S.); Dana–Farber Cancer Institute, Boston (M.M.A.); McGill University Health Centre, Montreal (J.D.S.); the National Cancer Center–National Clinical Research Center for Cancer–Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai (S.L.), and Hunan Cancer Hospital (L.W.) and Xiangya Hospital, Central South University (Y.G.), Changsha — all in China; the University of Occupational and Environmental Health, Kitakyushu (F.T.), Kanagawa Cancer Center, Yokohama (H.I.), and Saitama Cancer Center, Saitama (Y.W.) — all in Japan; Bloomberg–Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (J.M.T.); Erasmus MC Cancer Institute, Rotterdam, the Netherlands (R.C.); Thomayer Hospital (L.H.) and Charles University (L.B.P.) — both in Prague, Czech Republic; St. Petersburg State Budgetary Healthcare Institution, Clinical Oncology Dispensary (N.K.), and St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (F.V.M.) — both in St. Petersburg, Russia; Jagiellonian University Collegium Medicum, John Paul II Hospital, Krakow, Poland (J.K.); Montpellier Regional University Hospital, Montpellier, France (J.-L.P.); Prof. Dr. Ion Chiricuta and Universitatea de Medicina si Farmacie Iuliu Hatieganu, Cluj-Napoca (T.-E.C.), and Institutul Oncologic București Prof. Dr. Alexandru Trestioreanu, Bucharest (A.A.) — both in Romania; Hospital Israelita Albert Einstein, São Paulo (L.O.M.K.); Antwerp University Hospital, Edegem, Belgium (A.J.); Universitätsklinikum Schleswig-Holstein, Lübeck, Germany (S.B.); Bristol Myers Squibb, Princeton, NJ (C.C.E., P.S., S.M.-S., S.I.B.); and Hospital Universitario Puerta de Hierro, Madrid (M.P.P.).

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