FDA Approval Introduces New Treatment Options for Adults with Resectable Lung Cancer Lacking Key Genetic Mutations
On October 3, 2024, the FDA approved nivolumab (Opdivo) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adults with resectable non-small cell lung cancer (NSCLC) characterized by tumors of 4 cm or larger and/or node-positive status.
This treatment is specifically for patients without known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Following surgery, patients will receive single-agent nivolumab as adjuvant therapy. This approval represents a significant advancement in the treatment options available for this patient population.
Efficacy was evaluated in the CHECKMATE-77T trial (NCT04025879), a randomized, double-blind, placebo-controlled study involving 461 patients with previously untreated, resectable non-small cell lung cancer (NSCLC) at Stage IIA to selected Stage IIIB.
Patients were assigned (1:1) to receive either nivolumab or placebo with platinum-based chemotherapy every three weeks for up to four cycles as neoadjuvant treatment, followed by either single-agent nivolumab or placebo for up to 13 cycles. The primary outcome, event-free survival (EFS), was not reached in the nivolumab group, while the median EFS was 18.4 months in the chemotherapy arm (hazard ratio 0.58; p-value 0.00025). Descriptive analysis indicated no detriment to overall survival.
Adverse reactions were similar to those in other nivolumab studies, with 5.3% of neoadjuvant nivolumab patients unable to undergo surgery due to side effects, compared to 3.5% in the placebo group. The recommended dosage is 360 mg every three weeks for neoadjuvant treatment and 480 mg every four weeks for adjuvant therapy. This review was conducted under Project Orbis, an FDA initiative for concurrent drug submissions and reviews, in collaboration with agencies from Australia, Brazil, Canada, and Israel.
Perioperative Nivolumab in Resectable Lung Cancer | NEJM
Authors: Tina Cascone, Mark M. Awad, Jonathan D. Spicer, Jie He, Shun Lu, Boris Sepesi, Fumihiro Tanaka, Janis M. Taube, Robin Cornelissen, Libor Havel, Nina Karaseva, Jaroslaw Kuzdzal, Lubos B. Petruzelka, Lin Wu, Jean-Louis Pujol, Hiroyuki Ito, Tudor-Eliade Ciuleanu, Ludmila de Oliveira Muniz Koch, Annelies Janssens, Aurelia Alexandru, Sabine Bohnet, Fedor V. Moiseyenko, Yang Gao, Yasutaka Watanabe, Cinthya Coronado Erdmann, Padma Sathyanarayana, Stephanie Meadows-Shropshire, Steven I. Blum, Mariano Provencio Pulla
Principal Investigator – Tina Cascone
Tina Cascone is an Associate Professor of Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.
Dr. Cascone leads a research program focused on understanding tumor and immune responses to immunotherapy, specifically in non-small cell lung cancer (NSCLC). Her work aims to identify predictive biomarkers for therapeutic response and explore novel strategies to enhance immune-based therapies in early-stage NSCLC.
As Principal Investigator, she oversees clinical trials evaluating neoadjuvant and perioperative immunotherapies for operable NSCLC, including the NEOSTAR, NeoCOAST, NeoCOAST-2, and CheckMate-77T studies. Her research is supported by multiple grants, including an NIH/NCI MPI R01 and awards from the Lung SPORE and the Mark Foundation.
A graduate of the MD Anderson Physician Scientist Program, Dr. Cascone has received several accolades, including an ASCO Career Development Award. She has published extensively in prestigious journals such as Journal of Clinical Investigation, Cancer Discovery, and Nature Medicine.
Healthcare professionals and organizations shared about this on social media:
Stephen V Liu:
“FDA approves perioperative nivolumab plus chemotherapy for resectable NSCLC. Approval based on CheckMate 77T where adding nivolumab to 4 cycles of neoadjuvant chemo followed by 1y of adjuvant nivolumab improved EFS (HR 0.58, median not reached).”
Estela Rodriguez:
“FDA approves another neoadjuvant/adjuvant combo: Perioperative nivolumab for resectable NSCLC stage IIA-IIIB CM 77T trial
Preop Chemo-Nivo x 4–> adjuvant Nivo
EFS not reached (HR 0.58).”
Iván R. González:
“The FDA approves nivolumab as a neoadjuvant/adjuvant treatment for resectable NSCLC. The CHECKMATE-77T trial showed:
Median event-free survival (EFS) not reached in the nivolumab group vs 18.4 months in the chemotherapy group (HR: 0.58, 95% CI: 0.43-0.78, p=0.00025).
Surgery delays due to adverse reactions: 4.5% (nivolumab) vs 3.9% (placebo).
A promising option for stage IIA-IIIB NSCLC patients.”
Yüksel Ürün:
“DA approves nivolumab + chemo as neoadjuvant and adjuvant for resectable NSCLC without EGFR/ALK mutations!
Major EFS benefit in CHECKMATE-77T.”
Luis E. Raez:
“FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer.
Another option for perioperative therapy in lung cancer.”
Pharma Jonpi:
“U.S. Food and Drug Administration Approves Perioperative Treatment of Neoadjuvant Opdivo (Nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable Non-Small Cell Lung Cancer (NSCLC).”
Patrick Forde:
“Based on CheckMate 816 and 77T both neoadj only and perioperative chemo nivo approved! FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer.”
Rose Han:
“Bristol Myers announced that the FDA has approved Opdivo for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) who do not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
The approval is for use as a neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant therapy post-surgery known as perioperative therapy, which involves treatment both before and after surgery. This decision is based on results from the CheckMate-77T trial, Bristol Myers’ second successful Phase 3 randomized study using an immunotherapy-based combination for resectable NSCLC.”
Xihai Li:
“Folks, this is a game changer for translational immuno-oncology research – FDA approves neoadjuvant anti-PD1 ICB for resectable non-small cell lung cancer.”
Guilherme S. C. Correia:
“FDA approved periop nivolumab for patients with stage IIA-IIIB NSCLC and no EGFR/ALK -CheckMate-77T
-18m EFS 70.2% w neoadjuvant nivo+chemotherapy
-adjuvant nivo VS 50.0% with neoadj chemo (HR 0.58) -pCR 25.3%.”
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