CheckMate-77T Confirms Significant Benefit of Opdivo Perioperative Regimen in Resectable NSCLC

ShanghaiOctober 20, 2023PR Newswire -- Bristol-Myers Squibb announced for the first time the data from the Phase III study CheckMate -77T, which evaluated the perioperative regimen of neoadjuvant Opdivo (nivolumab) in combination with chemotherapy, followed by adjuvant Opdivo treatment after surgery, for patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). In the study, assessed by blinded independent central review (BICR), this perioperative treatment regimen demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the primary efficacy endpoint, compared to neoadjuvant chemotherapy plus placebo, followed by surgery and placebo adjuvant treatment.

At a median follow-up of 25.4 months, patients who received neoadjuvant Opdivo (Nivolumab) combined with chemotherapy, followed by adjuvant Opdivo after surgery, had a 42% reduction in the risk of disease recurrence, progression, or death (EFS hazard ratio [HR] 0.58; 97.36% confidence interval [CI]: 0.42~0.81; P=0.00025). Additionally, neoadjuvant Opdivo combined with chemotherapy showed improvements in the secondary efficacy endpoints of pathological complete response (pCR; 25.3% vs. 4.7%) and major pathological response (MPR; 35.4% vs. 12.1%). The study is evaluating another secondary endpoint—overall survival (OS). The rate of radical surgery was 78% in the Opdivo regimen group and 77% in the chemotherapy plus placebo group, with proportions of patients achieving complete resection being 89% and 90%, respectively. The safety profile of the Opdivo regimen was consistent with previously reported results in NSCLC studies, with no new safety signals identified.

The research data will be disclosed for the first time at the Presidential Symposium of the European Society for Medical Oncology (ESMO) 2023 Congress, held from 10:30 AM to 12:15 PM Eastern Time (ET) on October 21, 2023 / 4:30 PM to 6:15 PM Central European Time (CET) (Abstract #LBA1).

"Over the past few years, we have made surprising progress in treating patients with non-metastatic non-small cell lung cancer. Today, we are further evaluating treatment strategies based on these research advances, with the hope of providing clinical benefits to more patients with resectable disease."University of Texas MD Anderson Cancer Center Thoracic/Associate Professor of Head and Neck Medical Oncology, M.D. Tina Cascone Representation，"CheckMate -77T evaluated the efficacy of neoadjuvant nivolumab in combination with chemotherapy, sequential surgery, and adjuvant nivolumab treatment, as well as how continuing adjuvant nivolumab after surgery could further improve outcomes and potentially bring more sustained benefits to patients. These results are highly encouraging to me. The findings of the CheckMate -77T study are very promising for physicians, patients, and their families. I look forward to seeing more data from this ongoing study, particularly regarding overall survival, a secondary endpoint."

"The results of CheckMate -77T provide further evidence supporting the use of Opdivo-based regimens in resectable non-small cell lung cancer and reinforce our commitment to exploring treatment options in earlier stages of cancer to help patients achieve durable benefits."Vice President of Bristol-Myers Squibb Company, Global Program Head of Thoracic Oncology, M.D.Abderrahim Oukessou"We are pleased to present the results of our multiple studies in resectable NSCLC at the ESMO Congress, which demonstrate our deep scientific understanding of thoracic oncology treatment. We look forward to engaging with health authorities soon, hoping to provide more options for patients with non-metastatic NSCLC to help reduce their risk of disease recurrence, progression, or death and achieve better long-term outcomes."

To date, Opdivo and Opdivo-based combination therapies have demonstrated efficacy improvements in the neoadjuvant, adjuvant, or perioperative treatment of four cancer types, covering lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma.

Bristol-Myers Squibb sincerely thanks the patients and researchers who participated in the CheckMate -77T clinical trial.

AboutCheckMate -77T

CheckMate -77T is a Phase III randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of neoadjuvant Opdivo (Nivolumab) plus chemotherapy, followed by surgery and adjuvant Opdivo treatment, compared with neoadjuvant chemotherapy plus placebo, followed by surgery and placebo adjuvant treatment, in 452 patients with resectable non-small cell lung cancer (NSCLC) at stages IIA to IIIB. The primary endpoint of the study is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathological complete response (pCR), and major pathological response (MPR).

About Lung Cancer

Lung cancer is the leading cause of cancer death worldwide. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, accounting for 84% of all diagnosed cases. The majority of NSCLC diagnoses are non-metastatic patients (approximately 60%, of which up to half may be resectable), and with the increasing adoption of screening, this proportion is expected to increase over time. While many non-metastatic NSCLC patients can be cured through surgery, 30% to 55% of patients experience recurrence and die from the disease after surgical removal, thus necessitating the use of treatments before surgery (neoadjuvant therapy) and/or after surgery (adjuvant therapy) to improve long-term outcomes.