On October 17, 2023 Bristol Myers Squibb (NYSE: BMY) reported the first disclosure of data from the Phase 3 CheckMate -77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, OCT 17, 2023, View Source;77T-Trial/default.aspx [SID1234636057]). In the study, the perioperative regimen showed a statistically significant and clinically meaningful improvement in the primary efficacy endpoint of event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.

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With a median follow-up of 25.4 months, in patients treated with neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 97.36% Confidence Interval [CI]: 0.42 to 0.81; p=0.00025). Additionally, neoadjuvant Opdivo and chemotherapy showed improvements in the secondary efficacy endpoints of pathologic complete response (pCR; 25.3% vs. 4.7%) and major pathologic response (MPR; 35.4% vs 12.1%). The study is ongoing to assess its other secondary endpoint of overall survival (OS). Definitive surgery rates were 78% with the Opdivo-based regimen vs. 77% with chemotherapy and placebo, with complete resection achieved in 89% vs. 90% of patients, respectively. The safety profile of the Opdivo-based regimen was consistent with previously reported studies in NSCLC. No new safety signals were identified.

The first disclosure of these data will be featured in a Presidential Symposium during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 on October 21, 2023, from 10:30 a.m. to 12:15 p.m. EDT / 16:30 to 18:15 CEST (Abstract #LBA1).

"Over the past few years, we have witnessed incredible progress in the treatment of patients with non-metastatic non-small cell lung cancer. Now, we are evaluating therapeutic strategies that expand on these advances with the goal of providing clinical benefit to a greater number of patients with resectable disease," said Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "I am extremely encouraged by the findings of CheckMate -77T evaluating neoadjuvant nivolumab and chemotherapy followed by surgery and adjuvant nivolumab, and by how continuing adjuvant nivolumab after surgery may further improve outcomes and provide a potentially more durable benefit for our patients. The results from the CheckMate -77T study are promising for physicians, patients and their families alike. I look forward to seeing how the data from this ongoing trial continues to unfold, especially the secondary endpoint of overall survival."

"The results from the CheckMate -77T study add to the evidence supporting the use of Opdivo-based therapies in resectable non-small cell lung cancer and reinvigorate our commitment to treating cancer at earlier stages of the disease in the hopes of helping patients attain durable benefit," said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. "We are pleased to be presenting research from multiple trials in resectable NSCLC at ESMO (Free ESMO Whitepaper), building on our deep scientific understanding of thoracic cancer treatment. We look forward to upcoming discussions with regulatory authorities and hope that we may offer yet another option to patients with non-metastatic NSCLC that could potentially reduce their risk of disease recurrence, progression or death, and lead to better long-term outcomes."

To date, Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -77T clinical trial.

About CheckMate -77T

CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response (pCR) and major pathologic response (MPR).

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.