Perioperative Nivolumab Plus Chemotherapy Improves EFS in Resectable NSCLC

Neoadjuvant treatment with nivolumab (Opdivo) plus platinum-based chemotherapy, followed by surgery and adjuvant nivolumab monotherapy, generated a statistically significant and clinically meaningful improvement in event-free survival (EFS) vs neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant placebo, in patients with resectable stage IIA to IIIB non–small cell lung cancer (NSCLC), meeting the primary end point of the phase 3 CheckMate-77T trial (NCT04025879).¹

Evaluation of overall survival (OS) data is ongoing. Safety data were consistent with previously reported studies for nivolumab plus chemotherapy in patients with NSCLC.

Detailed data will be presented at an upcoming medical meeting and shared with regulatory authorities.

“We’ve seen tremendous scientific advancements in the treatment of non-metastatic NSCLC in recent years, and remain committed to researching new solutions that may help even more patients achieve better long-term outcomes,” Abderrahim Oukessou, MD, vice president and lead of the Thoracic Cancers Global Program at Bristol Myers Squibb, stated in a news release. “Taken together with the data from our [phase 3] CheckMate-816 trial [NCT02998528]–which led to [nivolumab] being the only anti–PD-1 with an approval in the neoadjuvant setting—today’s results reinforce our leadership in resectable NSCLC and add to our legacy of transformational science in thoracic cancers. We thank the patients and investigators involved in the trial who have allowed us to advance our understanding of the importance of immunotherapy in treating patients’ cancer in earlier stages.”

The randomized, double-blind, placebo-controlled, multicenter CheckMate-77T study enrolled patients with suspected or histologically confirmed resectable stage IIA (> 4 cm) to IIIB (T3N2) NSCLC.² Patients were required to be treatment-naive for NSCLC, be able to provide surgical or biopsy tumor tissue for biomarkers, and have an ECOG performance status of 0 or 1.

Patients with brain metastases were not permitted to enroll. Other key exclusion criteria included active, known, or suspected autoimmune disease; any positive test for hepatitis B virus, hepatitis C virus, or HIV; and any prior treatment with any agent including treatment targeting T-cell co-stimulation or checkpoint pathways.

Investigators randomly assigned 452 patients 1:1 to receive neoadjuvant nivolumab plus platinum-doublet chemotherapy, followed by surgery and adjuvant nivolumab; or neoadjuvant platinum-doublet chemotherapy plus placebo, followed by surgery and adjuvant placebo.^1,2

Along with the primary end point of EFS as assessed by blinded independent central review, secondary end points included OS, pathologic complete response (pCR) rate, major pathologic response rate, and safety.

References

1. Bristol Myers Squibb announces perioperative regimen of neoadjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo significantly improves event-free survival in patients with resectable non-small cell lung cancer. News release. Bristol Myers Squibb. September 22, 2023. Accessed September 22, 2023. https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Announces-Perioperative-Regimen-of-Neoadjuvant-Opdivo-nivolumab-and-Chemotherapy
2. A study of neoadjuvant chemotherapy plus nivolumab versus neoadjuvant chemotherapy plus placebo, followed by surgical removal and adjuvant treatment with nivolumab or placebo for participants with surgically removable early stage non-small cell lung cancer. ClinicalTrials.gov. Updated September 6, 2023. Accessed September 22, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04025879