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Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression =1%.
“This approval brings another perioperative immunotherapy treatment option for select patients with resectable NSCLC in the EU, helping address an ongoing need for interventions that can meaningfully reduce the risk of cancer returning after initial therapy,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global programme lead, Bristol Myers Squibb. “With this approval, Opdivo with chemotherapy followed by adjuvant Opdivo has the potential to change the course of certain patients’ disease by significantly reducing the risk of cancer recurrence and improving long-term outcomes earlier in the treatment journey.”
The decision is based on results from the CheckMate -77T study, which evaluated the perioperative regimen of neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy, compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo in adult patients with resectable NSCLC. The trial met its primary endpoint of event-free survival (EFS), showing that the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.43 to 0.78; P=0.00025) in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, after a median follow-up of 25.4 months. Furthermore, after 24–months, EFS was observed in 65% of patients in the Opdivo arm, compared to 44% of patients in the chemotherapy and placebo arm. The trial also demonstrated clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response (pCR) and major pathologic response (MPR). The regimen benefit was demonstrated across all efficacy endpoints and in all randomized subjects. Additionally, the safety profile of the perioperative regimen was consistent with previously reported studies in NSCLC. No new safety signals were identified.
The EFS, pCR and MPR results from the CheckMate -77T trial were first presented at the European Society of Medical Oncology (ESMO) Congress 2023 and published in The New England Journal of Medicine. Updated results were presented at the ESMO Congress 2024. CheckMate -77T is ongoing to assess the key secondary endpoint of overall survival (OS).
This approval by the EC for the treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumors have PD-L1 expression =1% is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. In addition to approvals in lung cancer, Opdivo-based options are also approved for treatment of multiple tumour types in the EU.
In October 2024, the CheckMate -77T trial was used as the basis for the US Food and Drug Administration’s (FDA) approval of Opdivo for the treatment of adult patients with resectable (tumours =4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery.
Bristol Myers Squibb thanks the patients and investigators for their significant contributions to the phase 3 CheckMate -77T clinical trial.
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 placebo plus chemotherapy followed by surgery and adjuvant placebo in 461 patients with resectable stage IIA to IIIB NSCLC. The primary endpoint of the trial is EFS. Secondary endpoints include OS, pCR and MPR.
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.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumour immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development programme is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including phase 3, in a variety of tumour types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
Checkmate 9DW - hepatocellular carcinoma, in combination with Yervoy; Checkmate 227—previously untreated metastatic non-small cell lung cancer, in combination with Yervoy; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with Yervoy and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 649–previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; Checkmate 040–hepatocellular carcinoma, in combination with Yervoy, after prior treatment with sorafenib; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 238–adjuvant treatment of patients with completely resected Stage III or Stage IV melanoma; Checkmate 76K–adjuvant treatment of patients 12 years of age and older with completely resected Stage IIB or Stage IIC melanoma; Checkmate 274–adjuvant treatment of urothelial carcinoma; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; 8HW: Previously Checkmate 142–MSI-H or dMMR metastatic colorectal cancer in combination with Yervoy; 8HW: Previously Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent; Attraction-3–esophageal squamous cell carcinoma; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma in combination with chemotherapy; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma combination with Yervoy; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with Yervoy; Checkmate 037–previously treated metastatic melanoma; Checkmate 066—previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with Yervoy; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 816–neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 77T–Neoadjuvant treatment with platinum-doublet chemotherapy for non-small cell lung cancer followed by single-agent Opdivo as adjuvant treatment after surgery; Checkmate 901–Adult patients with unresectable or metastatic urothelial carcinoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with Yervoy; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 205/039–classical Hodgkin lymphoma
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
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