The final analysis of the Phase III CheckMate -816 trial confirmed a statistically significant overall survival benefit for patients with resectable non-small cell lung cancer treated with neoadjuvant Opdivo (nivolumab) plus chemotherapy.
Credit: Sebastian Kaulitzki | stock.adobe.com
A final analysis of survival data from the Phase III CheckMate -816 trial (NCT02998528) showed a statistically significant benefit in overall survival (OS) among patients with resectable non-small cell lung cancer (NSCLC) administered neoadjuvant Opdivo (nivolumab; Bristol Myers Squibb) in combination with chemotherapy.1,2 Bristol Myers Squibb stated that the updated OS data will undergo a full analysis plans before being shared in a future peer reviewed publication.
“The final analysis of overall survival in the CheckMate -816 study underscores the potential of Opdivo in combination with chemotherapy to provide a meaningful survival benefit for patients with resectable NSCLC,” Dana Walker, MD, MSCE, vice president and global program lead, late development, oncology, Bristol Myers Squibb, said in a press release. “This is the first and only Phase III study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant benefit in patients with resectable NSCLC. Opdivo -based therapies have shown improved efficacy in the neoadjuvant and perioperative treatment of patients with resectable NSCLC.”1
Opdivo is a monoclonal antibody that binds to the PD-1 receptor and inhibits tumor growth by improving T-cell function.3,4 Opdivo has been approved across an array of indications, both as a single agent and in combination therapy, including for patients with unresectable or metastatic melanoma; metastatic NSCLC; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic urothelial carcinoma; microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.3
The randomized, open label, multi-center, Phase III CheckMate -816 trial analyzed Opdivo plus chemotherapy compared to chemotherapy alone in the neoadjuvant treatment of patients with resectable stage IB to IIIA NSCLC, regardless of PD-L1 expression. Patients with stage IB to IIIA resectable NSCLC were randomly assigned to receive Opdivo with platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection.
The trial’s primary endpoints were event-free survival (EFS) and pathological complete response as determined by blinded independent review. The trial’s key secondary endpoint was OS.
Data released in June 2024 show that at a median follow up of 57.6 months, neoadjuvant treatment with Opdivo plus chemotherapy produced a median EFS of 43.8 months compared to 18.4 months among patients in the chemotherapy alone cohort (HR, 0.66; 95% CI, 0.49 to 0.90).5
Rates of four-year EFS were 49% in the neoadjuvant Opdivo plus chemotherapy cohort compared with 38% in the chemotherapy alone cohort. At that time, OS had not yet reached statistical significance; however, the combination of neoadjuvant Opdivo plus chemotherapy continued demonstrating a clinically important OS improvement trend compared to chemotherapy alone (HR, 0.71; 98.36% CI, 0.47 to 1.07), which was reinforced by the updated findings.
In the June 2024 data release, 71% of patients administered neoadjuvant Opdivo plus chemotherapy were alive at the four-year mark compared to 58% of patients administered chemotherapy alone. There were no new safety signals reported among patients administered neoadjuvant Opdivo plus chemotherapy at the extended follow-up and no new safety signals were reported in the updated data.
References
1. Bristol Myers Squibb Announces Opdivo® Plus Chemotherapy as the First and Only Neoadjuvant-Only Immuno-Oncology Therapy to Demonstrate Statistically Significant and Clinically Meaningful Overall Survival in Resectable Non-Small Cell Lung Cancer. News release. Bristol Myers Squibb. February 19, 2025. Accessed February 19, 2025. https://news.bms.com/news/details/2025/Bristol-Myers-Squibb-Announces-Opdivo-Plus-Chemotherapy-as-the-First-and-Only-Neoadjuvant-Only-Immuno-Oncology-Therapy-to-Demonstrate-Statistically-Significant-and-Clinically-Meaningful-Overall-Survival-in-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx
2. A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816). ClinicalTrials.gov. Updated January 24, 2025. Accessed February 19, 2025. https://clinicaltrials.gov/study/NCT02998528
3. Opdivo. Prescribing information. Bristol Myers Squibb; 2021. Accessed February 19, 2025. https://packageinserts.bms.com/pi/pi_opdivo.pdf
4. FDA approves first immunotherapy for initial treatment of gastric cancer. News release. FDA. April 16, 2021. Accessed February 19, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-initial-treatment-gastric-cancer.
5. Bristol Myers Squibb Presents Multiple New Analyses at 2024 ASCO® Annual Meeting Highlighting Opdivo and Opdivo-based Combinations in Early and Advanced Stages of Non-Small Cell Lung Cancer. News release. Bristol Myers Squibb. June 3, 2024. Accessed February 19, 2025. https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Presents-Multiple-New-Analyses-at-2024-ASCO-Annual-Meeting-Highlighting-Opdivo-and-Opdivo-based-Combinations-in-Early-and-Advanced-Stages-of-Non-Small-Cell-Lung-Cancer/default.aspx
FOCUS Trial Results Show Solriamfetol Significantly Reduces ADHD Symptoms, Severity in Adults
March 27th 2025Solriamfetol achieved the primary and key secondary endpoint of the Phase III FOCUS trial by significantly lowering attention-deficit hyperactivity disorder symptoms and disease severity in adults compared to placebo, with a favorable safety and tolerability profile.
VERITAC-2 Trial Shows Vepdegestrant Significantly Improves Survival in ESR1-Mutant Breast Cancer
March 24th 2025Phase III VERITAC-2 trial results show vepdegestrant significantly improved progression-free survivalcompared to fulvestrant in patients with ESR1-mutant (ESR1m) advanced or metastatic breast cancer, but did not achieve statistical significance in the overall intent-to-treat population.
Phase II DAHLIAS Trial Results Lead to Fast Track Designation for Nipocalimab for Sjögren’s Disease
March 18th 2025FDA grants Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for the treatment of moderate-to-severe Sjögren’s disease, which could be the first FcRn blocker ever approved for the autoimmune condition.