Adjuvant Treatment With Nivolumab Shows Positive Results in Phase 3 Trial

Data from Bristol Myers Squibb’s phase 3 CheckMate-76k trial showed nivolumab (Opdivo; Bristol Myers Squibb) demonstrated statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) in patients with stage IIB/C melanoma.¹ CheckMate-76k evaluated nivolumab as a single agent in the adjuvant setting in patients with completely resected stage IIB/C melanoma. The clinical trial aimed to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric patients who had a complete resection of stage IIB/C melanoma with no evidence of disease and are at high risk for recurrence.²

The primary endpoint of the trial was recurrence-free survival. Key secondary endpoints of the trial include overall survival, distant metastases-free survival, progression-free survival on next-line therapy, and safety endpoints. CheckMate-76k met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in RFS compared to placebo at a pre-specified interim analysis. According to Bristol Myers Squibb, no new safety signals were observed at the time of the analysis.

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to use the body’s immune system to restore anti-tumor response.

CheckMate-76k was a randomized phase 3, double-blind study which evaluated adjuvant nivolumab 480 mg administered every 4 weeks for up to 12 months compared to placebo. 790 patients were enrolled. Inclusion criteria included:

• Participants had a negative sentinel lymph node biopsy
• Participants had not previously been treated for melanoma
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Participants must have been diagnosed with histologically confirmed, resected, stage IIB/C cutaneous melanoma

Melanoma is a type of skin cancer that develops when melanocytes grow uncontrollably. Melanoma may be a less common type of skin cancer, but it is more dangerous, as it’s more likely to spread to other parts of the body without early detection. Men typically develop melanomas on the chest or back. Women typically develop melanomas on the legs. The face and neck are also popular areas for melanoma to develop.³

According to Bristol Myers Squibb, “Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has been increasing steadily for the last 30 years. In the United States, 99,780 new diagnoses of melanoma and about 7,650 related deaths are estimated for 2022. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses.”²

References:

1. Effectiveness study of nivolumab compared to placebo in prevention of recurrent melanoma after complete resection of stage IIB/C melanoma (CheckMate76k). Identifier NCT04099251. Clinicaltrials.gov. Accessed September 15, 2022.https://clinicaltrials.gov/ct2/show/record/NCT04099251?term=checkmate-76k&draw=2&rank=1&view=record
2. Bristol Myers Squib announces adjuvant treatment with opdivo (nivolumab) demonstrated statistically significant and clinically meaningful improvement in recurrence-free survival (Rfs) in patients with stage iib/c melanoma in the checkmate -76k trial. Accessed September 15, 2022. https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Announces-Adjuvant-Treatment-with-Opdivo-nivolumab-Demonstrated-Statistically-Significant-and-Clinically-Meaningful-Improvement-in-Recurrence-Free-Survival-RFS-in-Patients-with-Stage-IIBC-Melanoma-in-the-CheckMate--76K-Trial/default.aspx
3. What is melanoma skin cancer? | what is melanoma? Accessed September 15, 2022. https://www.cancer.org/cancer/melanoma-skin-cancer/about/what-is-melanoma.html