Nivolumab Elicits Statistically Significant Improvement in RFS in Stage IIB/C Melanoma

Adjuvant nivolumab (Opdivo) monotherapy elicited a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) compared with placebo for patients with completely resected stage IIB/C melanoma, according to a press release from Bristol Myers Squibb (BMS).¹

The findings met the primary end point of the phase 3 CheckMate 76K trial (NCT04099251). Moreover, at the time of the prespecified interim analysis, investigators identified no new safety signals with the PD-1 inhibitor. BMS will complete a full assessment of the trial and plans to share the findings at an upcoming medical meeting.

“Patients with stage IIB/C melanoma are at high risk of disease recurrence, with approximately one-third of stage IIB and half of stage IIC patients experiencing recurrence within 5 years after surgery,” Gina Fusaro, PhD, development program lead of melanoma at BMS said in a press release. “The results of the CheckMate 76K study represent a significant advancement for patients with stage IIB/C melanoma and an extension of our legacy in the treatment of melanoma.”

Currently, pembrolizumab (Keytruda) is the only checkpoint inhibitor approved for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection.²

CheckMate 76K is a randomized phase 3, double-blind study evaluating adjuvant nivolumab at a dose of 480 mg every 4 weeks for up to 12 months vs placebo in patients with completely resected stage IIB/C melanoma.³

To be eligible for enrollment, patients must be at least 12 years of age and have had a negative sentinel lymph node biopsy; no prior treatments for melanoma; an ECOG performance status of 0 or 1; and received a diagnosis of histologically confirmed, resected, stage IIB/C cutaneous melanoma.

Patients were excluded if they had a history of ocular or mucosal melanoma; were pregnant or nursing; had active known or suspected autoimmune disease; a known history of allergy or hypersensitivity to study drug components; or prior therapy with an anti–PD-L1, anti–PD-L2, anti-CD137, or anti–CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways.

The primary end point of the trial is RFS. Secondary end points of the trial include overall survival, distant metastases-free survival, progression-free survival on next-line therapy, and safety.

“Recurrence represents a life-altering event for people living with cancer. Treating with [nivolumab] in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence – a critical goal of improving patient outcomes,” Fusaro concluded.

References

1. 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 IIB/C melanoma in the CheckMate -76K trial. News release. Bristol Myers Squibb. September 15, 2022. Accessed September 15, 2022. https://bit.ly/3LgJJmt
2. FDA approves Merck's KEYTRUDA (pembrolizumab) as adjuvant treatment for adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection. News release. Merck. December 3, 2021. Accessed September 15, 2022. https://bit.ly/3DrqYal
3. Effectiveness study of nivolumab compared to placebo in prevention of recurrent melanoma after complete resection of stage IIB/C melanoma (CheckMate76K). ClinicalTrials.gov. Updated September 2, 2022. Accessed September 15, 2022. https://clinicaltrials.gov/ct2/show/NCT04099251