Adjuvant Nivolumab Yields Meaningful Improvement in RFS Vs Placebo in Stage IIB/C Melanoma

Nivolumab (Opdivo) appears to be an effective treatment in the adjuvant setting, yielding a statistically significant and clinically meaningful increase in recurrence-free survival (RFS) compared with placebo in patients with completely resected stage IIB/C melanoma, according to a press release on a pre-specified analysis from the phase 3 CheckMate-76K trial (NCT04099251).¹

Findings from the analysis indicated that the study’s primary end point of RFS was met. The trial is part of a development program assessing nivolumab monotherapy and combination regimens in early stages of disease across 7 types of solid malignancies.

“[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 five years after surgery. The results of the CheckMate76K study represent a significant advancement for patients with stage IIB/C melanoma and an extension of our legacy in the treatment of melanoma. 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,” Gina Fusaro, PhD, development program lead of melanoma at Bristol Myers Squibb, said in the press release.

The CheckMate -76k was a randomized, double-blind, phase 3 study that compared the efficacy of adjuvant nivolumab with placebo in patients diagnosed with completely resected stage IIB/C melanoma. The patients who enrolled on the study were randomized to receive either adjuvant nivolumab at a dose of 480 mg every 4 weeks up to 12 months or a matched placebo.

Secondary outcome measures included overall survival (OS) up to 7 years, safety, distant metastases–free survival, and investigator-assessed overall response rate.

Patients 12 years and older who have been diagnosed with histologically confirmed, resected, stage IIB/C cutaneous melanoma were eligible to enroll on the trial. Additional enrollment criteria included having a negative sentinel lymph node biopsy, having no previously treatment for melanoma, and an ECOG performance status of 0 or 1. Patients were excluded from the trial if they had a history of ocular or mucosal melanoma, were pregnant or nursing, had an active known or suspected autoimmune disease, a known history of allergy to study drug components, and received prior treatment of an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody or any other similar methods of treatment.

Nivolumab was previously approved as an adjuvant treatment for patients with metastatic or lymph node–positive melanoma by the FDA in December 2017 based on data from the phase 3 CheckMate-238 trial (NCT02388906), which assessed the agent vs ipilimumab (Yervoy) in recurrent, completely resected stage IIB/C or stage IV melanoma.²

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 16, 2022. https://bit.ly/3dfAO8B
2. FDA grants regular approval to nivolumab for adjuvant treatment of melanoma. News release. FDA. December 20, 2017. Accessed September 16, 2022. https://bit.ly/3BmXbAL