Nivolumab and Pembrolizumab Have Similar Safety Profiles in Melanoma

Survival outcomes and response rates to nivolumab or pembrolizumab are similar among patients with advanced or metastatic melanoma who are treatment-naive, according to study findings published in Melanoma Research.

Researchers evaluated safety outcomes in patients (N=1037) with inoperable or metastatic melanoma who received first-line treatment with nivolumab (n=582) or pembrolizumab (n=455) between 2016 and 2020.

The nivolumab and pembrolizumab recipients were median ages 67 (range, 21-93) and 67 (range, 18-92) years, 57% and 59% were men, 88% and 88% had primary tumor of the skin, 22% and 22% had a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation, and 18% and 22% had brain metastasis, respectively.

After a median follow-up of 16 months, the median overall survival (OS) was 17.4 months for pembrolizumab and 20.0 months for nivolumab (hazard ratio [HR], 1.1; 95% CI, 0.94-1.28; P =.2323) and progression-free survival (PFS) was 5.6 and 7.5 months (HR, 1.13; 95% CI, 0.98-1.29; P =.0941), respectively.

Similarly, no group differences were observed for OS at 2 (42%-47%) and 3 (34%-37%) years or PFS at 2 (25%-29%) or 3 (21%-23%) years.

Among the pembrolizumab recipients, predictors for OS included Eastern Cooperative Oncology Group (ECOG) performance score of 0 (HR, 0.26; P <.0001), normal lactate dehydrogenase (LDH) levels (HR, 0.58; P <.0001), and no brain metastasis (HR, 0.7; P =.0088). Predictors for PFS included ECOG score of 0 (HR, 0.54; P =.0263) and normal LDH levels (HR, 0.57; P <.0001).

For nivolumab, OS was related with ECOG score of 0 (HR, 0.26; P <.0001), normal LDH levels (HR, 0.58; P <.0001), and no brain metastasis (HR, 0.7; P =.0088). Nivolumab’s PFS was associated with normal LDH levels (HR, 0.69; P =.0002), ECOG score of 0 (HR, 0.69; P =.0004), and no brain metastasis (HR, 0.73; P =.0110).

The rates of immune-related adverse events were 42% among pembrolizumab recipients and 53% among nivolumab recipients. The most common events in the pembrolizumab cohort were vitiligo (12%), hypothyroidism (9%), hepatitis or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation (6%), and dermatitis or pruritis (6%). In the nivolumab group, the most common events included hepatitis or AST or ALT elevation (12%), hypothyroidism (8%), hyperthyroidism (5%), and diarrhea or colitis (4%).

The major limitation of this analysis is the retrospective study design.

The study authors conclude, “The choice of treatment with a nivolumab or pembrolizumab should be based on the preferences of the patient and the clinician, as well as regional resources or pandemic restrictions.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.