SKIN CANCERS

Adjuvant nivolumab has been approved by the European Commission as a treatment for adult patients with&nbsp;completely resected melanoma with lymph node involvement or metastatic disease, regardless of <em>BRAF</em> mutation status,&nbsp;based on findings from the randomized phase III CheckMate-238 trial.

Patients aged &ge;62 years with melanoma were more likely to respond to treatment with pembrolizumab than younger patients, according to results published in <em>Clinical Cancer Research. </em>Investigators at The Wistar Institute in Philadelphia concluded that the risk for progression following anti&ndash;PD-1 therapy declined by 13% with each decade of life.

Paolo A. Ascierto, MD, National Tumour Institute &ldquo;Fondazione G. Pascale,&rdquo; Unit of Melanoma in Naples, Italy, discusses the promising results for nivolumab (Opdivo) in patients with melanoma.&nbsp;

General Cancer

A novel immunotherapy agent has demonstrated significant survival rates for patients with metastatic uveal melanoma, according to updated results released at the 2018 ASCO Annual Meeting.

Immune checkpoint inhibitors, alone or in combination, are associated with increased incidence of some cardiovascular toxicities in patients with cancer, according to results from a cross-trial pooled analysis presented in a poster at the 2018 ASCO Annual Meeting.

The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma, while also granting a priority review to glasdegib for acute myeloid leukemia.

Based on findings from the phase III CheckMate-238 trial, nivolumab (Opdivo) has been recommended for approval by the European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, according to Bristol-Myers Squibb, the developer of the PD-1 inhibitor.

The combination of&nbsp;the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) has been approved by the FDA&nbsp;for the treatment of patients with<em>&nbsp;BRAF</em>-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.&nbsp;The approval is based data from the phase III COLUMBUS trial.

A supplemental&nbsp;biologics license application for the use of pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma has been accepted by the FDA,&nbsp;according to Merck, the manufacturer of the PD-1 inhibitor.

Pembrolizumab (Keytruda) induced a median overall survival (OS) of 32.7 months versus 15.9 months for ipilimumab (Yervoy) in patients with unresectable stage III-IV melanoma, according to 4-year survival results from the KEYNOTE-006 trial presented at the 2018 ASCO Annual Meeting.

Alexander M. Eggermont, MD, PhD, director general of Gustave Roussy Cancer Campus Grand Paris in Villejuif, France, discusses the history of immune checkpoint inhibitors in the treatment landscape of melanoma.