Melanoma

According to an announcement from Array BioPharma, the company developing the regimen, the European Commission approved the combination of encorafenib, a BRAF inhibitor, and binimetinib, a MEK inhibitor, for treatment of adult patients with&nbsp;<em>BRAF</em>&nbsp;V600&ndash;mutant unresectable or metastatic melanoma.

Paolo A. Ascierto, MD, discusses&nbsp;results from the COLUMBUS trial and sheds light on how physicians can use these findings when choosing treatments for their patients. He also shared his insights on the CheckMate 238 trial investigating nivolumab in the adjuvant setting.

Sanjiv S. Agarwala, MD, chairman of medical oncology at St. Luke&rsquo;s University Health Network, discusses the combination of immunotherapy and a histone deacetylase inhibitor in patients with melanoma, as well as other types of cancer.

Keith T. Flaherty, MD, discusses results for the combination of encorafenib and binimetinib in patients with&nbsp;<em>BRAF</em>-mutated melanoma investigated in the COLUMBUS trial. He also highlights the potential implications and next steps.

The combination of&nbsp;dabrafenib (Tafinlar) and trametinib (Mekinist) has gained approval from the European Commission for the adjuvant treatment of patients with&nbsp;<em>BRAF&nbsp;</em>V600&ndash;positive stage III melanoma following complete resection.

Joseph Stilwill, MD,&nbsp;addresses recent advancements in melanoma and the focus of research moving forward.

Sanjiv S. Agarwala, MD, discusses the promising activity seen with the combination of pembrolizumab and entinostat in patients with advanced melanoma, according to initial results from the ongoing ENCORE 601 trial.

Keith T. Flaherty, MD, professor of Medicine, Harvard Medical School, director of Clinical Research, Massachusetts General Hospital, discusses the rationale for combining agents like dabrafenib with trametinib or binimetinib with encorafenib for patients with melanoma.<br /> &nbsp;

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.