Melanoma

Investigators recently reported 5-year follow-up data from a phase II study of dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with <em>BRAF</em> V600-mutant unresectable or metastatic melanoma.

A look back at all the FDA news that occurred in July.

Supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent&#39;s indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.&nbsp;

Russell Berman, MD, discusses&nbsp;ongoing surgical advances in the treatment of melanoma.

Avelumab (Bavencio) has been recommended for approval by the European Medicines Agency&#39;s&nbsp;Committee for Medicinal Products for Human Use (CHMP)&nbsp;for adults with metastatic Merkel cell carcinoma, according to Pfizer and Merck, the codevelopers of the PD-L1 inhibitor.

Ipilimumab (Yervoy) has been approved by the FDA for the treatment of patients aged &ge;12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.

Dirk Schadendorf, MD, professor, director, and chair of the clinic for dermatology at the University Hospital Essen in Germany, discusses the association between PD-L1 and CD8 expression and outcomes in patients with&nbsp;<em>BRAF V600E/K</em>-mutant metastatic melanoma who received dabrafenib (Tafinlar) plus trametinib (Mekinist) in the randomized phase III COMBI-v study.

In patients with advanced melanoma enrolled in the phase III CheckMate-238 trial,&nbsp;adjuvant nivolumab extended recurrence-free survival compared with adjuvant ipilimumab.

Psychological intervention can substantially lower fear of cancer recurrence (FCR) in survivors, improving their quality of life, anxiety, and cancer-specific distress.

More than one-fourth of patients with advanced <em>BRAF </em>V600-mutant melanoma remained alive at 5 years after treatment with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist), long-term follow-up from a randomized trial showed.

Georgina V. Long, BSc, PhD, MBBS,&nbsp;professor of medical melanoma oncology, Melanoma Institute Australia, discusses the activity seen with the combination of dabrafenib and trametinib for the treatment of patients with melanoma brain metastases.

Jennifer Wargo, MD, associate professor of Genomic Medicine and Surgical Oncology, discusses a study that looked at the association of the diversity and composition of the gut microbiome with responses and survival in metastatic melanoma patients on anti-PD-1 therapy.

Ragini R. Kudchadkar, MD, assistant professor, department of Hematology and Medical Oncology, Emory University School of Medicine, discusses how care for Merkel cell carcinoma has been revolutionized in recent years.&nbsp;

Patients with refractory advanced melanoma who had received prior treatment with a checkpoint inhibitor demonstrated promising overall response rate and duration of response in a phase II study involving the antibody-drug conjugate glembatumumab vedotin.

More than 40% of patients with melanoma brain metastases achieved objective intracranial responses to combination treatment with nivolumab (Opdivo) and ipilimumab (Yervoy), results of a randomized phase II trial showed.

Paola A. Ascierto, MD, medical oncologist, director of Melanoma Cancer Immunotherapy and Innovative Therapy, Istituto Nazionale Tumori &ldquo;Fondazione G. Pascal,&rdquo; discusses results of a phase Ib/II dose-escalation study evaluating triple combination therapy with encorafenib, binimetiinib, and ribociclib (Kisquali) in patients with <em>BRAF V600</em> solid tumors and melanoma.

More than half of patients with immunotherapy-relapsed/refractory melanoma benefited from treatment with nivolumab and an anti-lymphocyte activation gene-3 (LAG-3) antibody, according to data from an early clinical study.

Dabrafenib (Tafinlar) plus trametinib (Mekinist) achieved an intracranial response (IR) rate of 58% in melanoma that has metastasized to the brain. The median duration of overall response (OR) of 6.5 months was generally shorter than that observed in melanoma patients without brain metastases.&nbsp;These initial findings from the phase II COMBI-MB trial were presented during an oral abstract session at the 2017 ASCO Annual Meeting.

Nivolumab (Opdivo) plus ipilimumab (Yervoy) or ipilimumab alone are associated with a high incidence of gastrointestinal (GI) toxicity, but most adverse events (AEs) are effectively managed using immunomodulators, which do not appear to inhibit tumor response. Additionally, nivolumab plus ipilimumab significantly improved overall survival (OS) and objective response rate (ORR) versus ipilimumab alone in patients with untreated advanced melanoma.

Overall survival in advanced melanoma treated with targeted therapy had a strong association with high PD-L1 expression and high levels of tumor infiltrating lymphocytes, analysis of tissue specimens from a randomized trial showed.

Neoadjuvant and adjuvant dabrafenib (Tafinlar) plus trametinib (Mekinist) increased the overall response rate (ORR) to 85% in patients with high-risk resectable <em>BRAF</em>-mutant metastatic melanoma. And interestingly, the pathologic complete response (pCR) rate with the combination was 58%, as demonstrated in findings presented during the 2017 ASCO Annual Meeting.

A 3-drug regimen for advanced melanoma led to objective responses in a majority of patients with advanced <em>BRAF</em>-mutant disease but also proved to be somewhat toxic, a small phase II study showed.

Georgina V. Long, BSc, PhD, MBBS,&nbsp;professor of medical melanoma oncology, Melanoma Institute Australia, discusses 5-year overall survival data from a phase II trial of dabrafenib (Tafinlar) and trametinib (Mekinist) in patients with <em>BRAF V600</em>-mutant unresectable or metastatic melanoma during the 2017 ASCO Annual Meeting.

Combining the PD-1 inhibitor pembrolizumab (Keytruda) with the HDAC inhibitor entinostat demonstrated promising clinical activity and acceptable safety in patients with melanoma who were refractory to immune checkpoint inhibitors.&nbsp;

Charles M. Rudin, MD, PhD, chief, thoracic oncology, Memorial Sloan Kettering Cancer, discusses a study of intravenously delivered coxsackievirus A21 with pembrolizumab to treat patients with advanced cancers.