Melanoma

The FDA has issued a complete response letter to Bristol-Myers Squibb regarding its supplemental biologics license application for the use of single-agent nivolumab in previously untreated patients with BRAF V600 mutation-positive advanced melanoma.

A regimen of pembrolizumab (Keytruda) and low-dose ipilimumab (Yervoy) was effective, and tolerable, for patients with advanced melanoma, according to results from the phase Ib KEYNOTE-029 clinical trial presented by lead investigator Georgina Long, BSc, PhD, MBBS.

Nivolumab (Opdivo) has been approved by the FDA as a single-agent to include the frontline treatment of patients with BRAF wild-type advanced melanoma.

A combination of dabrafenib and trametinib has been approved by the FDA for patients with unresectable or metastatic BRAF-mutated melanoma, based on an extension in overall survival (OS) from two phase III studies.

Patients receiving a combination of MEK inhibitor trametinib and BRAF inhibitor dabrafenib not only greatly improves long-term outcomes, but also lowers some adverse events associated with either standalone agent for patients with BRAF-mutated metastatic melanoma.

Avelumab has been given breakthrough therapy designation by the FDA as a possible treatment for patients with metastatic Merkel cell carcinoma (MCC) following progression on at least one prior chemotherapy regimen

The FDA has approved a combination of vemurafenib (Zelboraf) and cobimetinib (Cotellic) to treat patients with metastatic or unresectable BRAF V600E/K mutation-positive melanoma.

Study data involving NY-ESO-1specific T-cell receptor transgenic lymphocytes with an NY-ESO-1 peptide-pulsed DC vaccination in patients with advanced sarcomas and melanoma with or without ipilimumab were detailed during a presentation at the 2015 CTOS Annual Meeting.

Jeffrey S. Weber, MD, PhD, deputy director, Laura and Isaac Perlmutter Cancer Center, co-director of its Melanoma Program, head of Experimental Therapeutics, NYU Langone Medical Center, discusses keys to targeted therapies for melanoma. These keys lie in BRAF and MEK inhibitors and combining those drugs with immunologic therapies.

Investigators of a new phase II study reported that favorable-risk oropharyngeal squamous cell carcinoma testing positive for human papillomavirus or p16 can be treated successfully using substantially decreased chemoradiotherapy doses.

Jedd D. Wolchok, MD, PhD, chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center in New York City, talks about the phase III CheckMate 067 trial.

Jason J. Luke, MD, FACP, assistant professor of medicine, The University of Chicago, discusses the international MSLT-II trial, which looks at the possibility of less surgery for melanoma patients in the future.

Pamela Kunz, MD, assistant professor, Division of Oncology, Stanford University School of Medicine, talks about the findings of the phase II study of everolimus plus bevacizumab in pNETs, as well as bevacizumab in progressive pNETS.

Although single-target inhibitors and have demonstrated significant clinical benefit, the toxicities are not limited to cancer cells alone and associated toxicities and adverse events are often observed.

The Weizmann Institute of Science recently revealed a new gene belonging to the tumor suppressor gene group, RASA2, which is driving a particular deadly subset of melanomas for patients with dysfunctioning RAS pathways.

A paper recently published online by a group at the University of Michigan details a mechanism by which epigenetic modulation can increase the number of tumor infiltrating CD8+ T cells and could potentially lead to increased immunotherapy response.

Ipilimumab (Yervoy) in melanoma has been approved to include adjuvant treatment of patients with stage III melanoma who are at high risk of recurrence following complete resection by the FDA.

A Q&A with Keith T. Flaherty, MD.

Approval for first-in-class oncolytic immunotherapy talimogene laherparepvec (T-VEC; Imlygic) has come down from the FDA based on the results from the phase III OPTiM study.

Pro-inflammatory cytokines were elevated in patients with melanoma undergoing the combination treatment of radiation therapy and the systemic anti�CTLA-4 immunotherapy, ipilimumab.

The combination of nivolumab and ipilimumab has received accelerated FDA approval as a treatment for patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Talimogene laherparepvec (T-VEC), an attenuated oncolytic virus, combined with pembrolizumab, an immune checkpoint inhibitor, passed an early safety evaluation for unresectable melanoma.

Two strategies of successive immunotherapy for the treatment of advanced melanoma recently showed similar safety and tolerability, yet substantially different efficacy.

Provectus Biopharmaceuticals, Inc recently announced it has completed development of its protocol for phase Ib/II testing in patients with stage IV melanoma.

A preclinical study using mouse and human melanoma cell lines published in a September, 2015, issue of Cell, outlines mechanisms by which melanoma can evade the immune system.