Melanoma

Based on data from the phase III COMBI-AD study, the combination of dabrafenib and trametinib has been granted FDA approval for the adjuvant treatment of patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

A 4-week dosing schedule for nivolumab has been approved by the European Commission for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma, Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor, has announced.

According to phase Ib study findings presented at the 2018 AACR Annual Meeting, combining the intratumoral toll-like receptor 9 (TLR9) agonist CMP-001 and pembrolizumab showed clinical activity in reversing PD-1 checkpoint inhibition resistance in patients with metastatic melanoma.

Alexander M. M. Eggermont, MD, PhD, director general of Gustave Roussy Cancer Campus Grand Paris in Villejuif, France, discusses the phase III results from the EORTC 1325-MG/KEYNOTE-054 trial presented at the 2018 AACR Annual Meeting.

According to the results from a phase I study, BLU-667, a next-generation tyrosine kinase inhibitor, was well-tolerated and demonstrated clinical benefit in patients with advanced,&nbsp;<em>RET</em>-altered solid tumors who had progressed on previous therapies. These findings were presented April 14 to 18 at the ASCR Annual Meeting 2018 in Chicago, Illinois.

According to phase III results from the EORTC 1325-MG/KEYNOTE-054 trial presented at the 2018 AACR Annual Meeting and published in the <em>New England Journal of Medicine, </em>adjuvant pembrolizumab (Keytruda) reduced the risk of recurrence or death by 43% in&nbsp;patients with resected, high-risk stage III melanoma.

According to findings from the phase III ECHO-301/KEYNOTE-252 trial, progression-free survival was not improved with the combination of&nbsp;the PD-1 inhibitor pembrolizumab (Keytruda) and the IDO1 inhibitor epacadostat versus single-agent&nbsp;pembrolizumab in patients with unresectable or metastatic melanoma.

Jason J. Luke, MD, assistant professor of medicine at the The University of Chicago Medicine, discusses the importance of conducting research into less common subsets of melanoma. After giving a talk on non-cutaneous melanoma, a rare subtype, Luke explained that not all cases of melanoma arise on the skin and shared why more research is necessary in the field.

The new drug application for larotrectinib (LOXO-101) for treatment of patients with locally advanced or metastatic solid tumors that harbor an NTRK gene fusion&nbsp;has been completed.&nbsp;

The FDA has approved a 4-week dosing schedule for the PD-1 inhibitor nivolumab (Opdivo) across several indications.

Robert Andtbacka, MD, associate professor in the Division of Surgical Oncology, Department of Surgery at the University of Utah School of Medicine, discusses a study exploring the role of talimogene laherparapvec (T-VEC; Imlygic) in the treatment of patients with metastatic melanoma.

Eric Whitman, MD, discusses data for pembrolizumab in the frontline treatment of advanced melanoma and ongoing research with the agent in other settings of the disease.

Obese men treated with targeted or immune therapies for metastatic melanoma had a 47% reduced risk of death compared with men who had a normal BMI, according to results from a retrospective multicohort analysis published in <em>The Lancet Oncology.</em><br /> &nbsp;

Ryan J. Sullivan, MD, discusses&nbsp;the available therapies for patients with <em>BRAF-</em>mutant and non-<em>BRAF</em>-mutant melanoma, as well as the current role of mutation status in treatment decision making.<br /> &nbsp;

Omid A. Hamid, MD, chief of Translational Research and Immunotherapy, director,&nbsp;Melanoma Therapeutics, The Angeles Clinic and Research Institute, discusses options for patients with melanoma who have exhausted standard therapies.

Jeffrey S. Weber, MD, PhD, discusses the phase III COMBI-AD study and the phase III CheckMate-238 trial,&nbsp;as well as the most exciting ongoing research at his institution.

In findings from the phase III COLUMBUS trial, the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved survival versus single-agent&nbsp;vemurafenib (Zelboraf) in patients with&nbsp;<em>BRAF</em>-mutant advanced, unresectable or metastatic melanoma.

Ulixertinib, a novel ERK1/2 inhibitor, demonstrated encouraging antitumor activity in patients with solid tumors harboring mutations in the MAPK/ERK pathway, according to the results of a phase I study published in <em>Cancer Discovery</em>.

Jeffrey S. Weber, MD, PhD,&nbsp;discusses the current and future state of immunotherapy in the treatment of melanoma.

During their 155th annual meeting, to be help April 29, the National Academy of Science (NAS) will award 19 individuals for their extraordinary scientific achievements in a wide range of fields including the physical, biological, and medical sciences.

Helmut Schaider, MD, associate professor, Dermatology Research Centre, The University of Queensland, Australia, discusses drug resistance in melanoma.<br /> &nbsp;

Adjuvant pembrolizumab (Keytruda) reduced the risk of recurrence by 43% in patients with stage III resected high-risk melanoma,&nbsp;according to findings from the phase III EORTC1325/KEYNOTE-054 trial

Hussein A. Tawbi, MD,&nbsp;discusses the considerations he makes when choosing between immunotherapy and targeted therapy for patients with melanoma and how long-term targeted therapy data can influence treatment decisions.<br /> &nbsp;

Richard D. Carvajal, MD,&nbsp;discusses considerations when diagnosing and treating extracutaneous melanomas and the importance of treating such diseases differently than the more commonly seen melanomas.

The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.