SKIN CANCERS

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.

Patrick Ott, MD, PhD, clinical director, Melanoma Center, Center for Immuno-Oncology, physician, assistant professor of medicine, Harvard Medical School, Dana-Farber Cancer Institute, discusses current and emerging immunotherapeutic strategies in melanoma.

Based on findings of the&nbsp;phase III COMBI-AD study, a supplemental new drug application for&nbsp;dabrafenib (Tafinlar) combined with trametinib (Mekinist)&nbsp;has been granted a priority review by the FDA&nbsp;as an adjuvant treatment for patients with <em>BRAF</em> V600E&ndash; or V600K&ndash;positive stage III melanoma following complete resection.

Adil Daud, MD, clinical professor, Department of Medicine, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, discusses challenges facing the field of melanoma.

For patients with high-risk melanoma, the area of adjuvant treatment has seen little progress until recently. In large part, this is due to the lack of&nbsp;consensus in the community on what treatments to use, when to use them, and in which patients to implement them, explains Michael B. Atkins, MD.

Michael A. Postow, MD, discusses the evolution of combination therapies for patients with melanoma.

Nivolumab (Opdivo) has received FDA approval for the adjuvant treatment of&nbsp;patients with completely resected melanoma with lymph node involvement or metastatic disease.

Chimeric antigen receptor T-cell therapy with bb2121 demonstrated an objective response rate of 94% in patients with&nbsp;relapsed/refractory multiple myeloma, according to findings from a dose-escalation study. The senior study author, James N. Kochenderfer, MD, presented updated findings from the study during the 2017 ASH Annual Meeting, and commented that 89% of patients had a very good partial response or better, and 56% of patients had a complete remission.&nbsp;<br /> &nbsp;

According to results from the phase II&nbsp;NCI9855 study, presented at&nbsp;the 2017 World Congress of Melanoma, glembatumumab vedotin (CDX-011) induced a 61%&nbsp;disease control rate in patients with&nbsp;metastatic uveal melanoma, despite a low a low objective response rate of 6%.

Victoria Atkinson, MD, medical oncologist, Princess Alexandra Hospital, University of Queensland, discusses combination regimens on the horizon in melanoma.

For patients with advanced cancers, including melanoma,&nbsp;non&ndash;small cell lung cancer, and renal cell carcinoma, the combination of the CD122-biased cytokine&nbsp;NKTR-214&nbsp;and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72%,&nbsp;according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.

The authors discuss the current standard of care and review the new data for immunotherapy in advanced merkel cell carcinoma (MCC).

Kelly Paulson, MD, PhD, a fellow at Seattle Cancer Care Alliance, discusses single-cell RNA sequencing in merkel cell carcinoma during&nbsp;The Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting.

The objective response rate with neoadjuvant nivolumab (Opdivo) plus ipilimumab (Yervoy) was almost tripled compared with nivolumab alone in patients with high-risk resectable melanoma, according to preliminary findings from a phase II study presented during the 32nd SITC Annual Meeting.

Jason Luke, MD, assistant professor of medicine, University of Chicago Medicine, discusses the promising combination of a PD-1 antibody plus an IDO inhibitor for the treatment of patients with melanoma.<br /> &nbsp;

According to data from the phase II OMS-I102 trial presented at the 2017 World Congress of Melanoma, the&nbsp;immune stimulator ImmunoPulse IL-12 induced promising activity when added to pembrolizumab (Keytruda) in patients with melanoma who have been identified as unlikely responders to&nbsp;anti&ndash;PD-1 therapies.

According to data presented&nbsp;at the 2017 World Congress of Melanoma, the combination of&nbsp;nivolumab (Opdivo) and ipilimumab (Yervoy) induced a 3-year relapse-free survival rate of 71% in the adjuvant treatment of patients with high-risk resected stage IIIC/IV melanoma, but it was also associated with significant toxicity.&nbsp;

Celeste Lebb&eacute;, MD, from the H&ocirc;pital Saint Louis, in Paris, France, discusses the use of immunotherapy for the treatment of melanoma.

The combination of&nbsp;dabrafenib and trametinib has been granted a breakthrough therapy designation by the FDA for the adjuvant treatment of patients with stage III melanoma with a <em>BRAF V600</em> mutation following complete resection.

Adjuvant treatment with a combination of dabrafenib (Tafinlar) and trametinib (Mekinist) continues to show a long-term survival benefit in patients with melanoma, even across subgroup populations, according to a presentation at the 2017 World Congress of Melanoma (WCM).

According to updated results from the phase II ABC trial presented at the 2017 World Congress of Melanoma, Nivolumab (Opdivo) combined with&nbsp;ipilimumab (Yervoy) showed activity in&nbsp;asymptomatic patients with melanoma brain metastases who had not received prior local therapy to the brain.

While immunotherapty has led a transformation for melanoma care, combinations of&nbsp;anti&ndash;PD-1 and CTLA-4 agents are toxic, and biomarkers are not yet available to help personalize treatment. Therefore, Carolina Robert, MD, PhD, says, further research is needed to explore less toxic, more effective options.

In a small phase I study, engineered tumor-infiltrating lymphocytes demonstrated signs of antitumor activity in patients with metastatic melanoma following treatment with a prior checkpoint inhibitor. Results of the pilot study of TILs that were engineered to express&nbsp;transforming growth factor-&beta; dominant negative receptor and nerve growth factor receptor were presented during the 2017 World Congress of Melanoma.