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A study by Marsavela et al published in Clinical Cancer Research evaluating the predictive value of pretreatment circulating tumor DNA (ctDNA) to inform therapeutic outcomes in patients with advanced-stage melanoma relative to type and line of treatment has found that baseline levels of ctDNA...
The 5-year outcomes of the CheckMate 066 trial, reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, of Gustave Roussy, Villejuif, France,and colleagues, show continued benefit of first-line nivolumab vs dacarbazine in advanced BRAF wild-type melanoma and support evidence that ...
As reported in The Lancet Oncology by Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, and colleagues, 4-year results of the CheckMate 238 trial show continued benefit of adjuvant nivolumab vs ipilimumab in recurrence-free survival and metastasis-free...
University of California, Los Angeles (UCLA) researchers have received a $13 million grant from the National Institutes of Health (NIH) to find new ways to overcome melanoma resistance to some of the most promising targeted therapies and immunotherapies. There have been significant advancements in...
Checkpoint inhibitors can be lifesaving for many patients with advanced melanoma, but those who experience disease progression currently have few treatment options. The combination of a tyrosine kinase inhibitor and an anti–PD-1 agent may offer some hope in this setting, according to a study of...
Skin cancers are the most common malignancy in the United States and worldwide. Between 1994 and 2014, the diagnosis and treatment of melanoma and nonmelanoma skin cancers in the United States increased by 77%.1 The cost of treating melanoma and nonmelanoma skin cancers to the health-care system...
The benefit of anti–PD-1 antibodies in the adjuvant treatment of patients with stage III or stage IV melanoma continues to be observed at around 4 years for both pembrolizumab and nivolumab, according to updates of pivotal trials presented at the European Society for Medical Oncology (ESMO) Virtual ...
Patients with unresectable or metastatic melanoma harboring BRAF V600 mutations did not benefit from the addition of the anti–PD-1 antibody spartalizumab to dabrafenib and trametinib in the COMBI-i trial, which was presented at the European Society for Medical Oncology (ESMO) Virtual Congress...
The increasing incidence rates of skin cancer in the United States are staggering. It is the most common cancer diagnosed in the country, and current estimates show that about 9,500 Americans are diagnosed with skin cancer every day. Over the course of a year, more than 3 million people are...
The 5-year outcomes of the CheckMate 066 trial, reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, and colleagues, showed continued benefit of first-line nivolumab vs dacarbazine in advanced BRAF wild-type melanoma. The results add to data indicating that nivolumab can be...
Jeffrey S. Weber, MD, PhD, of the Perlmutter Cancer Center, NYU Langone, discusses the 4-year recurrence-free and overall survival results from the CheckMate 238 study, which showed adjuvant nivolumab continues to be an effective treatment, vs the comparator ipilimumab, for patients with resected stage III/IV melanoma (Abstract 1076O).
As reported in The Lancet Oncology by Paolo A. Ascierto, MD, and colleagues, 4-year results of the CheckMate 238 trial show the continued benefit of adjuvant nivolumab vs ipilimumab in recurrence-free and metastasis-free survival in patients with resected stage IIIB–IIIC or IV melanoma, with no...
As reported in the Journal of Clinical Oncology by Alexander M.M. Eggermont, MD, PhD, and colleagues, adjuvant pembrolizumab maintained a significant recurrence-free survival benefit vs placebo in patients with high-risk stage III melanoma after a median 3-year follow-up in the phase III EORTC...
Alexander M. Eggermont, MD, PhD, of the Princess Maxima Center for Pediatric Oncology, discusses final results of the phase III EORTC 1325-MG/Keynote 054 trial, which confirmed a sustained recurrence-free survival benefit of pembrolizumab vs placebo in patients with resected high-risk stage III melanoma, as well as a decrease in the incidence of distant and locoregional recurrence (Abstract LBA46).
As reported in the Journal of Clinical Oncology by Jean-Jacques Grob, MD, PhD, of Aix-Marseille University, France, and colleagues, the first interim analysis of the phase II KEYNOTE-629 trial has shown the achievement of durable responses with pembrolizumab treatment of recurrent or metastatic...
Findings from a study among patients with melanoma randomly assigned to observation following removal of a positive sentinel lymph node “strongly support the therapeutic effect of the sentinel lymph node biopsy in providing long-term regional nodal disease control in the large majority of...
Long-term findings from the phase III CheckMate 238 study showed that nivolumab improved 4-year recurrence-free survival compared with ipilimumab in patients with resected stage IIIB to C or IV melanoma in the overall population as well as across subgroups of patients stratified by disease stage...
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori, discusses phase II results on progression-free survival for patients with advanced melanoma in the SECOMBIT study, whose aim is to evaluate the different sequencing of a BRAF inhibitor (encorafenib) plus a MEK inhibitor (binimetinib) with ipilimumab plus nivolumab (Abstract LBA45).
As reported in The New England Journal of Medicine by Reinhard Dummer, MD, and colleagues, 5-year follow-up of the phase III COMBI-AD trial has shown continued relapse-free survival benefit with adjuvant dabrafenib/trametinib vs placebo in patients with stage III melanoma and BRAF V600E or V600K...
On July 30, 2020, atezolizumab was granted approval for use in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation–positive unresectable or metastatic melanoma.1,2 Supporting Efficacy Data Approval was based on findings from the phase III, double-blind IMspire150 trial ...
With incredibly paced approvals and clinical advancements in the systemic therapy of cutaneous melanoma, the efficacy of immunotherapy in this disease is clear. However, many important questions remain regarding timing and dosing—in other words, which drug (or drugs) makes the most sense and in...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for the treatment of refractory multiple myeloma, metastatic breast cancer, and metastatic non–small cell lung cancer (NSCLC); gave Fast Track designation to treatments for NTRK mutation–positive solid tumors...
In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected...
As investigators, we were always determined to find the drug to work with BRAF/MEK inhibitor combination therapy. It had come on like a storm and showed us that we could help even those with the most advanced metastatic melanoma, as long as it harbored the magical BRAF V600E mutation.1...
As reported inThe Lancet by Ralf Gutzmer, MD, of Medizinische Hochschule Hannover, Germany, and colleagues, the phase III IMspire150 trial has shown that the addition of atezolizumab to BRAF and MEK inhibitor therapy with vemurafenib and cobimetinib improved progression-free survival in the...
A consensus statement published in JAMA Dermatology by an international group of melanoma researchers evaluated the use of prognostic gene-expression profile testing to guide clinical management of melanoma.1 The group cautioned against the routine use of currently available gene-expression...
In the French phase II CARSKIN trial reported in the Journal of Clinical Oncology, Maubec et al found that pembrolizumab monotherapy produced durable responses in the first-line treatment of unresectable cutaneous squamous cell carcinoma. Study Details In the multicenter trial, 39 patients (primary ...
A new 10-year analysis, led by Igor Puzanov, MD, MSci, FACP, Director of Early Phase Clinical Trials and Chief of Melanoma at Roswell Park Comprehensive Cancer Center and recently published in JAMA Oncology,1 provides new insights into an important question: whether BRAF V600E/K–mutation status or ...
On June 24, 2020, pembrolizumab was approved for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.1,2 Supporting Efficacy Data Approval was based on findings in the multicenter, multicohort, open-label KEYNOTE-629 trial ...
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...
On July 30, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab (Tecentriq) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive...
As reported in the Journal of Clinical Oncology by Grob et al, the first interim analysis of the phase II KEYNOTE-629 trial has shown that treatment with pembrolizumab resulted in durable responses in patients with recurrent or metastatic cutaneous squamous cell carcinoma. The study supported the...
The neoadjuvant combination of nivolumab and ipilimumab yielded a continued benefit in relapse-free survival vs adjuvant use of the same combination therapy in 20 patients with stage III macroscopic melanoma. This finding is based on 3-year follow-up results of the phase Ib OpACIN trial, presented...
In a pooled analysis reported in JAMA Oncology, Igor Puzanov, MD, MSCI, and colleagues identified objective response rates and progression-free and overall survival rates with pembrolizumab treatment among patients with advanced melanoma according to BRAF V600E/K–mutation status and prior BRAF/MEK...
In a study reported as a research letter in JAMA Oncology, Scovell et al identified a potential association between the use of immune checkpoint inhibitors and impaired spermatogenesis using autopsy tissue findings in men with a history of metastatic melanoma. Study Details The study involved...
The study’s invited discussant, Ryan J. Sullivan, MD, Assistant Professor of Medicine, Harvard Medical School, and Assistant Professor in Hematology/Oncology at Massachusetts General Hospital, welcomed the positive results from the updated analysis of lifileucel in treatment-refractory melanoma....
Patients with heavily pretreated metastatic melanoma treated with adoptive cell therapy based on tumor-infiltrating lymphocytes achieved a response rate of 36%, a disease control rate of 80%, and a median duration of response that had not been reached by 18 months in the global open-label phase II...
New, longer-term data from a pivotal phase II trial in advanced cutaneous squamous cell carcinoma (CSCC), were presented during the ASCO20 Virtual Scientific Program and discussed during a poster discussion.1 Danny Rischin, MD, of the Peter MacCallum Cancer Centre, Victoria, Australia, presented...
As reported in The Lancet by Gutzmer et al, the phase III IMspire150 trial has shown that the addition of atezolizumab to BRAF and MEK inhibitor therapy with vemurafenib and cobimetinib improved progression-free survival in first-line treatment of patients with unresectable BRAF V600–mutant...
As reported in the Journal of Clinical Oncology, Lo et al developed a novel risk calculator for sentinel node metastasis—the Melanoma Institute Australia Nomogram—that appears to more accurately predict risk of metastasis in patients with primary cutaneous melanoma than other commonly used risk...
On June 24, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable with surgery or radiation. KEYNOTE-629 Efficacy was investigated in KEYNOTE-629, a multicenter, multicohort,...
In a study reported in the Journal of Clinical Oncology, Garbe et al found that melanoma-specific survival rates for patients with stage III disease differed markedly in three independent cohorts compared with those reported in American Joint Committee on Cancer version 8 (AJCCv8) stage III...
Douglas B. Johnson, MD, of Vanderbilt University Medical Center, discusses three important melanoma abstracts: the need for more than two doses of nivolumab plus ipilimumab in combination immunotherapy; antitumor activity for low-dose ipilimumab with pembrolizumab after disease progression on PD-1 antibodies; and ipilimumab alone or in combination with anti–PD-1 therapy for metastatic disease resistant to PD-1 monotherapy (Abstracts 10003, 10004, and 10005).
Formal discussant of KEYNOTE-555, Siwen Hu-Lieskovan, MD, PhD, of Huntsman Cancer Institute, Salt Lake City, commented on the advantages of the new schedule. “Along with the promise of prolonged survival associated with checkpoint inhibitors, convenience, quality of life, and reducing health-care...
A less-frequent, more-convenient dosing schedule for pembrolizumab (400 mg every 6 weeks) was deemed safe and effective in patients with unresectable or metastatic melanoma, according to interim data from cohort B enrolled in the KEYNOTE-555 trial. These findings were presented at the 2020 Virtual...
The Sidney Kimmel Cancer Center—Jefferson Health (SKCC) recently announced that Andrew E. Aplin, PhD, was being recognized with the Melanoma Research Foundation Humanitarian Award. Dr. Aplin is the Kalbach-Newton Professor in Cancer Research, Enterprise Associate Director for Basic Research, and...
In an interim analysis of the German phase II IMMUNED study reported in The Lancet, Zimmer et al found that adjuvant therapy with nivolumab/ipilimumab or nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected stage IV melanoma and no evidence of...
Internationally recognized immune-oncology melanoma expert Jedd D. Wolchok, MD, PhD, FASCO, was born and reared in Staten Island, not far from where he would shape his noted career at Memorial Sloan Kettering Cancer Center (MSK) in New York, New York. “I went to Princeton University and, during my ...
In a research letter published by Fritz et al in the journal Allergy, researchers reported that the common allergy medications desloratadine and loratadine may be associated with improved survival in patients with malignant melanoma. “Previous studies have shown that the same antihistamines have...
Patients with non–immune-infiltrated “cold” tumors have low frequencies of intratumoral tumor-reactive, checkpoint-positive cytotoxic lymphocytes, making them less responsive to checkpoint blockage than patients with immune-infiltrated “hot” tumors. A phase II study by Alain P. Algazi, MD, and...