Fecal Microbiota Transplants May Help Patients With Advanced Melanoma Respond to Immunotherapy
For patients with melanoma who do not respond to treatment with immunotherapy, adjusting the composition of microorganisms in the intestines through the use of fecal transplants may aid in overcoming resistance to therapy. These findings were published by Davar et al in Science. In the study, some...
FDA Approves Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
On February 9, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc (Libtayo) for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. The FDA also granted...
High-Risk Cutaneous Squamous Cell Carcinomas: The Present and Future
Cutaneous squamous cell carcinoma is the second most common type of skin cancer, with more than 1 million cases diagnosed in the United States annually.1 Historically, cutaneous squamous cell carcinoma is grouped together with basal cell carcinoma and collectively referred to as nonmelanoma skin...
FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...
Small Study Finds Personalized Neoantigen Vaccines May Result in Durable Immune Response for Patients With Melanoma
Four years after patients with melanoma were treated with a personalized cancer vaccine, the immune response caused by the vaccine remained robust and effective in keeping cancer cells under control, according to a new study published by Hu et al in Nature Medicine. The findings demonstrate the...
First-Line Nivolumab/Ipilimumab in Metastatic Uveal Melanoma
In a Spanish phase II trial reported in the Journal of Clinical Oncology, Piulats et al found that nivolumab/ipilimumab produced a “modest” improvement in overall survival vs historical rates achieved with chemotherapy as first-line treatment for patients with metastatic uveal melanoma ineligible...
FDA Pipeline: Two Fast Track Designations for Cavrotolimod in Nonmelanoma Skin Cancers
The U.S. Food and Drug Administration (FDA) has granted two Fast Track designations to cavrotolimod (AST-008). The designations include cavrotolimod in combination with anti–PD-1 therapy for the treatment of patients with locally advanced or metastatic Merkel cell carcinoma refractory to prior...
New Study Investigates Role of Ultraviolet Radiation in Conjunctival Melanoma
Ultraviolet (UV) radiation may contribute to the development of a rare type of eye cancer, conjunctival melanoma, according to research published by Mundra et al in Nature Communications. The new study has revealed similar genetic changes in patients with conjunctival melanoma to those with...
New Study Explores the Use of Focused Ultradeep DNA Sequencing to Quantify Skin Cancer Risk
Recent research has shed new light on the carcinogenic effect of exposure to ultraviolet (UV) radiation, laying the groundwork for improvements in skin cancer risk stratification and prevention. A study published by Lei Wei, PhD, and colleagues in Science Advances detailed a method to measure the...
Intratumoral Injections May Boost Neoadjuvant Response in Resectable Melanoma
Studies reported at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting, which was held virtually, showed promise for the use of intratumoral injections of novel immunotherapies in treating advanced, resectable melanoma. In the 3-year interim analysis of a global phase II randomized...
Novel Combination Under Study in First-Line Treatment of Metastatic Melanoma
A first-line regimen combining the novel interleukin-2 (Il-2) agonist bempegaldesleukin (NKTR-214) with nivolumab showed encouraging clinical activity in patients with metastatic melanoma in the phase I/II PIVOT-02 trial, according to a presentation during the 2020 Annual Meeting of the Society for ...
ESMO Immuno-Oncology 2020: First-Line Anti–PD-1 Therapy vs BRAF/MEK Inhibition for Advanced BRAF V600–Mutated Melanoma
Findings from a propensity-matched survival analysis presented by van Breeschoten et al at the European Society for Medical Oncology (ESMO) Immuno-Oncology Virtual Congress 2020 (Abstract 37P) suggest that patients with advanced melanoma and a BRAF V600 mutation derive an enhanced survival benefit...
ESMO Immuno-Oncology 2020: Tebentafusp Shows Activity in Metastatic Uveal Melanoma
Tebentafusp is a novel bispecific molecule consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target gp100-positive cells. The agent showed clinical benefit, including target lesion reduction, in patients with metastatic uveal melanoma,...
Machine Learning Algorithms May Help Predict Response to Immunotherapy in Patients With Advanced Melanoma
A study investigating a computational method that integrates deep learning on histology specimens with clinicodemographic variables has found that the artificial intelligence may help predict response to immune checkpoint blockade among patients with advanced melanoma. This computational approach...
Expect Questions About Mohs Micrographic Surgery
A recent study finding similar overall survival rates for patients with melanomas of the trunk and extremities treated with Mohs micrographic surgery or wide local excision1 raises questions about why and when physicians might recommend, and patients opt for, one or the other procedure. “The most...
Mohs Surgery vs Wide Local Excision for Trunk and Extremity Melanomas: Comparable Overall Survival Rates
A cohort study of 188,862 cases of all-stage melanomas of the trunk and extremities found no differences in overall survival between patients treated with Mohs micrographic surgery or with wide local excision.1 “These findings add to the existing body of evidence demonstrating that wide local...
Meta-analysis of Outcomes With Gamma Knife Radiosurgery for Uveal Melanoma or Ocular Metastases
In a systematic review and meta-analysis reported in The Lancet Oncology, Parker et al found that Gamma Knife radiosurgery was associated with high local control and tumor regression rates in patients with uveal melanoma or intraocular metastases. As stated by the investigators, “Gamma [K]nife...
Pretreatment ctDNA May Help Predict Outcomes With First-Line—but Not Second-Line—Immunotherapy for Patients With Melanoma
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...
Continued Benefit of First-Line Nivolumab vs Dacarbazine in Advanced BRAF Wild-Type Melanoma
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 ...
Recurrence-Free Survival Benefit Maintained With Adjuvant Nivolumab vs Ipilimumab in Stage IIIB–IIIC and IV Melanoma
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...
UCLA Researchers’ Efforts in Melanoma Receive $13M Boost From NIH
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...
Advanced Melanoma: Lenvatinib Plus Pembrolizumab After Disease Progression on Anti–PD-1 Therapy
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...
Small Case Study Explores Novel Approach to Neoadjuvant Therapy for Skin Cancer
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...
Long-Term Benefit of Adjuvant Immunotherapy Sustained in Stage III or IV Melanoma
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 ...
COMBI-i Trial: No Statistical Benefit to Adding Spartalizumab to Dabrafenib/Trametinib in Melanoma
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...
ASCO’s Policy Statement on Skin Cancer Prevention Focuses on Four Key Areas to Reduce Incidence and Save Lives
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...
Five-Year Outcomes: First-Line Nivolumab vs Dacarbazine in Advanced BRAF Wild-Type Melanoma
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, on Melanoma: Adjuvant Nivolumab vs Ipilimumab
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).
Four-Year Outcomes in CheckMate 238: Adjuvant Nivolumab vs Ipilimumab in Stage IIIB–IIIC or IV Melanoma
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...
Benefit of Pembrolizumab in High-Risk Stage III Melanoma: 3-Year Follow-up
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, on Melanoma: Pembrolizumab vs Placebo After Complete Resection
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).
Pembrolizumab Produces Durable Responses in Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma
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...
Sentinel Lymph Node Biopsy and Age-Related Mutations: Therapeutic and Predictive Implications in Melanoma
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...
Adjuvant Nivolumab vs Ipilimumab in Resected Advanced Melanoma: Long-Term Follow-up of CheckMate 238
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, on Melanoma: Sequencing Targeted Treatments and Immunotherapy
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).
Long-Term Follow-up of the COMBI-AD Trial: Adjuvant Dabrafenib/Trametinib in Patients With Stage III Melanoma and BRAF V600 Mutations
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...
Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF V600–Positive Unresectable or Metastatic Melanoma
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 ...
Growing Body of Evidence Supports Adjuvant Immunotherapy for Stage IV Melanoma With No Evidence of Disease
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...
FDA Pipeline: Priority Reviews in Multiple Myeloma, Metastatic Breast Cancer, and NSCLC
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...
Adjuvant Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage IV Melanoma With No Evidence of Disease
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...
Adding Immunotherapy to BRAF/MEK Inhibition in BRAF V600–Mutant Melanoma: First Step on the Journey
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...
Addition of Atezolizumab to Vemurafenib/Cobimetinib in Unresectable Advanced BRAF V600–Mutant Melanoma
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...
Researchers Outline Need for Evaluation of Gene-Expression Profiling in Melanoma
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...
Pembrolizumab Monotherapy as First-Line Treatment for Patients With Unresectable Cutaneous Squamous Cell Carcinoma
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 ...
10-Year Study Indicates Pembrolizumab Provides Long-Term Benefits for Patients With Metastatic Melanoma
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 ...
Pembrolizumab for Cutaneous Squamous Cell Carcinoma
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 ...
FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More
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...
FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib for Advanced BRAF V600–Mutated Melanoma
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...
Pembrolizumab in Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma
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...
Small Study Evaluates Neoadjuvant vs Adjuvant Nivolumab Plus Ipilimumab in Stage III Melanoma
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...
