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Skin Cancer

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...

Skin Cancer

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...

Skin Cancer
Genomics/Genetics

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...

Skin Cancer

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...

Skin Cancer

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 ...

Skin Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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,...

Skin Cancer
Immunotherapy

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...

Skin Cancer

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...

Skin Cancer

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...

Skin Cancer
Solid Tumors

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...

Skin Cancer
Immunotherapy

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...

Immunotherapy
Skin Cancer

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 ...

Skin Cancer

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...

Skin Cancer

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...

Immunotherapy
Skin Cancer

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...

Skin Cancer

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...

Skin Cancer

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 ...

Skin Cancer

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...

Skin Cancer

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...

Skin Cancer
Immunotherapy

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...

skin cancer
immunotherapy

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).

Skin Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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...

skin cancer
immunotherapy

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).

Skin Cancer

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...

Skin Cancer

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...

Skin Cancer
Immunotherapy

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...

skin cancer
immunotherapy

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).

Skin Cancer

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...

Skin Cancer
Immunotherapy

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 ...

Skin Cancer
Immunotherapy

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...

Multiple Myeloma
Breast Cancer
Lung Cancer
Solid Tumors
Lymphoma
Leukemia
Skin Cancer

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...

Skin Cancer
Immunotherapy

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...

Skin Cancer

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...

Skin Cancer

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...

Skin Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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 ...

Skin Cancer

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 ...

Skin Cancer

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 ...

Kidney Cancer
Lung Cancer
Myelodysplastic Syndromes
Solid Tumors
Skin Cancer
Lymphoma
Pancreatic Cancer
Breast Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

Pembrolizumab for Advanced Melanoma: Impact of BRAF-Mutation Status and Prior Therapeutic Regimens

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...

Skin Cancer
Immunotherapy

Potential Association of Impaired Spermatogenesis and Immune Checkpoint Inhibitor Therapy in Patients With Metastatic Melanoma

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...

Skin Cancer

Expert Point of View: Ryan J. Sullivan, MD

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....

Skin Cancer

Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Proves Active in Refractory Metastatic 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...

Skin Cancer
Immunotherapy

Longer-Term Results of Pivotal Study in Advanced Cutaneous Squamous Cell Carcinoma

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...

Skin Cancer
Immunotherapy

Addition of First-Line Atezolizumab to Vemurafenib and Cobimetinib in Patients With Unresectable Advanced BRAF V600–Mutant Melanoma

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...

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