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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...

Skin Cancer

Novel Risk Calculator for Sentinel Node Positivity in Patients With Melanoma

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...

Skin Cancer
Immunotherapy

FDA Approves Pembrolizumab for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

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,...

Skin Cancer

Prognosis of Patients With Stage III Melanoma According to AJCCv8 vs Independent Cohorts

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...

skin cancer
immunotherapy

Douglas B. Johnson, MD, on Melanoma: Clinical Trials Update on PD-1 and CTLA-4 Blockade

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).

Skin Cancer
Immunotherapy

Expert Point of View: Siwen Hu-Lieskovan, MD, PhD

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...

Skin Cancer
Immunotherapy

KEYNOTE-555 Supports 6-Week Pembrolizumab Dosing Schedule in Melanoma

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...

Skin Cancer

Andrew E. Aplin, PhD, Receives Humanitarian Award From the Melanoma Research Foundation

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...

Skin Cancer
Immunotherapy

Adjuvant Nivolumab/Ipilimumab or Nivolumab Alone vs Placebo in Patients With Resected Stage IV Melanoma

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...

Immunotherapy
Skin Cancer

Internationally Regarded Cancer Immunologist Did Not Stray Far From Home

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 ...

Skin Cancer

Antihistamines May Improve Survival Among Patients With Malignant Melanoma

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...

Skin Cancer
Immunotherapy

Combining Pembrolizumab With IL-12 Electroporation May Improve Clinical Response in Patients With Immunologically 'Cold' Melanoma

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...

Skin Cancer

Expert Point of View: Charles L. Sawyers, MD

Charles L. Sawyers, MD, of Memorial Sloan Kettering Cancer Center, New York, commented on the SWOG S1320 study presented at the 2020 American Association for Cancer Research Virtual Annual Meeting. “Intermittent therapy is standard with chemotherapy due to toxicity, but targeted therapies...

Skin Cancer

AACR 2020: Continuous Dosing of Dabrafenib Plus Trametinib Improves Progression-Free Survival vs Intermittent Dosing in Advanced Melanoma

Continuous dosing with dabrafenib and trametinib improved progression-free survival in patients with BRAF-mutated advanced melanoma compared with an intermittent-dosing strategy, according to results of the phase II SWOG S1320 randomized trial reported at the opening Plenary Session of the 2020...

Sarcoma
Skin Cancer
CNS Cancers

Early Signs of Activity With Immunotherapies in Low-Incidence Cancers

Immunotherapy is showing promise for patients with rare cancers, offering new treatment opportunities and clinical trials to those with previously limited options. At the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium, presenters discussed the use of immunotherapy in three low-incidence cancers: ...

Skin Cancer
Immunotherapy

Expert Point of View: Omid Hamid, MD

Omid Hamid, MD, Chief of Research/Immuno-Oncology, The Angeles Clinic & Research Institute, and Co-Director of the Cutaneous Malignancy Program at Cedars-Sinai Cancer Center, Los Angeles, commented on these two studies for The ASCO Post. According to Dr. Hamid, the findings for the tumor...

Skin Cancer
Immunotherapy

Novel Treatment Strategies Under Study in Advanced Melanoma

Several novel strategies for the treatment of patients with stage III or IV melanoma showed promise in studies presented at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium.1,2 Vaccine for High-Risk Patients After Resection A tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine was...

Skin Cancer
Immunotherapy

New Guideline on Systemic Therapy for Melanoma Tackles Rapid Developments in Treatment Options

Systemic treatment of melanoma has changed rapidly since the introduction of ipilimumab in 2011. Newer therapies approved for melanoma since that time include immunotherapy, targeted therapy for mutation-bearing tumors, and injectional therapy for cutaneous or palpable lesions. ASCO has released...

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