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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...

skin cancer
immunotherapy

Grant A. McArthur, MBBS, PhD, on Melanoma: IMspire150 Trial of Atezolizumab, Cobimetinib, and Vemurafenib

Grant A. McArthur, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses phase III results from a study of previously untreated patients with BRAF V600 mutation–positive advanced melanoma. His team evaluated whether combining vemurafenib and cobimetinib with atezolizumab improved the durability of responses compared with targeted therapies plus placebo (Abstract CT012).

Skin Cancer
Immunotherapy

Expert Point of View: Charles Sawyers, MD

“The hypothesis of combining kinase inhibitors with checkpoint inhibitors could be a fantastic idea,” said formal study discussant Charles Sawyers, MD, of Memorial Sloan Kettering Cancer Center, New York. “This trial [IMspire150] is positive, and that is great news. Triple therapy is superior to...

Skin Cancer
Immunotherapy

AACR 2020: Triplet Regimen Improves Progression-Free Survival in Advanced Melanoma in IMspire150 Trial

The addition of the checkpoint inhibitor atezolizumab to two targeted therapies (the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib) as initial therapy improved outcomes compared with the two targeted therapies plus placebo in patients with newly diagnosed BRAF V600E/K–mutant advanced ...

Immunotherapy
Skin Cancer

Neoadjuvant Nivolumab for Resectable Merkel Cell Carcinoma

As reported in the Journal of Clinical Oncology by Suzanne L. Topalian, MD, and colleagues, neoadjuvant treatment with nivolumab was found to produce pathologic complete response in approximately half of patients with resectable Merkel cell carcinoma enrolled in the phase I/II CheckMate 358 trial....

Skin Cancer
Issues in Oncology

Are There Racial Differences in Time to Treatment for Melanoma?

Black patients with stage I to III melanoma are likely to experience a longer delay from diagnosis to surgery than non-Hispanic white patients, according to a study published by Tripathi et al in the Journal of the American Academy of Dermatology. “We already knew that black patients with melanoma...

Skin Cancer

AACR 2020: Continuous vs Intermittent Dabrafenib/Trametinib Dosing in Patients With BRAF-Mutated Melanoma

A randomized clinical trial offers evidence that a combination of two targeted melanoma drugs, when given continuously, improves progression-free survival when compared with intermittent treatment, according to study results presented by Algazi et al at the American Association for Cancer Research...

covid-19
global cancer care
skin cancer

Paolo A. Ascierto, MD, on Cancer Treatment During the COVID-19 Pandemic: The View From Southern Italy

Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori in Naples, Italy, talks about minimizing risks for patients with cancer, prioritizing surgery and other treatments for melanoma, and the state of clinical trials. Filmed April 17, 2020.

Immunotherapy
Breast Cancer
Skin Cancer
Lung Cancer

What’s the Current Status of Neoadjuvant Immunotherapy?

For several tumor types, can the successes achieved with immunotherapy in the metastatic and adjuvant settings be replicated in the neoadjuvant setting? An explosion in clinical trials—with more than 300 listed on ClinicalTrials.gov—point to “yes.” “The neoadjuvant use of immunotherapy is of great ...

Skin Cancer

Differences in Melanoma Incidence in Men vs Women by Age and Anatomic Site

In a study published by Olsen et al in JAMA Dermatology, researchers found that in predominantly fair-skinned populations, melanoma incidence differed by age and anatomic site in men and women. Methods A cross-sectional analysis of sex- and site-specific trends was performed for white patients...

Skin Cancer
Immunotherapy

Expert Point of View: Jarushka Naidoo, MBBCh

Discussant of the abstract on antibiotic exposure, Jarushka Naidoo, MBBCh, Assistant Professor of Oncology and Attending Physician at the Sidney Kimmel Cancer Center at Johns Hopkins University, said that Mr. Chu and colleagues have added to the recent literature examining concurrent use of...

Skin Cancer
Immunotherapy

Prior Antibiotic Use Linked to Poorer Survival in Patients With Advanced Melanoma Receiving Immune Checkpoint Inhibitors

Treatment with antibiotics prior to immune checkpoint inhibitor therapy may confer poorer overall survival and an increased risk of colitis in patients with advanced melanoma, according to data presented at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium.1 The largest institutional...

Skin Cancer

Clinical and Dermoscopic Features of Uncommon Melanoma Variants: Systematic Review

In a literature review published by Pampena et al in JAMA Dermatology, researchers provided detailed and extensive information about the features of several different kinds of rare cutaneous melanomas. According to the researchers, the analysis was performed to “…provide a comprehensive overview of ...

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