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Solid Tumors
Skin Cancer

FDA Approves Drug Combination for Adjuvant Treatment of BRAF V600–Mutant Melanoma

On April 30, 2018, the U.S. Food and Drug Administration (FDA) approved dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and lymph node involvement following...

Skin Cancer
Immunotherapy

Study Finds Desmoplastic Melanoma Highly Responsive to PD-1/PD-L1 Blockade

Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult, as these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of...

Skin Cancer
Immunotherapy

Nivolumab in Adjuvant Treatment of Melanoma

On December 20, 2017, nivolumab (Opdivo) was granted regular approval for adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection.1,2 Nivolumab was previously approved for the treatment of patients with unresectable or...

Skin Cancer

Melanoma Research Alliance Announces New Grants

The Melanoma Research Alliance has announced funding for research grants totaling more than $11 million. The awards will fund researchers at 23 institutions across the United States, Australia, and Belgium to conduct research to advance the prevention, diagnosis, and treatment of melanoma. This...

skin cancer
immunotherapy

FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations

On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar) and trametinib (Mekinist) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations (as detected by an FDA-approved test) and involvement of...

Skin Cancer
Immunotherapy

Immune-Related Toxicity With Combination Immunotherapy for Melanoma

As reported in JAMA Oncology by Alexander N. Shoushtari, MD, of the Memorial Sloan Kettering Cancer Center, and colleagues, a single-center experience has shown a very high rate of clinically significant immune-related adverse events with nivolumab (Opdivo) plus ipilimumab (Yervoy) for advanced...

Skin Cancer
Immunotherapy

Pembrolizumab vs Ipilimumab in Advanced Melanoma

The final overall survival analysis of the phase III KEYNOTE-006 trial showed maintained superiority of pembrolizumab (Keytruda) vs ipilimumab (Yervoy) in advanced melanoma. The results were reported by Jacob Schachter, MD, of the Ella Lemelbaum Institute for Melanoma, Sheba Medical Center, Tel...

lymphoma
skin cancer

Reciprocal Risks of Lymphoid Neoplasms and Cutaneous Melanoma

In a study reported in the Journal of the National Cancer Institute, Herr et al found that patients with specific types of primary lymphoid neoplasms were at increased risk of second primary cutaneous melanoma, with the reciprocal association also being observed. Occurrence of second primary...

skin cancer
immunotherapy

AACR 2018: Adjuvant Pembrolizumab in High-Risk Stage III Melanoma

As reported at the 2018 American Association for Cancer Research (AACR) Annual Meeting (Abstract CT001) and in The New England Journal of Medicine by Eggermont et al, the phase III EORTC 1325/KEYNOTE 054 trial has shown that adjuvant pembrolizumab (Keytruda) significantly prolonged recurrence-free...

skin cancer
immunotherapy

AACR 2018: TLR9 Agonist CMP-001/Pembrolizumab Combination Shows Early Efficacy in Patients With Metastatic Melanoma Resistant to Anti–PD-1

A combination of CMP-001, an intratumoral Toll-like receptor 9 (TLR9) agonist, and pembrolizumab (Keytruda) was well tolerated and had clinical activity in patients with metastatic melanoma resistant to programmed cell death protein 1 (PD-1) checkpoint inhibition, according to preliminary data...

cns cancers
skin cancer
immunotherapy

Nivolumab/Ipilimumab or Nivolumab Alone in Melanoma Brain Metastases

In an Australian phase II trial reported in The Lancet Oncology, Long et al found that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) and nivolumab alone showed intracranial activity in patients with melanoma brain metastases. Study Details In the open-label trial, 76 evaluable...

skin cancer
immunotherapy

First-Line Avelumab in Metastatic Merkel Cell Carcinoma

In a preplanned interim analysis of a phase II trial (JAVELIN Merkel 200 part B) reported in JAMA Oncology, D’Angelo et al found that avelumab was active in the first-line treatment of metastatic Merkel cell carcinoma. Avelumab was approved in March 2017 for treatment of patients aged ≥ 12 ...

Skin Cancer

Encorafenib Plus Binimetinib Improves Progression-Free Survival vs Vemurafenib in Advanced BRAF-Mutant Melanoma

IN THE PHASE III COLUMBUS trial reported in The Lancet Oncology, Reinhard Dummer, MD, of University Hospital Zurich, and colleagues found that the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved progression-free survival vs vemurafenib (Zelboraf) in...

skin cancer
immunotherapy

SSO 2018: Outcomes of Patients With Metastatic Melanoma Selected for Surgery After Immunotherapy

Immunotherapy has transformed the treatment of metastatic melanoma, with 3-year survival rates surpassing 50% for appropriate patients. However, many of these patients still require surgery, but very little research has been done on this group of patients to determine whether surgery after...

skin cancer

April K.S. Salama, MD, on Melanoma: Treating Recurrent or Progressive Distant Disease

April K.S. Salama, MD, of Duke Cancer Institute, talks about how to select systemic therapy for a patient with previously treated metastatic melanoma.

skin cancer
immunotherapy

Circulating Tumor DNA and Pseudoprogression in Metastatic Melanoma Treated with Anti–PD-1 Antibodies

In a study reported in JAMA Oncology, Lee et al found that measurement of circulating tumor DNA (ctDNA) can help distinguish between pseudoprogression (radiologic progression prior to response) and true progression in patients with metastatic melanoma receiving anti­–programmed cell death ...

Solid Tumors
Skin Cancer

Clinical Trials Actively Recruiting Patients With Melanoma

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies in melanoma. These studies focus on assessing response to checkpoint inhibitors; T-cell immunotherapy; combination therapies; adoptive cell therapy; combination therapy development; and...

Solid Tumors
Skin Cancer

The Skin Cancer Foundation Announces Office Relocation

The Skin Cancer Foundation, the leading nonprofit organization for public and professional skin cancer education, recently moved to a new office space at 205 Lexington Avenue in midtown Manhattan. The new office will allow the Foundation to grow its staff as it develops new patient support programs ...

skin cancer
immunotherapy

Body Mass Index and Outcomes With Targeted Therapy, Immunotherapy, or Chemotherapy in Metastatic Melanoma

In a study reported in The Lancet Oncology, McQuade et al found that obesity was associated with improved outcomes in treatment of metastatic melanoma with targeted therapy or immunotherapy—but not chemotherapy—with a survival benefit appearing to be restricted to obese male patients....

Skin Cancer

Retrospective Analysis Suggests Obesity Associated With Longer Survival for Men With Metastatic Melanoma

OBESE PATIENTS with metastatic melanoma who are treated with targeted or immune therapies live significantly longer than those with a normal body mass index (BMI), according to a study published in The Lancet Oncology of 1,918 patients in 6 independent clinical cohorts.1  This effect—referred to as ...

skin cancer
immunotherapy

Patients With Melanoma Treated With Anti–PD-1 Antibodies Beyond RECIST Progression

A pooled analysis by the U.S. Food and Drug Administration (FDA) has shown a benefit of treatment beyond progression, as defined by RECIST criteria, in many patients receiving anti–programmed cell death protein 1 (PD-1) antibodies for unresectable or metastatic melanoma. The analysis was ...

skin cancer
immunotherapy

Study Finds Desmoplastic Melanoma Highly Responsive to PD-1/PD-L1 Blockade

Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult, as these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of...

skin cancer
immunotherapy

Durable Complete Responses After Discontinuation of Immunotherapy in Metastatic Melanoma

As reported in the Journal of Clinical Oncology by Robert and colleagues, a high proportion of patients with metastatic melanoma achieving complete response on pembrolizumab (Keytruda) in the phase Ib KEYNOTE-001 trial maintained complete response for prolonged durations after treatment...

breast cancer
colorectal cancer
lung cancer
skin cancer
issues in oncology

Growing Socioeconomic and Racial Disparities in Management of Brain Metastases

Increasing use of a potentially life-saving treatment for metastatic cancer is leaving too many vulnerable patients behind, according to a new study from Yale Cancer Center/Smilow Cancer Hospital published by Kann et al in JNCCN – Journal of the National Comprehensive Cancer Network. The...

skin cancer
immunotherapy

Adjuvant Pembrolizumab Improves Recurrence-Free Survival in Stage III Resected High-Risk Melanoma

On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free...

breast cancer
skin cancer
issues in oncology
gastrointestinal cancer

Study Finds Increased Risk in Common Cancers in Female Night Shift Workers

In 2007, the International Agency for Research on Cancer classified shift work with circadian disruption or chronodisruption as a probable human carcinogen. Now, a meta-analysis investigating whether long-term shift work increases the risks of common cancers in women has found that, overall, night...

skin cancer

FDA Accepts sNDA, Grants Priority Review to Adjuvant Dabrafenib/Trametinib in BRAF V600E/K Mutation–Positive Melanoma

On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...

skin cancer

Nivolumab for Adjuvant Treatment of Melanoma Granted Regular Approval by FDA

On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...

Skin Cancer

Melanoma Mutations: What You Need to Know

CLINICIANS ARE now well acquainted with BRAF mutations in advanced melanoma, but there is more to genomics in this disease than identifying BRAF and prescribing a BRAF inhibitor.  At the 2017 Debates and Didactics Conference, held at Sea Island, Georgia, Melinda L. Yushak, MD, MPH, of Emory...

Skin Cancer

Balancing Immune-Related Adverse Events With Efficacy of Dual Checkpoint Inhibitor Therapy in Melanoma

MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...

skin cancer

Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation

On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...

skin cancer

FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma

On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete...

skin cancer

Long-Term Outcomes With BRAF and MEK Inhibition in BRAF V600–Mutant Metastatic Melanoma

As reported by Long et al in the Journal of Clinical Oncology, a 5-year landmark analysis of patients receiving dabrafenib (Tafinlar) and trametinib (Mekinist) for BRAF V600–mutant metastatic melanoma shows persistent overall and progression-free survival benefits. Study Details The...

skin cancer

Effectiveness of Sentinel Lymph Node Biopsy in Patients With Newly Diagnosed Melanoma

Research presented at the 9th World Congress of Melanoma supports the updated guideline recommendation that sentinel lymph node biopsy be performed in more patients newly diagnosed with melanoma, as it has the potential to save lives due to the information the procedure provides. This biopsy can...

skin cancer

Intratumoral Plasmid IL-12 With Electroporation in Stage III/IV Melanoma

OncoSec Medical Incorporated presented new clinical data on ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid] with electroporation) at the 9th World Congress of Melanoma. “We are excited to share updated data from our phase II clinical monotherapy trial with ImmunoPulse ...

skin cancer

Axl Inhibitor BGB324 in Combination With Trametinib Plus Dabrafenib or Pembrolizumab in Advanced Melanoma

BerGenBio ASA announced that the randomized phase Ib/II clinical study of the Axl inhibitor BGB324 in combination with either the MAP kinase inhibitors trametinib (Mekinist) plus dabrafenib (Tafinlar) or the immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with advanced melanoma is...

Skin Cancer

Regional Radiation Therapy Reduces Risk of Regional Recurrence in Node-Positive Cutaneous Melanoma

IN A LARGE single-institution study reported in the Journal of the National Comprehensive Cancer Network, Tobin Strom, MD, and colleagues found that regional radiotherapy was associated with a reduced risk of regional recurrence in patients with node-positive cutaneous melanoma, including those...

Skin Cancer

Nivolumab/Ipilimumab in Patients With Advanced Melanoma Who Did or Did Not Discontinue Induction Treatment due to Adverse Events

IN A RETROSPECTIVE pooled analysis of the CheckMate 069 and 067 studies reported in the Journal of Clinical Oncology, Dirk Schadendorf, MD, of the University Hospital Essen and the German Cancer Consortium, and colleagues found little difference in the efficacy of combined nivolumab (Opdivo) and...

Skin Cancer

Nivolumab Treatment Beyond Disease Progression in Advanced Melanoma

In a retrospective analysis reported in JAMA Oncology, Georgina V. Long, MBBS, PhD, of the Melanoma Institute Australia, North Sydney, and colleagues found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response...

Skin Cancer

Expert Point of View: Alexander Eggermont, MD, PhD

BASED ON THE RESULTS of COMBI-AD1 and CheckMate 238,2 invited discussant Alexander Eggermont, MD, PhD, Professor of Oncology at Gustave Roussy in Paris, commented: “It’s a good day for melanoma!”  In COMBI-AD, treatment with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist)...

Skin Cancer

CheckMate 238: Nivolumab Shows Benefit as Adjuvant Melanoma Treatment

IN THE TREATMENT of malignant melanoma, immune checkpoint inhibitors are no longer just for metastatic disease, and the best type may be agents targeting the programmed cell death protein 1 (PD-1), according to results of CheckMate 238, presented at the European Society for Medical Oncology (ESMO)...

Skin Cancer

Adjuvant BRAF/MEK Inhibition Improves Survival in Resectable Melanoma

FOR PATIENTS with locally advanced, resectable melanoma harboring BRAF mutations, adjuvant treatment with BRAF/ MEK inhibition significantly improves overall survival, results of the COMBI-AD trial have shown. The study was presented at the European Society for Medical Oncology (ESMO) 2017...

skin cancer

Combination Therapy for Patients With Advanced Unresectable Melanoma

A phase II study has shown that the addition of the oncolytic viral agent talimogene laherparepvec (Imlygic) to ipilimumab (Yervoy) significantly increased the response rate in patients with advanced unresectable melanoma. These findings were reported in the Journal of Clinical Oncology by Chesney...

skin cancer

Single-Center Study of Adjuvant Beta-Blocker Therapy for Cutaneous Melanoma

An Italian single-center prospective cohort study suggests that adjuvant treatment with the beta-blocker propranolol significantly reduces the risk of melanoma recurrence in patients with stage IB to IIIA cutaneous disease. The findings were reported in JAMA Oncology by De Giorgi et al. Preclinical ...

Skin Cancer

Overview of the Phase III MSLT-II Trial

THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...

Skin Cancer

Blood-Based Biomarker: Predicting Efficacy of Immunotherapy in Patients With Melanoma

IN WHAT APPEARS TO BE the largest blood-based biomarker study of a checkpoint inhibitor, an RNA transcript–based gene classifier was able to predict for melanoma patients’ response to tremelimumab. The study was recently published in the Journal for ImmunoTherapy of Cancer.1  “Our study, in many...

Skin Cancer

MSLT-II Completion Lymph Node Dissection Trial: Practice Changing but Not Likely Practice Abandoning

PROBABLY THE MOST IMPORTANT advance in the treatment of newly diagnosed primary melanoma has been the incorporation of sentinel lymph node biopsy as part of initial surgical management. The routine use of sentinel lymph node biopsy, often termed “sentinel lymphadenectomy,” in appropriately...

skin cancer

Pooled Analysis Safety Profile of Combination Immunotherapy for Advanced Melanoma

In a retrospective study reported in the Journal of Clinical Oncology, Sznol et al have provided a pooled safety profile of combination nivolumab (Opdivo) and ipilimumab (Yervoy) treatment in patients with advanced melanoma. Study Details The study included data from 448 patients from a phase Ib...

Solid Tumors
Skin Cancer

Adjuvant Nivolumab vs Ipilimumab in Resected Stage III or IV Melanoma

The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Jeffrey Weber and colleagues in The New England Journal of Medicine. Study Details In the ...

skin cancer

Adjuvant Dabrafenib and Trametinib in Resected Stage III BRAF-Mutated Melanoma

The phase III COMBI-AD trial has shown a significant improvement in relapse-free survival with the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) vs placebo as adjuvant therapy in patients with resected stage III melanoma with BRAF V600E or V600K ...

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