Overall Survival With Encorafenib Plus Binimetinib vs Vemurafenib in Advanced BRAF-Mutant Melanoma
As reported in The Lancet Oncology by Dummer et al, the phase III COLUMBUS trial has shown a significant improvement in overall survival with the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib vs vemurafenib in patients with advanced BRAF V600–mutant melanoma. ...
No Improvement in Survival Reported With Epacadostat Plus Pembrolizumab in Advanced Melanoma
IN PATIENTS with unresectable or metastatic melanoma, adding epacadostat to pembrolizumab (Keytruda) did not result in greater clinical benefit over pembrolizumab alone, according to data from the phase III ECHO-301/KEYNOTE-252 study. These results were originally presented at the 2018 ASCO Annual...
Overall Survival Improved With Encorafenib/Binimetinib Combination in BRAF-Mutant Melanoma
IN PATIENTS with advanced BRAF V600–mutant melanoma, combining the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) improved overall survival compared to vemurafenib (Zelboraf) or encorafenib as monotherapy, with a favorable toxicity profile, according to updated...
FDA Grants Priority Review to sBLA for Pembrolizumab in Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking accelerated approval for pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic...
Study Examines Link Between Squamous Cell Carcinoma and Recessive Dystrophic Epidermolysis Bullosa
Many patients with the rare skin disease recessive dystrophic epidermolysis bullosa (RDEB)—commonly called butterfly syndrome—also develop squamous cell carcinoma early in life. Now an international team of scientists led by researchers at the Sidney Kimmel Cancer...
Immunotherapy Combination in Melanoma Brain Metastases
In the phase II CheckMate 204 study reported in The New England Journal of Medicine, Tawbi et al found that combined nivolumab (Opdivo) and ipilimumab (Yervoy) produced a high rate of intracranial clinical benefit in patients with melanoma brain metastases. Study Details The study included 94...
Mogamulizumab vs Vorinostat in Previously Treated Cutaneous T-Cell Lymphoma
As reported by Kim and colleagues in The Lancet Oncology, the phase III MAVORIC trial showed that the anti-C-C chemokine receptor 4 (CCR4) monoclonal antibody mogamulizumab (Poteligeo) significantly improved progression-free survival vs vorinostat (Zolinza) among patients with previously treated...
Activity of T Cells in Metastatic Melanoma Resistant to Immune Checkpoint Inhibitor Treatment
In a study reported in the Annals of Oncology, Andersen et al found that tumor-infiltrating lymphocytes isolated from metastatic melanoma lesions in patients with disease progression after checkpoint inhibitor therapy remain functional. Moreover, they concluded these tumor-infiltrating lymphocytes...
Cutaneous Squamous Cell Carcinoma of the Lip and Risk of Nodal Metastasis
In a study reported in JAMA Dermatology, Wang et al found that the risk of nodal metastasis was higher for cutaneous squamous cell carcinoma of the lip with vermilion vs cutaneous location. Disease-specific and overall survival were similar for the two locations. Chrysalyne D. Schmults, MD, of the...
Gene-Expression Predictor for Immunotherapy Response in Melanoma
In a new study, researchers developed a gene expression predictor that can indicate whether melanoma in a specific patient is likely to respond to treatment with immune checkpoint inhibitors. Their research was published by Auslander et al in Nature Medicine. “There is a critical need to be...
Basal Cell Carcinoma and Risk for Development of Other Cancers
Patients who develop frequent cases of basal cell carcinoma appear to be at significantly increased risk for the development of other cancers, according to a study published by Cho et al in JCI Insight. Methods Researchers studied 61 people treated at Stanford Health Care for frequent...
Prognostic Model for Treatment Outcomes in BRAF V600–Mutated Metastatic Melanoma
In a study reported in JAMA Oncology, Hauschild et al identified baseline lactate dehydrogenase (LDH), performance status, disease burden, and gene signature as potential determinants of treatment outcomes in BRAF V600–mutant metastatic melanoma treated with BRAF and/or MEK inhibitors. Study ...
FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids
Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...
Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. This past June, encorafenib (Braftovi) and binimetinib...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
Research Finds Failings in Some Apps Used for the Diagnosis of Skin Cancer
In the scramble to bring successful apps for the diagnosis of skin cancer to market, there is a concern that a lack of testing is risking public safety, according to research led by the University of Birmingham. The research, outlined at the British Association of Dermatologists Annual...
Immunosuppressants and Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients
Research published by Jung et al in OncoImmunology showed organ transplant recipients may reduce their risk of developing secondary skin cancer by changing their immunosuppressant medication. University of Queensland (UQ) researchers have studied the impact of such medications on the immune...
Two Phase III Trials of KX2-391 in Actinic Keratosis Achieve Primary Endpoints
Two phase III studies—KX-AK-003 and KX-AK-004—achieved their primary endpoint of 100% clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, with each study achieving statistical significance (P < .0001). Statistical significance (P < .001) ...
Dabrafenib/Trametinib Combination Receives CHMP Recommendation for the Adjuvant Treatment of BRAF V600 Mutation–Positive Melanoma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of adult patients with stage III melanoma...
Indocyanine Green in Sentinel Lymph Node Biopsy for Merkel Cell Carcinoma
High rates of regional lymph node involvement and metastases are not uncommon in Merkel cell carcinoma. National Comprehensive Cancer Network (NCCN) Guidelines recommend sentinel lymph node biopsy (SLNB) for staging purposes in this malignancy. In a study by Knanckstedt et al in ...
Immunotherapy in Merkel Cell Carcinoma: ‘Field Has Been Thrown on Its Head’
At the 2018 ASCO Annual Meeting, investigators presented long-term follow-up data for immunotherapy in patients with Merkel cell carcinoma and new data for its use in the neoadjuvant setting. The results drew high interest from attendees and a number of questions were raised following the...
Human Papillomavirus Vaccine in Cutaneous Basaloid Squamous Cell Carcinomas
Squamous cell carcinoma is the second-most-common form of skin cancer. Evidence suggests the human papillomavirus (HPV) plays a role in the development of some types of this skin cancer. Two years ago, a 97-year-old woman whose right leg was covered with squamous cell tumors went to see...
First-Line Treatment With Checkpoint Inhibitors in Patients With Melanoma Brain Metastases
An analysis of newly diagnosed patients with cutaneous melanoma brain metastases treated with checkpoint blockade immunotherapy has found the treatment was associated with an increase in median overall survival of 12.4 months compared with 5.2 months—a 1.4-fold improvement. The benefit was...
Treatment Beyond Disease Progression in Melanoma: Challenge Centers on Knowing Who May Benefit
Dr. Weiss is Assistant Professor (Medical Oncology), Developmental Therapeutics, Melanoma Program, Yale Cancer Center. Dr. Sznol is Professor of Medicine (Medical Oncology); Co-Director, Cancer Immunology Program, Yale Cancer Center Co-Director, Yale SPORE in Skin Cancer, New Haven, Connecticut. ...
Outcomes in Patients With Melanoma Treated With Anti–PD-1 Antibody Beyond Disease Progression
A POOLED analysis by the U.S. Food and Drug Administration (FDA) has shown a benefit of treatment beyond disease progression on Response Evaluation Criteria in Solid Tumors (RECIST) in some patients receiving anti–programmed cell death protein 1 (anti–PD-1) antibodies for unresectable or...
Expert Point of View: Jedd Wolchok, MD, PhD
“THIS IS a wonderful presentation and a very exciting trial,” said formal discussant Jedd Wolchok, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York. Despite the remarkable advances achieved with anti–programmed cell death protein 1 and ligand 1 (anti–PD-1/anti–PD-L1) treatment, “there...
Early Data Suggest TLR9 Agonist May Combat PD-1 Resistance in Advanced Melanoma
COMBINING CMP-001, a Toll-like receptor 9 (TLR9) agonist, plus pembrolizumab (Keytruda) appears to overcome resistance to anti–programmed cell death protein 1 (anti–PD-1) therapy, according to a preliminary phase Ib study.1 Adding CMP-001 to pembrolizumab was well tolerated, with antitumor efficacy ...
Flight Attendants May Be at Increased Risk of Breast, Skin Cancers
Flight attendants showed an elevated incidence of several types of cancer compared with the general population, according to findings published by McNeely et al in Environmental Health. “Our findings of higher rates of several cancers among flight attendants is striking given the low rates...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) in patients with advanced BRAF V600–mutant melanoma, as detected by an FDA-approved test.1 Dual targeting of the MAPK...
New Guide Helps Clinicians Navigate Immunotherapy in Merkel Cell Carcinoma
Fred Hutchinson Cancer Research Center researchers have published a new guide to help clinicians navigate a recent revolution in care for advanced Merkel cell carcinoma. The guide was published in JNCCN–Journal of the National Comprehensive Cancer Network, and it accompanies NCCN’s new...
FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...
Educational Interventions Decrease Sunburns Among Operators of Heavy Equipment
The implementation of educational interventions among heavy equipment operators, or operating engineers, in Michigan significantly increased the use of sunscreen and decreased the number of sunburns, reported Duffy et al in Cancer Epidemiology, Biomarkers & Prevention. “The rates of...
MAGE-A3 Immunotherapeutic as Adjuvant Therapy for MAGE-A3–Positive Stage III Melanoma
In the phase III DERMA trial reported in The Lancet Oncology, Dreno et al found that an adjuvant MAGE-A3 immunotherapeutic provided no benefit vs placebo in patients with resected MAGE-A3–positive stage IIIB or IIIC melanoma. Development of the agent for use in melanoma has been stopped. The ...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...
The Raven
The call from the dermatologist came at noon on Good Friday, just after my wife left with our two young daughters for a week on her family’s tree farm in Northern Michigan. I was on call for the hospital inpatient leukemia service, so I could not join them. When the dermatologist solemnly began,...
Activity of the PD-1 Inhibitor Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma
As reported at the 2018 ASCO Annual Meeting (Abstract 9519) and in The New England Journal of Medicine by Migden et al, results of early-phase testing show activity of the programmed cell death protein 1 (PD-1) inhibitor cemiplimab in advanced cutaneous squamous cell carcinoma. Currently, no...
Older Patients With Melanoma Fare Better on Anti–PD-1 Immunotherapy Than Younger Patients
Recent research has shown that the tumor microenvironment in older patients promoted melanoma metastasis and resistance to targeted therapy with a BRAF inhibitor. Now, a new study investigating the relationships among age, response to anti–programmed cell death protein 1 (PD-1)...
Dabrafenib Plus Trametinib for Thyroid Cancer, Melanoma With BRAF Mutations
On May 4, 2018, dabrafenib (Tafinlar) and trametinib (Mekinist) in combination was granted approval for treatment of patients with locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and no satisfactory locoregional treatment options.1-3 Dabrafenib is not indicated for ...
Durable Complete Responses After Discontinuation of Pembrolizumab in Metastatic Melanoma
As reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, of Institut Gustave Roussy, Villejuif, France, and colleagues, a high proportion of patients with metastatic melanoma achieving a complete response on pembrolizumab (Keytruda) in the phase Ib KEYNOTE-001 trial maintained...
2018 ASCO: 2-Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses With Avelumab
Updated efficacy and safety data from the international, multicenter JAVELIN Merkel 200 trial of avelumab (Bavencio) in patients with metastatic Merkel cell carcinoma were presented by Nghiem et al at the 2018 ASCO Annual Meeting (Abstract 9507). 2-Year Follow-up At the 2-year follow-up update of ...
Paolo A. Ascierto, MD, on Melanoma: Results From the COLUMBUS Trial
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori–Fondazione Pascale, discusses phase III study findings on encorafenib plus binimetinib vs vemurafenib or encorafenib in BRAF-mutant melanoma (Abstract 9504).
Emily S. Ruiz, MD, MPH, on Squamous Cell Carcinoma: Expert Perspective
Emily S. Ruiz, MD, MPH, of Brigham and Women’s Cancer Center, discusses new developments in the treatment of squamous cell skin cancer and what she sees on the therapeutic horizon (Abstracts e18703, 9519, and 9577).
Danny Rischin, MD, on Squamous Cell Carcinoma: Treatment Trial Results
Danny Rischin, MD, of Peter MacCallum Cancer Centre, discusses phase II study findings on cemiplimab, a human monoclonal anti–PD-1 antibody, in patients with metastatic cutaneous squamous cell carcinoma (Abstract 9519).
Survival in Male vs Female Patients Receiving Immune Checkpoint Inhibitors
In a systematic review and meta-analysis reported in The Lancet Oncology, Conforti et al found a significant difference in overall survival benefit favoring male vs female patients receiving immune checkpoint inhibitor therapy for advanced cancers. Study Details The study involved database...
Surgery After Checkpoint Blockade for Selected Patients With Metastatic Melanoma
“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment are associated with survival of 75%, better than what has been previously reported,” Danielle M. Bello, MD, said in summarizing study results during ...
Outcomes for Cutaneous SCC of the Lip With Vermilion vs Cutaneous Location
In a study reported in JAMA Dermatology, Wang et al found that risk of nodal metastasis was higher for cutaneous squamous cell carcinoma (SCC) of the lip with vermilion vs cutaneous location. Disease-specific and overall survival were similar for the two locations. Study Details The retrospective ...
Updated ASCO/SSO Guideline on Sentinel Lymph Node Biopsy in Melanoma: Addressing Fundamental Clinical Questions
Dr. Thompson is Professor of Melanoma and Surgical Oncology, Sydney Medical School, The University of Sydney, and Senior Surgeon, Melanoma Institute Australia, Sydney. IN THE MID-1990s, the surgical management of patients presenting with primary cutaneous melanomas changed forever when the...
Sentinel Lymph Node Biopsy and Management of Regional Lymph Nodes in Melanoma: ASCO/SSO Clinical Practice Guideline Update
AS REPORTED IN the Journal of Clinical Oncology by Sandra L. Wong, MD, of Dartmouth-Hitchcock Medical Center, and colleagues, ASCO and the Society of Surgical Oncology (SSO) have issued an update to the ASCO/SSO clinical practice guideline on sentinel lymph node biopsy and management of regional...
Actively Recruiting Clinical Trials Focused on Nonmelanoma Skin Cancers
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on nonmelanoma skin cancers—basal cell carcinoma; merkel cell carcinoma; cutaneous lymphoma; and squamous cell carcinoma. These studies are investigating brachytherapy; topical...
Expert Point of View: Antoni Ribas, MD
FOUR RANDOMIZED trials have shown improvements in recurrence-free survival in patients with high-risk melanoma with the administration of adjuvant therapy over the past 3 years, noted formal discussant of the EORTC 1325/KEYNOTE-054 trial, Antoni Ribas, MD, Director of the Tumor Immunology Program...
