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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...
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...
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...
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 ...
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...
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...
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...
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...
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)...
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)...
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...
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...
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 ...
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...
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...
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...
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...
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 ...
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 ...
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 Weber and colleagues in The New England Journal of Medicine. Study Details In the...
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...
DOES COMPLETE lymph node dissection for sentinel node–positive melanoma still have a role in the management of this disease? That’s debatable. Although it does not improve overall survival over observation alone, complete lymphadenectomy may have other benefits, according to a dialogue at the...
ASSUMING THE regimens evaluated in COMBI-AD and CheckMate 238 are both approved by the U.S. Food and Drug Administration for the treatment of high-risk resected melanoma, clinicians may be faced with a tough choice. ESMO experts and the study’s investigators weighed in on this issue in a lively...
FOR PATIENTS with malignant melanoma, the significant improvement in outcomes with targeted agents and antibodies against the programmed cell death protein 1 (PD-1) has now been observed in the adjuvant setting. Two landmark studies presented at the European Society for Medical Oncology (ESMO) 2017 ...
Overall survival outcomes in the phase III CheckMate 067 trial indicate improved survival with nivolumab (Opdivo)/ipilimumab (Yervoy) vs ipilimumab and with nivolumab vs ipilimumab in patients with previously untreated advanced melanoma. These findings were reported in The New England Journal of...
Combination targeted adjuvant therapy with dabrafenib (Tafinlar) and trametinib (Mekinist) doubles relapse-free survival in patients with stage III BRAF-mutant melanoma, according to late-breaking results from the COMBI-AD trial presented on September 11 at the European Society for Medical Oncology ...
Adjuvant nivolumab (Opdivo) is superior to standard-of-care ipilimumab (Yervoy) in patients with surgically resected stage III/IV melanoma who are at high risk of relapse, according to late-breaking results from the CheckMate 238 trial presented on September 11 at the European Society for Medical...
Jeffrey S. Weber, MD, PhD, of New York University’s Langone Medical Center, discusses study results on adjuvant therapy with nivolumab vs ipilimumab after complete resection of stage III/IV melanoma (Abstract LBA8).
Karl D. Lewis, MD, of the Anschutz Cancer Pavilion, discusses study findings on adjuvant vemurafenib in patients with completely resected BRAF V600–positive melanoma at high risk for recurrence (Abstract LBA7).
Caroline Robert, MD, PhD, of Gustave Roussy, characterizes complete responses in patients with advanced melanoma who received the combination of nivolumab and ipilimumab, or nivolumab or ipilimumab alone (Abstract 1213O).
As reported in JAMA Oncology by Shoushtari et al, 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 melanoma. Their findings suggest that the full course of four doses of...
New technology being developed by researchers at the University of Waterloo and the Sunnybrook Research Institute is using artificial intelligence (AI) to help detect melanoma at earlier stages. The technology employs machine-learning software to analyze images of skin lesions and provide...
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 Schachter et al in The Lancet. An interim analysis showed improved progression-free and overall...
A phase II trial has shown that the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinst) produces responses in brain metastases in patients with BRAF V600–mutant melanoma. These findings were reported by Michael A. Davies, MD, of The University of...
In the phase IB KEYNOTE-029 study, standard-dose pembrolizumab (Keytruda) plus reduced-dose ipilimumab (Yervoy) produced high response rates in patients with advanced melanoma. These results were reported by Long et al in The Lancet Oncology. Study Details In the study, 153 patients with...
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of pediatric...
DISCUSSANT LYNN SCHUCHTER, MD, the C. Willard Professor of Medicine at the Abramson Cancer Center at the University of Pennsylvania, Philadelphia, said the findings herald “a new era on two fronts…. Systemic therapy as initial treatment for patients with asymptomatic central nervous system (CNS)...
STUDIES PRESENTED at the 2017 ASCO Annual Meeting have shown that for melanoma that metastasizes to the brain, the combined use of checkpoint inhibitors and targeted agents can be effective. In COMBI-MB, 58% of patients responded intracranially to the BRAF inhibitor dabrafenib (Tafinlar) plus the...
“Strong evidence suggests that using a tanning bed during adolescence or young adulthood can increase the risk of early-onset melanoma by over 40%,” Jeffrey E. Gershenwald, MD, wrote in an opinion piece for Newsweek.1 Dr. Gershenwald is Professor of Surgical Oncology, Medical Director of the...
“If minors don’t tan, then they may never become adult tanners,” Jeffrey E. Gershenwald, MD, said in explaining the emphasis on teaching sun safety behaviors to young children as part of the Melanoma Moon Shot Program at The University of Texas MD Anderson Cancer Center, Houston. Dr. Gershenwald is ...
In a retrospective analysis reported in JAMA Oncology, Long et al found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1–defined disease...
As reported in the Journal of Clinical Oncology by Larkin et al, the phase III CheckMate 037 trial has shown no difference in overall survival with nivolumab (Opdivo) vs investigator’s choice of chemotherapy in ipilimumab (Yervoy)-refractory advanced melanoma. More chemotherapy patients never ...
Postponing lymph node biopsy more than 30 days after melanoma diagnosis does not adversely impact long-term clinical outcomes, according to findings published by Nelson et al in the Journal of the American College of Surgeons. Today, management of high-risk melanomas starts with surgical removal...
A phase II trial has shown that the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinst) produces responses in brain metastases in patients with BRAF V600–mutant melanoma. These findings were reported by Davies et al in The Lancet Oncology. Study ...
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...
The blend of bacteria in the digestive tract of metastatic melanoma patients is associated with disease progression or delay in patients treated with immunotherapy, reported Wargo et al at the 2017 ASCO Annual Meeting (Abstract 3008). Their study of fecal samples from 105 patients treated with...
Attention is focused among the cancer community on identifying the optimal immunotherapy combinations, with more than 800 ongoing trials of combination therapy. Two studies presented at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) reported promising preliminary...
In patients with stage III/IV melanoma, immunologically “cold” tumors were rendered immunologically active through intratumoral injections of plasmid interleukin-12 (IL-12) combined with pembrolizumab (Keytruda).1 Describing the approach at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium,...
A Danish study reported in the European Journal of Cancer by Marco Donia, MD, PhD, of the Center for Cancer Immune Therapy, Herlev Hospital, Denmark, and colleagues indicates that more than half of patients with metastatic melanoma do not satisfy requirements for enrollment in phase III trials of...
In a phase II trial reported in The Lancet Oncology, Brigitte Dréno, MD, of Nantes University, Nantes, France, and colleagues found that two long-term intermittent vismodegib (Erivedge) dosing regimens provided a similar reduction in the number of clinically significant basal cell carcinomas among...