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The U.S. Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted...
Combining the immunostimulatory anti-CD40 monoclonal antibody CP-870,893 with the immune checkpoint inhibitor tremelimumab was found to be safe, with clinical evidence of response in patients with advanced melanoma, according to phase I clinical trial data presented at the AACR Annual Meeting 2015, ...
Giving the two immunotherapies ipilimumab (Yervoy) and nivolumab (Opdivo) simultaneously yielded better treatment responses than ipilimumab alone in patients with advanced melanoma who received no prior treatment, according to phase II clinical trial data presented at the AACR Annual Meeting 2015,...
A first-in-class immunotherapy called IMCgp100 yielded durable responses in patients with advanced cutaneous melanoma and those with advanced ocular melanoma, according to data from a phase I/IIa clinical trial presented at the AACR Annual Meeting 2015, held April 18 to 22 in Philadelphia (Abstract ...
In a study reported in JAMA Surgery, Luo et al found that microscopic melanoma metastases in sentinel lymph nodes that were not the most radioactive (“hottest”) were still associated with an increased risk of progression and mortality. The study involved data from 475 consecutive...
In the first randomized trial to compare two U.S. Food and Drug Administration–approved immune checkpoint inhibitors as first-line therapy for patients with advanced melanoma, pembrolizumab (Keytruda) yielded significantly better treatment outcomes than ipilimumab (Yervoy) for all endpoints...
A large retrospective cohort study of more than 32,000 Medicare beneficiaries diagnosed with melanoma has found that one in five patients experience a delay of surgery that is longer than 1.5 months. Those patients undergoing biopsy and surgery by dermatologists had the lowest risk for delay, which ...
In the phase III EORTC 18071 trial reported in The Lancet Oncology, Eggermont et al found that adjuvant ipilimumab (Yervoy) significantly improved recurrence-free survival vs placebo in patients with completely resected stage III melanoma at high risk of disease recurrence. Ipilimumab was...
In an analysis reported in the Journal of Clinical Oncology, Maio et al found a 5-year survival rate of 18% among treatment-naive patients receiving ipilimumab (Yervoy) plus dacarbazine in a phase III trial. The findings support other data indicating long-term survival in some patients receiving...
In the phase III CheckMate 037 trial reported in The Lancet Oncology, Weber et al found that treatment with the PD-1 inhibitor nivolumab (Opdivo) resulted in a significantly greater response rate vs chemotherapy as second- or later-line treatment in patients with advanced melanoma progressing after ...
In a study reported in the Journal of Clinical Oncology, Fang et al found that an elevated C-reactive protein level was associated with poorer overall and melanoma-specific survival in patients with melanoma and that sequential increases in C-reactive protein were associated with an increased risk...
In a pooled analysis reported in the Journal of Clinical Oncology, Schadendorf et al found 3-year overall survival rates of 26% and 20% in treatment-naive and previously treated patients receiving ipilimumab (Yervoy)-based treatment for unresectable or metastatic melanoma. A survival curve plateau...
In a case report in JAMA Dermatology, Carrera et al described development of multiple wild-type BRAF melanomas and a metastasis with a different BRAF mutation in a patient receiving dabrafenib (Tafinlar) for BRAF V600E–mutant metastatic melanoma. Development of Melanomas As described...
Researchers investigating whether tumor genotype correlates with benefit from immune therapy in melanoma has found that patients whose tumors had NRAS mutations had better response to immunotherapy and better outcomes than patients whose tumors had other genetic subtypes. The results suggest that...
In a new study reported by Shoshan et al in Nature Cell Biology, researchers at The University of Texas MD Anderson Cancer Center established a link between melanoma and lack of RNA editing, which leads to tumor growth and progression through manipulation of proteins. Study Findings Study lead...
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib (Zelboraf) for the treatment of people with BRAF V600 mutation–positive advanced melanoma. The FDA will make a...
In a systematic review and meta-analysis reported in the Journal of Clinical Oncology, Teulings et al found that development of vitiligo in patients receiving immunotherapy for stage III or IV melanoma was a significant predictor of improved progression-free and overall survival. The study...
The molecular determinants of benefit from immune checkpoint inhibitor treatment have not been characterized. In a study reported in The New England Journal of Medicine, Snyder et al found that benefit of the anti–cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies ipilimumab (Yervoy) and...
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a PD-1 inhibitor, is intended for patients who have been previously treated with ipilimumab...
Longer telomeres have been associated with increased risk of melanoma. In a GenoMEL Consortium genome-wide association study reported in the Journal of the National Cancer Institute, Iles et al found that several single-nucleotide polymorphisms (SNPs) previously associated with leukocyte telomere...
In a phase III study reported in The New England Journal of Medicine, Robert et al found that the combination of the BRAF inhibitor dabrafenib (Tafinlar) plus the MEK inhibitor trametinib (Mekinist) significantly improved overall survival compared with the BRAF inhibitor vemurafenib (Zelboraf) in...
In a phase III trial reported in The New England Journal of Medicine, Robert et al found that the PD-1 immune-checkpoint–inhibitor antibody nivolumab significantly increased overall survival, progression-free survival, and objective response rate compared with dacarbazine in patients with...
The combination of different patterns of sun exposure experienced by children and biomarkers of melanoma risk, such as the number of freckles or moles that develop as a result, may play a large role in future melanoma risk, a study investigating gene and environmental interactions has found....
In a phase III trial (Southwest Oncology Group Intergroup S0008) reported in the Journal of Clinical Oncology, Flaherty et al found that a shorter course of biochemotherapy consisting of cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b produced better relapse-free...
In a Surveillance, Epidemiology, and End Results (SEER) database analysis reported in JAMA Otolaryngology-Head & Neck Surgery, Sperry et al found that sentinel lymph node biopsy was not associated with improved disease-specific survival in propensity score–matched patients with head and...
A randomized clinical trial of patients with advanced metastatic melanoma treated with ipilimumab (Yervoy), an immune checkpoint inhibitor, in combination with sargramostim (Leukine), an immune stimulant, vs ipilimumab alone, has found a 1-year survival rate of 68.9% vs 52.9% in the ipilimumab-only ...
In a phase III trial reported in The New England Journal of Medicine, Long and colleagues found that the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) improved response rate and progression-free survival compared with dabrafenib alone in...
In a phase III trial reported in The New England Journal of Medicine, Larkin and colleagues found that the combination of the BRAF inhibitor vemurafenib (Zelboraf) and the MEK inhibitor cobimetinib improved response rate and progression-free survival compared with vemurafenib alone in...
The U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application for the expanded use of technetium 99m tilmanocept (Lymphoseek Injection) for lymphatic mapping in solid tumors and for adding sentinel lymph node detection for breast cancer and melanoma to the approved...
As reported in The Lancet by Robert et al, the anti–programmed-death receptor-1 (PD-1) antibody pembrolizumab (Keytruda) produced durable responses in a phase I trial in patients with ipilimumab (Yervoy)-refractory melanoma. The study provided the basis for the recent accelerated approval of...
In a large international population-based study reported in JAMA Dermatology, Thomas et al found that increased risk of melanoma-related mortality for patients with amelanotic vs those with pigmented melanomas was no longer evident after adjustment for tumor stage at diagnosis. The study involved...
TERT promoter mutations have been found to occur at high frequency in cutaneous melanoma tumor samples, exhibit a UV-signature, and lead to increased TERT gene expression. In a study reported in the Journal of the National Cancer Institute, Griewank et al found that TERT promoter mutation was...
The monoclonal antibody nivolumab achieved superior response rates and a longer duration of response than standard chemotherapy in patients whose melanoma has progressed after treatment with ipilimumab (Yervoy), according to preliminary data from a phase III trial presented at the ESMO 2014...
For advanced/metastatic melanoma patients with BRAF mutations, two pathway inhibitors are much better than one, according to studies presented at the ESMO 2014 Congress that demonstrated improved progression-free and overall survival for regimens combining a BRAF inhibitor with an inhibitor of the...
Eruptive melanocytic nevi are observed in patients receiving the multikinase inhibitor sorafenib (Nexavar) and the selective BRAF inhibitor vemurafenib (Zelboraf). In a case reported in JAMA Dermatology, Shen et al found that the addition of the MEK inhibitor cobimetinib to vemurafenib in a woman...
Airline pilots and cabin crew are occupationally exposed to higher levels of cosmic and ultraviolet radiation. In a meta-analysis reported in JAMA Dermatology, Sanlorenzo et al found that these people have a more than twofold greater risk of melanoma compared with the general population. Increased ...
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to the anti–PD-1 antibody pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Pembrolizumab is intended for use following...
High mitotic rate in primary melanomas appears to be an independent predictor of poorer survival. In a single-institution study reported in JAMA Dermatology, Shen et al found that high mitotic rate primary melanoma is associated with male sex, older age, amelanosis, and several aggressive...
Approximately half of all patients with posterior uveal melanoma develop metastatic liver disease within 15 years. Although brachytherapy utilizing current isotopes may be hindered by associated toxicities, the isotope ruthenium-106 has been reintroduced into the U.S. market. In a study published...
In a study reported in JAMA Dermatology, Youlden et al found that the incidence of Merkel cell carcinoma in Queensland, Australia, a known high-risk area, increased by 2.6% annually between 1993 and 2010. Five-year relative survival was 41%, with significantly better survival found in patients aged ...
In a single-institution study reported in JAMA Dermatology, Botella-Estrada et al found that regression of primary melanomas is not associated with sentinel node status. Study Details The retrospective study involved patients with melanomas with Breslow thickness > 0.75 mm undergoing sentinel...
In a phase Ib study reported in The Lancet Oncology, Ribas et al found that the combination of the BRAF inhibitor vemurafenib (Zelboraf) and the MEK inhibitor cobimetinib was safe and active in the treatment of advanced BRAF V600–mutant melanoma. Preclinical studies have shown that the...
As reported in The Lancet by Robert et al, the anti–programmed death receptor-1 (PD-1) antibody pembrolizumab produced responses and was well tolerated at two dose levels in an expansion cohort of a phase I trial in patients with ipilimumab (Yervoy)-refractory advanced melanoma. In this...
In a European study reported in the Journal of Clinical Oncology, Maurichi et al identified lymphovascular invasion and regression as important prognostic factors in thin melanoma. They developed a nomogram including age, mitotic rate, ulceration, lymphovascular invasion, regression, and sentinel...
In a study intended to help define optimal screening in individuals at high risk of melanoma, Moloney et al evaluated use of full-body examinations every 6 months along with dermoscopy and total-body photography for all patients and sequential digital dermoscopy imaging as indicated. The study,...
Surgical resection markedly improved survival among metastatic melanoma patients whose disease is isolated to a few areas in the liver, according to new study findings published in the Journal of the American College of Surgeons. These results mark a departure for melanoma, which is most often...
Although cancer immunotherapy with adoptive transfer of tumor-infiltrating lymphocytes represents an effective treatment for patients with metastatic melanoma, the antigen targets recognized by these effective tumor-infiltrating lymphocytes remain unclear. According to a new study, a novel...
Oncogenic mutations in GNAQ and GNA11, resulting in MAPK pathway activation, are observed in > 80% of uveal melanomas. In a phase II trial reported in JAMA, Carvajal et al found that treatment with the MEK1/MEK2 inhibitor selumetinib significantly prolonged progression-free survival vs...
Anorectal melanoma is a rare malignant neoplasm that has a variable natural history and nonspecific presentation. A review by Hicks et al of 18 patients treated at Johns Hopkins Hospital between October 1991 and August 2012, finds that the cancer tends to be diagnosed at stage II or later and is...
Concurrent treatment with ipilimumab (Yervoy) and nivolumab resulted in a 2-year survival rate of 79% for patients with advanced melanoma. “While this is a small trial, that is very impressive 2-year survival data,” noted Mario Sznol, MD, at a press briefing on progress in immunotherapy ...