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Excitement continues to build in the metastatic melanoma arena, as novel agents keep upping the ante for efficacy. The following news from the 2013 European Cancer Congress has added to the buzz. New MEK Inhibitor In the phase IB BRIM7 study, cobimetinib, a novel MEK inhibitor, when combined with...
A study by Sosman et al has identified two novel BRAF fusions in melanomas previously considered to be negative for molecular targets. In addition, these “pan-negative” melanomas were found to be sensitive to MEK inhibitors. According to the study, BRAF fusions define a new molecular subset of...
The U.S. Food and Drug Administration (FDA) has approved trametinib (Mekinist) for use in combination with dabrafenib (Tafinlar) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved...
On January 9, 2014, the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) was granted accelerated approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a U.S. Food and Drug Administration (FDA)-approved...
The headline, “Patients’ Costs Skyrocket, Specialists’ Incomes Soar,” aptly encapsulates the theme of a recent article in The New York Times,1 part of a series entitled, “Paying Till It Hurts.” “Oncologists benefit from the ability to mark up (and profit from) each dose of chemotherapy they...
Neoplasms originating from skin keratinocytes are increasing in frequency in the United States and include a spectrum of diseases culminating in the development of invasive cutaneous squamous cell carcinoma. Although most cases of cutaneous squamous cell carcinoma can be treated conservatively with ...
In a study reported in the Journal of Clinical Oncology, Pritesh S. Karia, MPH, and Chrysalyne D. Schmults, MD, MSCE, of Brigham and Women’s Hospital, Boston, and colleagues compared Brigham and Women’s Hospital, American Joint Committee on Cancer (AJCC), and International Union Against Cancer...
In a recent study, reviewed in this issue of The ASCO Post, Li et al present data from two long- term prospective studies—the Physicians Health Study (PHS, from 1982 to 1998), and the Health Professionals’ Follow-up Study (HPFS, from 1986 to 2010)—both of which suggest a strong association between...
History of severe acne, which is a surrogate for high androgen activity, has been associated with increased risk of prostate cancer, and recent data suggest that severe teenage acne is a risk factor for melanoma. Such findings suggest a role of androgens in etiology for both prostate cancer and...
Sentinel node status is “the most powerful predictor” of melanoma-specific survival in patients with thin melanoma, according to a presentation at the 2014 Society of Surgical Oncology (SSO) Cancer Symposium in Phoenix.1 As a result, sentinel lymph node biopsy should be considered in patients with...
The anti–PD-1 inhibitor MK-3475 (formerly lambrolizumab) is in late-stage trials for advanced melanoma and is also being studied in other malignancies, including non–small cell lung cancer (NSCLC). An important aspect of Merck’s development program for MK-3475, as well as for other anti–PD-1 agents ...
According to the Skin Cancer Foundation, more than 3.5 million cases of skin cancer are diagnosed each year, with the incidences of skin cancer outnumbering all cases of breast, colon, lung, and prostate cancers combined. Of the three most common types of skin cancer—basal cell carcinoma, squamous...
Genetic screening of cancer can help doctors customize treatments so that patients with melanoma have the best chance of beating it, according to the results of a clinical trial by researchers at the University of Pittsburgh Cancer Institute. The trial, funded by the National Institutes of...
At the 19th Annual Conference of the National Comprehensive Cancer Network (NCCN), held recently in Hollywood, Florida, NCCN Panel members presented updates for several tumor types, briefly summarized here. For a more complete description of all updates, visit www.nccn.org. Breast Cancer Guidelines ...
Amgen recently announced top-line results from the primary overall survival analysis of a phase III trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec (also known as T-VEC) for the treatment of unresected stage IIIB, IIIC, or IV melanoma compared to treatment...
Patients with uveal melanoma treated with selumetinib had modestly improved progression-free survival and response rate compared to patients treated with chemotherapy, but no improvement in overall survival, according to results of a randomized, open-label, phase II trial. “Improvement in clinical...
In advanced melanoma, two immune checkpoint inhibitors may be better than one, according to the promising outcomes of a study reported at the 2014 ASCO Annual Meeting. Concurrent treatment with the anti–CTLA-4 antibody ipilimumab (Yervoy) and nivolumab, an antibody targeting the programmed death...
In the longest follow-up to date of any programmed death (PD)-1 receptor inhibitor in previously treated advanced melanoma, one-third of patients are demonstrating durable responses to the investigational agent nivolumab, and in some cases, these persist following discontinuation of the drug,...
Ipilimumab (Yervoy) has transformed the treatment of metastatic melanoma, producing long-term responses in about 20% of patients. A phase III study has now evaluated its impact in the adjuvant setting, and the results are a bit less striking. Primary Endpoint The European Organisation for Research...
The latest bit of good news for the programmed death receptor-1 (PD-1)–targeting antibodies in advanced melanoma comes for pembrolizumab (MK-3475). While the results came from only a phase I study, they were among those chosen for presentation at an ASCO press briefing during the Annual Meeting....
Intertriginous areas refer to skin folds (such as axillae, inguinal creases, and inframammary creases), which are characterized by increased friction, temperature, and occlusion. Intertriginous drug reactions are an underrecognized side effect associated with pegylated liposomal doxorubicin...
The Conquer Cancer Foundation has an excellent track record of finding and funding the most promising young investigators. Past recipients Joyce F. Liu, MD, MPH, and Antoni Ribas, MD, PhD, received funding from the Conquer Cancer Foundation early in their career and at the 2014 ASCO Annual Meeting...
The emerging approach to treating metastatic melanoma is a full-throttle effort to stimulate an immune response. One of the components of this strategy could be intralesional injections, according to studies presented at the 2014 ASCO Annual Meeting. T-VEC Oncolytic Immunotherapy Talimogene...
In a study reported in Clinical Cancer Research, Bartlett and colleagues found that melanoma metastases exhibit site-specific antigen heterogeneity that correlates with T-cell infiltration. A total of 3,086 metastatic tumors involving various anatomic sites were assessed for a panel of melanocyte...
In a study reported in the Journal of the National Cancer Institute, Aydin and colleagues found that mutation in and inactivation of FBXW7 and accumulation of NOTCH1, a substrate of FBXW7, were associated with melanoma tumorigenesis. FBXW7 was found to be mutated in 8% of 103 melanoma patients, and ...
Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun. Over the last few years, the FDA has taken a number of...
On July 29, 2014, the Surgeon General issued a Call to Action urging immediate action steps to prevent skin cancer. The report encourages increased awareness of the disease and calls for immediate and collaborative actions to reduce its risk. Nearly 5 million people are treated for skin cancer in...
A prospective, clinicopathologic study involving 268 patients with biopsy-proven basal cell carcinoma, squamous cell carcinoma, malignant melanoma, or melanoma in situ “revealed that pain is associated with histologic features that involve deeper dermal processes in [squamous cell carcinoma]...
Adoptive transfer of tumor-infiltrating lymphocytes can mediate regression of metastatic melanoma. However, there are no effective markers to identify and select patient-specific repertoires of tumor-reactive and mutation-specific CD8-positive lymphocytes, limiting the ability to develop strategies ...
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 treatment...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 4, 2014, pembrolizumab (Keytruda) was granted...
Nivolumab yielded an “impressive” duration of response when used as second- or third-line treatment for patients with advanced melanoma, according to Jeffrey S. Weber, MD, of the Moffitt Cancer Center in Tampa, Florida, who presented preliminary results of a phase III trial at the European Society...
For advanced/metastatic melanoma patients with BRAF mutations, two pathway inhibitors are better than one, according to studies presented at the European Society for Medical Oncology (ESMO) 2014 Congress that demonstrated improved progression-free and overall survival for regimens combining a BRAF...
Preliminary evidence of efficacy for BRAF inhibitors as monotherapy in advanced melanoma first emerged in 2009.1 Phase II and III trials rapidly ensued for vemurafenib (Zelboraf) and dabrafenib (Tafinlar), leading to U.S. Food and Drug Administration (FDA) approval in 2011. As a result of melanoma...
Two phase III trials have shown that the strategy of adding MEK inhibitor therapy to BRAF inhibitor therapy significantly improves progression-free survival in previously untreated patients with advanced BRAF-mutant melanoma.1,2 Overall survival benefit is also suggested by interim analysis in both ...
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 ...
The costs associated with skin cancer increased five times as fast as treatments for other cancers between 2002 and 2011, according to a Centers for Disease Control and Prevention (CDC) study published online in the American Journal of Preventive Medicine.1 The average annual cost for skin cancer...
A collaborative team of leaders in the field of cancer immunology from Memorial Sloan Kettering Cancer Center has made a key discovery that advances the understanding of why some patients respond to the CTLA-4 blocking antibody ipilimumab (Yervoy), an immunotherapy drug, while others do not. A...
Ipilimumab (Yervoy) was first approved by the U.S. Food and Drug Administration (FDA) in 2011 on the basis of an improvement in overall survival compared with gp100 vaccine in patients with advanced melanoma.1 Response rates with ipilimumab have been modest at best—10% to 15% using 3 mg/kg and 15%...
Use of the granulocyte-macrophage colony-stimulating factor (GM-CSF) sargramostim (Leukine) together with the cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitor ipilimumab (Yervoy) prolonged overall survival but not progression-free survival in patients with metastatic melanoma,...
A new and inexpensive serologic assay may help to predict recurrences of Merkel cell carcinoma, according to Paul Nghiem, MD, PhD, the Michael Piepkorn Endowed Chair in Dermatology Research at the University of Washington, Seattle, who helped develop the test.1 Dr. Nghiem and other experts in...
What advanced basal cell carcinomas lack in frequency, they make up for in morbidity, and for these challenging patients, the hedgehog inhibitors have changed lives, according to experts at the 3rd Annual World Cutaneous Malignancies Congress, held recently in San Francisco. “The majority of basal...
As reported in this issue of The ASCO Post, Robert and colleagues recently published a phase III study comparing the anti–programmed death 1 (PD-1) antibody nivolumab with the standard melanoma chemotherapy dacarbazine in the front-line treatment of patients with advanced BRAF wild-type melanoma.1...
In a phase III trial reported in The New England Journal of Medicine, Robert and colleagues found that the programmed cell death protein-1 (PD-1) immune-checkpoint–inhibitor antibody nivolumab (Opdivo) significantly increased overall survival, progression-free survival, and objective response rate...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 22, 2014, the anti–PD-1 (programmed cell death...
In the treatment of advanced/metastatic melanoma, recent debate has focused on the choice of initial therapy: ipilimumab (Yervoy) or, for patients with BRAF-mutant cancer, a BRAF/MEK inhibitor. This issue is now taking a back seat to the emerging conversation about the positioning of antibodies...
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, is intended for patients who have been...
Patients with unresectable stage III or IV melanoma treated with ipilimumab (Yervoy) plus sargramostim (Leukine) had longer overall survival and less toxicity than did those treated with ipilimumab alone, according to a phase II randomized clinical trial conducted by the Eastern Cooperative...
The Melanoma Research Alliance has reported that Suzanne Topalian, MD, Chair of the group’s Scientific Advisory Panel, and former Chief Scientific Officer, has been named one of 10 people in science who mattered in 2014 by the Nature International Weekly Journal of Science. Dr. Topalian was cited...
When melanoma patients develop metastases to the gastrointestinal (GI) tract or pancreas, resection of these lesions may improve survival, according to two single-institution studies presented at the 2015 Gastrointestinal Cancers Symposium. In a study that earned a Merit Award, researchers reported ...