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Recent research1 conducted by Robert H. Pierce, MD, and his colleagues investigating why PD-1 (programmed cell death protein 1) inhibitors result in remarkably durable clinical remissions in some patients with melanoma, whereas others reap a short-term benefit or no benefit at all is showing that...
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 decision on...
The average annual number of adults treated for skin cancer, both melanoma and nonmelanoma, in the United States increased from 3.4 million in 2002 to 2006 to 4.9 million in 2007 to 2011 (P < .001), according to a study published in the American Journal of Preventive Medicine. “During this...
The quality and quantity of original research presented at the National Comprehensive Cancer Network (NCCN) Annual Conference continue to grow since poster sessions debuted a few years ago. The ASCO Post offers summaries for just a few that caught our eye, out of more than 65 presented this year....
As clinical research struggles to keep up with the pace of new immunotherapies, one of the burning questions is how best to combine the new drugs. A new study found that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) is superior to ipilimumab alone as front-line therapy for untreated ...
Pembrolizumab (Keytruda) proved superior to ipilimumab (Yervoy) for the treatment of unresectable advanced melanoma in the global phase III KEYNOTE-006 trial. Pembrolizumab significantly improved overall survival, progression-free survival, and overall response rate compared with ipilimumab, which...
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 Priority...
The treatment landscape for metastatic melanoma has recently undergone a remarkable transformation. Prior to 2011, clinicians and patients were presented with difficult decisions between therapies without proven survival benefit. Now, similarly difficult but much more hopeful choices are posed...
In the phase III KEYNOTE-006 trial reported in The New England Journal of Medicine,1 Caroline Robert, MD, PhD, Head of the Dermatology Unit at the Institut Gustave Roussy, Paris, and colleagues found that the anti–programmed cell death protein 1 (PD-1) antibody pembrolizumab (Keytruda) increased...
For 2 decades, the NCCN Guidelines® have been recognized as the standard of cancer care in the United States, combining evidence, experience, and choice, so that multidisciplinary cancer treatment teams—including patients—are empowered to make informed decisions about cancer care,” said Robert W....
Two daily doses of nicotinamide, a form of vitamin B3, significantly reduced the occurrence of nonmelanoma skin cancers by 23% in individuals considered at high risk for these lesions in an Australian study. Results of the phase III ONTRAC trial, which will be presented at the 2015 ASCO Annual...
The past 3 years have witnessed transformative changes in the way that solid tumors and hematologic malignancies are approached, in almost every instance now including consideration of some form of immunomodulation in the first- or later-line therapeutic setting. The greatest success has occurred...
In a phase III trial (CheckMate 037) reported in The Lancet Oncology, Jeffrey S. Weber, MD, PhD, of the Moffitt Cancer Center, and colleagues found that treatment with the PD-1 (programmed cell death protein 1) inhibitor nivolumab (Opdivo) resulted in a significantly greater response rate vs...
In advanced melanoma, combination treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) more than doubled the median progression-free survival time over ipilimumab alone in the CheckMate 067 trial. That said, single-agent nivolumab proved almost as powerful in patients expressing the programmed ...
Patients’ preference for how they receive biopsy results “has shifted from face-to-face visit to discussion over the telephone because of a desire for rapid notification,” according to a survey of 301 patients recruited at three different melanoma clinics. Although 67.1% of the patients preferred...
Complete lymph node dissection did not improve survival in melanoma patients randomized to this practice, vs sentinel lymph node biopsy alone, German investigators reported at the 2015 ASCO Annual Meeting.1 “This is the first study that tested the typical recommendation of complete lymph node...
The benefit from immune-directed therapies in patients with advanced melanoma is not limited to the exploding field of checkpoint inhibitors. According to Robert Andtbacka, MD, Associate Professor of Surgical Oncology, at the Huntsman Cancer Institute at the University of Utah, Salt Lake City,...
Amid the encouraging studies reported at the 2015 ASCO Annual Meeting about advances in the treatment of melanoma was a troubling finding about the incidence of melanoma increasing. An analysis of data from nine Surveillance, Epidemiology, and End Results (SEER) registries found that the incidence...
Ipilimumab (Yervoy) is a fully human monoclonal antibody that blocks the negative T-cell regulator cytotoxic T-lymphocyte antigen 4 (CTLA-4) and has improved overall survival for patients with unresectable or metastatic melanoma in two phase III studies.1,2 Based upon these results, ipilimumab was...
In the phase III European Organisation for Research and Treatment of Cancer (EORTC) 18071 trial reported in The Lancet Oncology, Alexander M.M. Eggermont, MD, PhD, Director General of the Gustave Roussy Cancer Center in Villejuif, France, and colleagues found that adjuvant therapy with the immune...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with melanoma. The trials are investigating immune response; vaccine therapy; ipilimumab in conjunction with numerous therapies; and chemotherapy regimens. All of the studies ...
In monitoring patients with melanoma at high risk for relapse, surveillance imaging with 18F-fluorodeoxyglucose–positron-emission tomography (FDG-PET)/computed tomography (CT) can detect asymptomatic metastases and thus facilitate early treatment, according to Australian investigators who presented ...
Could too much citrus cause skin cancer?” was the lead-in of an NBC News item about a study linking consumption of grapefruits and oranges to an increased risk of melanoma.1 “Citrus consumption and skin cancer: How real is the link?” was the question posed by a headline in The Washington Post.2...
A study finding a link between citrus consumption and increased risk of melanoma1 may provide food for thought about the findings and implications as well as whet the appetite for more evidence, but according to several experts commenting on the study, it does not mean you should stop eating citrus ...
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 July 24, 2015, sonidegib (Odomzo) was approved for treatment...
The U.S. Food and Drug Administration (FDA) approved sonidegib (Odomzo) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy. The approval was based on...
As reviewed in this issue of The ASCO Post, Long et al1 have reported the final overall survival analysis of the COMBI-d phase III trial comparing combination therapy with the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) to monotherapy with dabrafenib alone,...
Overall survival results of the phase III COMBI-d trial reported in The Lancet by Georgina V. Long, MD, and colleagues showed that the combination of the BRAF inhibitor dabrafenib (Tafinlar) with the MEK inhibitor trametinib (Mekinist) resulted in significantly prolonged overall survival vs...
Immunotherapy, once considered a niche treatment for a few specific cancers, has rapidly emerged as an additional pillar of cancer therapeutics. With the proliferation of promising results, clinical trials, and new drug approvals, one cannot help but be amazed that only 3 years have elapsed since...
In a randomized phase II trial (KEYNOTE-002) reported in The Lancet Oncology, Antoni Ribas, MD, of UCLA Jonsson Comprehensive Cancer Center, Los Angeles, and colleagues found that treatment with the anti–PD-1 (programmed cell death protein 1) antibody pembrolizumab (Keytruda) prolonged...
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 30, 2015, the U.S. Food and Drug Administration...
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for talimogene laherparepvec (Imlygic), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma...
The incidence of melanoma among children, adolescents, and young adults has reached epidemic proportions, increasing more than 250% over the past 4 decades, with young females at highest risk for the deadly cancer, according to a study1 by researchers at Roswell Park Cancer Institute in Buffalo,...
On October 28, 2015, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody ipilimumab (Yervoy) for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including ...
While inhibitors of programmed cell death protein 1 (PD-1) or its ligand (PD-L1) are becoming established in melanoma, non–small cell lung cancer, and renal cell carcinoma, their efficacy is also being evaluated in numerous other tumor types, with promising results, according to studies presented...
Combined BRAF and MEK inhibition was superior to BRAF inhibition alone in unresectable metastatic melanoma, according to the updated survival analysis of the large randomized COMBI-v trial.1 These findings were reported at the 2015 European Cancer Congress recently held in Vienna, Austria....
On November 10, 2015, the U.S. Food and Drug Administration (FDA) approved the MEK inhibitor cobimetinib (Cotellic) in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma in patients whose tumors express the BRAF V600E or V600K mutation. Approval...
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 October 27, 2015, talimogene laherparepvec (Imlygic) was...
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 October 28, 2015, ipilimumab (Yervoy) was approved for adjuvant ...
The 2015 European Cancer Congress (ECC), held recently in Vienna, represented the combined efforts of the European Cancer Organisation (ECCO), the European Society for Medical Oncology (ESMO), and other partner organisations, constituting the largest European platform for oncology education. At...
Patients with rheumatoid arthritis treated with methotrexate had an increased risk of a second nonmelanoma skin cancer, and adding anti–tumor necrosis factor (TNF) may increase that risk, according to results of a retrospective cohort study reported in JAMA Dermatology. A similar association was...
Could the manipulation of bacteria in the gut pack the same punch in melanoma as antibodies targeting the programmed cell death protein and its ligand (PD-1/PD-L1)? It’s possible, at least in mice, according to research from the University of Chicago, recently published in Science.1 The researchers ...
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 November 10, 2015, the U.S. Food and Drug Administration...
Nivolumab (Opdivo) is a monoclonal antibody that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2, releasing PD-1 pathway–mediated inhibition of the immune response. Late last month, the U.S. Food and Drug Administration (FDA)...
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 November 24, 2015, nivolumab (Opdivo) was approved for use as...
On December 18, 2015, the U.S. Food and Drug Administration (FDA) expanded the pembrolizumab (Keytruda) label to include approval of the drug for the treatment of patients with unresectable or metastatic melanoma. This expansion now includes the initial treatment of patients with unresectable or...
In a study reported in The New England Journal of Medicine, Shain et al identified the order of occurrence of mutations in the progression of melanoma as well as characterized point mutation burden and chromosomal instability during disease evolution. Study Details The study involved sequencing...
In a retrospective single-center cohort study reported in JAMA Dermatology, Carlos et al identified the cutaneous toxicities associated with the use of the BRAF inhibitors dabrafenib (Tafinlar) and vemurafenib (Zelboraf) alone or dabrafenib combined with the MEK inhibitor trametinib (Mekinist)....
The U.S. Food and Drug Administration (FDA) today approved the programmed cell death protein 1 (PD-1) inhibitor nivolumab (Opdivo) as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Clinical Trial Results The approval is based on data...
For patients with kidney failure, poor kidney function and immunosuppressant medications may increase their risk of developing different types of cancer. The findings, which are published by Yanik et al in the Journal of the American Society of Nephrology, suggest the need for persistent cancer...