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On March 23, 2017, avelumab (Bavencio) was granted accelerated approval for treatment of patients aged ≥ 12 years with metastatic Merkel cell carcinoma. Avelumab is the first U.S. Food and Drug Administration–approved product to treat this disease.1,2 Supporting Efficacy Data Approval was based on ...
Melanoma is an immunogenic tumor, as it expresses various melanoma-specific antigens. However, it is both biologically and clinically heterogeneous. Biologically, it expresses different melanoma antigens and has diverse genetic profiles among different patients. Clinically, it varies in the amount ...
Gary K. Schwartz, MD, Chief of Hematology/Oncology and Deputy Director of the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian/Columbia University Medical Center, New York, is not sold on using the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for all patients with...
The race is on to identify combinations of immune checkpoint inhibitors that can improve outcomes over the use of immune checkpoint inhibitor monotherapy. Updated results of the phase III CheckMate 067 trial found the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) improved survival in...
Although cancer immunotherapy can produce dramatic responses, only a minority of patients benefit from such therapy. Being able to differentiate treated responders from nonresponders early in the course of therapy would help to triage nonresponding patients away from ineffective therapies, reducing ...
Survivors of melanoma are more likely to limit their exposure to ultraviolet radiation than those who have not had the disease, but more than 10% continue to intentionally tan, according to a study published in Cancer Epidemiology, Biomarkers and Prevention.1 The study surveyed 724 people diagnosed ...
Long-term survivors of melanoma are more likely than those who have not been diagnosed with the disease to use sunscreen, protective clothing, and other means to limit exposure to the sun, according to a survey of melanoma survivors and controls about ultraviolet radiation exposure and protective...
Three clinical trials of the immunotherapy pembrolizumab (Keytruda) have shown that it is active against a rare subtype of skin cancer, mucosal melanoma. The findings were presented by Butler et al at the 2017 European Cancer Congress (ECCO).1 Mucosal melanoma has often been excluded from...
“Avelumab (Bavencio) is the very first drug approved for Merkel cell carcinoma, an orphan disease that is uncommon in the United States. For that reason, pharmacologic development has been slow. In this case, laboratory evidence provided a rationale for testing checkpoint inhibitors in Merkel cell ...
Avelumab (Bavencio) achieved durable responses in patients with metastatic Merkel cell carcinoma, according to longer-term follow-up of the phase II JAVELIN study, the largest study conducted to date in this relatively rare orphan cancer.1 Results were presented at the 2017 American Association for ...
In an Australian study reported in the Journal of Clinical Oncology, Haydu et al found that conditional melanoma-specific survival was worse within the first 2 years of diagnosis of stage III disease for men, increasing age, and increasing American Joint Committee on Cancer (AJCC) stage. The...
Matching the size of a tumor to the body’s immune response could help physicians tailor immunotherapy treatments for patients with metastatic melanoma. Researchers found that patients who didn’t respond to treatment had an imbalance between the size of their tumor and how exhausted...
The U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) on March 23, 2017, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a...
Treatment with a combination of ipilimumab (Yervoy) and coxsackievirus A21 (CVA21; Cavatak) led to durable responses in a number of patients with advanced melanoma, including some whose melanoma had progressed despite prior treatment with an immune checkpoint inhibitor, and fewer-than-anticipated...
Adding the investigational immunotherapy indoximod to the immunotherapy pembrolizumab (Keytruda) increased the proportion of patients with advanced melanoma who responded to treatment compared with previously reported response rates for pembrolizumab monotherapy, according to interim results from a ...
The microbiome has become an area of intense interest for many health-related reasons. Add to this list the potential for a positive or a negative effect on responsiveness to immunotherapy. Gut microbiota that were more diverse, and that contained an abundance of a particular bacterial species,...
Among patients with advanced melanoma, those who received both nivolumab (Opdivo) and ipilimumab (Yervoy) had improved overall survival compared with those who received only ipilimumab, and appeared to have more favorable survival outcomes compared with those who received nivolumab, according to...
In a phase III trial reported by Ascierto et al in The Lancet Oncology, treatment with ipilimumab (Yervoy) at 10 mg/kg vs 3 mg/kg resulted in improved overall survival in patients with advanced unresectable or metastatic melanoma. As noted by the investigators, although options for first-line...
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a programmed cell...
A key challenge in advancing immunotherapies is to understand mechanisms of response and resistance. Emerging research in this area—including evidence that early on-treatment biopsies can predict response—was discussed at the 2017 ASCO-SITC (Society for Immunotherapy of Cancer) Clinical...
In a Belgian two-center phase II trial reported in The Lancet Oncology, Schreuer et al found that rechallenge with the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) showed activity in patients with BRAF V600–mutant melanoma whose disease had progressed on...
In the phase III NEMO trial reported in The Lancet Oncology, Dummer et al found that treatment with the MEK inhibitor binimetinib improved progression-free survival vs dacarbazine in patients with advanced NRAS-mutant melanoma. Study Details In the open-label trial, 402 patients from 118 sites in ...
Marie-Andrée Forget, PhD, of The University of Texas MD Anderson Cancer Center, discusses study findings on the impact of checkpoint blockade prior to adoptive cell therapy using tumor-infiltrating lymphocytes for metastatic melanoma. (Abstract 138)
Howard Kaufman, MD, of Rutgers Cancer Institute of New Jersey, discusses a subgroup analysis of efficacy results on avelumab in chemotherapy-refractory metastatic Merkel cell carcinoma. (Abstract 80)
A Danish study reported in the European Journal of Cancer by Donia et al indicates that more than half of patients with metastatic melanoma do not satisfy requirements for enrollment in phase III trials of immune checkpoint inhibitors. Study Details The study involved 276 unselected cases...
Researchers have found a link between microbes in the gut (the microbiome) and response to immunotherapy. In the study, the ability of patients with advanced melanoma to respond to programmed cell death protein 1 (PD-1) immune checkpoint inhibitors depended on the presence of a diverse microbiome...
As reported in The Lancet Oncology by Coens et al, there was little difference between adjuvant ipilimumab (Yervoy) vs placebo in health-related quality of life in patients with high-risk stage III melanoma in the phase III EORTC 18071 trial supporting the 2014 approval of ipilimumab in this...
Recurrences of early-stage (stage II) melanoma are more often detected by patients and their physicians than by routine imaging tests, according to study results published by Berger et al in the Journal of the American College of Surgeons. “We are most concerned about patients who have stage ...
In a phase II trial reported in The Lancet Oncology, Dréno et al found that two long-term intermittent vismodegib (Erivedge) dosing regimens provided a similar reduction in the number of clinically significant basal cell carcinomas among patients with multiple lesions. Study Details In the ...
Although alcohol consumption is associated with increasing the risk of many cancers, including liver, pancreatic, colon, rectal, and breast, the link between alcohol and higher risk of melanoma is equivocal. Now, a large prospective study by Andrew Rivera, MD, of Harvard Medical School, Boston, and ...
Three clinical trials of the immunotherapy pembrolizumab (Keytruda) have shown that it is active against a rare subtype of skin cancer, mucosal melanoma. The findings were presented by Butler et al at the 2017 European Cancer Congress (ECCO) (Abstract 1142). Until now, mucosal melanoma has often...
By 2050, the death rates from malignant melanoma will have decreased from their current levels, but the numbers of people dying from the disease will have increased due to the aging of populations. However, if new treatments for the deadly skin cancer prove to be effective, the numbers of deaths...
The statistics on the rising rates of skin cancer are alarming. According to the Skin Cancer Foundation, each year over 5.4 million cases of nonmelanoma skin cancer are treated in more than 3.3 million people, and an additional 76,380 people are diagnosed with the deadliest form of skin cancer,...
A large international survey on sun exposure behaviors and skin cancer detection found there are many imperfections and geographic disparities in primary and secondary prevention of skin cancer. This information could help inform future awareness campaigns developed to address the global need to...
The investigational immunotherapeutic IMC-20D7S was found to be well tolerated and somewhat active in patients with advanced melanoma, including one complete response, according to the results of a phase I/Ib trial reported by Danny N. Khalil, MD, PhD, and colleagues in Clinical Cancer Research....
The future treatment of melanoma may rely on combinations of immunotherapy agents beyond the current checkpoint inhibitors, and they are entering clinical trials, according to Jeffrey Weber, MD, PhD, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at New York University Langone...
Although alcohol consumption is associated with increasing the risk of many cancers, including liver, pancreatic, colon, rectal, and breast, the link between alcohol and higher risk of melanoma is equivocal. Now, a large prospective study by Rivera et al investigating the link between alcohol...
As reported in the Journal of Clinical Oncology, Weber et al performed a pooled analysis of the safety profile of nivolumab (Opdivo) monotherapy in advanced melanoma, including a focus on potential immune-related (select) adverse events. The analysis pooled safety data from 576 patients receiving...
Long et al identified factors predictive of progression-free and overall survival with combined dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with BRAF V600E–mutant or BRAF V600K–mutant metastatic melanoma, according to a pooled individual data analysis reported in The...
A pooled analysis of outcomes in patients receiving nivolumab (Opdivo) or nivolumab plus ipilimumab (Yervoy) for advanced mucosal or cutaneous melanoma in clinical trials was reported by D’Angelo et al in the Journal of Clinical Oncology. The pooled analysis involved 889 patients who...
The 2016 European Society for Medical Oncology (ESMO) Congress was jam-packed with studies of the anti–programmed cell death protein 1 (PD-1) antibodies in non–small cell lung cancer and melanoma, where they have clearly changed the treatment paradigm. Here is a roundup of some of those trials,...
Cutaneous T-cell lymphomas are a heterogeneous group of cancers. Some subtypes of cutaneous T-cell lymphomas are often misdiagnosed as benign skin diseases, making it challenging to gather reliable epidemiologic data. At the 3rd World Congress of Cutaneous Lymphomas (sponsored by the International...
William H. Sharfman, MD, has been awarded the first Mary Jo Rogers Professorship in Cancer Immunology and Melanoma Research at Johns Hopkins University. Dr. Sharfman is Associate Professor of Oncology and Dermatology, Director of Cutaneous Oncology, Clinical Co-Director of the Johns Hopkins...
Immunotherapy with an anti–programmed cell death protein 1 (PD-1) inhibitor—pembrolizumab (Keytruda)—showed encouraging responses in patients with advanced cutaneous T-cell lymphoma (either mycosis fungoides or Sézary syndrome). Pembrolizumab achieved a 38% overall response rate and responses...
Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute, discusses in German study findings on neoadjuvant ipilimumab plus nivolumab in patients with palpable stage III melanoma. (Abstract LBA39)
A collaboration of international experts is tackling the challenges involved in understanding and managing the treatment of cutaneous lymphomas. The Prospective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study from the Cutaneous Lymphoma International Consortium brings together...
High-throughput sequencing of T-cell receptors may be a solution to some of the challenges confronting oncologists who treat cutaneous T-cell lymphomas. According to experts who presented talks on high-throughput sequencing of T-cell receptors at the 3rd World Congress of Cutaneous Lymphoma...
In an article in The New England Journal of Medicine, Johnson et al reported the occurrence of fulminant, fatal immune-related myocarditis in two patients who received combined ipilimumab (Yervoy) and nivolumab (Opdivo) for metastatic melanoma. Patient Courses One patient was a 65-year-old woman...
Safety and efficacy data from a phase I/II study of urelumab in combination with nivolumab (Opdivo) in patients with hematologic and solid tumors, including biomarker analyses by level of programmed death ligand 1 (PD-L1) expression, was recently presented at the Society for Immunotherapy of Cancer ...
In an analysis of National Cancer Data Base data reported in the Journal of the National Cancer Institute, Shailender Bhatia, MD, of the University of Washington/Fred Hutchinson Cancer Research Center, and colleagues found that adjuvant radiotherapy was associated with a survival benefit in...