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Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for the treatment of refractory multiple myeloma, metastatic breast cancer, and metastatic non–small cell lung cancer (NSCLC); gave Fast Track designation to treatments for NTRK mutation–positive solid tumors...
In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected...
As investigators, we were always determined to find the drug to work with BRAF/MEK inhibitor combination therapy. It had come on like a storm and showed us that we could help even those with the most advanced metastatic melanoma, as long as it harbored the magical BRAF V600E mutation.1...
As reported inThe Lancet by Ralf Gutzmer, MD, of Medizinische Hochschule Hannover, Germany, and colleagues, the phase III IMspire150 trial has shown that the addition of atezolizumab to BRAF and MEK inhibitor therapy with vemurafenib and cobimetinib improved progression-free survival in the...
A consensus statement published in JAMA Dermatology by an international group of melanoma researchers evaluated the use of prognostic gene-expression profile testing to guide clinical management of melanoma.1 The group cautioned against the routine use of currently available gene-expression...
In the French phase II CARSKIN trial reported in the Journal of Clinical Oncology, Maubec et al found that pembrolizumab monotherapy produced durable responses in the first-line treatment of unresectable cutaneous squamous cell carcinoma. Study Details In the multicenter trial, 39 patients (primary ...
A new 10-year analysis, led by Igor Puzanov, MD, MSci, FACP, Director of Early Phase Clinical Trials and Chief of Melanoma at Roswell Park Comprehensive Cancer Center and recently published in JAMA Oncology,1 provides new insights into an important question: whether BRAF V600E/K–mutation status or ...
On June 24, 2020, pembrolizumab was approved for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.1,2 Supporting Efficacy Data Approval was based on findings in the multicenter, multicohort, open-label KEYNOTE-629 trial ...
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...
On July 30, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab (Tecentriq) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive...
As reported in the Journal of Clinical Oncology by Grob et al, the first interim analysis of the phase II KEYNOTE-629 trial has shown that treatment with pembrolizumab resulted in durable responses in patients with recurrent or metastatic cutaneous squamous cell carcinoma. The study supported the...
The neoadjuvant combination of nivolumab and ipilimumab yielded a continued benefit in relapse-free survival vs adjuvant use of the same combination therapy in 20 patients with stage III macroscopic melanoma. This finding is based on 3-year follow-up results of the phase Ib OpACIN trial, presented...
In a pooled analysis reported in JAMA Oncology, Igor Puzanov, MD, MSCI, and colleagues identified objective response rates and progression-free and overall survival rates with pembrolizumab treatment among patients with advanced melanoma according to BRAF V600E/K–mutation status and prior BRAF/MEK...
In a study reported as a research letter in JAMA Oncology, Scovell et al identified a potential association between the use of immune checkpoint inhibitors and impaired spermatogenesis using autopsy tissue findings in men with a history of metastatic melanoma. Study Details The study involved...
The study’s invited discussant, Ryan J. Sullivan, MD, Assistant Professor of Medicine, Harvard Medical School, and Assistant Professor in Hematology/Oncology at Massachusetts General Hospital, welcomed the positive results from the updated analysis of lifileucel in treatment-refractory melanoma....
Patients with heavily pretreated metastatic melanoma treated with adoptive cell therapy based on tumor-infiltrating lymphocytes achieved a response rate of 36%, a disease control rate of 80%, and a median duration of response that had not been reached by 18 months in the global open-label phase II...
New, longer-term data from a pivotal phase II trial in advanced cutaneous squamous cell carcinoma (CSCC), were presented during the ASCO20 Virtual Scientific Program and discussed during a poster discussion.1 Danny Rischin, MD, of the Peter MacCallum Cancer Centre, Victoria, Australia, presented...
As reported in The Lancet by Gutzmer et al, the phase III IMspire150 trial has shown that the addition of atezolizumab to BRAF and MEK inhibitor therapy with vemurafenib and cobimetinib improved progression-free survival in first-line treatment of patients with unresectable BRAF V600–mutant...
As reported in the Journal of Clinical Oncology, Lo et al developed a novel risk calculator for sentinel node metastasis—the Melanoma Institute Australia Nomogram—that appears to more accurately predict risk of metastasis in patients with primary cutaneous melanoma than other commonly used risk...
On June 24, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable with surgery or radiation. KEYNOTE-629 Efficacy was investigated in KEYNOTE-629, a multicenter, multicohort,...
In a study reported in the Journal of Clinical Oncology, Garbe et al found that melanoma-specific survival rates for patients with stage III disease differed markedly in three independent cohorts compared with those reported in American Joint Committee on Cancer version 8 (AJCCv8) stage III...
Douglas B. Johnson, MD, of Vanderbilt University Medical Center, discusses three important melanoma abstracts: the need for more than two doses of nivolumab plus ipilimumab in combination immunotherapy; antitumor activity for low-dose ipilimumab with pembrolizumab after disease progression on PD-1 antibodies; and ipilimumab alone or in combination with anti–PD-1 therapy for metastatic disease resistant to PD-1 monotherapy (Abstracts 10003, 10004, and 10005).
Formal discussant of KEYNOTE-555, Siwen Hu-Lieskovan, MD, PhD, of Huntsman Cancer Institute, Salt Lake City, commented on the advantages of the new schedule. “Along with the promise of prolonged survival associated with checkpoint inhibitors, convenience, quality of life, and reducing health-care...
A less-frequent, more-convenient dosing schedule for pembrolizumab (400 mg every 6 weeks) was deemed safe and effective in patients with unresectable or metastatic melanoma, according to interim data from cohort B enrolled in the KEYNOTE-555 trial. These findings were presented at the 2020 Virtual...
The Sidney Kimmel Cancer Center—Jefferson Health (SKCC) recently announced that Andrew E. Aplin, PhD, was being recognized with the Melanoma Research Foundation Humanitarian Award. Dr. Aplin is the Kalbach-Newton Professor in Cancer Research, Enterprise Associate Director for Basic Research, and...
In an interim analysis of the German phase II IMMUNED study reported in The Lancet, Zimmer et al found that adjuvant therapy with nivolumab/ipilimumab or nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected stage IV melanoma and no evidence of...
Internationally recognized immune-oncology melanoma expert Jedd D. Wolchok, MD, PhD, FASCO, was born and reared in Staten Island, not far from where he would shape his noted career at Memorial Sloan Kettering Cancer Center (MSK) in New York, New York. “I went to Princeton University and, during my ...
In a research letter published by Fritz et al in the journal Allergy, researchers reported that the common allergy medications desloratadine and loratadine may be associated with improved survival in patients with malignant melanoma. “Previous studies have shown that the same antihistamines have...
Patients with non–immune-infiltrated “cold” tumors have low frequencies of intratumoral tumor-reactive, checkpoint-positive cytotoxic lymphocytes, making them less responsive to checkpoint blockage than patients with immune-infiltrated “hot” tumors. A phase II study by Alain P. Algazi, MD, and...
Charles L. Sawyers, MD, of Memorial Sloan Kettering Cancer Center, New York, commented on the SWOG S1320 study presented at the 2020 American Association for Cancer Research Virtual Annual Meeting. “Intermittent therapy is standard with chemotherapy due to toxicity, but targeted therapies...
Continuous dosing with dabrafenib and trametinib improved progression-free survival in patients with BRAF-mutated advanced melanoma compared with an intermittent-dosing strategy, according to results of the phase II SWOG S1320 randomized trial reported at the opening Plenary Session of the 2020...
Immunotherapy is showing promise for patients with rare cancers, offering new treatment opportunities and clinical trials to those with previously limited options. At the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium, presenters discussed the use of immunotherapy in three low-incidence cancers: ...
Omid Hamid, MD, Chief of Research/Immuno-Oncology, The Angeles Clinic & Research Institute, and Co-Director of the Cutaneous Malignancy Program at Cedars-Sinai Cancer Center, Los Angeles, commented on these two studies for The ASCO Post. According to Dr. Hamid, the findings for the tumor...
Several novel strategies for the treatment of patients with stage III or IV melanoma showed promise in studies presented at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium.1,2 Vaccine for High-Risk Patients After Resection A tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine was...
Systemic treatment of melanoma has changed rapidly since the introduction of ipilimumab in 2011. Newer therapies approved for melanoma since that time include immunotherapy, targeted therapy for mutation-bearing tumors, and injectional therapy for cutaneous or palpable lesions. ASCO has released...
Grant A. McArthur, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses phase III results from a study of previously untreated patients with BRAF V600 mutation–positive advanced melanoma. His team evaluated whether combining vemurafenib and cobimetinib with atezolizumab improved the durability of responses compared with targeted therapies plus placebo (Abstract CT012).
“The hypothesis of combining kinase inhibitors with checkpoint inhibitors could be a fantastic idea,” said formal study discussant Charles Sawyers, MD, of Memorial Sloan Kettering Cancer Center, New York. “This trial [IMspire150] is positive, and that is great news. Triple therapy is superior to...
The addition of the checkpoint inhibitor atezolizumab to two targeted therapies (the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib) as initial therapy improved outcomes compared with the two targeted therapies plus placebo in patients with newly diagnosed BRAF V600E/K–mutant advanced ...
As reported in the Journal of Clinical Oncology by Suzanne L. Topalian, MD, and colleagues, neoadjuvant treatment with nivolumab was found to produce pathologic complete response in approximately half of patients with resectable Merkel cell carcinoma enrolled in the phase I/II CheckMate 358 trial....
Black patients with stage I to III melanoma are likely to experience a longer delay from diagnosis to surgery than non-Hispanic white patients, according to a study published by Tripathi et al in the Journal of the American Academy of Dermatology. “We already knew that black patients with melanoma...
A randomized clinical trial offers evidence that a combination of two targeted melanoma drugs, when given continuously, improves progression-free survival when compared with intermittent treatment, according to study results presented by Algazi et al at the American Association for Cancer Research...
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori in Naples, Italy, talks about minimizing risks for patients with cancer, prioritizing surgery and other treatments for melanoma, and the state of clinical trials. Filmed April 17, 2020.
For several tumor types, can the successes achieved with immunotherapy in the metastatic and adjuvant settings be replicated in the neoadjuvant setting? An explosion in clinical trials—with more than 300 listed on ClinicalTrials.gov—point to “yes.” “The neoadjuvant use of immunotherapy is of great ...
In a study published by Olsen et al in JAMA Dermatology, researchers found that in predominantly fair-skinned populations, melanoma incidence differed by age and anatomic site in men and women. Methods A cross-sectional analysis of sex- and site-specific trends was performed for white patients...
Discussant of the abstract on antibiotic exposure, Jarushka Naidoo, MBBCh, Assistant Professor of Oncology and Attending Physician at the Sidney Kimmel Cancer Center at Johns Hopkins University, said that Mr. Chu and colleagues have added to the recent literature examining concurrent use of...
Treatment with antibiotics prior to immune checkpoint inhibitor therapy may confer poorer overall survival and an increased risk of colitis in patients with advanced melanoma, according to data presented at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium.1 The largest institutional...
In a literature review published by Pampena et al in JAMA Dermatology, researchers provided detailed and extensive information about the features of several different kinds of rare cutaneous melanomas. According to the researchers, the analysis was performed to “…provide a comprehensive overview of ...
Recent treatment advances in metastatic melanoma resulted in reductions in population-level mortality from the disease, according to a study published by Polsky et al in the American Journal of Public Health. Methods Researchers analyzed new cases and deaths from melanoma from nine U.S....
Individuals who experience the loss of a partner are less likely to be diagnosed with melanoma—but face an increased risk of dying from the disease, according to research published by Wong et al in the British Journal of Dermatology. While previous studies have suggested a link between various...
In a single-center study reported in the Journal of Clinical Oncology, Allison Betof Warner, MD, PhD, and colleagues found that approximately three-quarters of patients with advanced melanoma achieving a complete response on programmed cell death protein 1 (PD-1) inhibitor therapy were alive...