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On July 6, the U.S. Food and Drug Administration (FDA) approved an expanded label for pembrolizumab, an anti–PD-1 agent, as monotherapy for patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation. This approval is based on data from the second...
Answers to questions about first-line treatment of metastatic melanoma are “going to be shifting,” Jason J. Luke, MD, told The ASCO Post, with the change coming on the heels of the phase III RELATIVITY-047 trial reported at the 2021 ASCO Annual Meeting.1 That abstract reported that using two...
Despite new and effective treatments for melanoma with checkpoint inhibitors and targeted therapies, patients with metastatic melanoma who progress on frontline treatment generally do very poorly. “We really need to make sure we give these patients access to drugs that we know have some efficacy,”...
In a retrospective cohort study reported in JAMA Oncology, Erickson et al found that real-world use of targeted therapy after diagnosis of intracranial metastatic disease was associated with improved overall survival vs no use of targeted therapy in patients with HER2-positive breast cancer,...
In a study reported in a research letter in JAMA Oncology, Corbett et al found that the majority of phase III trials investigating systemic therapy in patients with advanced lung cancer, breast cancer, and melanoma over the past 20 years have excluded or restricted enrollment of those with brain...
Omid Hamid, MD, Chief of Translational Research/Immuno-Oncology at The Angeles Clinic & Research Institute, Los Angeles, and Co-Director of the Cutaneous Malignancy Program at Cedars-Sinai Cancer Institute, shared his thoughts on the RELATIVITY-047 study1 for The ASCO Post, referring to them as ...
Immune checkpoint inhibition has been established as an effective treatment for patients with metastatic melanoma. A novel immunotherapeutic combination—this one targeting the LAG-3 (lymphocyte-activation gene 3) and PD-1 immune checkpoints—delayed time to disease progression significantly more...
Patients with high-risk melanoma who had a course of pembrolizumab had longer recurrence-free survival than patients who received either ipilimumab or high-dose interferon after surgery. These findings of a large SWOG Cancer Research Network clinical trial, S1404, were presented by Grossmann et al...
In the longest follow-up results from a clinical trial of combination immunotherapy for metastatic melanoma, investigators report that nearly half the patients who received the drugs nivolumab and ipilimumab were alive at a median of 6.5 years after treatment. These long-term results from the...
Evan J. Lipson, MD, of Johns Hopkins University, discusses primary phase III results from the RELATIVITY-047 study, which showed that relatlimab plus nivolumab as a fixed-dose combination may improve progression-free survival compared with nivolumab monotherapy in patients with advanced melanoma. This is the first study to demonstrate a benefit from dual inhibition of the LAG-3 and PD-1 pathways.
As reported in The Lancet Oncology by Stratigos et al, findings in a subgroup of a phase II trial have shown that the PD-1 antibody cemiplimab-rwlc produces enduring responses in patients with locally advanced basal cell carcinoma who had progressive disease on or intolerance to prior hedgehog...
In a retrospective cohort study reported in The Lancet Oncology, da Silva et al found that better outcomes were achieved with the combination of an anti–PD-1 agent plus ipilimumab vs ipilimumab alone in patients with advanced melanoma who were resistant to prior anti–PD-1 or anti–PD-L1 ...
Treatment with the anti–PD-1 therapy nivolumab plus the LAG-3–blocking antibody relatlimab extended time to disease progression for patients with previously untreated, unresectable, or metastatic melanoma. Findings from the RELATIVITY-047 trial were presented by Evan J. Lipson, MD, and colleagues...
Formal discussant Stefania Scala, MD, of the Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, was impressed by the findings of KEYNOTE-629. “The second interim analysis for the locally advanced disease cohort and updated data for the recurrent/metastatic disease cohort of KEYNOTE-629 had ...
Single-agent pembrolizumab achieved durable responses and promising survival in patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma, according to the second interim analysis of the phase II KEYNOTE-629 study, which was presented at the virtual American...
In a cohort of a phase II study reported in the Journal of Clinical Oncology, Amod A. Sarnaik, MD, and colleagues found that the tumor-infiltrating lymphocyte therapy lifileucel produced durable responses in patients with metastatic melanoma previously treated with checkpoint inhibitors and BRAF-...
Melanocytic nevi are nonmalignant growths that arise from pigment-producing cells of the skin. They are mostly found in sun-exposed areas; however, they also can be found in sun-protected areas, such as the palms, soles of the feet, and nail beds, where they are known as acral nevi. While the...
In a phase II trial reported in the Journal of Clinical Oncology, Olson et al found that pembrolizumab plus low-dose ipilimumab produced durable responses in patients with advanced melanoma whose disease had progressed on immediate prior PD-1 or PD-L1 inhibitor therapy. Study Details In the U.S....
A significant survival advantage accrued to patients with stage IIB and IIC cutaneous melanoma who received adjuvant immunotherapy, a large retrospective cohort study reported at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 The 3-year overall...
Formal discussant of CheckMate 915, Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands, suggested that the lower doses of ipilimumab used in the current study may explain the lack of effect on relapse-free survival. The...
The addition of ipilimumab to nivolumab failed to improve outcomes compared with nivolumab alone as adjuvant therapy for resected melanoma, according to the results of the CheckMate 915 trial, presented at the virtual edition of the American Association for Cancer Research (AACR) Annual Meeting...
This is the first randomized trial that is positive for overall survival in uveal melanoma, and I’m very excited about the results, which I consider seminal and practice-changing,” said formal discussant Caroline Robert, MD, of Gustave Roussy, Villejuif, France. “This is such a rare tumor, but it...
Treatment with tebentafusp—a novel bispecific fusion protein—reduced the risk of death from metastatic uveal melanoma by half, compared with available treatments, in a phase III study presented at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021.1 This is the first...
As reported in The Lancet Oncology by Andrew Bottomley, PhD, and colleagues, an analysis of the phase III EORTC 1325-MG/KEYNOTE-054 trial showed no clinically significant decline in health-related quality of life (HRQoL) with adjuvant pembrolizumab vs placebo in resected high-risk stage III...
On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for...
As reported in The Lancet Oncology by Alexander M.M. Eggermont, MD, and colleagues, the pivotal phase III EORTC 1325/KEYNOTE-054 trial has shown significant improvement in the secondary endpoint of distant metastasis–free survival—as well as continued benefit in the primary endpoint of...
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, University of Sydney, discusses results of the CheckMate 915 trial, which may reinforce nivolumab as an adjuvant standard of care in patients with stage IIIB–D/IV melanoma, with or without complete lymphadenectomy (Abstract CT004).
In the next 2 decades, rankings of incidence and death across cancer types in the United States will undergo important changes, according to new research published by Lola Rahib, PhD, and colleagues in JAMA Network Open. The study estimates that pancreatic cancer is on course to become the...
Tumor mutational burden (TMB) was an accurate predictor of response to treatment with immune checkpoint inhibitors for female patients with melanoma, but not for male patients, according to results of a study presented by Sinha et al during the virtual American Association for Cancer Research...
Samra Turajlic, MBBS, PhD, of The Francis Crick Institute, discusses our limited understanding of metastases in terms of the timing of dissemination, the many metastatic phenotypes and varieties of seeding, as well as how the spread of cancer evades the immune system and resists treatment. Expanding this knowledge base is critical to better managing malignant disease.
Jessica C. Hassel, MD, of University Hospital Heidelberg, discusses phase III results of a study that compared tebentafusp, a bispecific fusion protein, with investigator’s choice in patients with metastatic uveal melanoma. Tebentafusp nearly halved the risk of death among patients in the trial with this rare eye cancer (Abstract CT002).
Treatment with tebentafusp, a novel bispecific fusion protein, reduced the risk of death from metastatic uveal melanoma at 14 months by half, compared with available treatments, in a phase III study presented by Piperno-Neumann et al at the virtual American Association for Cancer Research (AACR)...
Treatment with unselected autologous tumor-infiltrating lymphocytes (TILs) showed early clinical efficacy among patients with advanced melanoma, according to results presented by Hawkins et al during week 1 of the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 (Abstract ...
In a single-institution study reported in JCO Oncology Practice, Menjak et al found that a nurse-led telephone surveillance program for toxicity associated with ipilimumab in patients with metastatic melanoma led to earlier identification of toxicities and earlier intervention, with an apparent...
April K. Salama, MD, of Duke Cancer Institute, discusses the shift in recent years, as more effective therapies have become available, toward integrating systemic upfront treatment of patients with brain metastases from cutaneous melanoma; pivotal studies that have provided key data; and the need for a multidisciplinary approach incorporating medical, surgical, and radiation oncology.
Among patients at high risk of melanoma, those who received routine skin cancer screening and education about skin self-exams were significantly more likely to be diagnosed with thinner and earlier-stage melanomas, according to results published by Michael Sargen, MD, and colleagues in Cancer...
In a retrospective cohort study reported in JAMA Oncology, Patrinely et al found that chronic immune-related adverse events occurred in a high proportion of patients receiving adjuvant PD-1–targeted therapy for high-risk resected melanoma and frequently persisted even during prolonged follow-up....
The results of a large cohort study suggest that a proportion of patients with cutaneous melanoma could potentially avoid sentinel node biopsy, according to data presented by Moncrieff et al at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (Abstract 59)....
Susan M. Swetter, MD, of Stanford Cancer Institute, discusses molecular prognostic tests for cutaneous melanoma, which may improve staging accuracy, reduce unnecessary sentinel lymph node biopsies, and inform decisions on surveillance imaging and/or adjuvant therapy.
An observational study of 10,592 patients from the National Cancer Database with stage IIB/IIC melanoma who had undergone surgical resection demonstrated a significant survival advantage with immunotherapy. The research was presented by Wong et al at the Society of Surgical Oncology 2021...
As reported in the Journal of Clinical Oncology, El Sharouni et al have developed nomograms to predict local, regional, and distant recurrence in patients with T1 melanomas. Study Details The study used data from a Dutch population-based cohort of 25,930 patients to develop the nomograms. The...
Researchers have created a new technique that may help to uncover mechanisms cancer cells use to evade immunotherapies, which could lead to the development of more effective treatments. Investigators tested their new technique with cancer cells and matching immune cells from patients with melanoma...
In a study reported in The Lancet Oncology, Syeda et al found that higher BRAF V600–mutant cell-free circulating tumor DNA (ctDNA) levels prior to and during treatment with dabrafenib or dabrafenib/trametinib were associated with poorer outcomes among patients with advanced melanoma. Study Details...
For patients with melanoma who do not respond to treatment with immunotherapy, adjusting the composition of microorganisms in the intestines through the use of fecal transplants may aid in overcoming resistance to therapy. These findings were published by Davar et al in Science. In the study, some...
On February 9, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc (Libtayo) for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. The FDA also granted...
Cutaneous squamous cell carcinoma is the second most common type of skin cancer, with more than 1 million cases diagnosed in the United States annually.1 Historically, cutaneous squamous cell carcinoma is grouped together with basal cell carcinoma and collectively referred to as nonmelanoma skin...
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...
Four years after patients with melanoma were treated with a personalized cancer vaccine, the immune response caused by the vaccine remained robust and effective in keeping cancer cells under control, according to a new study published by Hu et al in Nature Medicine. The findings demonstrate the...
In a Spanish phase II trial reported in the Journal of Clinical Oncology, Piulats et al found that nivolumab/ipilimumab produced a “modest” improvement in overall survival vs historical rates achieved with chemotherapy as first-line treatment for patients with metastatic uveal melanoma ineligible...
The U.S. Food and Drug Administration (FDA) has granted two Fast Track designations to cavrotolimod (AST-008). The designations include cavrotolimod in combination with anti–PD-1 therapy for the treatment of patients with locally advanced or metastatic Merkel cell carcinoma refractory to prior...