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A novel immunotherapeutic combination that targets PD-1 and the LAG-3 pathway significantly delayed disease progression as a first-line treatment of advanced or unresectable melanoma. Updated results of the global phase III RELATIVITY-047 trial validated the study’s initial findings and were...
Genevieve Boland, MD, PhD, of Massachusetts General Hospital Cancer Center, discusses targeted treatments and immunotherapies and how they have dramatically changed the landscape in melanoma. Initially used in advanced disease, these agents are now being used in local or locoregional melanoma in the adjuvant and/or neoadjuvant settings. Dr. Boland also talks about the critical importance of multidisciplinary teams to integrate the latest recommendations for patient care.
In a single-center study reported in JCO Oncology Practice, Ceballos et al identified turnaround times for request and receipt of melanoma BRAF testing results. They also analyzed factors in differences in turnaround times and effects on time to initiation of treatment. The study included 66...
Patients with advanced melanoma whose cancer does not respond to treatment with PD-1 inhibitors are often switched to treatment with a second type of immunotherapy drug, a CTLA-4 inhibitor such as the drug ipilimumab. In a phase II trial presented by Vanderwalde et al during the American...
As reported in The Lancet by Luke et al, the phase III KEYNOTE-716 trial has shown significantly prolonged recurrence-free survival with adjuvant pembrolizumab vs placebo in patients with high-risk completely resected stage IIB/IIC melanoma at both first and second interim analyses. The first...
Iván Márquez-Rodas, MD, PhD, of Spain’s Hospital General Universitario Gregorio Marañón, discusses final results of the phase II SPOTLIGHT203 study of systemic pembrolizumab in combination with intratumoral BO-112 for patients with advanced melanoma refractory to anti–PD-1–based therapy. The regimen achieved an overall response rate of 25% and a disease control rate of 65% (Abstract CT014).
Ari M. VanderWalde, MD, MPH, MBioeth, of The West Clinic, discusses results from the S1616 trial involving patients with metastatic or unresectable melanoma who had primary resistance to PD-1 or PD-L1 inhibitors. Compared with ipilimumab alone, the combination of ipilimumab plus nivolumab benefited some patients: those with tumors that responded to therapy showed an increased amount of CD8+ cells. Because there is no standard treatment for metastatic melanoma after failure of PD-1 inhibitors in BRAF wild-type disease, this research may provide a viable option in the future (Abstract CT013).
In the recently published results of the RELATIVITY-047 trial,1 summarized in this issue of The ASCO Post, the addition of relatlimab to nivolumab monotherapy was associated with improved progression-free survival compared with nivolumab alone in patients with previously untreated advanced,...
In a phase II/III trial (RELATIVITY-047) reported in The New England Journal of Medicine, Hussein A. Tawbi, MD, PhD, of The University of Texas MD Anderson Cancer Center, and colleagues found that the addition of relatlimab, a lymphocyte-activation gene 3 (LAG-3)–blocking antibody, to nivolumab...
In a population-based cohort study reported in JAMA Network Open, Schonfeld et al identified the incidence of immune-related adverse events among White patients aged ≥ 65 years with newly diagnosed melanoma treated with immune checkpoint inhibitors. They compared the risk of these adverse events...
In a population-based cohort study reported in JAMA Oncology, Chen et al found that the incidence of overall cutaneous melanoma and thinner tumors was stable in the United States from 2010 to 2018, with an increased incidence of the thickest (T4) melanomas being observed. Lower socioeconomic status ...
On March 18, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approved treatment is a fixed-dose combination of the LAG-3–blocking antibody relatlimab ...
A novel immunotherapeutic combination that targets PD-1 and the LAG-3 pathway may significantly delay disease progression as a first-line treatment of advanced or unresectable melanoma. Updated results of the global phase III RELATIVITY-047 trial validated the study’s initial findings and were...
Intratumor injection of the oncolytic virus RP1 in combination with the checkpoint inhibitor nivolumab has demonstrated durable antitumor activity in patients with nonmelanoma skin cancer of the head and neck, according to data presented at the 2022 Multidisciplinary Head and Neck Cancers...
In a retrospective analysis reported in JAMA Surgery, Reijers et al found that pathologic response in largest lymph node metastasis (index lymph node [ILN]) was highly concordant with response in the total lymph node bed in patients with stage III melanoma receiving neoadjuvant...
Patients treated for Merkel cell carcinoma face a 5-year recurrence rate of 40%—markedly higher than the recurrence rates for melanoma and other skin cancers, according to research published by McEvoy et al in JAMA Dermatology. Additionally, in the study cohort of more than 600 patients, 95% of...
In a study reported in the Journal of Clinical Oncology, Pires da Silva et al developed predictive models for objective response and progression-free and overall survival among patients receiving anti–PD-1 antibodies with or without ipilimumab for metastatic melanoma. The analyses involved data...
On January 25, 2022, tebentafusp-tebn, a bispecific gp100 peptide-HLA–directed CD3 T-cell engager, was approved for treatment of adults with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma.1 Supporting Efficacy Data Approval was based on findings in the open-label, multicenter...
Melanoma is often curable when detected and treated in its early stages. However, the disease can rapidly spread to other organs in the body and become deadly. Immune checkpoint inhibitors have transformed the treatment of certain cancers, including melanoma, and improved patient care. But despite...
In a Danish retrospective study reported in the International Journal of Cancer, Ellebaek et al found that patients with advanced melanoma responding to PD-1 inhibitor therapy who stopped treatment within 18 months had improved survival outcomes when fluorodeoxyglucose (F-18) positron-emission...
As reported in the Journal of Oncology by Reinhard Dummer, MD, and colleagues, the phase III COMBI-i trial has shown no significant progression-free survival benefit with the addition of the anti–PD-1 antibody spartalizumab to dabrafenib and trametinib in patients with no prior systemic treatment...
On January 26, the U.S. Food and Drug Administration (FDA) granted approval to tebentafusp-tebn (Kimmtrak) for the treatment of adult patients with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma. Tebentafusp’s approval establishes several firsts: as the first T-cell receptor...
On December 3, 2021, pembrolizumab was approved for adjuvant treatment of adult and pediatric (≥ 12 years of age) patients with stage IIB or IIC melanoma following complete resection.1 Supporting Efficacy Data Approval was based on findings in the phase III, double-blind KEYNOTE-716 trial...
After almost a century of limited efficacy of cancer immunotherapy,1 the breakthrough happened in 2012 with the discovery of immune checkpoint inhibitors,2,3 leading to the 2018 Nobel Prize in Physiology or Medicine for James P. Allison and Tasuku Honjo. Yet about 40% of patients on immune...
In a single-institution study reported in The Lancet Oncology, David C. Qian, MD, PhD, and Zachary S. Buchwald, MD, PhD, of Winship Cancer Institute of Emory University, Atlanta, and colleagues found that patients with metastatic melanoma who received at least 20% of immune checkpoint inhibitor...
In the phase II/III RELATIVITY-047 trial reported in The New England Journal of Medicine, Hussein A. Tawbi, MD, PhD, and colleagues found that the addition of relatlimab, a lymphocyte-activation gene 3 (LAG-3)-blocking antibody, to nivolumab, a PD-1 inhibitor, significantly prolonged...
In the phase II ADAPT-IT trial reported in the Journal of Clinical Oncology, Michael A. Postow, MD, and colleagues showed that findings on interim computed tomography (CT) allowed patients to avoid the third and fourth doses of combination nivolumab/ipilimumab for the treatment of advanced...
Patients with melanoma who reported eating more fiber-rich foods when they began treatment with immunotherapy survived longer without cancer growth than patients with insufficient dietary fiber intake, according to new research published by Spencer et al in Science. The benefit was most noticeable...
In a study reported in JAMA Network Open, Jang et al found that women with advanced melanoma receiving combination immune checkpoint inhibitor therapy with nivolumab/ipilimumab as their most recent immune checkpoint inhibitor therapy (all with prior ipilimumab treatment) had a poorer survival...
In a 6.5-year update of the phase III CheckMate 067 trial reported in the Journal of Clinical Oncology, Jedd D. Wolchok, MD, PhD, FASCO, and colleagues provided long-term overall survival as well as melanoma-specific survival findings among patients with advanced melanoma who received nivolumab...
On December 3, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients aged 12 years and older with stage IIB or IIC melanoma following complete resection. KEYNOTE-716 Efficacy was evaluated in KEYNOTE-716, a...
The addition of vidutolimod to pembrolizumab could help overcome resistance to immune checkpoint inhibition in patients with metastatic or unresectable cutaneous melanoma, according to data presented by John M. Kirkwood, MD, and colleagues at the Society for Immunotherapy of Cancer (SITC) 2021...
Immune checkpoint inhibitors have revolutionized the treatment of metastatic melanoma, but a significant number of patients still fail to respond to anti–PD-1 therapy. The novel combination of sotigalimab, an anti-CD40 monoclonal antibody, and the PD-1 inhibitor nivolumab could help address this...
John M. Kirkwood, MD, of the University of Pittsburgh Medical Center, discusses phase Ib findings on the combination of vidutolimod plus pembrolizumab, as well as vidutolimod monotherapy, both of which showed clinical activity in patients with PD-1 blockade–refractory melanoma. The duration of response with the combination therapy was substantially longer. Phase II studies are ongoing (Abstract 950).
Invited discussant of the phase III DREAMseq trial, Keith T. Flaherty, MD, said the findings still leave room for nuanced decision-making.1 Dr. Flaherty is Professor of Medicine at Harvard and Director of the Henri and Belinda Termeer Center for Targeted Therapy at the Massachusetts General...
In the treatment of patients with advanced melanoma containing BRAF mutations, initial treatment with an immunotherapy combination achieved superior overall survival compared with targeted therapy in the phase III DREAMseq trial, also known as the ECOG-ACRIN EA6134 trial. The results were reported ...
Moles and melanomas both originate from the same type of cell—melanocytes. A study published by McNeal et al in eLife Magazine aimed to explain how common moles and melanomas form and why moles can subsequently change into melanoma. Melanocytes are cells that give color to the skin to protect it...
In a single-institution study reported in The Lancet Oncology, Qian et al found that the administration of immune checkpoint inhibitors after 4:30 PM was associated with poorer overall survival vs infusion earlier in the day in patients with metastatic melanoma. As stated by the investigators, “The ...
Patients with BRAF V600–mutated advanced melanoma who received an immunotherapy regimen of nivolumab/ipilimumab followed by targeted therapy with dabrafenib/trametinib experienced greater overall survival (72%) compared with patients receiving the converse sequence (52%). According to the study...
As reported in The Lancet Oncology by Tawbi et al, final results of the phase II CheckMate 204 trial indicate good long-term outcomes with the combination of nivolumab and ipilimumab in patients with asymptomatic active melanoma brain metastases, with poorer outcomes observed in those with...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for several kinds of lymphoma, as well as nasopharyngeal cancer; a Breakthrough Therapy designation for a treatment for patients with NTRK-positive advanced solid tumors; and Fast Track designation for...
Commenting on the SECOMBIT trial was Omid Hamid, MD, Chief of Translational Research and Immunotherapy at The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate, and Co-Director, Cutaneous Malignancy Program, Cedars-Sinai Cancer. Dr. Hamid said SECOMBIT addresses an important...
Patients with untreated, metastatic BRAF-mutated melanoma may benefit from receiving immunotherapy first, moving to targeted therapy in the second line, data from the updated overall survival analysis of the randomized, phase II SECOMBIT trial suggest.1 The study aimed to define the optimal...
“The U.S. Food and Drug Administration is currently examining pembrolizumab for the adjuvant treatment of stage IIB and IIC melanoma; if approved, we would be introducing immunotherapy earlier in the patient journey,” commented invited discussant Omid Hamid, MD (@OmidHamidMD), who was an...
Adjuvant pembrolizumab reduced the risk of recurrence in adults and children older than age 12 with high-risk stage II (AJCC 8th edition, stage IIB/IIC) melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial, presented during the European Society for...
Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...
In an interim analysis of the phase III IMCgp100-202 trial reported in The New England Journal of Medicine, Nathan et al found that tebentafusp, a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector, significantly improved overall survival vs...
Oncologists who treat patients with melanoma will need to become familiar with another immunotherapy approach. For refractory metastatic disease, adoptive cell therapy is on the horizon. “Adoptive cell therapy will offer additional hope for our patients with melanoma. We’ll likely be seeing this...
Adjuvant pembrolizumab reduced the risk of disease recurrence in adults and children aged 12 years and older with high-risk stage II melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial presented by Jason J. Luke, MD, and colleagues at the European...
Jason J. Luke, MD, of UPMC Hillman Cancer Center, discusses phase III results showing that adjuvant pembrolizumab for patients with resected stage IIB and IIC melanoma decreased the risk of disease recurrence or death by 35% compared with placebo. It was also associated with significantly prolonged recurrence-free survival (Abstract LBA3).