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Allison Betof Warner, MD, PhD, reviews important clinical research in the treatment of advanced melanoma, including tumor-infiltrating lymphocyte (TIL) therapy, the role of this innovative treatment in advanced melanoma, and relevant data, peer-reviewed literature, and FDA approvals in 2024. She also provides a look ahead at what is on the horizon in 2025 with regard to care for patients with advanced melanoma.
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia and The University of Sydney, discusses final results with up to 10 years’ follow-up data of the COMBI-AD study of patients with stage III BRAF-mutated melanoma who received adjuvant dabrafenib plus trametinib (Abstract 9500).
Omid Hamid, MD, of The Angeles Clinic and Research Institute, a Cedars-Sinai affiliate, discusses updated data on IMC-F106C, a novel bispecific protein that, in a phase I safety and efficacy study, exhibited clinical activity in patients with unresectable or metastatic cutaneous melanoma who were pretreated with immune checkpoint inhibitors. A phase III trial of IMC-F106C with nivolumab in the first-line setting of metastatic disease has been initiated (NCT06112314; Abstract 9507).
Axel Hauschild, MD, of Germany’s University of Kiel and University Hospital Schleswig-Holstein, discusses phase III study results on neoadjuvant intralesional daromun vs immediate surgery for patients with fully resectable, locally advanced melanoma (Abstract LBA9501).
Pauline Funchain, MD, of Stanford University and the Stanford Cancer Institute, and Paolo A. Ascierto, MD, of Italy’s Istituto Nazionale Tumori and IRCCS Fondazione G. Pascale, discuss efficacy and safety findings of the triplet therapy nivolumab, relatlimab-rmbw, and ipilimumab in patients with advanced melanoma (Abstract 9504).
Pauline Funchain, MD, of Stanford University, and Caroline Robert, MD, PhD, of Gustave Roussy, discuss phase II findings showing that combining encorafenib and binimetinib followed by ipilimumab and nivolumab vs ipilimumab and nivolumab can improve progression-free survival in patients with BRAF-V600E/K-mutated melanoma characterized by high lactate dehydrogenase and liver metastases (Abstract LBA9503).
Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute, discusses findings of an investigator-initiated phase III trial showing that neoadjuvant ipilimumab plus nivolumab followed by response-driven adjuvant treatment improved event-free survival in patients with macroscopic, resectable stage III melanoma compared with adjuvant nivolumab (LBA2)
Douglas B. Johnson, MD, MSCI, of Vanderbilt-Ingram Cancer Center, discusses updated guidelines on the use of neoadjuvant therapy, as well as first- and later-line systemic therapies to treat patients with cutaneous melanoma.
Sophia McKinley, MD, EdM, of Massachusetts General Hospital, discusses patterns of recurrence in patients with resected cutaneous melanoma during or after adjuvant immunotherapy. She identifies the risk factors associated with overall survival and treatment failure (Abstract 60).
Jenny H. Chang, MD, of the Cleveland Clinic, discusses the current surgical and radiologic treatment paradigm for patients with stage III Merkel cell carcinoma and the potential for neoadjuvant immunotherapy to help manage the disease and regional lymph node metastases (Abstract 67).
Christopher A. Barker, MD, of Memorial Sloan Kettering Cancer Center, discusses phase II study results showing that patients with locally advanced, unresectable basal cell carcinoma of the head and neck experienced improved quality of life after induction and concurrent vismodegib with curative-intent radiation treatment. According to Dr. Barker, the data on this strategy may provide a beneficial benchmark for clinical practice (Abstract 9).
This is Part 4 of Evolving Skin Cancer Management, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Pauline Funchain, Alison Vidimos, and Lisa Zaba review the case of a 32-year-old patient who recently gave birth to her first child; following childbirth, she noticed a suspicious lesion on her thigh. A biopsy confirms that the lesion is a melanoma, with a Breslow depth of 3 mm. In the conversation that follows, the faculty note the rising incidence of skin cancer in people younger than 40, including melanoma, and also point out skin changes during pregnancy that may warrant surveillance in the perinatal and postnatal periods. They also discuss the debate surrounding the role of prognostic gene expression profiling in this patient population.
This is Part 3 of Evolving Skin Cancer Management, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Pauline Funchain, Alison Vidimos, and Lisa Zaba discuss the importance of early detection and multidisciplinary treatment of Merkel cell carcinoma. The patient is a 72-year-old male with a history of extensive sun exposure. He presents with a rapidly growing, firm—but painless—1.5 cm nodule on the back of his hand. In the conversation that follows, the faculty emphasize the importance of early detection and timely diagnosis of Merkel cell carcinoma due to its aggressive natural history, rapid growth, and lack of distinguishing clinical features; touch on the multidisciplinary collaboration between dermatology, surgery, and oncology necessary for optimal care; and discuss upcoming data on the role of adjuvant immunotherapy for this malignancy.
This is Part 2 of Evolving Skin Cancer Management, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Pauline Funchain, Alison Vidimos, and Lisa Zaba review how the multidisciplinary team comes together to treat cutaneous squamous cell carcinoma. The patient is a 65-year-old man with a history of long-term sun exposure and has had multiple actinic keratoses. He presents to dermatology with a large, aggressive cutaneous squamous cell carcinoma on his cheek; it is approximately 4 cm. He also has a history of chronic lymphocytic leukemia, for which he is undergoing observation. In the conversation that follows, the faculty discuss how a multidisciplinary team of practitioners may come together to care for this patient, and discuss if and when they would consider treatment options such as surgery, radiation, and systemic therapy.
This is Part 1 of Evolving Skin Cancer Management, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Pauline Funchain, Alison Vidimos, and Lisa Zaba discuss nonsurgical treatment options for basal cell carcinoma. The patient is a 68-year-old female who presents with a 1.5 cm nodular lesion on her nose. A biopsy shows that the lesion is indeed a basal cell carcinoma, with no signs of aggressive growth or invasion. The patient is concerned about undergoing surgery due to the risk of facial scarring and wants to know more about alternative, nonsurgical treatment options. In the conversation that follows, the faculty discuss nonsurgical options for patients with basal cell carcinoma, including photodynamic therapy, laser therapy, topical agents, hedgehog inhibitors, immunotherapy, and more.
Shailender Bhatia, MD, of the University of Washington and Fred Hutchinson Cancer Center, discusses phase I/II results on the efficacy of nivolumab with or without ipilimumab in patients with recurrent or metastatic Merkel cell carcinoma. The study found that, for this rare and aggressive skin cancer, nivolumab showed clinical activity in advanced disease. However, these results from CheckMate 358 do not suggest an additional benefit with ipilimumab added to nivolumab (Abstract 9506).
Allison Betof Warner, MD, PhD, of Stanford University Medical Center, and Zeynep Eroglu, MD, of H. Lee Moffitt Cancer Center and Research Institute, discusses phase II findings showing that in patients with BRAF-mutant metastatic melanoma, dabrafenib plus trametinib and navitoclax (DTN) was associated with a complete response rate of 20% and an overall response rate of 84%. Additionally, there was a trend toward improved overall survival in patients treated with DTN compared with dabrafenib plus trametinib alone; the difference in overall survival was more pronounced in patients with a smaller tumor burden (Abstract 9511).
Jason J. Luke, MD, of the University of Pittsburgh Medical Center Hillman Cancer Center, discusses adjuvant pembrolizumab, which, in previous results, improved distant metastasis– and recurrence-free survival in patients with resected stage IIB or IIC melanoma vs placebo. After a median follow-up of 39.4 months, adjuvant pembrolizumab continued to show a benefit over placebo, with no new safety signals (Abstract LBA9505).
Allison Betof Warner, MD, PhD, of Stanford University Medical Center, and Adnan Khattak, MBBS, FRACP, PhD, of Australia’s Hollywood Private Hospital & Edith Cowan University, discuss the use of the mRNA-4157 vaccine in combination with pembrolizumab as adjuvant therapy for resected high-risk melanoma, which prolonged distant metastasis–free survival compared with pembrolizumab alone. These results provide further evidence that a personalized neoantigen approach is potentially beneficial (Abstract LBA9503).
Georgina V. Long, MD, PhD, of Melanoma Institute Australia and The University of Sydney, discusses new data showing that patients with resected stage IIB/C melanoma who were treated with adjuvant nivolumab had prolonged recurrence-free survival compared with placebo across all biomarker subgroups. The baseline biomarkers most predictive of prolonged recurrence-free survival with nivolumab were high interferon gamma score, high tumor mutational burden, CD8 T-cell infiltration, and low C-reactive protein (Abstract 9504).
Omid Hamid, MD, of The Angeles Clinic & Research Institute, discusses study findings on fianlimab plus cemiplimab-rwlc, which showed clinical activity in patients with advanced melanoma, comparing favorably with other approved combinations of immune checkpoint inhibitors in the same clinical setting. This is the first indication that dual LAG-3 blockade may produce a high level of activity with significant overall response rate after adjuvant anti–PD-1 treatment. A phase III trial of this regimen in treatment-naive patients with advanced melanoma is ongoing (Abstract 9501).
Marcus O. Butler, MD, of Toronto’s Princess Margaret Cancer Centre, discusses evidence of tumor response in orbital lesions treated with tebentafusp in patients with metastatic uveal melanoma. Tebentafusp is a first-in-class novel bispecific protein, the first therapy to show superior overall survival compared with standard therapy for metastatic uveal melanoma. Based on these study findings, a role for this agent as a neoadjuvant treatment warrants further investigation. (Abstract LB 118/1)
Jeffrey S. Weber, MD, PhD, of the Perlmutter Cancer Center at New York University Langone, discusses efficacy and safety results from the phase II KEYNOTE-942 trial, which showed that a personalized mRNA-based cancer vaccine, combined with the immune checkpoint inhibitor pembrolizumab, improved recurrence-free survival compared with pembrolizumab alone in patients with high-risk melanoma. The clinical benefit was observed regardless of the tumor mutational burden status. (Abstract CT001)
This is Part 4 of Updates in Melanoma, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Omid Hamid, Sapna Patel, and Ryan Sullivan discuss the second- and third-line therapy options for unresectable and metastatic melanoma. The patient is a 55-year-old man diagnosed with metastatic melanoma that has spread to the lung and liver. He was previously treated with combination checkpoint inhibitor therapy without benefit, and his providers are debating the next steps. The faculty review the recent data in advanced melanoma in the second line and beyond, focusing in particular on tumor-infiltrating lymphocyte (TIL) therapy. They provide an overview of what the practicing clinician and patients should know about TIL therapy, the logistics involved, and recent data.
This is Part 3 of Updates in Melanoma, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Omid Hamid, Sapna Patel, and Ryan Sullivan discuss the first-line treatment of metastatic melanoma. The patient is a 32-year-old woman recently diagnosed with BRAF V600E–negative melanoma that has metastasized to the liver. MRI of the brain was negative, her EVOG performance score is 1, and she has no contraindications to targeted therapy or immune checkpoint inhibitors. The faculty review the changing first-line treatment landscape in metastatic and unresectable melanoma, discussing the many immunotherapy combinations that have entered the field. In particular, they highlight the results of the recent RELATIVITY-047, CheckMate 067, and DREAMseq trials.
This is Part 2 of Updates in Melanoma, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Omid Hamid, Sapna Patel, and Ryan Sullivan discuss current adjuvant treatment options in malignant melanoma. The patient is a 67-year-old man with a long-standing mole on his leg that has begun to change over the past year. A biopsy shows a 2.2-mm melanoma, nonulcerated, and the tumor is BRAF-positive. Physical examination reveals palpable lymphadenopathy in the inguinal area. The faculty discuss the current neoadjuvant armamentarium for malignant melanoma, reviewing the implications of the OpACIN and S1801 trials and highlighting possible ways to deescalate surgery and adjuvant therapy.
This is Part 1 of Updates in Melanoma, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Omid Hamid, Sapna Patel, and Ryan Sullivan discuss current adjuvant treatment options in malignant melanoma. The patient is a 67-year-old man with a long-standing mole on his leg that has begun to change over the past year. A biopsy shows a 2.2-mm melanoma, nonulcerated, with no palpable lymph nodes in the inguinal area. CT and PET scans show no evidence of metastatic disease, sentinel lymph nodes are negative, and the tumor is BRAF-positive. The faculty discuss the role of immunotherapy in the adjuvant treatment of stage II-IV melanoma, highlighting recent trials such as COMBI-AD, CheckMate 238, and KEYNOTE-54. In addition, they emphasize the importance of testing for BRAF status when making treatment decisions.
Saman Maleki, PhD, of Canada’s Western University and Lawson Health Research Institute, discusses modifying the gut microbiome in patients with advanced melanoma to induce a response to anti–PD-1 therapy and potentially reduce primary resistance to immunotherapy. A fecal microbiota transplant from healthy donors before treatment appears to be beneficial (Abstract 614).
John B.A.G. Haanen, MD, PhD, of The Netherlands Cancer Institute, discusses recent phase III findings, which show that tumor-infiltrating lymphocytes (TILs) improve progression-free survival compared with ipilimumab by 50% in patients with advanced melanoma after not responding to anti–PD-1 treatment. Around 50% of TIL-treated patients had a response, and 20% had a complete response (Abstract LBA3).
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, discusses results from the CheckMate 915 trial, an analysis of the pretreatment circulating tumor DNA, along with other clinical and translational baseline factors, and their association with disease recurrence in patients with stage IIIB–D/IV melanoma treated with adjuvant immunotherapy (Abstract 788O).
Neil D. Gross, MD, of The University of Texas MD Anderson Cancer Center, discusses data from a phase II study, which showed that neoadjuvant cemiplimab-rwlc in patients with stage II–IV (M0) resectable cutaneous squamous cell carcinoma is active and may enable function-preserving surgery in some cases (Abstract 789O).
Sapna P. Patel, MD, of The University of Texas MD Anderson Cancer Center, discusses the latest findings from the SWOG S1801 trial, which showed that using single-agent pembrolizumab as neoadjuvant therapy improved event-free survival compared to adjuvant therapy in high-risk resectable stage III–IV melanoma (Abstract LBA6).
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, The University of Sydney, discusses phase III findings from the KEYNOTE-716 study. The trial showed that compared with placebo, adjuvant pembrolizumab significantly improved distant metastasis–free survival in patients with resected stage IIB and IIC melanoma. The findings also suggest a continued reduction in the risk of recurrence and a favorable benefit-risk profile (Abstract LBA9500).
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, The University of Sydney, discusses findings from the NeoTrio trial on neoadjuvant pembrolizumab alone, in sequence with, or concurrent with dabrafenib plus trametinib in patients with resectable BRAF-mutant stage III melanoma. The study may help clinicians determine the optimal combination of therapy (Abstract 9503).
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.
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).
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).
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).
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.
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).
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).
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.
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.
Jeffrey S. Weber, MD, PhD, of the Perlmutter Cancer Center, NYU Langone, discusses the 4-year recurrence-free and overall survival results from the CheckMate 238 study, which showed adjuvant nivolumab continues to be an effective treatment, vs the comparator ipilimumab, for patients with resected stage III/IV melanoma (Abstract 1076O).
Alexander M. Eggermont, MD, PhD, of the Princess Maxima Center for Pediatric Oncology, discusses final results of the phase III EORTC 1325-MG/Keynote 054 trial, which confirmed a sustained recurrence-free survival benefit of pembrolizumab vs placebo in patients with resected high-risk stage III melanoma, as well as a decrease in the incidence of distant and locoregional recurrence (Abstract LBA46).
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori, discusses phase II results on progression-free survival for patients with advanced melanoma in the SECOMBIT study, whose aim is to evaluate the different sequencing of a BRAF inhibitor (encorafenib) plus a MEK inhibitor (binimetinib) with ipilimumab plus nivolumab (Abstract LBA45).
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).
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).