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Skin Cancer
Immunotherapy

Addition of Anti–LAG-3 Antibody Relatlimab to Nivolumab in Previously Untreated Patients With Advanced Melanoma

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...

Skin Cancer
Immunotherapy

Interim Radiographic Assessment for Adaptive Dosing of Combination Immunotherapy in Advanced Melanoma

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...

Skin Cancer
Immunotherapy

Is a High-Fiber Diet Associated With Improved Survival and Treatment Response in Patients With Melanoma?

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...

Skin Cancer
Immunotherapy

Immune Checkpoint Inhibitor Treatment in Patients Aged 65 and Older With Advanced Melanoma: Association Between Sex and Survival

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...

Skin Cancer
Immunotherapy

Long-Term Outcomes From CheckMate 067: Nivolumab/Ipilimumab, Nivolumab, or Ipilimumab in Advanced Melanoma

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...

Skin Cancer
Immunotherapy

FDA Approves Pembrolizumab for the Adjuvant Treatment of Stage IIB or IIC Melanoma

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...

Skin Cancer
Immunotherapy

Vidutolimad Plus Pembrolizumab in PD-1 Refractory Melanoma

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...

Skin Cancer
Immunotherapy

Sotigalimab Plus Nivolumab in Anti–PD-1/PD-L1–Refractory Melanoma

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...

skin cancer
immunotherapy

John M. Kirkwood, MD, on Melanoma: Early Study Results on Vidutolimod and Pembrolizumab

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).

Skin Cancer
Immunotherapy
Genomics/Genetics

Keith T. Flaherty, MD, on Results From the DREAMseq Trial

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...

Skin Cancer
Immunotherapy
Genomics/Genetics

DREAMseq Trial: In Advanced Melanoma With BRAF Mutations, Start With Immunotherapy

 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 ...

Skin Cancer

Research Assesses Molecular Hallmarks of Moles and Melanomas

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...

Skin Cancer
Immunotherapy

Impact of Time of Day of Immune Checkpoint Inhibitor Infusion on Overall Survival in Patients With Metastatic Melanoma

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 ...

Skin Cancer

Immunotherapy Followed by Targeted Therapy Yields Greater Overall Survival in Patients With BRAF V600–Mutated Advanced Melanoma

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...

Skin Cancer

CheckMate 204: Long-Term Outcomes With Nivolumab Plus Ipilimumab in Active Melanoma Brain Metastases

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...

Lymphoma
Head and Neck Cancer
Solid Tumors
Genomics/Genetics
Gynecologic Cancers
Skin Cancer
Immunotherapy

FDA Pipeline: Novel Treatments in Lymphoma, Nasopharyngeal Cancer, Solid Tumors, and More

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...

Skin Cancer
Genomics/Genetics
Immunotherapy

Expert Point of View: Omid Hamid, MD

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...

Skin Cancer
Genomics/Genetics
Immunotherapy

SECOMBIT Trial Evaluates Optimal Treatment Sequencing in BRAF-Mutated Melanoma

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...

Skin Cancer
Immunotherapy

Expert Point of View: Omid Hamid, MD

“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...

Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab Shows Efficacy in High-Risk Stage II Melanoma in Adults and Children Older Than 12

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...

Skin Cancer
Gynecologic Cancers
Prostate Cancer
Breast Cancer
Solid Tumors
Hepatobiliary Cancer
Gastroesophageal Cancer
Immunotherapy

FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space

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...

Skin Cancer

Overall Survival With the Bispecific Fusion Protein Tebentafusp for Metastatic Uveal Melanoma

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...

Skin Cancer

Adoptive Cell Therapy May Soon Be Available for Patients With Melanoma

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...

Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab for High-Risk Stage II Melanoma: Efficacy and Safety Examined

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...

skin cancer
immunotherapy

Jason J. Luke, MD, on Melanoma: KEYNOTE-716 Trial of Pembrolizumab vs Placebo

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).

Skin Cancer

Lifileucel After Disease Progression in Metastatic Melanoma: Durable Responses Achieved in Phase II Trial

Despite the fact that we have made significant progress in metastatic melanoma with immune checkpoint inhibitors—now the standard of care—most patients experience disease progression and are left without approved treatments. There is a need for newer treatments with clinical benefit. Lifileucel, an ...

Skin Cancer

Targeting LAG-3 and PD-1 With Relatlimab and Nivolumab: A New Option Under Study in Advanced Melanoma

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 the time to disease progression significantly more ...

Skin Cancer
Immunotherapy

Phase II Trial Evaluates Oncolytic Coxsackievirus A21 for Unresectable Advanced Melanoma

In a phase II trial reported in the Journal of Clinical Oncology, Robert H.I. Andtbacka, MD, and colleagues found that intratumoral injection of the oncolytic RNA virus Coxsackievirus A21 (V937) was well tolerated and produced responses in some patients with unresectable stage III or stage IV...

Skin Cancer
Immunotherapy

Pembrolizumab/Entinostat for Metastatic Uveal Melanoma

In the phase II PEMDAC study, researchers showed that the combination of the PD-1 inhibitor pembrolizumab and the histone deacetylase (HDAC) inhibitor entinostat resulted in durable responses in a small group of patients with metastatic uveal melanoma. These findings were published by Ny et al in...

Skin Cancer

Are Triplets Necessary for BRAF-Mutated Melanoma?

Where does triplet therapy fit in the treatment of patients with stage IV BRAF-mutated melanoma? Is there strong evidence for combining a BRAF inhibitor, MEK inhibitor, and checkpoint inhibitor? Ragini Kudchadkar, MD, Chair of the Protocol Review and Monitoring Committee at Winship Cancer Institute ...

Skin Cancer
Immunotherapy

Patients With Melanoma Previously Treated With PD-1 or MAPK Inhibitors May Be Less Likely to Respond to ACT-TIL Therapy

Patients with metastatic melanoma who were previously treated with PD-1 or MAPK inhibition are significantly less likely to develop durable objective responses to adoptive cell transfer of tumor-infiltrating lymphocytes (ACT-TIL) than patients naive to these treatments, according to a study...

Leukemia
Skin Cancer
Gynecologic Cancers
Kidney Cancer
Lung Cancer
Thyroid Cancer
Immunotherapy

FDA Pipeline: Reviews for Agents in Lung Cancer, Thyroid Cancer, Kidney Cancer, and More

Recently, the U.S. Food and Drug Administration (FDA) accepted applications for agents aiming to treat non–small cell lung cancer (NSCLC), differentiated thyroid cancer, renal cell carcinoma (RCC), hypersensitive acute lymphoblastic leukemia (ALL), mucosal melanoma, and endometrial carcinoma....

Skin Cancer

Topical HDAC Inhibitor Remetinostat for Basal Cell Carcinoma

A small phase II study of the topical histone deacetylase (HDAC) inhibitor remetinostat in patients with basal cell carcinoma found that the therapy was well tolerated and demonstrated clinical efficacy with no systemic side effects. The findings suggest that HDAC inhibitors are likely an effective ...

Skin Cancer

Cutaneous HPV May Be a Predictor of Cutaneous Squamous Cell Carcinoma Risk

In an article published by Rollison et al in Cancer Research, researchers demonstrated a link between the presence of cutaneous human papillomavirus (HPV) and the incidence of cutaneous squamous cell carcinomas. They also identified key characteristics of infection that may contribute to...

Skin Cancer
Immunotherapy

Pembrolizumab Shows Durable Antitumor Activity in Both Locally Advanced and Recurrent/Metastatic Squamous Cell Carcinomas

The results of the second interim analysis of the KEYNOTE-629 study of pembrolizumab in cutaneous squamous cell carcinoma confirmed durable antitumor activity in both the locally advanced and the recurrent/metastatic settings. Adverse events with pembrolizumab were generally consistent with its...

Immunotherapy
Skin Cancer

Benefits of Adjuvant Pembrolizumab in Melanoma Reinforced by EORTC 1325/KEYNOTE-054 Updates

Adjuvant anti–PD-1 antibody therapy is widely used for stage III melanoma, given the approvals of pembrolizumab and nivolumab. These approvals were based on significantly improved relapse-free survival in the CheckMate 238 trial of nivolumab compared with ipilimumab and the EORTC 1325/KEYNOTE-054...

Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab Improves Distant Metastasis–Free Survival in Resected High-Risk Stage III Melanoma

As reported in The Lancet Oncology by Alexander M.M. Eggermont, MD, of Princess Máxima Center, Utrecht, the Netherlands, 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...

Skin Cancer
Immunotherapy

Interleukin-2 Pathway Agonist Bempegaldesleukin Plus Nivolumab in the First-Line Treatment of Metastatic Melanoma

In the phase II cohort of a phase I/II trial (PIVOT-02) reported in the Journal of Clinical Oncology, Adi Diab, MD, and colleagues found that the combination of the interleukin-2 pathway agonist bempegaldesleukin and nivolumab produced high response rates and extended progression-free survival in...

Immunotherapy
Skin Cancer

Study Identifies Gut Microbes Associated With Combination Immunotherapy Response and Adverse Events

Researchers have found that specific intestinal microbiota signatures may correlate with high-grade adverse events and response to combined CTLA-4 and PD-1 blockade treatment. The study, published by Andrews et al in Nature Medicine, also identified a potential new strategy to treat toxicity—while...

Skin Cancer

Expert Point of View: Jason J. Luke, MD

The invited discussant of LEAP-004, Jason J. Luke, MD, Associate Professor of Medicine and Director of the Cancer Immunotherapeutics Center, University of Pittsburgh Hillman Cancer Center, said the investigators of LEAP-0041 deserve credit for designing a study with a clearly defined...

Skin Cancer

LEAP-004 Trial Update on Lenvatinib Plus Pembrolizumab After Disease Progression in Metastatic Melanoma

Longer follow-up of the LEAP-004 trial in metastatic melanoma upheld the benefit seen with the VEGF kinase inhibitor lenvatinib plus the PD-1 inhibitor pembrolizumab for patients experiencing disease progression on prior checkpoint blockade, investigators reported at the 2021 ASCO Annual Meeting.1 ...

Skin Cancer

Registry Provides Information on Pediatric Melanoma

Pediatric melanoma is a rare disease, with only around 400 cases diagnosed in the United States every year. To better understand this disease and how best to treat it, St. Jude Children’s Research Hospital scientists created a registry called Molecular Analysis of Childhood MELanocytic Tumors...

Skin Cancer
Immunotherapy

Expert Point of View: Jason J. Luke, MD

Invited discussant of the C-144-01 study,1 Jason J. Luke, MD, Associate Professor of Medicine and Director of the Cancer Immunotherapeutics Center, University of Pittsburgh Hillman Cancer Center, Pittsburgh, noted that lifileucel is “clearly an active regimen in the post–PD-1/CTLA-4 setting and one ...

Skin Cancer
Immunotherapy

Lifileucel After Disease Progression in Metastatic Melanoma: Durable Responses Achieved in Phase II Trial

Despite the fact that we have made significant progress in metastatic melanoma with immune checkpoint inhibitors—now the standard of care—most patients experience disease progression and are left without approved treatments. There is a need for newer treatments with clinical benefit. Lifileucel, an ...

Immunotherapy
Skin Cancer

FDA Approves Expanded Indication for Pembrolizumab in Locally Advanced Cutaneous Squamous Cell Carcinoma

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...

Skin Cancer
Immunotherapy

A Shift in the Treatment of Advanced Melanoma

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...

Skin Cancer
Immunotherapy

Responses to Pembrolizumab and Ipilimumab After Anti–PD-1/L1 Failure in Advanced Melanoma

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,”...

Breast Cancer
Lung Cancer
Skin Cancer
Genomics/Genetics

Real-World Survival Outcomes With Targeted Therapy for Intracranial Metastatic Disease

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,...

Issues in Oncology
Bladder Cancer
Lung Cancer
Skin Cancer

Inclusion of Patients With Brain Metastases in Phase III Trials in Advanced Breast Cancer, Lung Cancer, and Melanoma

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...

Skin Cancer
Immunotherapy

Omid Hamid, MD, Discusses RELATIVITY-047

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 ...

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