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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 ...

Skin Cancer
Immunotherapy

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 time to disease progression significantly more...

Skin Cancer
Immunotherapy

High-Dose Interferon or Ipilimumab vs Pembrolizumab for High-Risk Resected Melanoma

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...

Skin Cancer
Immunotherapy

Extended Follow-up of Nivolumab/Ipilimumab for Metastatic Melanoma

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...

skin cancer
immunotherapy

Evan J. Lipson, MD, on Melanoma: Relatlimab and Nivolumab in First-Line Treatment of Advanced Disease

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.

Skin Cancer
Immunotherapy

Cemiplimab-rwlc for Patients With Locally Advanced Basal Cell Carcinoma After Hedgehog Inhibitor Therapy

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...

Skin Cancer
Immunotherapy

Ipilimumab Plus Anti–PD-1 Therapy vs Ipilimumab Alone for Patients With Advanced Melanoma Resistant to Anti–PD-1/PD-L1 Monotherapy

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 ...

Skin Cancer
Immunotherapy

First-Line Nivolumab/Relatlimab vs Nivolumab Alone for Advanced Melanoma

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...

Skin Cancer
Immunotherapy

Expert Point of View: Stefania Scala, MD

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 ...

Skin Cancer
Immunotherapy

Single-Agent Pembrolizumab Yields High Response Rates in Patients With Cutaneous Squamous Cell Carcinoma

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...

Skin Cancer

Lifileucel for Patients With Previously Treated Metastatic Melanoma

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-...

Skin Cancer
Genomics/Genetics

Mutational Profile of Acral Nevi May Differ From Acral Melanoma

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...

Immunotherapy
Skin Cancer

Pembrolizumab/Ipilimumab After Disease Progression on PD-1/PD-L1 Inhibitor Therapy in Advanced Melanoma

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....

Skin Cancer
Immunotherapy

Study Finds Adjuvant Immunotherapy of Benefit to Patients With Stage IIB/C Melanoma

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...

Skin Cancer
Immunotherapy

Expert Point of View: Alexander Eggermont, MD, PhD

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...

Skin Cancer
Immunotherapy

Comparing Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage III to IV Melanoma

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...

Skin Cancer

Expert Point of View: Caroline Robert, MD

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...

Skin Cancer

Tebentafusp Shows Overall Survival Benefit in First-Line Treatment of Metastatic Uveal Melanoma

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...

Skin Cancer
Immunotherapy

Health-Related Quality of Life With Adjuvant Pembrolizumab vs Placebo in Resected Stage III Melanoma

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...

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