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

The FDA has approved pembrolizumab (Keytruda®, Merck), a programmed death cell death protein 1 (PD-1)–blocking antibody, for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB or IIC melanoma following complete resection. "Current standard of care for patients after resection of high-risk stage II melanoma is observation," wrote Jason Luke, MD, Director of the Cancer Immunotherapeutics Center in the Division of Hematology/Oncology at the University of Pittsb...

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Trunk and Extremity Melanoma Debate: Similar Outcomes for Mohs Micrographic Surgery Versus Wide Local Excision

Survival outcomes did not change significantly for patients with melanoma of the trunk or extremity when treated with Mohs micrographic surgery (MMS) compared with wide local excision, according to the results of a retrospective cohort study published recently in JAMA Dermatology. The retrospective cohort study was designed because previous studies indicated differences in overall survival outcomes for patients with head and neck cancers. However, this study indicates that those results do not a...

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Neoadjuvant Ipilimumab/Nivolumab for Locally Advanced/Oligometastatic Melanoma: Emilia Cocorocchio, MD

With high rates of metastasis and progression, locally advanced/oligometastatic melanoma is a challenging disease to treat. According to results of a trial recently presented at the European Medical Society for Oncology (ESMO) Virtual Congress, neoadjuvant ipilimumab/nivolumab is a safe and effective treatment for patients with this disease. In this interview with i3 Health, lead study author Emilia Cocorocchio, MD, discusses the benefits of neoadjuvant ipilimumab/nivolumab and shares advice for...

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Melanoma With Brain Metastases: Nivolumab/Ipilimumab Effective

Nivolumab/ipilimumab demonstrates efficacy in patients with melanoma and brain metastases, according to results of the primary analysis of the phase 3 NIBIT-M2 trial, presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. "Brain metastases represent a high unmet medical need, in which the therapeutic potential of immune-checkpoint(s) is being actively investigated," note the investigators in their presentation abstract, led by Anna Di Giacomo, MD, Associate Director ...

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Atezolizumab Triplet Therapy for BRAF V600-Mutant Melanoma: Paolo A. Ascierto, MD

Recently, the FDA approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) and cobimetinib (Cotellic®, Genentech) for the treatment of BRAF V600-mutant advanced melanoma. In this interview with i3 Health, Paolo A. Ascierto, MD, principal investigator of the IMspire150 trial, on which the approval was based, discusses the approval's significance and the most promising research developments in the treatment of BRAF...

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Atezolizumab Combo Approved in BRAF V600-Mutant Melanoma

The FDA has approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with cobimetinib (Cotellic®, Genentech) and vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) for the treatment of BRAF V600-mutated advanced melanoma. The approval was granted under a supplemental Biologics License Application (sBLA) with priority review. The approval was based on data from the double-blind, international phase 3 IMspire150 trial (NCT02908672), for which 514 patients with unresecta...

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Delivering Immunotherapeutics Intratumorally: Safe for Treating Cancer?

Intravenous administration of chemotherapy is the conventional method of delivery. However, several issues arise with this method, including insufficient drug penetration into the tumor tissue. Intratumoral injections of immunotherapies directly into the tumor have been a possible solution to this problem, and, according to a recent study, results of which are published in JAMA Network Open, this technique has been found to be a viable option for a variety of histological conditions and target o...

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Advanced Melanoma: Pembrolizumab Effective Regardless of BRAF V600E/K Mutations

In patients with advanced melanoma, pembrolizumab achieves efficacy regardless of BRAF V600E/K mutation status or prior treatment with BRAF and/or MEK inhibitors, according to the results of a new pooled analysis published in JAMA Oncology. Approximately 40% of metastatic melanomas harbor a BRAF mutation, 90% of which are an activating BRAF V600E/K mutation. While targeted agents and immune checkpoint inhibitors, including pembrolizumab, have considerably improved outcomes for patients with adva...

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New Dosing Guidelines for Pembrolizumab FDA Approved

The FDA recently approved new dosing guidelines of 400 mg of pembrolizumab (KEYTRUDA®, Merck) to be taken every six weeks. The current recommended dose of pembrolizumab is 200 mg every three weeks. This new dosing regimen is approved across all adult indications of pembrolizumab. Pembrolizumab is FDA approved to treat several cancers including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-...

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Encorafenib/Binimetinib for BRAF V600-Mutant Melanoma With Paolo Ascierto, MD

Combination BRAF/MEK inhibitors such as encorafenib/binimetinib are the current standard of care for patients with BRAF V600-mutant melanoma. Until now, however, the long-term efficacy of encorafenib/binimetinib had not been established. In an updated analysis of the phase 3 COLUMBUS trial, a team of researchers led by Paolo Ascierto, MD, Director of the Unit of Melanoma, Cancer Immunotherapy, and Innovative Therapy at the National Tumor Institute Fondazione G. Pascale in Naples, Italy, found th...

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Nanovaccines: A New Approach for Melanoma Treatment

Researchers have developed a nanovaccine that, when combined with antibodies and ibrutinib, shows potential as an effective treatment for melanoma. Immune checkpoint therapy, a form of cancer therapy which targets the immune system, has proven to be an effective treatment method for melanoma, the most aggressive type of skin cancer. However, immune checkpoint therapy is limited by a low response rate, severe side effects, and acquired resistance to treatment. There is a need to develop an altern...

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Nivolumab: Five-Year Survival for Melanoma, RCC, and NSCLC

​Five-year overall survival results have now been revealed for nivolumab in advanced melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC). "We report, to our knowledge, the longest combined clinical follow-up for patients with multiple cancer types receiving any anti–PD-L1 drug," the researchers comment in their secondary analysis of data from the phase I CA209-003 trial and expansion cohorts. This trial was the first multidose trial of nivolumab, an immunotherapy drug th...

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Fat Cells Help Melanoma Cells Metastasize

According to a new study, published in Science Signaling, fat cells play a role in transforming local melanoma cells in the epidermis to metastatic melanoma cells that migrate to attack different organs. "We have answered a major question that has preoccupied scientists for years," stated lead study author, Carmit Levy, MD, PhD, and Professor at Tel Aviv University. "What makes melanoma change form, turning aggressive and violent? Locked in the skin's outer layer, the epidermis, melanoma is very...

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Metastatic Melanoma: Dabrafenib/Trametinib Improves Outcomes

Historically, patients with metastatic melanoma have a poor prognosis. However, due to the development of BRAF- and MEK-targeted therapies, patient outcomes have improved. To further characterize the outcomes associated with these treatments, researchers compiled and analyzed data from two clinical trials and found that in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, dabrafenib plus trametinib had many long-term benefits in about one third of patients. D...

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High-Risk Melanoma: Dabrafenib/Trametinib Preserves Quality of Life While Preventing Relapse

Previously, the researchers of the phase 3 COMBI-AD study found that adjuvant combination therapy consisting of dabrafenib (Taflinar®, Novartis) plus trametinib (Mekinist®, Novartis) helped to prevent relapse in patients with high-risk BRAF V600–mutant melanoma after surgical resection. The investigators now report that dabrafenib/trametinib combination therapy also helps to maintain quality of life. A targeted therapy drug, trametinib is an MEK inhibitor that works by targeting the MEK 1 and ME...

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New Therapeutic Target for Melanoma Brain Metastases

Almost half of patients with malignant melanoma develop metastases in different organs, with 60% of metastases spreading to the brain. Once the cancer metastasizes, the 5-year survival rate plummets to 5% to 19%. Metastasized malignancies are resistant to current immunotherapies and targeted therapies; however, researchers at the University of Texas MD Anderson Cancer Center discovered that oxidative phosphorylation (OXPHOS) can be a potential treatment target. "Brain metastases are increasingly...

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Pembrolizumab Approved for Resected Stage III Melanoma

​The FDA has approved pembrolizumab (Keytruda®, Merck) for treatment of patients with melanoma experiencing lymph node involvement following complete resection. The approval was based on EORTC1325/KEYNOTE‑054 (NCT02362594), a phase 3 clinical trial which enrolled 1,019 patients with completely resected stage III melanoma with negative margins, lymph node dissection, and completion of radiotherapy, if indicated, within 13 weeks prior to treatment. Patients were randomly assigned in a 1:1 ratio, w...

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In Melanoma, Smoking Impacts Antitumor Immune Response

The immune system's response to melanoma both improves survival for untreated patients and predicts a patient's response to immune checkpoint blockade therapy. A British study has now identified several genetic factors that can be used to predict a patient's immune response to melanoma. The study has also identified a significant environmental cause of lowered antitumor immunity: cigarette smoking. For the study, published in Cancer Research, investigators used a bioinformatic analysis of 703 tu...

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Oncolytic Herpes Virus Injection for Advanced Melanoma

A recent study has confirmed that talimogene laherparepvec (TVEC) (Imlygic®, Amgen, Inc.), an FDA-approved intralesional injection of an oncolytic herpes virus, is an effective treatment for patients with unresectable stage IIIB-IV melanoma. "Our findings in the real world mimic what the clinical trials have found," commented David W. Ollila, MD, General Surgical Oncologist at the University of North Carolina (UNC) Linebacker Comprehensive Cancer Center and corresponding author of the study, whi...

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New Protein Mimics Interleukin 2 Sans Side Effects

Researchers have used a computer program to design a protein that mimics the action of interleukin 2 (IL-2) and interleukin 15 (IL-15) without the toxic side effects. Interleukin 2 (IL-2), a cytokine that regulates the activities of the immune system's white blood cells, is a powerful anti-cancer drug used to treat metastatic melanoma and renal cell carcinoma. However, its toxic side effects, such as impairment of kidney function, have limited its use as a cancer-fighting agent. "People have tri...

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