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Thirty Years in the Making: The Groundbreaking Approval of Lifileucel for Metastatic Melanoma With Matthew Hadfield, DO, and Richard Carvajal, MD

Oncology Data Advisor® · Thirty Years in the Making: The Approval of Lifileucel for Metastatic Melanoma Following the recent approval of lifileucel for unresectable or metastatic melanoma—the first cellular therapy to receive an approval for solid tumors—Matthew Hadfield, DO, member of the Oncology Data Advisor Fellows Forum and third-year Fellow at Brown University, sat down with Richard Carvajal, MD, Oncology Data Advisor Editorial Board Member and the Deputy Physician-in-Chief at t...

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Thirty Years in the Making: The Groundbreaking Approval of Lifileucel for Metastatic Melanoma With Matthew Hadfield, DO, and Richard Carvajal, MD

Following the recent approval of lifileucel for unresectable or metastatic melanoma—the first cellular therapy to receive an approval for solid tumors—Matthew Hadfield, DO, member of the Oncology Data Advisor Fellows Forum and third-year Fellow at Brown University, sat down with Richard Carvajal, MD, Oncology Data Advisor Editorial Board Member and the Deputy Physician-in-Chief at the Northwell Health Cancer Institute, to discuss the significance of this approval, what it means for the treatment...

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Lifileucel Granted Accelerated Approval for Unresectable or Metastatic Melanoma

The FDA has granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) for adult patients with unresectable or metastatic melanoma previously treated with a programmed cell death protein 1 (PD-1) blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor. Lifileucel is a tumor-derived autologous T-cell immunotherapy and is the first cellular therapy to receive an approval for solid tumors.   Why ...

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Piloting Melanoma Research and Local Cancer Care: An Oncology Data Advisor® Editorial Board Spotlight Interview With Richard Carvajal, MD

Oncology Data Advisor® · Piloting Melanoma Research and Local Cancer Care With Richard Carvajal, MD This interview is the first in a new series spotlighting the Oncology Data Advisor® Editorial Board, featuring Dr. Richard Carvajal, Director of Medical Oncology at Northwell Health Cancer Institute. Dr. Carvajal tells the story of how he became a melanoma researcher and shares his passions for developing targeted therapies for unique clinical subsets of melanoma and for providing high-...

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Nivolumab Approved for Adjuvant Treatment of Stage IIB/C Melanoma

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb Company) for adjuvant treatment of patients 12 and older with completely resected stage IIB/C melanoma.   Why it matters: "Patients with resected stage IIB/C melanoma are at high risk of recurrence with outcomes similar to patients with resected stage IIIB disease," wrote Dr. Georgina Long, the Co-Medical Director of Melanoma Institute Australia, and colleagues, in their abstract on the CHECKMATE-76K trial (NCT04099251), on which...

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Piloting Melanoma Research and Local Cancer Care: An Oncology Data Advisor® Editorial Board Spotlight Interview With Richard Carvajal, MD

This interview is the first in a new series spotlighting the Oncology Data Advisor® Editorial Board, featuring Dr. Richard Carvajal, Director of Medical Oncology at Northwell Health Cancer Institute. Dr. Carvajal tells the story of how he became a melanoma researcher and shares his passions for developing targeted therapies for unique clinical subsets of melanoma and for providing high-quality cancer care for patients in their own neighborhoods.  

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The Groundbreaking Approval of Tebentafusp for Uveal Melanoma With Richard Carvajal, MD

Recently, the FDA granted approval to tebentafusp for the treatment of patients with human leukocyte antigen (HLA)-A*02:01–positive unresectable or metastatic uveal melanoma, marking the first agent to be approved for this rare ocular malignancy. In this interview, Dr. Richard Carvajal, Associate Professor of Medicine at Columbia University Irving Medical Center and editorial board member of Oncology Data Advisor, discusses the practice-changing significance of the approval of tebentafusp and delves further into future directions in the development of treatments for uveal melanoma.  

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Exploring the Impact of Cemiplimab and Pembrolizumab in Cutaneous Squamous Cell Carcinoma With Shaheer Khan, DO

Oncology Data Advisor™ · Exploring the Impact of Cemiplimab and Pembrolizumab in Cutaneous Squamous Cell Carcinoma In honor of Melanoma Awareness Month, Oncology Data Advisor spoke with Dr. Shaheer Khan, an Assistant Professor of Medicine at Columbia University Irving Medical Center. Dr. Khan shares the promising results of two recent trials of cemiplimab and pembrolizumab for cutaneous squamous cell carcinoma, explains future directions in the treatment of patients who are ineligib...

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Combination of Nivolumab and Relatlimab Approved for Unresectable or Metastatic Melanoma

The FDA has approved the combination of nivolumab and relatlimab-rmbw (Opdualag™, Bristol-Myers Squibb) for patients with unresectable or metastatic melanoma. OpdualagTM is a fixed-dose dual immunotherapy combination of nivolumab, a programmed cell death protein 1 (PD-1)–blocking antibody, and relatlimab, a first-in-class human lymphocyte–activation gene 3 (LAG-3)–blocking antibody, and is administered as a single intravenous (IV) infusion. "LAG-3 and PD-1 are distinct inhibitory immune checkpoi...

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The Groundbreaking Approval of Tebentafusp for Uveal Melanoma With Richard Carvajal, MD

Oncology Data Advisor™ · The Groundbreaking Approval of Tebentafusp for Uveal Melanoma With Richard Carvajal, MD Recently, the FDA granted approval to tebentafusp for the treatment of patients with human leukocyte antigen (HLA)-A*02:01–positive unresectable or metastatic uveal melanoma, marking the first agent to be approved for this rare ocular malignancy. In this interview, Dr. Richard Carvajal, Associate Professor of Medicine at Columbia University Irving Medical Center and edito...

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A Cure in Sight for Ocular Melanoma With Danet Peterson

At the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Danet Peterson sat down with Oncology Data Advisor to talk about her work with A Cure in Sight, a nonprofit organization which seeks to support patients with ocular melanoma throughout the diagnosis, treatment, and survivorship journey.

This podcast episode was recorded live at the 2022 ASCO Annual Meeting in Chicago by Oncology Data Advisor and ConveyMed. 

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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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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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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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