Long-Term Survival Achieved in Metastatic Melanoma With Personalized Vaccine

Excerpt:

“Two patients with melanoma that had spread to the liver survived for at least 8.5 and 12 years after resection of the hepatic tumor and treatment with patient-specific immunotherapeutic vaccines. The vaccines, designed to activate the immune system against the tumor, were derived from the patients’ own dendritic cells loaded with proteins isolated from their tumors, as described in an article published in Cancer Biotherapy and Radiopharmaceuticals.

“Robert O. Dillman, MD, formerly Vice President Oncology, Caladrius Biosciences, Inc. and currently Chief Medical Officer, NeoStem Oncology (Irvine, CA) and Executive Medical and Scientific Director, Hoag Cancer Institute (Newport Beach, CA) discusses the typically poor prognosis for patients with melanoma of the eye or skin that spreads to the liver, and reports on the potential to achieve long-term survival without disease progression in a subset of patients using the eltrapuldencel-T vaccine. One patient had no disease progression for more than 4.5 years, while the other patient survived and remained disease-free for more than 12 years.”

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Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Yervoy® (ipilimumab) for Treatment of Advanced Melanoma

Excerpt:

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults. The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Opdivo monotherapy is already approved by the EC for advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC), and was recommended for approval by the CHMP in February for previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma (RCC).”

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TILs Advancing as Melanoma Immunotherapy Option

Excerpt:

“After nearly 30 years of research, tumor-infiltrating lymphocyte (TIL) technology is being investigated as a means of producing personalized immunotherapy for patients with metastatic melanoma in a small clinical trial that may help open the door for broader application in other solid tumor types.

“The form of adoptive cell therapy, which utilizes TILs from the patient’s tumor, represents an intriguing way of overcoming the immunosuppressive power of cancer, according to Jeffrey S. Weber, MD, PhD. The melanoma expert provided an overview of the technology and its potential benefit in a lecture for oncologists and oncology professionals presented by Targeted Oncology, a division of MJH Associates, the publisher of OncologyLive, on February 19 in Miami Beach, Florida. Weber is the deputy director of the Laura and Isaac Perlmutter Cancer Center, co-director of its melanoma program, and head of Experimental Therapeutics at NYU Langone Medical Center.”

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Talimogene Laherparepvec, Pembrolizumab Combination Safely Treats Advanced Melanoma

Excerpt:

“Patients with advanced unresectable melanoma can safely receive combination therapy with full doses of talimogene laherparepvec and pembrolizumab, according to study results presented at HemOnc TodayMelanoma and Cutaneous Malignancies.

“In previous studies, talimogene laherparepvec (Imlygic, Amgen) — a herpes simplex virus-1-based oncolytic immunotherapy — significantly improved durable response rate in patients with advanced melanoma. Also, pembrolizumab (Keytruda, Merck) — an anti–PD-1 antibody — showed superiority over ipilimumab (Yervoy, Bristol Meyers Squibb) in patients with stage III or IV melanoma.

“Both drugs appeared tolerable and demonstrated nonoverlapping adverse event profiles…”

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Melanoma Therapy Tied to Cutaneous Adverse Events

“Anti-programmed cell death (PD)-1 therapy for metastatic melanoma is associated with the development of immune-related cutaneous events, according to research published in the March issue of the Journal of the American Academy of Dermatology.

“Shelley Ji Eun Hwang, M.B.B.S., from the University of Sydney, and colleagues reviewed the clinical and histologic information of 82 patients treated with single-agent anti-PD-1 therapy for  at one institution from May 2012 to February 2015.”


New Biomarker Identifies Eye Cancer Patients at High Risk for Metastasis

“A study by J. William Harbour, M.D., Associate Director for Basic Research and leader of the Eye Cancer Site Disease Group at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, and colleagues, published today in Clinical Cancer Research, details the discovery of a biomarker that puts patients at a higher risk for metastasis of uveal melanoma.

“Among uveal melanomas categorized as class 1, those with high levels of the biomarker PRAME mRNA were more likely to metastasize than those with low levels of PRAME mRNA, indicating that patients with this biomarker be monitored more closely for metastatic disease.

“The estimated five-year rate of metastasis was 0 percent for PRAME mRNA–low class 1 uveal melanomas and 38 percent for PRAME mRNA–high class 1 uveal melanomas. This research builds upon Harbour’s identification of class 1 and 2 uveal melanomas in 2004.”


Nivolumab Combined with Radiation Therapy May Be New Treatment Option for Patients with Melanoma Brain Metastases, Say Moffitt Cancer Center Researchers

“President Jimmy Carter’s battle with metastatic melanoma to the brain has placed increased attention on management of this disease. President Carter was treated with focused stereotactic radiation to the brain and anti-PD-1 therapy. Researchers at Moffitt Cancer Center recently reported the first series of patients treated with this combined modality approach. They found that radiation therapy combined with the immune-targeting drug nivolumab in melanoma patients with brain metastases is safe and improves their survival compared to historical data.

“Nivolumab is a therapeutic agent that targets a protein on immune cells called PD-1. Binding of PD-1 to its ligand PD-L1, which is found on tumor cells, causes immune cells to decrease their activity and allows cancer cells to escape immune detection and cell death.  Nivolumab blocks the PD-1/PD-L1 interaction and restimulates the body’s own immune system to target tumor cells. Nivolumab has been approved by the Food and Drug Administration to treat advanced non-small cell lung cancer, renal cell carcinoma, and melanoma; however, the impact of nivolumab on brain metastases is unclear.”


Opdivo Plus Yervoy Gets FDA OK for Melanoma

“Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.

“The indication includes both BRAF-wild type and BRAF-mutant melanoma. At the same time, the FDA expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma.

“Granted by the FDA’s accelerated approval process, the indication is the seventh for nivolumab, both indications leave the door open for the FDA to request confirmatory data or clinical trials. The approvals increase the number of nivolumab indications to seven, including four in melanoma, all granted since late 2014.”


NICE Draft Guidance Recommends Nivolumab for Advanced Skin Cancer

“NICE recommends that nivolumab (also called Opdivo, and manufactured by Bristol Myers Squibb) is made available on the NHS as a treatment option for patients with advanced (unresectable or metastatic) melanoma.

“The independent Committee decided that a consultation on the draft recommendations was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licence.

“Professor Carole Longson, Health Technology Evaluation Centre Director said: ‘We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance. In 2011, over 13,000 people were diagnosed with melanoma in the UK, and it accounts for more deaths than all other skin cancers combined. I am sure this will be welcome news to patients and healthcare professionals alike.’ ”