FDA to Review Treatment Injected into Metastatic Melanoma Tumors

The gist: A treatment for metastatic melanoma called talimogene laherparepvec (T-VEC) will soon be reviewed by the FDA for treating patients with metastatic melanoma. If T-VEC is approved, doctors in the U.S. will be free to prescribe it to their patients. T-VEC is an immune system-boosting treatment that is injected directly into melanoma tumors. Learn more about it in this Need to Know blog post.

“Amgen (NASDAQ: AMGN) announced today that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) will jointly review the Company’s Biologics License Application (BLA) for talimogene laherparepvec. The FDA is currently reviewing the talimogene laherparepvec BLA for the treatment of patients with injectable regionally or distantly metastatic melanoma. The advisory committees will review talimogene laherparepvec at a meeting on April 29, 2015.

” ‘The incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need,’ said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. ‘We look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees, and we are committed to working closely with the FDA during its review of the BLA.’ “


Amgen Initiates Study to Evaluate Combined Talimogene Laherparepvec, Keytruda for Melanoma

The gist: A new clinical trial will give patients a new treatment to treat their metastatic melanoma. (The trial is currently enrolling patients). The treatment combines talimogene laherparepvec (T-VEC) and Keytruda (pembrolizumab), both immunotherapies that boost a patient’s own immune system to fight cancer. The researchers running the clinical trial hope that the combination will work better than either treatment alone. Learn more about T-VEC in our latest blog post.

“Amgen announced the beginning of a study to evaluate the safety and efficacy of talimogene laherparepvec in combination with the investigational use of Merck’s pembrolizumab in patients with regionally or distantly metastatic melanoma, according to a press release.

“Talimogene laherparepvec is an investigational oncolytic immunotherapy and Keytruda (pembrolizumab) is a U.S. Food and Drug Administration-approved anti-PD-1 therapy. The trial has started enrollment and will evaluate the combined therapy in 110 patients at 35 clinical trial sites in the United States, Australia and Europe.

“ ‘Talimogene laherparepvec is designed to promote tumor antigen release and presentation to initiate an anti-tumor response, which may be complementary to Keytruda’s role in releasing PD-1 pathway-mediated inhibition of anti-tumor responses,’ F. Stephen Hodi, MD, steering committee chair for the study, said in the release.”


Advanced Melanoma: The Promise and Shortcomings of Drugs Injected Directly into Tumors


In the past 3 years, the treatment landscape for metastatic melanoma has changed dramatically. We saw the advent of drugs that inhibit mutant BRAF and activate MEK proteins (vemurafenib, dabrafenib, and trametinib) and drugs known as immune checkpoint inhibitors (ipilimumab, Keytruda, Opdivo, and others). These treatments are ‘systemic’; that is, they are taken by mouth or injected directly into the bloodstream and spread throughout the body. However, as I reported earlier this year, drugs that are injected directly into tumors—’intralesional drugs’—have recently gained some attention. Two of them were featured at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting. New data, and doubts, on these drugs have since emerged. Continue reading…


Immune System-Activating Drugs in Combination Treatments May Be Next Big Thing for Melanoma


Among solid tumors, the curative potential of immunotherapies has been explored most in melanoma. One reason for this is that melanoma tumors often contain so-called immune infiltrates—patches of T cells, the killer cells of the immune system. It seems that these fighter cells arrive at the ‘battlefield’ to target tumor cells for killing, but instead become ‘frozen,’ unable to attack.  How to activate the tumor-killing potential of T cells has been an area of intense and fruitful research, leading to the development of several immunotherapy drugs. Continue reading…


Amgen Submits Marketing Authorization Application for Oncolytic Immunotherapy in EU

Editor’s note: Before a drug can be made widely available to patients in the European Union, it must first be approved by the European Medicines Agency. The drug company Amgen recently submitted a proposal for approval of its melanoma treatment talimogene laherparepvec (T-VEC). T-VEC is a modified virus that is injected directly into tumors, where it destroys tumor cells. It has shown some promising results in clinical trials—research studies in volunteer patients.

“Amgen announced the submission of a marketing authorization application to the European Medicines Agency for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma in adults.

“If the application is approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies, according to a company press release.

“The marketing authorization application contains data from more than 400 patients and is based on a global, randomized, open-label, phase 3 trial evaluating its efficacy and safety in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended.”


ASCO 2014: Highlights for People Dealing with Melanoma


Every year, new cancer treatment insights are shared at the American Society of Clinical Oncology (ASCO) Annual Meeting. Here are some of the most notable recent developments in melanoma treatment, gleaned from researchers’ presentations at ASCO last month: Continue reading…


Amgen Presents New Data On Talimogene Laherparepvec As Single Agent And Combination Therapy In Metastatic Melanoma At ASCO

“Amgen today announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. The findings were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.”

Editor’s note: This article describes promising results for a melanoma treatment called talimogene laherparepvec (T-VEC), an immunotherapy that boosts a patient’s own immune system to fight cancer. Previous testing of the drug has found mixed results.


Melanoma Treatment 2014: Emerging News


Immunotherapy may be patients’ biggest hope for transforming cancer treatment. This approach boosts a patient’s own immune system to fight cancer. More and more immunotherapy treatments are showing promise for more and more patients, and Science magazine named immunotherapies 2013’s Breakthrough of the Year. Continue reading…


UPDATE 1-Amgen Melanoma Drug Fails to Improve Overall Survival Rates

“Amgen Inc said its experimental drug to treat a deadly form of skin cancer did not significantly improve overall survival rates in patients enrolled in a late-stage study.

“The company said the drug met the study’s main goal of shrinking tumors, as it had previously reported, but did not meet the secondary goal of improving overall survival in patients with melanoma.”

Editor’s note: Earlier results from this trial showed that the drug (called T-Vec) improved “progression free survival,” which refers to the length of time before a patient’s tumor begins growing again. Now, T-Vec has been shown not to affect overall survival times.