Historic turn in cancer treatment: First oncolytic drug approved by FDA

cancer preventionA study just published in the Journal of Clinical Oncology has created a stir. Accordingly, patients with advanced melanoma can be treated with a genetically modified form of the herpes virus that causes herpes. The FDA approved Imlygic, the first oncolytic virus treatment after the results of the study. Findings from a phase III clinical trial examining the size reduction capacity of injection-treated melanoma tumors produced with the oncolytic virus talimogene laherparepveci were recently published in the Journal of Clinical Oncology. According to the results of the study, when patients with advanced melanoma were treated with the genetically modified form of the herpes virus that causes herpes, there was a significant improvement in the long-term response rate. Evaluating the study’s findings, the FDA approved Imlygic, the first oncolytic virus therapy. One of the authors of the study, Rutgers Cancer Institute experts Prof. Dr. Howard L. Kaufman answered our questions about the new treatment.

– What is Talimogene laherparepvec and how does it work?

prof. Dr. Kaufman: Talimogene laherparepvec is an investigational cancer treatment based on the herpes simplex 1 virus. Usually, the herpes simplex 1 virus causes common cold sores. Talimogene laherparepvec has been made safer by deleting two viral genes and further modified to encode the human gene for a molecule called granulocyte-macrophage colony stimulating factor (also known as GM-CSF).

A new stage in the history of medicine: FDA approves first virus treatment against cancer

Talimogene laherparepvec is designed to fight cancer by two different mechanisms. First, after the virus is injected locally into cancers, it replicates selectively in tumor tissue and not in normal tissue. Second, the GM-CSF in the virus helps strengthen the body’s innate immune system to fight cancer throughout the body.

– What was found in this study and why are these results important?

kaufmanprof. Dr. Kaufman: The global, randomized, phase III study included 436 patients with the potentially fatal form of skin cancer stage IIIB, IIIC, and IV melanoma. The primary objective of the study was to evaluate the safety and efficacy of oncolytic virus immunotherapy, called T-VEC, in comparison to patients treated with GM-CSF alone. In 2013, talimogene laherparepvecin was reported to actually improve long-term responses in patients with advanced melanoma. This was defined as an objective response (at least 50% reduction in the size of both injected and non-injected tumors) within the first 12 months of treatment lasting at least six months or longer. In addition, in patients who achieved an objective response, almost 40% of the responses were complete responses.

An important secondary endpoint was overall survival assessment, and these data show a trend towards improved survival in patients treated with talimogene laherparepvec, with patients achieving a 21% reduction in risk of death when treated with talimogene laherparepvec.

An exploratory subset analysis found that patients with stage IIIB/C and IVM1a melanoma and those receiving talimogene laherparepvec as first-line therapy achieved a particularly significant improvement in response and overall survival. Another important finding was a very tolerable safety profile, with the most common adverse events being fatigue, chills, nausea, and injection site reactions. These data are important because this is the first randomized trial with oncolytic virus in cancer patients and demonstrates that talimogene laherparepvecin is safe and may result in long-term clinical responses with a trend towards improved survival.

– Is immunotherapy a new concept in cancer treatment?

prof. Dr. Kaufman: No, the potential promise of immunotherapy has been around for over a century, but we have only recently understood the molecular and cellular basis of how the immune system fights cancer. Since the tumor appears to be highly susceptible to immune attack, melanoma has become a model for immunotherapy. Interleukin-2 was the first immunotherapy approved by the FDA for the treatment of melanoma in 1998.

The first successful study for the treatment of cancer with viruses and the drug with its product is on the market.

Major progress in melanoma immunotherapy came with the T-cell checkpoint inhibitor ipilimumab, which showed a significant improvement in overall survival for patients with metastatic melanoma, and achieved FDA approval in 2011. Since then, many promising immunotherapy approaches against melanoma have been tested, including inhibitors of another T-cell checkpoint, PD-1.

The T-VEC findings provide a new class of immunotherapy agents that exhibit an acceptable safety profile that may benefit patients who do not respond to other treatments, and T-VEC may be useful, especially in combination with other agents. It is being actively tested in clinical trials, many of which have been administered to patients at New Jersey’s Rutgers Cancer Institute and other centers around the country.

– The US Food and Drug Administration has approved this treatment for patients with melanoma. Why is this development important?

prof. Dr. Kaufman: Melanoma is the deadliest of skin cancers and can be difficult to treat in its advanced stages or when it has spread to other parts of the body. With the annual incidence rate of melanoma increasing by over 70% over the past 20 years, we need to continue to find new ways to help improve patient outcomes. New drugs in development hold great promise for melanoma patients. In addition, since oncolytic viruses now show an acceptable risk/benefit profile in melanoma, this therapy can certainly be tested in other types of cancer where options are more limited.

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