A collaborative team of international researchers led by Dr. Howard L. Kaufman, MD, FACS, associate director for clinical science and chief surgical officer at Rutgers Cancer Institute of New Jersey, recently revealed a new investigational therapy with the potential to aid in the treatment of advanced-stage melanoma. The findings from the study, entitled, “Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma,”, were published in the Journal of Clinical Oncology.
In a University interview about the study, Dr. Kaufman explained the science of the investigational treatment, “Talimogene laherparepvec (T-VEC) is an investigational cancer treatment based on the herpes simplex 1 virus. Ordinarily, herpes simplex 1 virus causes the common cold sore. T-VEC has been made safer by deleting two viral genes and has been further modified to encode the human gene for a molecule called granulocyte-macrophage colony stimulating factor (also known as GM-CSF). T-VEC is designed to fight cancer through two different mechanisms. First, the virus selectively replicates in tumor tissue – not normal tissue — after local injection into cancers. Secondly, the GM-CSF in the virus helps provide a boost to the body’s natural immune system, which helps fight cancer throughout the body.”
In this study, Dr. Kaufman and his team recruited 436 patients with injectable melanoma that was not surgically resectable and randomized them into groups that received either the investigational treatment, T-VEC, or GM-CSF.
The primary study finding showed that patients in the T-VEC group had a significantly higher durable response rate than those patients who were treated with GM-CSF. Other important secondary findings included:
- The Overall treatment response rate was higher for patients who received T-VEC in comparison to those who were given GM-CSF
- The average overall survival rate was 23.3 months for patients who received T-VEC in comparison to 18.9 months for those who were given GM-CSF
- T-VEC treatment success was higher for patients with stage IIIB, IIIC, or IVM1a disease in comparison to patients with treatment-naive disease
- The most common observed adverse event with T-VEC was fatigue, chills, and fever
When discussing the importance of the findings and what the future implications may be, Dr. Kaufman, said,”Melanoma is the deadliest of skin cancers and can be difficult to treat when in advanced stages or has spread to other parts of the body. With the annual incidence rate of melanoma having increased (in the Caucasian population) by more than 70 percent over the past 20 years, we need to continue to find new ways to help improve patient outcomes. The new drugs in development are offering major hope for patients with melanoma. In addition, now that oncolytic viruses have demonstrated an acceptable risk/benefit profile in melanoma, this treatment may be tested against other types of cancer where options are more limited.”