Phase III Trial Retrospective Analysis Finds Talimogene Laherparepvec Reduced Tumors

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

A retrospective analysis of a phase III study found that talimogene laherparepvec reduced the size of injected tumors and non-injected metastatic melanoma tumors that had metastasized to other parts of the body.

The study evaluated talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor. Full results were presented during an oral session at the Society of Surgical Oncology Annual Cancer Symposium in Phoenix.

Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response. It is also engineered to express GM-CSF, a white blood cell growth factor, which can help to activate the immune system.

Of the 295 patients treated with talimogene laherparepvec, almost 4,000 tumor lesions were tracked for this analysis. Half of these lesions were injected with talimogene laherparepvec at least once, while the rest were not injected, including visceral tumor lesions, such as tumors involving solid organs such as the lungs and liver.

The results showed a 50 percent or greater reduction in tumor size in 64 percent of injected tumors. In addition, one-third of uninjected non-visceral tumors, and 15 percent of visceral tumors were also reduced by at least 50 percent. There were 35 melanoma-related surgeries performed during this trial of which 30 percent successfully removed all residual disease.

The most frequently observed adverse events in the phase III study were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both groups, and cellulitis and pyrexia in the talimogene laherparepvec group. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients. Immune-mediated events were reported infrequently.

YOU MAY BE INTERESTED IN

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models. 
The American Cancer Society’s recent report on the increasing incidence rates of colorectal cancer in young adults once again rang an alarm bell for adults over 45 to get checked, especially if they are having symptoms. But as an oncologist with more than 40 years of experience, I also believe that this should be a clarion call to scientists and researchers, and for regulators at the FDA.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login