Amgen To Discuss Details Of The Biologics License Application For Talimogene Laherparepvec For Patients With Metastatic Melanoma
At the meeting,
"The incidence of melanoma, the most serious form of skin cancer, has continued to rise over the last 30 years, even as many other cancers are in decline," said
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. Then, the rupture of the cancer cells can release tumor-derived antigens, along with granulocyte-macrophage colony-stimulating factor (GM-CSF), which can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
According to the
OPTiM Study Design and Results
Study 005/05, referred to as
In the 436-patient study, talimogene laherparepvec significantly improved DRR with 16.3 percent of talimogene laherparepvec patients achieving a complete response (CR) or partial response (PR) within the first 12 months of treatment and maintaining it continuously for at least six months compared to 2.1 percent of patients treated with GM-CSF (p <0.001).
- Improved overall (CR + PR) response rate compared with GM-CSF, 26.4 percent vs. 5.7 percent, respectively. In particular, the CR rate was higher in the talimogene laherparepvec arm than in the GM-CSF arm (10.8 percent vs. 0.7 percent, respectively).
- A strong trend in overall survival (OS). The median OS was 4.4 months longer in the talimogene laherparepvec arm than in the GM-CSF arm (hazard ratio: 0.79; p=0.051).
- Evidence of a systemic effect. Eight of 71 patients (11.3 percent) with visceral lesions that could not be injected (predominately in the lung and liver) had an overall decrease in those lesions of more than 50 percent.
The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection-site pain. Most adverse reactions reported were mild or moderate in severity and generally resolved within 72 hours. The most common serious adverse reaction was cellulitis.
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American Cancer Society. Cancer Facts & Figures 2014. http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics. Accessed April 13, 2015.
American Cancer Society. Melanoma Skin Cancer. http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-survival-rates. Accessed April 13, 2015.
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