Amgen recently presented additional results from the company’s Phase 3 clinical trial of Imlygic (talimogene laherparepvec) as a monotherapy for the treatment of metastatic melanoma, as well as new results from its ongoing Phase 1b combination clinical trial with Merck’s anti-PD-1 therapy. The presentations were made to the 12th International Congress of the Society for Melanoma Research (SMR), held in mid-November in San Francisco.
Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). Imlygic causes cell lysis (cell rupture and death), releasing tumor-derived antigens that, along with GM-CSF, may promote an anti-tumor immune response. Results from Amgen’s OPTiM Phase 3 trial served as the basis for the U.S. Food and Drug Administration’s approval of Imlygic in October 2015 as a treatment for melanoma lesions in the skin and lymph nodes.
“The analyses from our Phase 3 monotherapy trial confirm the clinical significance of durable responses and the benefit IMLYGIC may bring to patients living with metastatic melanoma,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a news release. “As we advance understanding in the emerging science of oncolytic viral therapy, we are also excited to share early data on the use of IMLYGIC in combination with another immunotherapy.”
The Phase 1b trial, part of a study titled “Primary analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma,” is examining Imlygic combined with Keytruda (pembrolizumab), an investigational use of Merck’s anti-PD-1 therapy in patients with a diagnosis of unresectable metastatic melanoma. Primary outcome data from this trial, measuring dose limiting toxicities and safety, is expected to be collected by September 2016.
The Amgen presentations included:
- “Safety profile of talimogene laherparepvec (T-VEC) in OPTiM, a phase 3 trial for melanoma”
- “Long-term follow up from the phase 2 study of talimogene laherparepvec (T-VEC) for metastatic melanoma”
- “Durable-response (DR)-associated benefits in patients (pts) with unresected stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) or GM-CSF in OPTiM“
- “Durable complete responses (CR) in patients (pts) with stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) in OPTiM”
- “Reduced risk of developing visceral/bone metastasis (VM) in patients (pts) with stage IIIB/C/IVM1a melanoma treated with talimogene laherparepvec (T-VEC) vs GM-CSF”
- “Did patients in OPTiM have truly unresectable disease? Results of an independent review”
- “Current treatment patterns in patients with metastatic melanoma: A retrospective claims database analysis in the United States (U.S.)”