Talimogene Laherparepvec Versus GM-CSF in Unresectable Melanoma
Posted: Tuesday, July 30, 2019
Published in the Journal for ImmunoTherapy of Cancer, the phase III OPTiM trial, conducted by Robert H. I. Andtbacka, MD, of Huntsman Cancer Institute, Salt Lake City, and colleagues found that the oncolytic immunotherapy talimogene laherparepvec was more effective than granulocyte-macrophage colony-stimulating factor (GM-CSF) in treating patients with unresectable stage IIIB/C/IV melanoma. In fact, talimogene laherparepvec was associated with complete responses that were linked to prolonged survival, according to the investigators.
“The favorable clinical outcomes observed in some patients treated with [talimogene laherparepvec], along with its good safety profile, support continued efforts to further define its future role in melanoma as a combination partner with immunotherapy,” the study authors concluded.
A group of 436 patients were the focus of this randomized, open label study. Of them, 295 were given talimogene laherparepvec, and 141 were given subcutaneous recombinant GM-CSF. All eligible patients had histologically confirmed, unresectable, bidimensionally measurable stage IIIB/C/IV melanoma.
Results showed that median overall survival was 23.3 months with talimogene laherparepvec and 18.9 months with GM-CSF (unstratified hazard ratio = 0.79). The durable response rate was 19.0% and 1.4% percent, respectively; the objective response rate was 31.5% and 6.4%, respectively. Complete responses were achieved by 50 patients treated with talimogene laherparepvec and 1 patient treated with GM-CSF. Investigators said that of those who achieved a complete response, 88.5% were estimated to survive at a 5-year analysis.
“In this final planned OPTiM analysis, talimogene laherparepvec continued to result in improved longer-term efficacy versus GM-CSF and remained well tolerated,” the investigators said. “The final analysis also confirms that talimogene laherparepvec was associated with durable [complete responses] that were associated with prolonged survival.”
Disclosure: The study authors’ disclosure information may be found at jitc.biomedcentral.com.