2019 ASCO: OPTiM Study on T-VEC for Unresectable Melanoma
New research on the immunotherapy talimogene laherparepvec (T-VEC)—an injectable oncolytic virus—for patients with unresectable melanoma was presented by Milhem et al at the 2019 ASCO Annual Meeting (Abstract 9524). Researchers reported the ad hoc analysis of progression-free survival for T-VEC compared to cytokine-based immunotherapy with granulocyte macrophage colony-stimulating factor (GM-CSF) in the phase III OPTiM trial.
OPTiM Trial Details
OPTiM included patients with unresectable stage IIIB–IV melanoma; ≥1 injectable cutaneous, subcutaneous, or nodal lesion; ECOG performance status ≤ 1; lactate dehydrogenase ≤ 1.5 times the upper limit of normal; ≤ 3 visceral metastases (excluding lung) with none > 3 cm.
Patients were randomly assigned 2:1 to receive intralesional T-VEC or GM-CSF. The primary endpoint was durable response rate.
Results
This analysis included 436 patients. Results show that single-agent T-VEC demonstrated an improvement in progression-free survival compared to GM-CSF in the overall intent-to-treat population, in whom 12-month progression-free survival was estimated to be 14.4% for patients treated with T-VEC and 4.6% for GM-CSF. The finding was driven primarily by patients with advanced (stage IIIB to stage IVM1a) melanoma, in whom 12-month progression-free survival was estimated to be 19.9% for T-VEC and 3.2% for GM-CSF.
“Our findings are consistent with previous data showing a more pronounced overall survival benefit with T-VEC for patients with local/regional melanoma, or disease that had not spread to other organs,” said senior author Igor Puzanov, MD, Director of the Early-Phase Clinical Trials Program and Chief of Melanoma at Roswell Park Comprehensive Cancer Center. “Significantly, we observed no difference in median progression-free survival between patients with progression prior to response and those whose disease had not progressed prior to response.”
A subgroup analysis showed that patients who did not have disease progression within 6 months of therapy with T-VEC had a 50% reduced chance of future progression compared to patients treated with GM-CSF.
Disclosure: For full disclosures of the study authors, visit coi.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
