OPTiM Study: T-VEC Shows Improved Survival Over Cytokine Therapy in Patients With Melanoma

CHICAGO — Igor Puzanov, MD, Director of the Early Phase Clinical Trials Program and Chief of Melanoma at Roswell Park Comprehensive Cancer Center, led research on the immunotherapy T-VEC, or talimogene laherparepvec, to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

Dr. Puzanov is senior author on the study, which is the first to report the ad hoc analysis of progression-free survival (PFS) for T-VEC compared to cytokine-based immunotherapy with granulocyte-macrophage colony-stimulating factor, or GM-CSF, in the pivotal OPTiM randomized phase III trial (NCT identifier no. 00769704).

T-VEC (brand name Imlygic) is an injectable immunotherapy designed to kill melanoma cells in the skin and lymph nodes. An oncolytic virus, it targets cancer cells without affecting normal, nonmalignant cells.

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 T-VEC and 4.6% for GM-CSF. The finding was driven primarily by patients with advanced, stage 3b to stage 4M1a melanoma, in whom 12-month progression-free survival was estimated to be 19.9% for T-VEC and only 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,” says Dr. Puzanov. “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 shows that patients who did not progress within six months of therapy with T-VEC had 50% reduced chance of future progression compared to patients treated with GM-CSF. 

ASCO 2019, the organization’s 55th annual gathering, continues through June 4 at McCormick Place in Chicago.

ASCO 2019 Presentation Details
Progression-free survival (PFS) in unresectable melanoma patients (pts) treated with talimogene laherparepvec (T-VEC) versus granulocyte macrophage colony-stimulating factor (GM-CSF) in OPTiM
Abstract  9524
Presenting author: Mohammed Milhem, MBBS, University of Iowa Hospitals and Clinics
Time/date: Monday, June 3, from 1:15 to 4:15 p.m. CDT
Location: Hall A
Session: Melanoma/Skin Cancers Poster Session
Board: 95

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Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.