Expert Discusses Next Steps With T-VEC in Melanoma
Source: OncLive, February 2016
Talimogene laherparepvec (T-VEC; Imlygic) was approved by the FDA in October 2015, for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma after initial surgery, based on results from the phase III OPTiM study.1
In the study, which compared T-VEC to GM-CSF, patients who received T-VEC experienced a durable response rate (DRR) of 16.3% compared with 2.1% for GM-CSF. The objective response rate (ORR) was 26.4% versus 5.7%, and the complete response rate (CRR) was 11% compared with 1% for T-VEC and GM-CSF, respectively.
Since then, the first-in-class oncolytic immunotherapy has continued to show promise, both as a single agent and in combination trials.
In the phase Ib portion of a phase Ib/II multicenter trial of T-VEC and ipilimumab (Yervoy) with previously untreated, unresected stage IIIB/IV melanoma, the ORR was 56% (33% CRR), and the DRR was 44% in 18 evaluable patients who received the combination.2