OPTiM Trial for T-VEC in Unresectable Melanoma
Phase 3/4 Trials
The OPTiM trial for T-VEC (formerly OncoVEXGM-CSF), an oncolytic HSV1 that selectively replicates in tumors, is now underway, according to a presentation by Kaufman, et al. at ASCO 2012. The randomized phase 3 trial will evaluate the efficacy and safety of talimogene laherparepvec (T-VEC) compared with subcutaneously administered GM-CSF for the treatment of unresectable stage IIIb, IIIc, and IV melanoma. The proposed MOA includes lytic destruction of injected tumors and induction of a systemic anti-tumor immune response enhanced by local GM-CSF expression. In a 50-patient phase 2 study, intratumoral T-VEC was well tolerated and achieved a high rate and duration of response, including 20% CR (Senzer et al., JCO 2009; 27: 5763-71). The pivotal ph 3 study is expected to report during 2012. The agent is in development by Amgen.