Table 1.
Clinical activity of talimogene laherparepvec in advanced melanoma.
Phase II T-VEC study | Phase III T-VEC study | |
---|---|---|
Patient numbers | 50 | 295 (T-VEC arm) |
Stage | IIIc, 20% IVa, 32% IVb, 8% IVc, 40% |
IIIb/c, 30% IVa, 27% IVb, 21% IVc, 22% |
Objective response rate | 26% | 26.4% (16.3% durable response rate) |
Overall survival | 58% 1 year 52% 2 year |
23.3 months (median) |
Toxicities | Grade 1–2: fever 52%, chills 48%, fatigue 32%, nausea 30% No Grade 3 AEs noted |
All grades: fatigue 50%, chills 49%, fever 43%, nausea 36% Grade 3/4: cellulitis 2%, fatigue 2%, vomiting 2%, dehydration 2% |
NCT trial ID, Reference | NCT00289016 [27] | NCT00769704 [29] |
T-VEC: Talimogene laherparepvec.