Table 2.
Summary of key efficacy data from OPTiM
| ITT (stage IIIB–IVM1c)
|
Stage IIIB–IVM1a subseta
|
|||
|---|---|---|---|---|
| T-VEC (n=295) | GM-CSF (n=141) | T-VEC (n=163) | GM-CSF (n=86) | |
| Durable response rate, n (%) | 48 (16.3) | 3 (2.1) | 41 (25.2) | 1 (1.2) |
| Treatment difference, % (95% CI) | 14.1 (9.3–19.0) | 24.0 (17.0–31.0) | ||
| P-value | <0.0001 | <0.0001b | ||
| Best response, n (%) | ||||
| Complete response | 32 (10.8) | 1 (0.7) | 27 (16.6) | 0 (0.0) |
| Partial response | 46 (15.6) | 7 (5.0) | 39 (23.9) | 2 (2.3) |
| Objective response rate, % (95% CI) | 26.4 (21.4–31.5) | 5.7 (1.9–9.5) | 40.5 (32.9–48.4) | 2.3 (0.3–8.1) |
| P-value | <0.0001b | <0.0001b | ||
| Overall survival, median – months (95% CI) | 23.3 (19.5–29.6) | 18.9 (16.0–23.7) | 41.1 (30.6–NR) | 21.5 (17.4–29.6) |
| HR (95% CI) | 0.79 (0.62–1.00) | 0.57 (0.40–0.80) | ||
| P-value | 0.051 | <0.001b | ||
Notes:
a
Analyses are exploratory for this subpopulation.
Abbreviations: CI, confidence interval; GM-CSF, granulocyte–macrophage colony-stimulating factor; HR, hazard ratio; ITT, intent-to-treat; NR, not reached; OPTiM, Oncovex (GM-CSF) Pivotal Trial in Melanoma; T-VEC, talimogene laherparepvec.