Fig. 2.
Analyses of CR in stage IIIB–IVM1c melanoma. a Time to achieve CR in patients treated with talimogene laherparepvec; b Duration of CR in patients treated with talimogene laherparepvec; c Kaplan-Meier plot of OS in patients who achieved a CR versus patients who did not achieve a CR prior to a landmark time of 9 months; d Kaplan-Meier plot of TFI in patients who achieved a CR versus patients who did not achieve a CR prior to a landmark time of 9 months; e RFS after achieving a CR with talimogene laherparepvec; f Factors associated with achieving CR with talimogene laherparepvecf. aCR duration was defined as the interval from the initial date of CR to the first response of non-CR. Ongoing CRs were censored at the date with a CR. The longest interval was utilized due to multiple CR intervals. Median follow-up for CR duration = 7 months (range < 1 to 20 months). bFor landmark analyses, OS was calculated from the landmark time of 9 months after randomization to death. Unadjusted hazard ratios and log-rank P-values are shown. cTFI was defined as the interval from the last dose of study therapy and the first dose of systemic therapy categorized as chemotherapy/targeted agent or immunotherapy. The TFI analysis was limited to treated patients with tumor assessments ≥9 months. Unadjusted hazard ratios (HR) and log-rank P-values are shown. dRFS after achieving a CR was calculated from date of CR to date of recurrence, death due to disease progression, or start of new anti-melanoma therapy. Median follow-up for RFS = 31 months (range 1 to 53 months). e14.5 cm2 was the median tumor burden. fPatients treated with talimogene laherparepvec who achieved CR (n = 50) versus those who did not (n = 245) using logistic regression models. AJCC, American Joint Committee on Cancer; CI, confidence interval; CR, complete response; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; ITT, intent-to-treat; NE, not evaluable; OR, odds ratio; OS, overall survival; RFS, recurrence-free survival; TFI, treatment-free interval