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Four-Year Survival Update For Metastatic Melanoma (MM) Patients (PTS) Treated With Ipilimumab (IPI) + Dacarbazine (DTIC) On Phase 3 Study CA184-024
Published 2012 · Medicine
ABSTRACT Background Data from clinical trials suggest a long-term survival effect (beyond 4 yrs) of IPI therapy in some pts with MM. An analysis of 177 pts from 3 phase I/II IPI studies conducted at NCI demonstrated 5-yr survival rates of 13-25% (Prieto, et al., CCR 2012). In other phase II trials, IPI monotherapy was associated with long-term survival of 4+ yrs in some pts with MM (Wolchok, et al., 2011 PIM). IPI in combination with DTIC in previously untreated MM patients significantly improved OS in phase III study CA184-024 (Robert, et al, NEJM 2011). Safety data from study 024 has been previously published. Here we report 4-yr survival data from study 024, the longest IPI survival follow-up from a phase III study. Table: 1127P Treatment group Median OS, months [95% CI] Overall survival rate, % [95% CI] 1-year 2-year 3-year 4-year IPI + DTIC N = 250 11.2 [9.4-13.6] 47.5% [41.2–53.8] 28.8% [23.2–34.6] 21.2% [16.1–26.5] 19.0% [14.2 - 24.2] Placebo + DTIC N = 252 9.1 [7.8-10.5] 36.4% [30.4–42.4] 17.8% [13.2–22.6] 12.1% [8.1–16.3] 9.6% [6.1 - 13.5] Methods Pts with treatment-naive MM were randomized to receive either IPI (10 mg/kg) + DTIC (850 mg/m2) or placebo + DTIC (850 mg/m2) given at Wks 1, 4, 7, 10 followed by DTIC q 3 wks through Wk 22. Pts with stable disease or better then received IPI or placebo q 12 wks as maintenance. This analysis reports OS with updated last known alive date or death date based on data collected through April 2012. Results The table summarizes median OS, previously reported survival rates at 1, 2, and 3 years, and current analyses for 4-year survival rates by treatment group. Conclusions The 4-year survival rates observed in an extended follow-up of a completed phase III trial suggests that IPI 10 mg/kg in combination with DTIC continues to demonstrate a survival benefit compared to the control arm. The continued survival of some patients at 4 yrs suggests that prolonged survival may indeed be obtained in some pts with treatment-naive MM. This observation of long-term survival benefit in a phase III RCT is consistent with observations from phase I/II studies of IPI in patients with advanced melanoma. Disclosure M. Maio: Paid advisor in boards from BMS and Roche. C. Robert: Consultant for BMS, GSK, Roche and Novartis. C. Garbe: I received honoraria and research funding from BMS. S. Francis: Employed by BMS. K. Chin: Employed by BMS and have Stock ownership. J. Wolchok: I am a consultant to BMS, Merck and GSK. I receive rsearch funding from BMS. All other authors have declared no conflicts of interest.