Abstract
20023 Background: Elesclomol is a novel small-molecule oxidative stress inducer known to synergize with taxanes and certain other chemotherapeutics. Methods: This 2:1 randomized, double-blinded, placebo-controlled multicenter study compared 213 mg/m2 elesclomol co- infused with 80 mg/m2 paclitaxel (E+P) versus paclitaxel alone (P). Patients (pts) received 4-week cycles of once weekly E+P or P for 3 weeks and 1 week’s rest until disease progression. Eligible pts with Stage IV MM and 1 or 0 prior chemotherapies were evaluated every 8 weeks for progression by RECIST criteria. P-treated pts were eligible for post-progression crossover to E+P. This trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival. We now report the results of 2-year OS follow-up data. Results: At 21 sites, a total of 81 subjects were randomized to E+P (53 pts) or P (28 pts). The median duration of study medication exposure was 102.0 d for E+P pts and 43.5 d for P pts. Of pts progressed on P, 19 crossed over to E+P. Adverse events for E+P-treated pts were typical of P use, with slight/moderate incidence increases in hypoesthesia, neutropenia, stomatitis, arthralgia, and fatigue for E+P pts. Conclusions: The E+P safety profile was tolerable and similar to P alone. Crossover may have confounded OS comparison; nonetheless, median and 2-year OS results for E+P pts warrant further study of E+P in MM. A multinational Phase 3 trial of E+P versus P (SYMMETRYSM) is now enrolling. Group* E+P P** P (Crossover) P (No Crossover) N 53 28 19 9 Median OS † 11.9 mo 7.8 mo 14.3 mo 5.6 mo (95% CI) (8.5–17.7) (5.7–16.0) (6.9–20.5) (2.3–6.1) 1-year OS † 49% 43% 53% 22% 2- year OS † 27% 21% 26% NE Median OS follow-up time ‡ 24.8 mo 26.5 mo 26.9 mo 22.0 mo * Intent-to-Treat; ** of these, 19/28 crossed over to E+P; † from date randomized; ‡ for censored subjects Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Synta Synta Synta Synta Synta
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