Lilly reports 79% response rate in early ovarian-cancer combination study

Eli Lilly ($LLY) reported the first platinum-sensitive ovarian-cancer results for its investigational antibody-drug conjugate sofetabart mipitecan, given with bevacizumab. In a Phase 1 cohort of 33 women, 23 of the 29 patients with measurable disease had confirmed responses, a 79.3% rate. Six responses were complete. Participants had received a median of three previous systemic regimens, and two-thirds had prior PARP-inhibitor exposure.

The findings support Lilly’s ongoing Phase 3 FRAmework-01 program, but the small early study does not establish superiority over existing treatments. Median response duration and progression-free survival had not yet been reached. Grade 3 or worse neutropenia occurred in 42% and anemia in 24%; 42% required dose reductions. The Phase 3 program uses a lower dose than this cohort, an important qualification when interpreting the preliminary response rate.

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