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OnKure Therapeutics
OnKure Therapeutics (OKUR) investor relations material
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OnKure Therapeutics Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary3 Dec, 2025
Pipeline progress and upcoming data
Anticipates a data-rich 2026, with key clinical results for monotherapy, doublet, and triplet regimens of OKI-219 expected in Q1, providing momentum for the year.
Initial data from the PIKture-01 phase 1 study was shifted to Q1 2026 to ensure more mature, context-rich results, allowing for robust comparisons to competitors.
All patients in ongoing studies will have over four months of follow-up, enabling early assessment of response durability and efficacy.
Patient cohorts are heavily pretreated, with efforts to identify subsets for fair comparison to recent Relay and Scorpion studies.
Triplet and combination strategies
Triplet regimens, especially those using ribociclib and fulvestrant, are prioritized for early-line therapy due to their potential for differentiation in tolerability and efficacy.
Demonstrating combinability with ribociclib in frontline triplet settings is seen as a major value driver.
Early triplet data will focus on tolerability and initial efficacy, guiding go/no-go decisions for expansion cohorts.
Full durability data will require longer follow-up, but early results will inform further investment and study expansion.
Efficacy, safety, and competitive positioning
Doublet studies will be scrutinized for high safety standards and efficacy comparable to competitors, focusing on patient characteristics like prior lines and disease type.
The goal is to match efficacy and surpass tolerability benchmarks set by Relay and inavolisib studies.
Maintaining dose intensity is emphasized as key to achieving better long-term outcomes.
OKI-219 triplet: What defines expansion success?
Pan-mutant selectivity: What's the competitive bar?
HER2 triplet: What drives this unique strategy?
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