Sutro STRO-002 Phase 1 shows 43.8% ORR in FolRα-selected ovarian cancer; registrational study Q2 2023

SUTRO BIOPHARMA, INC.

STRO-002 (luvelta) Phase 1 dose-expansion: 43.8% ORR, median DOR 5.4 mo, median PFS 6.6 mo at 5.2 mg/kg in FolRα-selected (TPS>25%) patients.
FolRα-selected population (~80% of advanced ovarian cancer) drove benefit; unselected patients had 11.1% ORR.
Prophylactic pegfilgrastim reduced Grade 3+ neutropenia 85% (66.7% to 10%) and dose delays 60.6% at cycle 2.
Phase 2/3 registration-directed study REFRaME to start Q2 2023; potential accelerated approval based on ORR endpoint.

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