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Sutro Biopharma Posts Updated Data From Ovarian Cancer Candidate

  • Sutro Biopharma Inc (NASDAQ: STROannounced results from a Phase 1 dose-expansion study of STRO-002 (luvelta) and interim safety data from exploratory cohort C of advanced ovarian cancer treated at the higher dose of luvelta (5.2mg/kg), along with prophylactic pegfilgrastim.

  • Results demonstrated that luvelta provided substantial clinical benefit, with a 37.5% overall response rate (ORR), a median duration of response (median DOR) of 5.5 months, and median progression-free survival (median PFS) of 6.1 months, regardless of starting dose.

  • Results also demonstrated that the higher starting dose of 5.2 mg/kg provides greater patient benefit than the lower dose of 4.3mg/kg.

  • Consistent with prior luvelta data, the primary adverse event from the dose-expansion cohort was predominantly asymptomatic neutropenia, with no meaningful ocular toxicity signals or complications reported.

  • In cohort C, an additional 15 patients with advanced ovarian cancer were enrolled and treated with prophylactic pegfilgrastim on Day 8 after each 5.2 mg/kg administration of luvelta. Initial data on neutropenia and dose delays were available on the first ten patients. This showed that patients in cohort C experienced substantial decreases in neutropenia and potential increases in dose intensity due to decreased dose delays.

  • Sutro plans to initiate a Phase 2/3 registration-directed study called REFRaME in the second quarter of 2023.

  • Price Action: STRO shares closed at $8.29 on Monday.

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