Slide 1: Luveltamab Tazevibulin (Luvelta, STRO-002) Phase 1 Data and Regulatory Strategy
Luveltamab Tazevibulin (Luvelta, STRO-002) Phase 1 Data and Regulatory Strategy January 9, 2023 Exhibit 99.3
Slide 2: Agenda for Today
Agenda for Today January 9, 2023 Topic Speaker Welcome and Introduction Forward-Looking Statements Ed Albini, Chief Financial Officer, Sutro Biopharma Bill Newell, Chief Executive Officer, Sutro Biopharma Luvelta (STRO-002) Phase 1 Dose-Expansion Study Results Dr. R. Wendel Naumann, Professor and Di
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than state
Slide 4: Luveltamab Tazevibulin (Luvelta, STRO-002) Phase 1 Dose-Expansion Study
Luveltamab Tazevibulin (Luvelta, STRO-002) Phase 1 Dose-Expansion Study
Slide 5: Advanced Ovarian Cancer Has a High Unmet Medical Need
Advanced Ovarian Cancer Has a High Unmet Medical Need Ovarian cancer is the most common cause of death from gynecological cancers Accounts for 2.1% of all estimated cancer deaths(1,2) Almost half of affected women live less than five years following diagnosis1,2 In 2022, an estimated 19,880 new ovar
Slide 6: Luvelta: Next-generation ADC across a broad range of FolRα-expression levels
Luveltamab Tazevibulin (Luvelta, STRO-002) Next-generation ADC designed to have efficacy across a broad range of FolRα-expression levels ADC, antibody drug conjugate. DAR, drug antibody ratio. 1. Sutro-proprietary tubulin-targeting 3-aminophenol hemiasterlin warhead, SC209. 2. Based on STRO-002 pre-
Slide 7: Two-Part Phase 1 Study for Patients with Advanced Ovarian Cancer
Two-Part Phase 1 Study for Patients with Advanced Ovarian Cancer(1) Explored dosing regimen and biomarker levels for which luvelta is optimal 1. Phase 1 for patients with advanced ovarian cancer is named STRO-001-GM1, clinicaltrials.gov NCT identifier: NCT03748186. 2. Three patients were not evaluab
Slide 8: Luvelta Phase 1 Data Establishes FolRα-Selection Criteria
RECIST-Evaluable Patients N=41 N=32 N=9 N=12 N=20 N=16 N=16 PR 13 12 1 4 8 5 7 ORR (95%, CI), % 31.7 (18.1, 48.1) 37.5 (21.1, 56.3) 11.1 (0.3, 48.3) 33.3 (10.0, 65.1) 40.0 (19.1, 63.9) 31.3 (11.0, 58.7) 43.8 (19.8, 70.1) Median DOR (95% CI), mo 5.4 (2.9, 11.0) 5.5 (2.5, 11.0) 2.9 5.6 (2.5, NE) 5.5 (
Slide 9: Majority of FolRα-Selected Patients Experienced Disease Control
Majority of FolRα-Selected Patients Experienced Disease Control 12 FolRα-selected patients demonstrated confirmed partial response Note: Data are as of November 8, 2022. 1. Data on FolRα-selected patients who are evaluable for RECIST v1.1. 2. Disease control includes SD ≥ 6 weeks. BOR, best overall
Slide 10: Robust Anti-Tumor Activity and Disease Control Demonstrated
Robust Anti-Tumor Activity and Disease Control Demonstrated Responders experienced rapid tumor reduction or a steady deepening of response Note: Data are as of November 8, 2022. 1. Data are from Cohort A of Phase 1 dose expansion on FolRα-selected patients who are evaluable for RECIST v1.1. 20 -30 C
Slide 11: Patients Had Durable Responses even with Dose Modifications
Patients Had Durable Responses even with Dose Modifications Patients who started at the higher dose experienced rapid time to response Note: Data are as of November 8, 2022. 1. Data are from Cohort A of Phase 1 dose expansion on FolRα-selected patients who are evaluable for RECIST v1.1. 2. Patients
Slide 12: Cohort C as a Deep Dive Into Managing Neutropenia
Cohort C as a Deep Dive Into Managing Neutropenia Prophylactic use of pegfilgrastim reduced Grade 3+ neutropenia and dose delays Grade 3+ Neutropenia at Cycle 1 P=0.006 85.0% less grade 3+ neutropenia at cycle 1 Dose Delays at Cycle 2 P=0.021 60.6% less dose delay at cycle 2 Part 2 Dose-expansion co
Slide 13: Most Common Treatment-Emergent Adverse Event was Neutropenia
Most Common Treatment-Emergent Adverse Event was Neutropenia Most Common Grade 3+ TEAEs (≥2 Subjects) by Dose and General Category No new safety signals were observed, including the absence of meaningful drug-related ocular and lung AEs Note: Data are as of November 8, 2022 on all patients enrolled
Slide 14: Registrational Path Forward for Luveltamab Tazevibulin (Luvelta, STRO-002)
Registrational Path Forward for Luveltamab Tazevibulin (Luvelta, STRO-002)
Slide 15: Luvelta (STRO-002) Has a Favorable Product Target Profile
Luvelta (STRO-002) Has a Favorable Product Target Profile Confidence to move forward into registrational-enabling study Note: Cohort A data are as of November 8, 2022. Cohort C data are as of December 8, 2022. Potential to treat ~80% of patients with platinum-resistant ovarian cancer Efficacy demons
Slide 16: Luvelta Clinical Integrated Strategy for Phase 2/3 Study, REFRaME
Luvelta Clinical Integrated Strategy for Phase 2/3 Study, REFRaME Integrated design to potentially support accelerated and full approvals in platinum-resistant ovarian cancer Part 1: Lead-In Dose Selection Key eligibility criteria Platinum resistant ovarian cancer, prior bevacizumab required 1–3 pri
Slide 17: Market Opportunity for Luveltamab Tazevibulin (Luvelta, STRO-002) and Ovarian Cancer
Market Opportunity for Luveltamab Tazevibulin (Luvelta, STRO-002) and Ovarian Cancer
Slide 18: Luvelta Development Across Indications and Market Size
Monotherapy Platinum-resistant ovarian cancer Phase 2/3 Market size: ~4K patients per year in the U.S. (FolRα-selected) Endometrial cancer Phase 1 expansion Incidence: Across all stages, not FolRα-selected, ~66K newly diagnosed/year Pediatric RAM phenotype AML with CBF/GLIS2 mutation Compassionate u
Slide 19: High Unmet Need Remains in Platinum-Resistant Ovarian Cancer
High Unmet Need Remains in Platinum-Resistant Ovarian Cancer Majority of patients are FolRα expressors and candidates for luvelta 1L, first line; 2L, second line; 3L, third line; 4L, fourth line; adj, adjuvant; bev, bevacizumab; chemo, chemotherapy; MT, maintenance; PARPi, PARP inhibitor; PROC, plat
Slide 20: Closing Remarks and Q&A
Closing Remarks and Q&A BIOPHARMA