Olema Pharmaceuticals, Inc. · NASDAQ:OLMA
Olema Pharmaceuticals — ESMO Breast Cancer 2024
19 slides from Olema Pharmaceuticals's conference presentation, May 15, 2024
Slide 1: Palazestrant-Ribociclib Combination Interim Results
ESMO Breast Cancer 2024 Palazestrant-Ribociclib Combination Interim Results May 15, 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such
Slide 3: Unmatched Combinability and Promising Efficacy for Palazestrant-Ribociclib Combo
Interim Phase 1b/2 data across 50 patients (on treatment for >4wks); 60-patient study now fully enrolled Strong investigator enthusiasm resulted in rapid study enrollment Largest data set for any CERAN/SERD in combination with ribociclib to be presented Compelling combinability Well tolerated with n
Slide 4: Phase 1b/2 Palazestrant-Ribociclib Combination Clinical Study
Phase 1b/2 Palazestrant-Ribociclib Combination Clinical Study
Slide 5: Demonstrating Palazestrant's Combinability with Other Targeted Agents
Demonstrating Palazestrant’s Combinability with Other Targeted Agents + + ER+/HER2- MBC (CDK4/6 naïve or previously treated) ER+/HER2- MBC w/ PIK3Ca mutation Palazestrant + Ribociclib 600 mg Palazestrant + Alpelisib Ribociclib 600 mg Alpelisib 300/250 mg Dose Expansion Dose Escalation Primary object
Slide 6: Palazestrant-Ribociclib Demographics
Demographic and disease characteristics Total (N=50)^ Median age (years) (min-max) 62 (37–85) ECOG performance status, n (%) 0 24 (48%) 1 22 (44%) Not reported 4 (8%) Measurable disease at baseline, n (%) 31 (62%) Visceral disease, n (%) 29 (58%) Prior lines of therapy in advanced setting, n (%) 0 1
Slide 7: Palazestrant-Ribociclib Treatment Emergent Adverse Events
Palazestrant-Ribociclib Treatment Emergent Adverse Events Well tolerated with no DLTs, safety and tolerability profile consistent with ribociclib + ET TEAEs in ≥20% of patients Ribociclib + Palazestrant(1) MONALEESA-2* Ribociclib + Letrozole(2) (n=50) (n=334) All grades Grade 3 Grade 4 All grades Gr
Slide 8: Palazestrant-Ribociclib Pharmacokinetics: No Effect on Ribociclib Exposure
Pharmacokinetics Palazestrant-Ribociclib Pharmacokinetics No effect of palazestrant on ribociclib exposure levels across dose levels No drug-drug interaction (DDI) between ribociclib and palazestrant in the dose range of 30 to 120 mg Palazestrant did not affect ribociclib 600 mg exposure when compar
Slide 9: Palazestrant-Ribociclib Pharmacokinetics: Effect of Ribociclib on Palazestrant Exposure
Palazestrant-Ribociclib Pharmacokinetics Effect of ribociclib on palazestrant exposure is not clinically meaningful Steady-state trough values between the combination and single-agent palazestrant were overlapping. Ribociclib had no clinically meaningful effect on palazestrant exposure Data Cut-off
Slide 10: Palazestrant-Ribociclib Preliminary Efficacy: 85% Clinical Benefit Rate
Palazestrant-Ribociclib Preliminary Efficacy 85% Clinical Benefit Rate Across Wild-type and ESR1 Mutant Patients Duration of Treatment as of March 13, 20241 (n=50) 1Each lane represents one patient. 2 Progression by radiographic assessment only. a: Two patients discontinued ribociclib but continued
Slide 11: Anti-tumor Activity Shown in Wild-Type and ESR1 Mutant Patients
Palazestrant-Ribociclib Preliminary Efficacy Anti-tumor Activity Shown Both in Wild-Type and ESR1 Mutant Patients 30 mg Treatment group (palazestrant dose): 60 mg 120 mg Treatment ongoing ESR1 mutation Prior AI Prior CDK4/6i Prior chemotherapy Prior fulvestrant Patients of efficacy population 40 20
Slide 12: Comparison of Combination Efficacy in 2/3L+ Patients
Comparison of Combination Efficacy in 2/3L+ Patients MAINTAIN study of ribociclib after CDK4/6i progression serves as clinical benchmark for patient population Benchmark Clinical Benefit Rate*^ in CDK4/6i pre-treated patients Early signals of efficacy for palazestrant in combination with ribociclib
Slide 13: Ribociclib Only CDK4/6i with Confirmed OS Benefit in Combo with AI
Ribociclib Only CDK4/6i with Confirmed OS Benefit in Combo with AI CDK4/6is were approved with PFS but ribociclib has strongest evidence of OS benefit * NOTE: This analysis is the aggregation of results across independent studies. There are risks inherent in conducting cross-trial comparisons and re
Slide 14: Improvement in Upper GI Adverse Events with Palazestrant Tablets
Improvement in Upper GI Adverse Events with Palazestrant Tablets Up to 50% of nausea and vomiting incidence reduced vs. capsule formulation Data Cutoff Date: March 20, 2024. Abbreviations: GI, gastrointestinal; TRAE, treatment-related adverse event Palazestrant 120 mg Capsule Palazestrant 120 mg Tab
Slide 15: Advancing Value – Palazestrant and Pipeline
Advancing Value – Palazestrant and Pipeline
Slide 16: OPERA-01 Designed to Show Effectiveness over Standard of Care
510-Patient Phase 3 2/3L Monotherapy Trial vs. Standard of Care (SoC) OPERA-01 Designed to Show Effectiveness over Standard of Care Study Initiated in 4Q2023. Results Expected in 2026. Palazestrant 120 mg SoC Endocrine Therapy STRATIFICATION: 1. Visceral metastasis: Yes vs No 2. Prior ET lines: 1 vs
Slide 17: Olema's Expanding Pipeline Focused on Women's Oncology
Advancing Palazestrant in 2nd/3rd Line and in 1st Line Metastatic Breast Cancer Olema’s Expanding Pipeline Focused on Women’s Oncology LINE PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Palazestrant 2nd/3rd Palazestrant + Ribociclib 2nd/3rd 1st Palazestrant + Palbociclib 2nd/3rd Palazestrant + Alpelisib 2nd/
Slide 18: Olema: A Compelling Late-Stage Opportunity in Women's Oncology
Olema: A Compelling Late-Stage Opportunity in Women’s Oncology Well-capitalized with ~$249M of cash and cash equivalents as of March 31, 20241 Palazestrant full-dose combinations with CDK4/6 inhibitors position it for first-line indication Palazestrant is highly differentiated within the new class o
Slide 19: Olema
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