Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Investor Presentation (October 2019)
23 slides from Astellas Pharma's investor presentation, Oct 1, 2019
Slide 1: Conference Call: Enfortumab Vedotin
CONFERENCE CALL: ENFORTUMAB VEDOTIN Bernie Zeiher, M.D. Steven Benner, M.D. Chief Medical Officer President of Development Astellas Pharma Inc. October 1, 2019 (JST)
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING FORWARD- 2 LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These st
Slide 3: Six Growth Drivers in Late-Stage Development
SIX GROWTH DRIVERS IN LATE-STAGE 3 DEVELOPMENT Indication Stage enzalutamide M1 hormone-sensitive prostate cancer Filed (US, EU, JP) ONCOLOGY M0 hormone-sensitive prostate cancer P3 M1 castration-resistant prostate cancer Filed (China) gilteritinib Relapsed or refractory AML Approved (US, JP) Filed
Slide 4: Enfortumab Vedotin Summary
ENFORTUMAB VEDOTIN SUMMARY 4 • First and only antibody drug conjugate (ADC) that targets Nectin-4, which is highly expressed in urothelial cancers • Developing in collaboration with Seattle Genetics as a potential treatment for patients with locally advanced or metastatic urothelial cancer • Data co
Slide 5: Enfortumab Vedotin Is the First and Only ADC Targeting Nectin-4
ENFORTUMAB VEDOTIN IS THE FIRST AND ONLY 5 ADC TARGETING NECTIN-4 Transitional bladder • The Nectin family of cell adhesion carcinoma with strong expression of Nectin-4 molecules play a role in the formation of cell-cell adherens junctions.1,2 • Nectin-4 (PVRL4), a transmembrane polypeptide belongin
Slide 6: Enfortumab Vedotin: How It Works
ENFORTUMAB VEDOTIN: HOW IT WORKS 6 ADC: Antibody-drug conjugate
Slide 7: Enfortumab Vedotin Program Is Exploring the Full mUC Treatment Landscape
ENFORTUMAB VEDOTIN PROGRAM IS EXPLORING 7 THE FULL mUC TREATMENT LANDSCAPE PD-1/L1 inhibitor Platinum and PD-1/L1 1st line pretreated inhibitor pretreated EV-301 BLA in US submitted cisplatin based on EV-201 (Cohort 1) Platinum and PD-1/L1 this data; eligible Gem-Cis inhibitor pretreated Accepted an
Slide 8: EV-201 Cohort 1 Data Used for U.S. BLA Submission
ENFORTUMAB VEDOTIN IN PD-1/L1 INHIBITOR PRE-TREATED POPULATION: 8 EV-201 COHORT 1 DATA USED FOR U.S. BLA SUBMISSION ORR was 44% in platinum and PD-1/L1 inhibitor pretreated patients Patients (N=125) ORR per RECIST v1.1 assessed by BICR n (%) Confirmed objective response rate 55 (44) 95% confidence i
Slide 9: EV-201 Cohort 1: Duration of Response and Safety
ENFORTUMAB VEDOTIN IN PD-1/L1 INHIBITOR PRE-TREATED POPULATION: 9 EV-201 COHORT 1 DATA USED FOR U.S. BLA SUBMISSION DOR was 7.6 months in this heavily pre-treated patient population EV-201: Cohort 1 Safety data • The most common TEAEs occurring in more than 40% of patients • Fatigue, alopecia, rash,
Slide 10: EV-103: Initial Results of Enfortumab Vedotin Plus Pembrolizumab
EV-103: INITIAL RESULTS OF ENFORTUMAB VEDOTIN PLUS PEMBROLIZUMAB FOR LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA As presented at ESMO 2019 Christopher J. Hoimes, Jonathan E. Rosenberg, Sandy Srinivas, Daniel P. Petrylak, Matthew I. Milowsky, Jaime R. Merchan, Mehmet A. Bilen, Shilpa Gupta, A
Slide 11: Study Design: EV-103
STUDY DESIGN: EV-103 (NCT03288545) 11 An ongoing multi-cohort, open-label, multicenter, Phase 1 study Dose Escalation Cohort Dose Expansion Cohorts Patient Cohort D Recommended EV dose Population EV + cisplatin Dose Escalation Cohort A Cohort G Locally 1L Advanced EV + pembro EV + pembro EV + cis/ca
Slide 12: Enfortumab Vedotin + Pembrolizumab Cohorts
ENFORTUMAB VEDOTIN + PEMBROLIZUMAB 12 COHORTS EV 1.25 mg/kg + pembrolizumab (200 mg) in 1L la/mUC patients Patient Dosing: EV days 1 and 8 of 3-wk cycle to Dose Escalation1 Dose Expansion Population align with pembro (day 1 of 3-wk cycle) Cohort A Locally EV 1.25 mg/kg EV + pembro EV exposure: Compa
Slide 13: Key Demographics and Disease Characteristics
KEY DEMOGRAPHICS AND DISEASE 13 CHARACTERISTICS EV 1.25 mg/kg + pembrolizumab in 1L setting Patients (N=45) 18 June 2019 data cut-off n (%) Male sex, n (%) 36 (80) Age, yrs, Median (min, max) 69 (51, 90) ECOG performance status, n (%) 0 16 (36) 1 23 (51) 2 6 (13) Primary tumor location, n (%) 1 Lowe
Slide 14: Summary of Disposition
SUMMARY OF DISPOSITION 14 EV 1.25 mg/kg + pembrolizumab in 1L setting Patients (N=45) 18 June 2019 data cut-off n (%) Patients on treatment 24 (53) Patients off treatment 21 (47) Reason for treatment discontinuation Progressive disease 12 (27) Adverse event 5 (11) Patient decision 4 (9) Patients off
Slide 15: Duration of Treatment
DURATION OF TREATMENT 15 EV 1.25 mg/kg + pembrolizumab in 1L setting 18 June 2019 data cut-off Patients (N=45) Duration of treatment (months) Median 6.0 Min, Max 1, 13+ Number of treatment cycles per patient Median 7.0 Min, Max 1, 17+ Patients on treatment n (%) 24 (53) Patients off treatment n (%)
Slide 16: Objective Response Rate
OBJECTIVE RESPONSE RATE 16 ORR per RECIST v1.1 by investigator Patients (N=45) 18 Jun 2019 data cut-off n (%) Confirmed Objective Response Rate (ORR) 32 (71) 95% confidence interval (55.7, 83.6) Best Overall Response per RECIST v1.1 Complete response 6 (13) Partial response 26 (58) Stable disease 10
Slide 17: Maximum Percent Reduction From Baseline in Sum of Diameters of Target Lesions
MAXIMUM PERCENT REDUCTION FROM BASELINE IN SUM OF DIAMETERS OF TARGET LESIONS PER 17 INVESTIGATOR 93% PD-L1 tested using the 22C3 PharmDx assay from Agilent/Dako
Slide 18: Percent Change From Baseline in Sum of Diameters of Target Lesions
PERCENT CHANGE FROM BASELINE IN SUM OF DIAMETERS OF TARGET LESIONS PER 18 INVESTIGATOR • 91% of responses observed at first assessment (Week 9±1 week) • Median time to response: 2.0 months (range: 1.4 to 4.2) • Duration of response range: 1 to 10.5 months and ongoing • 22 of 32 responders remain on
Slide 19: Treatment-Related Adverse Events (TRAE)
TREATMENT-RELATED ADVERSE EVENTS (TRAE) 19 TRAEs by preferred term Patients (N=45) Any grade in ≥20% of patients and n (%) ≥Grade 3 in ≥10% of patients Any Grade ≥Grade 3 Overall 43 (96) 23 (51) 7 patients had treatment-related Fatigue 22 (49) 4 (9) serious AEs (16%) Alopecia 21 (47) N/A 4 treatment
Slide 20: Treatment-Related Adverse Events of Clinical Interest (AECI)
TREATMENT-RELATED ADVERSE EVENTS OF 20 CLINICAL INTEREST (AECI) Rates of peripheral neuropathy, rash, and hyperglycemia similar to EV monotherapy in post-platinum, post-PD-1/L1 mUC patients (EV-201, Cohort 1)1 Patients (N=45) Time to first onset (months) n (%) median (min, max) AECI: categorized by
Slide 21: EV-103 Summary and Conclusions
EV-103 SUMMARY AND CONCLUSIONS 21 • High unmet need for effective and tolerable therapies in 1L cisplatin-ineligible la/mUC patients • Enfortumab vedotin + pembrolizumab demonstrates encouraging activity in 1L cisplatin- ineligible la/mUC patients in EV-103 High ORR (71%) Rapid responses (91% at
Slide 22: Next Steps
NEXT STEPS 22 • Continue progressing EV clinical development program What we look forward to next with enfortumab • Continue engagement with regulatory authorities globally vedotin • Plan a Phase 3 study combining EV and pembrolizumab
Slide 23: Thank You
J THANK YOU QUESTIONS PWastellas
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