Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Corporate Update (March 2024)
26 slides from Astellas Pharma's corporate update, Mar 29, 2024
Slide 1: VYLOY (Zolbetuximab) Japan Regulatory Update
VYLOY™ (ZOLBETUXIMAB) JAPAN REGULATORY UPDATE March 29, 2024 (JST)
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING 2 FORWARD-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. These statements
Slide 3: 注意事項
注意事項 3 本資料には、医薬品に関する情報が含まれています。それらの医薬品は、すべての国で発売されていると は限らず、また、国によって商標、効能・効果、用法・用量等が異なる可能性もあります。ここに記載されて いる内容は、株主や投資家の皆さまのための情報開示を目的としており、開発品を含むいかなる医療用 医薬品の宣伝広告、医学的アドバイスを意図するものではありません。 PROPRIETARY INFORMATION—FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 4: Agenda
AGENDA 4 Presenter I Gastric Cancer Disease State VYLOY Product Profile & II Commercial Strategy John Demaree Head, Strategic Brand Marketing, Oncology III Future Plans Q&A Participants IV Q&A Tomoko Nakajima, Ph.D. Shelley Shaw Asset Lead, zolbetuximab Global Brand Lead, zolbetuximab PROPRIETARY IN
Slide 5: Gastric Cancer Disease State
GASTRIC CANCER DISEASE STATE PROPRIETARY INFORMATION—FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 6: Gastric Cancer Has a Devastating Impact on Patients
GASTRIC CANCER HAS A DEVASTATING IMPACT ON PATIENTS 6 ~1 Million Cases of Gastric Cancer Diagnosed Globally in 20221 3rd Deadliest Cancer in Japan1 US 26,000 Europe >70% 136,000 China Japan Early Detection of 359,000 127,000 Gastric Cancer in Japan2 Effective Treatment Options Are Limited PROPRIETAR
Slide 7: Patients with CLDN18.2 Positive Gastric Cancer Need New Treatment Options
PATIENTS WITH CLDN18.2 POSITIVE, UNRESECTABLE, ADVANCED OR 7 RECURRENT GASTRIC CANCER NEED NEW TREATMENT OPTIONS 78% 78% of 1L advanced gastric cancer population is HER2-negative 3 In Japan, chemotherapy ± CPI is the current standard of care4 Oncologists are seeking new treatment options that may im
Slide 8: CLDN18.2 Is a Novel Biomarker in Advanced Gastric Cancer
CLDN18.2 IS A NOVEL BIOMARKER IN ADVANCED GASTRIC CANCER 8 High prevalence and 38% 69% strength of clinical data patients had tumors that were aided awareness of CLDN18.2 provide strong reason to CLDN18.2 positive in SPOTLIGHT and among treating HCPs in Japan**4 test for CLDN18.2 positivity GLOW tri
Slide 9: Diagnostic Testing Education Resources to Support Pathologists
DIAGNOSTIC TESTING EDUCATION RESOURCES 9 TO SUPPORT PATHOLOGISTS Claudin182.JP Unique peer-to-peer education platform on biomarker testing for pathologists PROPRIETARY INFORMATION—FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 10: VYLOY Product Profile & Commercial Strategy
VYLOY PRODUCT PROFILE & COMMERCIAL STRATEGY PROPRIETARY INFORMATION—FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 11: The Journey of VYLOY
THE JOURNEY OF VYLOY 11 First Approved Completion of Targeted 2 Global Treatment for Astellas Completion of Pivotal Global CLDN18.2 Acquisition of Phase 2 Phase 3 Regulatory Positive, Ganymed FAST Trial SPOTLIGHT Submissions** Unresectable, and GLOW Advanced or Trials* Recurrent Gastric Cancer *Phas
Slide 12: Identifying Potential Candidates for VYLOY
IDENTIFYING POTENTIAL CANDIDATES FOR VYLOY 12 There are approximately 400,0009 patients diagnosed globally with Stage IV mGC/GEJ** Biomarker Testing HER2 Status CLDN18.2 Status 79%*10 78%*3 38%*6,7 Tested for HER2 HER2-negative CLDN18.2 positive (and CLDN18.2 in future) *Percentages represent global
Slide 13: VYLOY Provides a Targeted Treatment Option
VYLOY PROVIDES A TARGETED TREATMENT OPTION 13 1. VYLOY is indicated for CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer 2. VYLOY is first and only approved CLDN18.2-targeted therapy 3. VYLOY can be used in eligible patients regardless of combined positive score (CPS) PROPRIETAR
Slide 14: Data from Pivotal Phase 3 Trials Supported Approval: SPOTLIGHT
DATA FROM PIVOTAL PHASE 3 TRIALS SUPPORTED APPROVAL: SPOTLIGHT6 14 Median OS was the longest OS observed in a global Phase 3 trial in this patient population.11,12 *PFS was assessed per RECIST v1.1 by IRC mFOLFOX6: 5-FU, leucovorin and oxaliplatin; PFS: Progression-free survival; OS: Overall surviva
Slide 15: Data from Pivotal Phase 3 Trials Supported Approval: GLOW
DATA FROM PIVOTAL PHASE 3 TRIALS SUPPORTED APPROVAL: GLOW7 15 SPOTLIGHT and GLOW had similar overall survival hazard ratios, validating the effectiveness of zolbetuximab combined with chemotherapy.6,7 *PFS was assessed per RECIST v1.1 by IRC CAPOX: Capecitabine and oxaliplatin; PFS: Progression-free
Slide 16: Safety Data from SPOTLIGHT and GLOW
SAFETY DATA FROM SPOTLIGHT AND GLOW 16 SPOTLIGHT GLOW Incidence of serious TEAEs* was Incidence of serious TEAEs was similar between both arms similar between both arms (44.8% vs. 43.5%)6 (47.2% vs. 49.8%)7 Most frequent TEAEs in the VYLOY Most frequent TEAEs in the VYLOY versus control arms: versus
Slide 17: Dr. Kohei Shitara Discusses Significance of MHLW Approval of VYLOY
DR. KOHEI SHITARA DISCUSSES SIGNIFICANCE OF MHLW APPROVAL OF VYLOY 17 Projection Only PROPRIETARY INFORMATION—FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 18: Maximizing the Value of VYLOY: Leveraging Oncology Expertise
MAXIMIZING THE VALUE OF VYLOY: LEVERAGING ONCOLOGY EXPERTISE 18 Successfully launching oncology products into areas of high unmet need Building market leadership Creating strong relationships in oncology Preparing experienced, knowledgeable, and agile sales force for readiness upon launch PROPRIETAR
Slide 19: Activating Labs for Immediate Testing for CLDN18.2 Positivity in Japan
ACTIVATING LABS FOR IMMEDIATE TESTING FOR CLDN18.2 POSITIVITY IN JAPAN 19 Recently, VENTANA® CLDN18 (43-14A) RxDx Assay, developed by 20 Labs Roche, was approved as an IHC companion diagnostic. 60 Labs At VYLOY launch, strategic partnerships with the top 3 central labs and major cancer centers will
Slide 20: Future Plans
FUTURE PLANS PROPRIETARY INFORMATION—FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 21: Global Launch Plan
GLOBAL LAUNCH PLAN 21 Global Launch: ~50 VYLOY country launches Multiple launches in Asian VYLOY + Roche VENTANA CDx planned13 countries where disease incidence is highest1 Anticipated Approval Timings* FY2023 FY2024 March 26, 2024 Q2-Q3 Q2-Q4 Q4 JAPAN US EUROPE CHINA Approved Anticipated *Global re
Slide 22: Looking Ahead to a Potential Pancreatic Cancer Indication
LOOKING AHEAD TO A POTENTIAL PANCREATIC CANCER INDICATION 22 Leading cause of 5-year survival 4th cancer death in <5% globally for patients at Japan14 the metastatic stage15 Phase 2 registrational trial in metastatic pancreatic adenocarcinoma is in progress16 Potential pancreatic cancer indication r
Slide 23: Key Takeaways
KEY TAKEAWAYS 23 CLDN18.2 is a novel and highly prevalent predictive biomarker in advanced gastric cancer that can be readily detected via IHC6,7 VYLOY is approved for patients with HER2-negative, CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer, which is the third deadliest in
Slide 24: Thank You
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Slide 25: Appendix
APPENDIX PROPRIETARY INFORMATION—FOR USE WITH INVESTORS ONLY. NOT FOR PROMOTIONAL USE.
Slide 26: References
REFERENCES 26 1. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available at https://gco.iarc.fr/today. 2. Yashima K, Shabana M, Kurumi