Zymeworks Inc. · NASDAQ:ZYME
Zymeworks — Technical Presentation (November 2020)
13 slides from Zymeworks's technical presentation, Nov 16, 2020
Slide 1: Zanidatamab (ZW25) in HER2-expressing Gastroesophageal Adenocarcinoma (GEA): Results from a Phase 1 Study
Zanidatamab (ZW25) in HER2-expressing Gastroesophageal Adenocarcinoma (GEA): Results from a Phase 1 Study Funda Meric-Bernstam1; Erika Hamilton2; Murali Beeram3; Diana Hanna4; Anthony El-Khoueiry4; Yoon-Koo Kang 5; Keun-Wook Lee6; Jeeyun Lee7; Sun Young Rha8; Jose Chaves 9; Do-Youn Oh; Rachel Goodwi
Slide 2: Background
Background • Human epidermal growth factor receptor 2 (HER2) is overexpressed in ~20% of gastroesophageal adenocarcinoma (GEA)1,2 • For patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma: • trastuzumab in combination with chemotherapy is the only approve
Slide 3: ZW25-101 (NCT02892123)
ZW25-101 (NCT02892123) Key Study Objectives • To characterize the safety and tolerability, and potential anti-tumor effects of zanidatamab, both as monotherapy and in combination with select chemotherapy Patient Population • Patients with HER2-expressing cancers, including GEA • Progression after st
Slide 4: Study Design (GEA Focused)
Study Design (GEA Focused) BID=twice daily; DLT=dose-limiting toxicity; GEA=gastroesophageal adenocarcinoma; IV=intravenous; MTD=maximum -tolerated dose; PS=performance status; QW=weekly; Q2W=every 2 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; RD=recommended dose; wks=weeks. PRESENTE
Slide 5: GEA Patient Characteristics
GEA Patient Characteristics • The majority of patients had received at least two prior systemic regimens, including trastuzumab Zanidatamab Zanidatamab + Chemotherapy Combination Monotherapy a Zanidatamabb + Pac Zanidatamabc + Cape (N = 35) (N = 11) (N = 17) Median age, year (range) 62 (24–86) 61 (2
Slide 6: Safety: Treatment-related AEs
Safety: Treatment-relateda (AEs) • The majoritya of treatment-related b AEs were Grade 1 or 2 in severity and manageable in the outpatient setting Zanidatamab Zanidatamab + Chemotherapy Combination Monotherapy Zanidatamab + Pac Zanidatamab + Cape (N = 35) (N = 11) (N = 17) Any Grade 3 Any Grade 3 An
Slide 7: Anti-tumor Activity: Zanidatamab Monotherapy
Anti-tumor Activity: Zanidatamab Monotherapy Tumor shrinkage observed in majority of patients with response-evaluable measurable disease E=esophageal; FISH=fluorescence in situ hybridization; G=gastric; IHC=immunohistochemistry; J=gastroesophageal junction; K=T-DM1; N=Neratinib; T=trastuzumab; Tx=tr
Slide 8: Duration of Treatment: Zanidatamab Monotherapy
Duration of Treatment: Zanidatamab Monotherapy Duration of Treatment (c)PR=(confirmed) partial response; E=esophageal; FISH=fluorescence in situ hybridization; G=gastric; IHC=Immunohistochemistry; J=gastroesophageal junction; K=T-DM1; N=Neratinib; PD=progressive disease; SD=stable disease; T=Trastuz
Slide 9: Anti-Tumor Activity: Zanidatamab + Chemotherapy
Anti-Tumor Activity: Zanidatamab + Chemotherapy Tumor shrinkage observed in majority of patients with response-evaluable measurable disease E=esophageal; FISH=fluorescence in situ hybridization; G=gastric; IHC=immunohistochemistry; J=gastroesophageal junction; K=T-DM1; N=Neratinib; T=Trastuzumab; Tx
Slide 10: Duration of Treatment: Zanidatamab + Chemotherapy
Duration of Treatment: Zanidatamab + Chemotherapy Duration of Treatment (c)PR=(confirmed) partial response; CR=complete response; FISH=fluorescence in situ hybridization; IHC=Immunohistochemistry; PD=progressive disease; SD=stable disease; T=Trastuzumab; Tx=treatment. ▼, Clinical progression; *, Dea
Slide 11: Disease Response per RECIST 1.1 in Response-Evaluable Patients
Disease Response per RECIST 1.1 in Response- Evaluablea Patients Zanidatamab Zanidatamab + Chemotherapy Combination Monotherapy Zanidatamab + Pac Zanidatamab + Cape Combo Total (N = 33) (N = 10) (N = 14) (N = 24) Confirmed objective response b, n (%) 11 (33) 5 (50) 8 (57) 13 (54) Complete response 0
Slide 12: Conclusions
Conclusions • Zanidatamab is well tolerated with promising anti-tumor activity in patients with HER2-expressing GEA that has progressed after prior therapies, including HER2-targeted agents • The majority of the treatment-related AEs were Grade 1 or 2 and manageable in the outpatient setting • Durab
Slide 13: Acknowledgments and Other Information
Acknowledgments and Other Information Acknowledgments We sincerely thank all patients and their families. Thanks to all the investigators, clinical trial researchers, personnel and staff who contributed to the trial in any way. Thanks also to Dr. Michael Press and Ms. Ivonne Villalobos at USC Medica