Zymeworks Inc. · NASDAQ:ZYME
Zymeworks — Technical Presentation (August 2023)
15 slides from Zymeworks's technical presentation, Aug 10, 2023
Slide 1: Results from the Pivotal Phase 2b HERIZON-BTC-01 Study: Zanidatamab in HER2-amplified BTC
Results from the Pivotal Phase 2b HERIZON-BTC-01 Study: Zanidatamab in Previously-treated HER2-amplified Biliary Tract Cancer (BTC) Shubham Pant, MD1; Jia Fan, MD, PhD2; Do-Youn Oh, MD, PhD3; Hye Jin Choi, MD, PhD4; Jin Won Kim, MD, PhD5; Heung-Moon Chang, MD, PhD6; Lequn Bao, MD7; Sun Huichuan, MD,
Slide 2: Unmet Need in Patients with Biliary Tract Cancer (BTC)
2 Unmet Need in Patients with Biliary Tract Cancer (BTC) • BTC is uncommon (< 1% of all adult cancers)1,2 • For patients with locally advanced/metastatic BTC, standard 2L+ offers limited clinical benefit ORR 5 – 15%3,4 mPFS 4.0 mo3 • HER2 amplification/overexpression is observed in a subset of B
Slide 3: Zanidatamab is a HER2-targeted Bispecific Antibody with a Unique Mechanism of Action
Zanidatamab is a HER2-targeted Bispecific Antibody with a 3 Unique Mechanism of Action (MOA) • Zanidatamab simultaneously binds 2 separate HER2 molecules in trans1 • Unique binding properties of zanidatamab to HER2 result in multiple MOAs1 • Preclinical studies demonstrate greater activity than tras
Slide 4: HERIZON-BTC-01 Study Design
4 HERIZON-BTC-01 Study Design • Phase 2b study of zanidatamab monotherapy in patients with HER2-amplified BTC Key Eligibility Criteria • Locally advanced or metastatic BTC1 • Tissue required to confirm HER2 status by central lab • Progressed after treatment with a gemcitabine-containing regimen • No
Slide 5: Enrollment
5 Enrollment • Enrollment: September 2020 – March 2022 • Sites: 32 in Asia, Europe, North America, & South America • Data cutoff date for the primary analysis: 10 October 2022 • Study is ongoing but recruitment is complete: 87 patients treated Cohort 1: 80 patients Cohort 2: 7 patients HERIZON-B
Slide 6: Demographics and Baseline Disease Characteristics (Cohort 1)
6 Demographics and Baseline Disease Characteristics (Cohort 1) (N = 80) (N = 80) Age, years, median (range) 64 (32, 79) Disease stage at Stage III 9 (11.3) Sex: Female, n (%) 45 (56.3) baseline, n (%) Stage IV 71 (88.8) Race, n (%) Asian 52 (65.0) Prior therapies in the locally White 23 (28.8) advan
Slide 7: Disease Response in Patients with HER2-positive BTC (Cohort 1)
Disease Response in Patients with HER2-positive BTC 7 (Cohort 1) • 16 patients had ongoing responses at the time of data cutoff By ICR By Investigator Assessment Assessment (N = 80) (N = 80) cORR, % (95% CI) 41.3 (30.4, 52.8) 41.3 (30.4, 52.8) Confirmed BOR, n (%) CR 1 (1.3) 4 (5.0) PR 32 (40.0) 29
Slide 8: Majority of evaluable patients had a decrease in target lesions (Cohort 1)
Majority of evaluable patients (68.4%) had a decrease in target 8 lesions (Cohort 1) 120 100 Percent change from baseline in sum of diameters 80 * * 60 40 ** * * * 20 ** * 0 ** -20 * * * -40 ** -60 -80 -100 BTC subtype: GBC ICC ECC *Indicates patients with IHC 2+ status; all other patients had IHC s
Slide 9: Treatment Duration for Patients with Response or Stable Disease per RECIST v1.1
Treatment Duration for Patients with Response (CR or PR) or 9 Stable Disease per RECIST v1.1 by ICR (Cohort 1) N=80 Median duration of response, months (range) 12.9 (1.5, 16.9+) Median time to first response, months (range) 1.8 (1.6, 5.5) Patients Median duration of follow-up, months (range) 12.4 (7
Slide 10: Progression-free Survival in Patients with HER2-positive BTC (Cohort 1)
Progression-free Survival in Patients with HER2-positive BTC 10 (Cohort 1) • OS data not yet mature 1.0 0.9 Median PFS, months (range) 5.5 (0.3 – 18.5) 0.8 Progression-free survival probability 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0 2 4 6 8 10 12 14 16 18 20 Number of patients at risk: Time from treatmen
Slide 11: Adverse Events
11 Adverse Events Cohort 1 (N = 80) Total (N = 87) • 2 TRAEs led to zanidatamab Any Grade Grade ≥ 3 Any Grade Grade ≥ 3 discontinuation: Any TEAE, n (%) 78 (97.5) 46 (57.5) 84 (96.6) 52 (59.8) 1 Grade 2 ejection Any TRAE, n (%) 61 (76.3) 15 (18.8) 63 (72.4) 16 (18.4) fraction decreased 1 Grade 3
Slide 12: Adverse Events of Special Interest (AESI)
12 Adverse Events of Special Interest (AESI) Cohort 1 (N = 80) Total (N = 87) Any Grade Grade ≥ 3 Any Grade Grade ≥ 3 AESI, n (%) IRR 28 (35.0) 1 (1.3) 29 (33.3) 1 (1.1) Confirmed cardiac events 5 (6.3) 3 (3.8) 5 (5.7) 3 (3.4) Non-infectious pulmonary toxicities 1 (1.3) 1 (1.3) 1 (1.1) 1 (1.1) Selec
Slide 13: Conclusions
13 Conclusions • Zanidatamab demonstrated antitumor activity, including rapid and durable responses, in patients with treatment-refractory HER2-positive BTC cORR per ICR of 41.3%; most responses were identified at first disease assessment Median DOR: 12.9 months • Zanidatamab demonstrated a mana
Slide 14: Acknowledgement, Disclosure
14 Acknowledgement, Disclosure We sincerely thank all patients and their caregivers. Thanks to all the investigators, clinical trial researchers, personnel and staff who contributed to the trial in any way. The HERIZON-BTC-01 study is funded by Zymeworks BC Inc., Jazz Pharmaceuticals, Inc., and BeiG
Slide 15: Full Publication – The Lancet Oncology
15 Full Publication – The Lancet Oncology • www.thelancet.com/oncology • Published online June 2, 2023 https://doi.org/10.1016/S1470-2045(23)00242-5 PRESENTED BY: Shubham Pant, MD