- Zanidatamab zovodotin shown to have manageable safety profile with encouraging, single-agent anti-tumor activity in patients with HER2+ cancers
- Results to be reviewed in an oral presentation at European Society for Medical Oncology (ESMO) Congress 2022 in Paris Monday, September 12 at 5:25 pm Central European Summer Time (CEST)
VANCOUVER, British Columbia & SEATTLE — Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the release of an abstract by ESMO with preliminary results from the company’s Phase 1 study of zanidatamab zovodotin (ZW49), an investigational novel bispecific HER2 targeted antibody-drug conjugate.
Results from the study entitled “ Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers” will be presented by Komal Jhaveri, MD, FACP, Medical Oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation on Monday, September 12 at 5:25 pm CEST during the ESMO meeting being held September 9-13, 2022, at the Paris Expo Porte de Versailles in Paris, France.
“Treatment of HER2-expressing solid cancers remains an area with significant unmet need, and these preliminary Phase 1 clinical results for zanidatamab zovodotin (ZW49) show that it offers a manageable safety profile and encouraging single-agent anti-tumor activity in patients with advanced disease that has progressed after treatment with standard of care therapies,” said Dr. Jhaveri. “We look forward to continuing enrollment in the trial and to reporting on additional data as it becomes available in the months ahead.”
In an ongoing Phase 1 study of 76 patients with HER2+ cancers including gastric (28%) and breast (22%) cancers, preliminary results show that the majority of treatment related adverse events (TRAEs) were Grade 1 or 2 and included keratitis (42%), alopecia (25%) and diarrhea (21%). Among seven patients who experienced TRAEs of grade 3 or higher, two were grade 4 events including infusion-related reaction and decreased neutrophil count. There were three patient discontinuations associated with TRAEs and no reported treatment-related patient deaths or cases of interstitial lung disease. Results also showed encouraging single-agent anti-tumor activity in heavily pretreated patients with HER2+ cancers, including a confirmed objective response rate of 28% and a disease control rate of 72% in 29 patients treated at a dose of 2.5 mg/kg on an every three week (Q3W) schedule.
“We are excited to share our preliminary results from the ongoing Phase 1 study at ESMO,” said Kenneth Galbraith, Chair and CEO of Zymeworks. “We look forward to Dr. Jhaveri’s presentation of updated study results on September 12th in Paris and discussing the future development of zanidatamab zovodin, on our conference call and webcast following the ESMO presentation.”
Conference Call and Webcast
Zymeworks will host a conference call and webcast on Monday, September 12th at 4:30 pm Eastern Standard Time (EST) to discuss the clinical data presented at ESMO and provide an overview on future clinical development plans for zanidatamab zovodotin. The event will feature a presentation by Komal Jhaveri, MD, FACP, Clinical Oncology, Memorial Sloan Kettering in NYC, and Neil Josephson, M.D., Zymeworks’ Chief Medical Officer. An open question & answer session with all presenters will conclude the event.
Interested parties can access the live webcast via Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations. A recorded replay will be accessible after the event on the Zymeworks website.
Disclosure: Dr. Jhaveri has a consulting relationship with Zymeworks.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, zanidatamab, is a novel Azymetric™ HER2-targeted bispecific antibody currently being evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. Zymeworks’ second clinical candidate, zanidatamab zovodotin (ZW49), is a novel bispecific HER2 ‑targeted antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks’ proprietary ZymeLink™ linker and cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with global biopharmaceutical companies. For more information on our ongoing clinical trials visit www.zymeworksclinicaltrials.com. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.
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