Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody. Zanidatamab in combination with palbociclib and fulvestrant was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive HR+ breast cancer. A poster with an updated and expanded data set will be presented at SABCS taking place in San Antonio, Texas and virtually on December 6-9, 2022.
Abstract highlights from the February 24, 2022 data cut:
- Thirty-four heavily pretreated patients with HER2-positive HR+ breast cancer were treated with zanidatamab in combination with palbociclib and fulvestrant.
- The confirmed objective response rate was 34.5% and the disease control rate was 93.1% in 29 response-evaluable patients.
- Ongoing durable responses were seen out to 14.9+ months, with 18 patients still on treatment at the time of the data cut.
- Treatment-related adverse events were generally consistent with previous reports of zanidatamab and/or chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.
- This regimen has the potential to be a chemotherapy-free treatment option in patients with HER2-positive HR+ metastatic breast cancer.
The abstract is available on the SABCS conference website. The spotlight poster presentation will be available on Friday, December 9 at 7:00 am Central Time (CT) to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.
Title: Treatment of HER2-positive (HER2+) hormone-receptor positive (HR+) metastatic breast cancer (mBC) with the novel combination of zanidatamab, palbociclib, and fulvestrant
Lead Author: Santiago Escrivá-de-Romani, MD, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital; Barcelona, Spain
Program Number: PD18-10
Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2 and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.
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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