HER2 Positive Cancer Treatment Moves Into Expansion Study

Zymeworks Inc. has recently began enrollment for an expansion cohort of the Phase 1 trial of ZW49. ZW49 is an antibody-drug conjugate (ADC) that targets HER2 positive cancer cells. This expansion comes after positive results from the dose escalation portion of the Phase 1 study.

About ZW49

Using Zymeworks’ proprietary ZymeLink and Azymetric platforms, ZW49 targets cancer cells that are positive for HER2 expression. The creators of this treatment took the design of zanidatamab and paired it with a cytotoxin and cleavable linker, allowing for the enhanced killing of tumor cells and internalization.

In terms of safety and tolerability, there have been

  • No toxicities that stop dose escalation
  • No pulmonary toxicities related to treatment
  • No liver toxicities related to treatment
  • No hematologic toxicities related to treatment
  • No treatment-related deaths

For the adverse events that did arise, over 90% were mild to moderate in severity. The most common are diarrhea, fatigue, keratitis, all of which can either be reversed or managed. Nobody has discontinued treatment.

Data from Phase 1

The dose escalation portion of the Phase 1 study utilized a 3 + 3 design, escalating doses either once every other week or once every three weeks. The purpose of this study was to find a dose and dosing schedule to use in expansion cohorts.

Many patients across the US and Canada were included in this study. They all had HER2-positive malignancies, such as anal cancer, non-small cell lung cancer, breast cancer, colorectal cancer, gastroesophageal adenocarcinoma, and gynecologic cancers.

In terms of data, ZW49 has demonstrated anti-tumor activity throughout all regimens and doses. A number of patients have achieved a partial response or stable disease. These positive results are very encouraging, and researchers are excited to “fully realize the therapeutic potential” of this drug.

About the Expansion Study

There will be three indication-specific cohorts in the expansion study, all of which will administer 2.5 mg/kg of ZW49 every three weeks. They are currently open for enrollment. There are currently sites across the United States and Canada, but sites are expected to open in South Korea and Australia as well.

As ZW49 has shown anti-tumor activity, a favorable safety profile, and no dose limitations, researchers are very excited to move forward in the clinical trial process. They hope that this treatment continues to perform successfully.

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