breast cancer

Oncothyreon and Array BioPharma have started a Phase Ib study of ONT-380 (ARRY-380) in combination with Kadcyla (ado-trastuzumab emtansine or TDM-1) for the treatment of patients with metastatic HER2+ breast cancer.

Discovered by Array, ONT-380 is an orally active, reversible and selective small-molecule HER2 inhibitor being developed in collaboration with Oncothyreon.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

A total of 48 patients who have been previously treated with Herceptin (trastuzumab) and a taxane for metastatic breast cancer will be enrolled in the dose-escalation Phase Ib study.

The primary objective of the trial is to determine the maximum-tolerated and/or recommended Phase II dose (MTD/RP2D) of ONT-380 in combination with the approved dose of Kadcyla, while secondary objectives include an evaluation of the safety and preliminary anti-tumour activity of the combination.

After determination of the MTD/RP2D, the study will include an expansion arm at the MTD/RP2D, as well as an optional second expansion arm in patients with central nervous system metastases.

Oncothyreon chief medical officer Diana Hausman said ONT-380 and Kadcyla are both directed at HER2, but with differing mechanisms of action.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
"The strategy of combining two agents targeting HER2 has previously proven useful in HER2+ breast cancer, and we believe the combination of ONT-380 and Kadcyla is particularly relevant to evaluate as the treatment of metastatic HER2+ breast cancer continues to evolve."

"The strategy of combining two agents targeting HER2 has previously proven useful in HER2+ breast cancer, and we believe the combination of ONT-380 and Kadcyla is particularly relevant to evaluate as the treatment of metastatic HER2+ breast cancer continues to evolve," Hausman said.

ONT-380 was well-tolerated and demonstrated significant dose-related tumour growth inhibition that was superior to Herceptin and Tykerb (lapatinib) in multiple preclinical tumour models.

In these models, ONT-380 showed synergistic or additive tumour growth inhibition when dosed in combination with the standard-of-care therapeutics Herceptin or Taxotere (docetaxel).

Compared with Tykerb and the investigational drug neratinib, ONT-380 showed superior activity, based on overall survival in an intracranial HER2+ breast cancer xenograft model.

The company said that a Phase I trial of ONT-380, with both dose-escalation and expansion components, has been completed in 50 patients, with 43 having HER2+ metastatic breast cancer.

Apart from the Phase Ib trial of ONT-380 in combination with Kadcyla, the company has recently started a second Phase Ib study of ONT-380 in combination with Herceptin and/or Xeloda (capecitabine) in patients with metastatic HER2+ breast cancer.

Image: Breast cancer is more common in women than in men. Photo: courtesy of freedigitalphotos.net.