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Metastatic Breast Cancer Therapy Gains Fast Track Designation

Trastuzumab Deruxtecan Improves Survival in HER2-Positive Breast Cancer

Interim results from a phase 3 clinical trial comparing trastuzumab deruxtecan to trastuzumab emtansine (T-DM1) found the former provided significant benefits for patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

The DESTINY-Breast03 trial of more than 500 patients met the primary endpoint of progression-free survival with trastuzumab deruxtecan, showing a statistically significant and clinically meaningful improvement compared to T-DM1, according to a release from the manufacturer.

Results trended toward improved overall survival, though in the release the manufacturer said data on that endpoint “are still immature.”

The safety profile for trastuzumab deruxtecan was consistent with previous studies. So far, the trial has shown no new safety concerns and no grade 4 or 5 treatment-related interstitial lung disease events.

“These transformative progression-free survival results demonstrate the superiority of [trastuzumab deruxtecan] compared to T-DM1, and the encouraging safety data may open future opportunities to bring this benefit to patients in earlier treatment settings,” Susan Galbraith, Executive Vice President, Oncology R&D of AstraZeneca said in the release.

Trastuzumab deruxtecan is currently approved in Canada, the EU, Israel, Japan, the UK, and the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who received two or more prior anti-HER2-based regimens in the metastatic setting, according to the release.

The medication is being studied “across multiple HER2-targetable cancers, including breast, gastric, lung, and colorectal cancers.”

A higher dosage (6.4mg/kg) is also approved in Israel, Japan and the US to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who received a prior trastuzumab-based regimen.

Reference:
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/enhertu-head-to-head-trial-meets-primary-endpoint.html

Images: Getty Images, Pixabay

By Adam Hochron

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