Genentech: Subcutaneous Perjeta/Herceptin Combo Comparable to IV

By Colin Kellaher

Roche Holdings AG's (ROG.EB) Genentech unit on Thursday said a fixed-dose combination of Perjeta and Herceptin administered by subcutaneous injection showed non-inferior pharmacokinetics and comparable efficacy and safety to standard intravenous infusions while significantly reducing the time spent receiving treatment in patients with HER2-positive early breast cancer.

Genentech said the study met its primary endpoint, with subcutaneous administration of the combination showing non-inferior levels of Perjeta in the blood when compared to IV administration of Perjeta.

A secondary endpoint of non-inferior levels of Herceptin was also met.

Genentech said subcutaneous administration of the combination takes about eight minutes for the initial loading dose and roughly five minutes for subsequent maintenance doses, compared with 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and 60 to 150 minutes for subsequent infusions.

Genentech, which noted that the new subcutaneous formulation combines Perjeta and Herceptin with Halozyme Therapeutics Inc.'s (HALO) Enhanze drug-delivery technology, said it plans to submit the study data to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

December 12, 2019 11:29 ET (16:29 GMT)

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