Policy & Regulation
Genentech's Fixed Dose Subcutaneous Combination of Perjeta and Herceptin Showed Non-Inferiority When Compared to Intravenous Formulations for People With HER2-Positive Breast Cancer
18 September 2019 - - The Phase III FeDeriCa study met its primary endpoint, US-based biotechnology company Genentech, a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY), said.

The study showed a new investigational fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) compared to standard IV infusion of Perjeta plus Herceptin and chemotherapy in people with HER2-positive early breast cancer.

The safety profile of Perjeta and Herceptin FDC was consistent with that of Perjeta and Herceptin administered intravenously.

SC administration of the FDC takes approximately 8 minutes for the initial loading dose, and approximately 5 minutes for each subsequent maintenance dose.

This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions for the combination.

Full data from the FeDeriCa study will be submitted for presentation at an upcoming medical meeting and to health authorities around the world.

FeDeriCa is an international, multi-center, two-arm, randomized, open-label, Phase III study evaluating the pharmacokinetics, efficacy and safety of SC injection of the FDC of Perjeta and Herceptin in combination with chemotherapy, compared with standard IV infusion of Perjeta and Herceptin in combination with chemotherapy in people with HER2-positive eBC who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings.

The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough).

Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pCR, meaning there is no tumor tissue detectable at the time of surgery.

The safety profile of Perjeta and Herceptin FDC was consistent with that of Perjeta and Herceptin administered intravenously.

Breast cancer is one of the most common cancers among women worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019.

Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells.

Approximately 15-20% of breast cancers are HER2-positive based on the result of a diagnostic test.

The FDC of Perjeta and Herceptin is a new SC formulation that combines pertuzumab and trastuzumab with Halozyme Therapeutics' Enhanze drug delivery technology.

Trastuzumab in the FDC is the same monoclonal antibody in IV Herceptin, and pertuzumab is the same monoclonal antibody in IV Perjeta.

The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signaling pathways.

Halozyme's Enhanze drug delivery technology may enable and optimize SC drug delivery for appropriate co-administered therapeutics.

The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan - a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.

Perjeta (pertuzumab) is approved for use in combination with Herceptin (trastuzumab) and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
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