Phase III FeDeriCa study of Perjeta + Herceptin meets secondary endpoint in breast cancer.- Genentech/Roche + Halozyme Therapeutics

Halozyme Therapeutics announced that new data from the global phase III FeDeriCa study conducted by Genentech/Roche will be presented at the 2019 San Antonio Breast Cancer Symposium (SABCS). The FeDeriCa study investigated a fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) for subcutaneous administration using Halozyme's ENHANZE drug delivery technology in combination with intravenous (IV) chemotherapy. The FeDeriCa study has already been shown to meet its primary endpoint, with subcutaneous administration of the FDC showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough) when compared to IV administration of Perjeta. The geometric mean ratio (GMR; a type of average used when assessing pharmacokinetics) for the primary endpoint was 1.22 (90% CI: 1.14 to 1.31), with the lower limit of the 90% CI of the GMR=1.14?0.80 (the pre-specified non-inferiority margin).

A secondary endpoint of non-inferior Ctrough of Herceptin was also met, with blood concentrations for people receiving the FDC non-inferior to those receiving IV Herceptin (GMR=1.33 [90% CI: 1.24 to 1.43]; lower limit of 90% CI of GMR=1.24?0.80). A non-inferiority endpoint was chosen for the study to ensure that people were receiving sufficient dosing with Perjeta and Herceptin as compared to the established IV doses at the same treatment intervals. In addition, rates of total pathological complete response (pCR), a secondary endpoint, were comparable between the treatment arms, with 59.7% of patients receiving the FDC and 59.5% of patients treated with IV Perjeta and Herceptin achieving a total pCR � a difference of 0.15% (95% CI: -8.67 to 8.97).

The safety profile of the FDC in combination with chemotherapy was comparable to that of IV administration of Perjeta plus Herceptin and chemotherapy and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia.