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HALO presenting today onstudy using ENHANZE which CDMO produces:

DATA FROM PHASE 3 TRIAL EVALUATING FIXED-DOSE SUBCUTANEOUS COMBINATION OF PERJETA® AND HERCEPTIN® USING HALOZYME'S ENHANZE® DRUG DELIVERY TECHNOLOGY TO BE PRESENTED AT SAN ANTONIO BREAST CANCER SYMPOSIUM THANX GWEN ...

- Data from Primary Analysis to be Presented in a Spotlight Session Today - - Data Expected to be Submitted to U.S. Food and Drug Administration and to the European Medicines Agency in the Near Term -

SAN DIEGO, Dec. 12, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that new data from the global phase III FeDeriCa study conducted by Genentech, a member of the Roche Group, will be presented today at the 2019 San Antonio Breast Cancer Symposium (SABCS).

The FeDeriCa study investigated a fixed-dose combination (FDC) of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's ENHANZE® drug delivery technology in combination with intravenous (IV) chemotherapy.

The FeDeriCa study met 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).(1)

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). (1)

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. (1)

"We are excited to see these more detailed results from the primary analysis of the FeDeriCa study presented at this important symposium," said Dr. Helen Torley, President and CEO. "We look forward to our partner beginning regulatory submissions in the near term so that patients suffering from HER2-positive breast cancer may have the option to receive Perjeta and Herceptin in a shorter administration time."

These new data from a primary analysis of the FeDeriCa study will be presented in a spotlight session at 7:00 AM CST today at the 2019 San Antonio Breast Cancer Symposium (SABCS) in Texas, US (Abstract #PD4-07).

Subcutaneous administration of the fixed-dose combination of Perjeta® and Herceptin® is approximately 8 minutes for the initial loading dose and approximately 5 minutes for each subsequent maintenance dose. Intravenous administration is approximately 150 minutes for the loading dose of Perjeta® and Herceptin® using standard IV formulations and between 60-150 minutes for subsequent maintenance infusions for the combination.