Biopharmaceutical company Halozyme Therapeutics, Inc. announced today that Roche has completed patient enrollment for the pivotal Phase III study of Herceptin SC. The compound is a subcutaneous formulation that uses Halozyme’s Enhanze technology.
The Phase III trial is a randomized, open-label, non-inferiority design that has enrolled 595 patients with early stage HER2-positive breast cancer. The study will evaluate two primary endpoints that compare Herceptin administered IV and SC for complete pathologic response between treatment cycles 8 and 9 and serum concentration during the first 8 cycles. Secondary endpoints will also be measured in this investigational study including an evaluation of safety and tolerability.
In the study, patients will receive chemotherapy concurrent with either Herceptin intravenous (IV) or Herceptin SC every three weeks for the first 8 cycles. Halozyme’s subcutaneous alternative is expected to take less than five minutes to administer and should allow patients with HER2-positive breast cancer to receive their treatment in their physician’s office or potentially at home without having to go to a hospital.
Gregory Frost, Ph.D., Halozyme’s president and CEO, commented, “The timely completion of patient enrollment for this multicenter Phase III clinical trial marks a significant achievement for the Herceptin SC development program and exemplifies the full support and commitment of the Halozyme-Roche alliance to offering patients more advanced treatment options. Herceptin SC has the potential to offer both patient benefits and treatment efficiencies, and I congratulate the team on this important accomplishment.”