Roche completes enrollment in Herceptin SC Phase 3 trial for HER2-positive breast cancer

Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced that Roche has completed patient enrollment for the pivotal Phase 3 study of Herceptin SC (trastuzumab subcutaneous), a subcutaneous formulation that uses Halozyme's Enhanze™ technology (rHuPH20, recombinant human hyaluronidase). Patients in the study receive chemotherapy concurrent with either Herceptin intravenous (IV) or Herceptin SC every three weeks for the first 8 cycles. Herceptin is approved to treat HER2-positive breast and gastric cancer and currently is given intravenously over 30 to 90 minutes. This innovative 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.

"The timely completion of patient enrollment for this multicenter Phase 3 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," said Gregory Frost, Ph.D., Halozyme's president and CEO. "Herceptin SC has the potential to offer both patient benefits and treatment efficiencies, and I congratulate the team on this important accomplishment."

The Phase 3 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. Additional information about this Phase 3 trial can be found at clinicaltrials.gov and roche-trials.com.