Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Roche’s Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq® (atezolizumab) with Halozyme’s ENHANZE® technology met its co-primary endpoints.
The study showed non-inferior levels of Tecentriq® in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq®.
“These positive results further demonstrate the opportunity for a coformulation of ENHANZE to potentially benefit patients by reducing the treatment time of Tecentriq to 3-8 minutes as a SC delivery from 30-60 minutes for IV treatment,” commented Dr. Helen Torley, president and chief executive officer of Halozyme. “We are delighted to announce these positive results, which represent our second positive Phase III trial announcement this year for our Wave Three products.”
Roche will share detailed findings of the IMscin001 study at an upcoming medical meeting and submit the data for regulatory approval to health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency.
