Racing Merck and Pfizer, Roche readies to file subcutaneous Tecentriq after posting phase 3 data

Roche has taken the lead in the race to bring subcutaneous checkpoint inhibitors to market in the West, reporting phase 3 results that tee it up to file for approval in the U.S. and the EU.

The potential for subcutaneous delivery to slash the time needed to administer PD-1/L1 checkpoint inhibitors has attracted multiple companies. Late last year, Chinese authorities approved a locally developed product. In the West, Merck and Pfizer are running phase 3 trials with estimated primary completion dates in 2023 and 2024, respectively. 

Roche wrapped up a phase 3 trial of its subcutaneous candidate earlier this year. Tuesday, the Swiss drugmaker revealed the clinical trial of 437 non-small cell lung cancer patients found the subcutaneous and intravenous formulations resulted in similar levels of checkpoint inhibitor Tecentriq in the blood.

With the study meeting its co-primary endpoints, Roche is preparing to submit the subcutaneous candidate for approval in the U.S. and the EU. Roche expects subcutaneous administration to take three to eight minutes per injection compared to 30 to 60 minutes for standard intravenous infusion.

“By reducing the administration time, this new Tecentriq formulation could help save time for patients and healthcare systems,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a statement. “We are excited by the potential of bringing a subcutaneous cancer immunotherapy to patients globally, delivering on our commitment to improve the treatment experience for patients.”

Roche developed the formulation by combining its PD-L1 checkpoint inhibitor Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology. Enhanze is based on a recombinant enzyme that temporarily degrades hyaluronan in the subcutaneous space to increase permeability and enable the drug to enter the bloodstream quickly. The technology already enables other subcutaneous formulations such as Johnson & Johnson’s Darzalex Faspro.