Roche Gains PD-1 Edge on Merck With FDA Nod for Subcutaneous Tecentriq

 

Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.

The FDA on Friday signed off on the subcutaneous formulation of Roche’s PD-1 blocker Tecentriq—which will carry the brand name Tecentriq Hybriza (atezolizumab and hyaluronidase-tqjs) to differentiate itself from the intravenous version—for the treatment of various cancers.

According to Roche, Tecentriq Hybriza is the first and only PD-(L)1 blocker approved for subcutaneous use in the U.S. Tecentriq Hybriza is indicated for all cancers that its intravenous formulation is, including several different types of skin, liver, lung and soft-tissue cancers.

Roche CMO Levi Garraway in a statement said that the approval of Tecentriq Hybriza “builds on the established safety and efficacy of intravenous Tecentriq.” The subcutaneous formulation “can treat patients faster and in more accessible settings” and “offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Garraway said.

To enable subcutaneous administration, Tecentriq Hybriza leverages Halozyme Therapeutics’ Enhanze technology, which uses its patented recombinant hyaluronidase PH20 enzyme, which digests hyaluronan proteins beneath the skin to improve fluid flow in the subcutaneous space. In turn, this effect allows large volumes of fluids to be injected under the skin, while also boosting its dispersion and absorption.

Through this technology, Tecentriq Hybriza takes approximately seven minutes to be administered, while an intravenous infusion of Tecentriq usually takes 30 minutes to 60 minutes.

In the Phase Ib/III IMscin001 study, a subcutaneous injection of Tecentriq reached comparable levels of the drug in the blood as its intravenous formulation, with similar safety and efficacy profiles.

Roche also included results from the Phase II IMscin002 study in its application, highlighting that 71% of patients preferred the Hybriza formulation versus intravenous treatment. Convenience—including less time in the clinic, comfort and lower emotional distress—was the most common reason for this preference.

With Friday’s approval, Roche carves out a niche for its PD-1 inhibitor in a market dominated by Merck’s Keytruda (pembrolizumab). In 2023, Tecentriq generated approximately $4.45 billion, while Keytruda easily retained its PD-1 leadership with more than $25 billion in revenue.

Roche has struggled to keep up with Keytruda in cancer, with a late-stage defeat in July 2024. Results from the Phase II/III SKYSCRAPER-06 showed that Tecentriq plus an investigational anti-TIGIT antibody tiragolumab had reduced efficacy in terms of progression-free survival, compared with Keytruda plus chemotherapy.

The trial, which was testing Roche’s investigational regimen for the first-line treatment of non-small cell lung cancer, has since been discontinued.

Merck is hot on Roche’s heels with a subcutaneous formulation of Keytruda in a Phase III study, which is scheduled for completion in late 2026.

https://www.biospace.com/fda/roche-gains-pd-1-edge-on-merck-with-fda-nod-for-subcutaneous-tecentriq