Just in time for the first day of ESMO, the FDA has approved its first-ever subcutaneous immunotherapy targeting PD-L1 for cancer.
The new formulation of Roche’s Tecentriq — to be marketed as Tecentriq Hybreza — can be injected into the skin in just seven minutes, compared with the 30 to 60 minutes needed for standard intravenous infusion with Tecentriq. Importantly, Tecentriq Hybreza will be marketed for all the same indications as IV Tecentriq in adults, including more than 10 forms of lung, liver, skin and soft tissue malignancies, according to a Friday release.
In the first half of the year, Tecentriq IV sales totaled CHF1.79 billion ($2.12 billion).
Before Tecentriq Hybreza, the US was behind in having a subcutaneous PD-L1 immunotherapy on the market. In September 2023, Roche said it had to refile its FDA application to update its CMC processes. Tecentriq SC was first greenlit in the UK in August 2023 and is now approved in more than 50 countries.
The approval of a subcutaneous approach can not only speed up treatment and improve access, but could also extend the patent life for immunotherapies that are bracing for potential biosimilar competition in the future. Apart from Tecentriq, there are no other subcutaneous PD-L1 targeting immunotherapies approved anywhere in the world.
Roche’s FDA approval was supported by results from the 438-participant Phase 1b/3 IMscin001 trial in people with pretreated locally advanced or metastatic non-small cell lung cancer. These data showed Tecentriq Hybreza produced “comparable levels” of active ingredient in the blood and displayed a risk-benefit profile “consistent with” the original version of the drug.
Tecentriq Hybreza was co-formulated using Halozyme’s ENHANZE drug delivery technology, which has been licensed by other drugmakers, including Takeda, Pfizer and Eli Lilly. Bristol Myers Squibb is also using ENHANZE for a subcutaneous version of its PD-1 drug Opdivo. That formulation is under FDA review with a PDUFA date set for Dec. 29.
Merck is also developing a subcutaneous formulation of its PD-1 Keytruda. Back in February, the company said that an approval could potentially help it extend the patent life of its blockbuster drug, which is set to face IV biosimilar competition starting in 2028.
Editor’s note: The story and headline have been corrected to say that Tecentriq is a PD-L1.