Roche's Tecentriq Gains First US Approval for Subcutaneous PD-1

Just in time for the commencement of the ESMO event, the FDA has approved its first subcutaneous immunotherapy targeting PD-1 for cancer treatment. This new formulation of Roche’s Tecentriq, named Tecentriq Hybreza, can be administered via injection into the skin in merely seven minutes, significantly reducing the time compared to the 30 to 60 minutes required for the conventional intravenous (IV) infusion of Tecentriq. Notably, Tecentriq Hybreza will be available for all the same medical indications as the IV version, which includes more than ten types of lung, liver, skin, and soft tissue cancers.

In the first half of the year, Tecentriq IV generated sales amounting to CHF1.79 billion ($2.12 billion). Prior to the approval of Tecentriq Hybreza, the United States did not have any subcutaneous PD-1 immunotherapy available in the market. In September 2023, Roche had to resubmit its FDA application to update its Chemistry, Manufacturing, and Controls (CMC) processes. Tecentriq SC first received approval in the United Kingdom in August 2023 and is now authorized for use in over 50 countries.

The subcutaneous approach's approval is expected to accelerate treatment times and improve patient accessibility. Additionally, it has the potential to extend the patent life of immunotherapies, which are preparing to face possible biosimilar competition in the near future. Besides Tecentriq, there are no other subcutaneous PD-1 targeting immunotherapies approved anywhere globally.

Roche’s FDA approval was backed by results from the Phase 1b/3 IMscin001 trial, which involved 438 participants with pretreated locally advanced or metastatic non-small cell lung cancer. The data indicated that Tecentriq Hybreza produced "comparable levels" of the active ingredient in the bloodstream and displayed a risk-benefit profile that was "consistent with" the original IV version of Tecentriq.

Tecentriq Hybreza was co-formulated using Halozyme’s ENHANZE drug delivery technology. This technology has also been licensed by other pharmaceutical companies including Takeda, Pfizer, and Eli Lilly. Bristol Myers Squibb is currently utilizing ENHANZE to develop a subcutaneous version of its PD-1 drug Opdivo. This formulation is under FDA review with an action date set for December 29.

Similarly, Merck is working on a subcutaneous version of its PD-1 drug Keytruda. In February, Merck announced that this new formulation could potentially help extend the patent life of its blockbuster drug, which is expected to face IV biosimilar competition beginning in 2028.