Data in hand, Roche readies to file subcutaneous Tecentriq

Aug. 2, 2022

Roche announced that its phase 3 study evaluating a subcutaneous formulation of cancer immunotherapy Tecentriq met its co-primary endpoints — and the drugmaker is ready to submit its findings to regulatory agencies.

The IMscin001 study showed non-inferior levels of Tecentriq in the blood, when injected subcutaneously, compared with intravenous infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed.

Normally administered through IV infusion, subcutaneous treatment could reduce pain and discomfort, ease administration and shorten duration of treatment.  According to Roche, administering Tecentriq subcutaneously reduces the treatment time to 3-8 minutes per injection, compared with 30-60 minutes for standard IV infusion.

First approved in 2016, Tecentriq is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, NSCLC, small cell lung cancer, heptatocellular carcinoma and melanoma.

Roche's investigational subcutaneous formulation combines Tecentriq with Halozyme Therapeutics’ proprietary Enhanze drug delivery technology.

Roche isn't the only pharma giant chasing a subcutaneous route for checkpoint inhibitors. Merck is currently in phase 3 trials testing a subcutaneous formulations of its blockbuster checkpoint inhibitor Keytruda. Pfizer began a phase 3 trial of its candidate sasanlimab in late 2019.

Roche said it will share detailed findings of the IMscin001 study at an upcoming medical meeting and submit them for regulatory approval to health authorities globally, including the U.S. FDA and the EMA.