Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes.- Roche

Injecting Tecentriq subcutaneously (under the skin) takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq SC will be available to patients in Great Britain for all indications in which the IV formulation of Tecentriq has been previously approved, including certain types of lung, bladder, breast and liver cancer.

Tecentriq SC is Roche’s fourth subcutaneous cancer therapy. Multiple oncology studies suggest that the majority of cancer patients generally prefer SC over IV administration due to reduced discomfort, ease of administration and shorter duration of treatment.

“Cancer immunotherapy has transformed the way we treat cancer. Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are working with health authorities globally to bring this option to many more patients around the world.”

The MHRA regulatory approval is the first for Tecentriq SC worldwide. It is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.While the IMscin001 trial was conducted within the hospital setting, Tecentriq SC may be suitable for out of hospital administration by a healthcare professional.

For Northern Ireland, the Tecentriq SC marketing authorisation application is currently under assessment by the European Medicines Agency (EMA). Evaluations by the FDA and other health authorities globally are also ongoing.

In August 2022, part 2 of the study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum C trough and model-predicted area under the curve. Efficacy, as measured by the overall response rate and progression-free survival, was similar between the SC and IV treatment arms and consistent with the known profile of Tecentriq IV. The safety profile of Tecentriq SC was also consistent with that of Tecentriq IV.