Roche’s Tecentriq demonstrates positive phase 3 results as a subcutaneous injection

Roche has announced results from its phase 3 IMscin001 study assessing Tecentriq (atezolizumab) as a subcutaneous formulation. The results show the formulation met its co-primary endpoints and demonstrated non-inferior levels of Tecentriq in the blood, when injected subcutaneously.

This was compared with an intravenous (IV) infusion in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed.

The safety profile of the subcutaneous formulation was consistent with that of Tecentriq as an IV dose. An additional benefit to injecting Tecentriq subcutaneously is the reduction of time needed for treatment, as the study demonstrated that the treatment time totalled between three to eight minutes per injection, compared to the 30-60 minutes needed for a standard IV infusion.

IMscin001 is a phase 1b/3, global, multicentre, randomised study evaluating the pharmacokinetics – the time for the course of drug absorption, distribution, metabolism, and excretion – safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq. The investigational subcutaneous formulation combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.

Several oncology studies indicate that the majority of cancer patients generally prefer subcutaneous treatment because of reduced pain and discomfort, the ease of administration and the shorter duration of treatment, when compared to IV treatment.

Tecentriq is a cancer immunotherapy that has the potential to be used in combination with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. IV Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer and was the first cancer immunotherapy approved to treat a specific type of early-stage NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).

“By reducing the administration time, this new Tecentriq formulation could help save time for patients and healthcare systems,” said Levi Garraway, Roche’s chief medical officer and head of global product development.

He added: “We are excited by the potential of bringing a subcutaneous cancer immunotherapy to patients globally, delivering on our commitment to improve the treatment experience for patients.”

Roche plans to share its detailed findings of the IMscin001 trial at an upcoming medical meeting and will submit them for regulatory approval to health authorities worldwide, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).