Roche announced that Tecentriq SC (atezolizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.
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It will be provided by the National Health Service (NHS) England.
Injecting Tecentriq subcutaneously (under the skin) takes approximately seven minutes, compared with 30 to 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.
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 US Food and Drug Administration (FDA) and other health authorities globally are also ongoing.
IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of Tecentriq SC, compared with Tecentriq IV, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed.
The study enrolled 371 patients.
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 Ctrough 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.
Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
By inhibiting PD-L1, Tecentriq may enable the activation of T-cells.
Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space.
This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream.
Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).
Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS). ■
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