EMA committee recommends approval of Roche subcutaneous injection, Tecentriq for multiple cancer types

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq (atezolizumab). Tecentriq SC can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous (IV) infusion, which can free up time for patients, healthcare teams and caregivers. The CHMP recommended Tecentriq SC for all indications in which Tecentriq IV has been previously approved, including certain types of lung, liver, bladder and breast cancer. A final decision on its approval is expected from the European Commission in the near future.

“Tecentriq has helped to treat more than 430,000 people diagnosed with some of the most aggressive forms of cancer,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development. “Subcutaneous administration offers a faster and more convenient alternative to IV infusion. The CHMP’s recommendation brings us a step closer to offering the first subcutaneous PD-L1 cancer immunotherapy treatment to patients in the EU.”

The CHMP’s positive opinion 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. Roche recently presented mature overall survival (OS) data with a median follow-up of 9.5 months at the European Society for Medical Oncology (ESMO) Congress 2023. The updated analysis confirmed the earlier results and showed that OS and other efficacy endpoints were consistent between the SC and IV treatment arms. A majority of healthcare professionals who were surveyed as part of the study agreed that the SC formulation is easy to administer (90%) and that it could save time for healthcare teams compared with the IV formulation (75%).

Tecentriq SC, which recently received its first marketing authorisation in Great Britain, was developed to provide patients with an alternative to the IV administration of Tecentriq and the potential for treatment outside of the hospital setting. It 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.

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 non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The study enrolled 371 patients.

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 progression-free survival (PFS), objective response rates (ORR) and OS, 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) 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).

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world.

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