If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1
The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2
A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV
Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.1 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.2 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.3 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.1 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%).1
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.4-6 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.
About the IMscin001 study
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.
AAbout Tecentriq SC (subcutaneous)
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).
About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan