CHMP recommends new immunotherapy delivery method

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq^® (atezolizumab). Roche’s monoclonal antibody cancer immunotherapy was recommended for all indications in which Tecentriq intravenous (IV) has been previously approved, including certain lung, liver, bladder and breast cancer types. As Roche’s fourth subcutaneous cancer therapy, Tecentriq SC received its first marketing authorisation in Great Britain.

The CHMP’s recommendation brings us a step closer to offering the first subcutaneous programmed death ligand-1 (PD-L1) cancer immunotherapy treatment to patients in the EU"

“Tecentriq has helped to treat more than 430,000 people diagnosed with some of the most aggressive forms of cancer,” stated Dr Levi Garraway, PhD, Chief Medical Officer and Head of Global Product Development at Roche. “Subcutaneous administration offers a faster and more convenient alternative to IV infusion.”

Roche highlighted that Tecentriq SC can be injected in approximately seven minutes. “The CHMP’s recommendation brings us a step closer to offering the first subcutaneous programmed death ligand-1 (PD-L1) cancer immunotherapy treatment to patients in the EU,” Dr Garraway added.

Evidence of efficacy for subcutaneous injection of Tecentriq

The CHMP’s positive opinion is based on pivotal data from the Phase IB/III IMscin001 study. The findings revealed that when administered subcutaneously, compared to the IV formulation, the medicine facilitated comparable levels of Tecentriq in the blood, alongside a consistent safety and efficacy profile.

Having enrolled 371 patients, the clinical trial compared Tecentriq SC 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.

At the recent European Society for Medical Oncology (ESMO) Congress 2023, Roche presented mature overall survival (OS) data with a median follow-up of 9.5 months from the study. 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 final decision on the approval of Tecentriq SC formulation from the European Commission (EC) is anticipated soon.

https://www.europeanpharmaceuticalreview.com/news/186124/roche-subcutaneous-cancer-immunotherapy-granted-mhra-approval/