Roche announced that the European Commission has granted marketing authorisation for Tecentriq SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous (under the skin) injection.
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Last year, more than 38,000 people in the EU received Tecentriq to treat different types of lung, liver, bladder and breast cancer.
Until now, Tecentriq has been given directly into patients’ veins by IV infusion which takes approximately 30-60 minutes.
The new subcutaneous injection will cut treatment time to approximately seven minutes, with most injections taking between four and eight minutes. The marketing authorisation applies to all approved indications of Tecentriq IV.
The approval 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.
90% of healthcare professionals who were surveyed as part of the study agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation.
In addition to offering shorter treatment time, Tecentriq SC may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient's home, depending on national regulations and health systems.
Roche is in discussion with several providers in Europe to include Tecentriq SC in cancer homecare initiatives where possible.
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.
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, progression-free survival, overall survival and duration of response, 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. ■