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TECENTRIQ (atezolizumab) was initially approved as an intravenous (IV) infusion for use either as a single agent and/or in combination with other therapies in a number of indications at a dose of 1200 mg as an IV infusion every three weeks (q3w).
In May 2019, a supplemental Biologics Licensing Application (sBLA) was approved to register the 840-mg every 2 weeks (q2w) and 1680-mg every 4 weeks (q4w) IV dosing regimens when TECENTRIQ is administered as a single agent, in addition to the previously approved 1200-mg IV q3w dosing schedule, to provide greater convenience and flexibility in patient care. In lieu of clinical data with the 840-mg q2w and 1680-mg q4w dosing regimen in pivotal trials, this application demonstrated flat exposure-response (ER)‑relationship for efficacy and safety, comparable exposure across the alternative IV dosing regimens (840-mg q2w, 1200-mg q3w, and 1680-mg q4w) based on virtual trial simulations, and similar safety profiles based on eight monotherapy studies.
In order to further optimize the administration of TECENTRIQ and improve the treatment experience and convenience for patients and healthcare providers in light of the COVID-19 pandemic, Genentech pursued a new sBLA for the inclusion of 840-mg q2w, 1200-mg q3w, and 1680-mg q4w IV dosing regimens when atezolizumab is administered in the combination setting. With a similar approach to the monotherapy setting, PK modeling and simulation and safety analyses were the basis for the new application and reviewed in more detail below.
As of Feb 2021, the atezolizumab sBLA to include additional flexible dosing regimens (840 mg Q2W, 1200 mg Q3W and 1680 mg Q4W) for all currently approved combination indications (including 1L NSCLC, 1L SCLC, 1L mTNBC, 1L HCC, and 1L melanoma) has been approved.
We used modeling approaches to (1) simulate alternative dosing regimens without conducting a separate trial and (2) extrapolate the new dose to be used across the different cancer indications. This was also a cost effective way to bring treatment options to patients.
To serve our pharma vision and patient community, patients can now receive their atezolizumab treatment in the combination setting every four weeks, instead of every two, or every three, providing patients with greater flexibility, reducing healthcare visits during the COVID-19 pandemic, and alleviating healthcare costs to society.
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