During the COVID-19 pandemic, the Clinical Pharmacology team continued to support programs virtually and we made several changes to programs because of the impact of COVID-19 on our medicines. Three key areas are summarized below.
Phase II Trial Design Updates Guided by Virtual Simulation from Predictive Model
During 2020 and the pandemic, we used model-based virtual trial simulations to impact COVID-19 related clinical trial design decisions. Examples include;
- Model-based formulation bridging to enable aST2 IV dosing in the Phase 2 trial for COVID-19 (Covastil) without additional clinical data.
- Design updates of the aHtrA1 Phase 2 trial in GA (GAllego) and the semorinemab Phase 2 trial in moderate AD (Lauriet) based on predictive PK/PD models, to mitigate the impact of missed patient treatment due to the COVID-19 and ensure the robustness of these Phase 2 trials during the pandemic.
COVID-19 Co-medication Strategy
We developed a co-medication strategy based on evaluation of commonly used COVID-19 medications and their drug-drug interaction risk for PK or PD (QTc), and provided consistent co-med dosing recommendations for all clinical trials during COVID-19 to minimize confounding and risk of our investigational drugs. Example for ipatasertib is provided below for illustration.
More Convenient Dosing Options During COVID-19
With the COVID-19 pandemic, decreases in healthcare facility capacity and social distancing demands more flexible, convenient or at-home administration of therapeutic proteins.
- Tecentriq Flexible Dosing (Q for Combo) sBLA based on virtual trial simulations without running additional clinical trial was submitted in 2020 to include additional dosing regimens (Q2W, Q3W, Q4W) in the Tecentriq USPI for all currently approved combination indications (1L NSCLC, 1L SCLC, 1L mTNBC, 1L HCC, and 1L melanoma) aiming to provide greater convenience and flexibility in patient care, particularly relevant amid the ongoing pandemic.
- Based on our first “PK only Bridging to SC” Phase 3 in the Roche portfolio, PHESGO, fixed-dose combination of Perjeta + Herceptin in one ready-to-use vial for SC administration, was approved 4 months ahead of the PDUFA goal date and gained positive CHMP opinions 1 month ahead of the base case. PHESGO offers a faster, less invasive, and more convenient treatment option that is strongly preferred by patients, together with improved healthcare capacity especially during the pandemic as it can be administered in a treatment center or at a patient’s home.
- Xolair home use sBLA was expedited due to COVID-19 and was submitted weeks earlier than originally planned.
