Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

(2019) Y Bi et al.   ANNALS OF ONCOLOGY

A Model of Overall Survival Predicts Treatment Outcomes with Atezolizumab versus Chemotherapy in Non–Small Cell Lung Cancer Based on Early Tumor Kinetics

(2018) Laurent Claret et al.   CLINICAL CANCER RESEARCH

A tumor growth rate/overall survival model for atezolizumab as an early predictor of OS in patients with first or second line metastatic urothelial carcinoma.

(2018) Rene Bruno et al.   JOURNAL OF CLINICAL ONCOLOGY

Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial

(2018) Thomas Powles et al.   LANCET

Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer

(2018) Daniel P. Petrylak et al.   JAMA Oncology

Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study

(2018) Leora Horn et al.   EUROPEAN JOURNAL OF CANCER

A six-weekly (Q6W) dosing schedule for pembrolizumab based on an exposure-response (E-R) evaluation using modeling and simulation.

(2018) Mallika Lala et al.   JOURNAL OF CLINICAL ONCOLOGY

Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer

(2018) Peter Schmid et al.   NEW ENGLAND JOURNAL OF MEDICINE

Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response

(2017) Hongshan Li et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial

(2017) Achim Rittmeyer et al.   LANCET

Evaluation of dosing strategy for pembrolizumab for oncology indications

(2017) Tomoko Freshwater et al.   Journal for ImmunoTherapy of Cancer

Phase I dose-finding study of monotherapy with atezolizumab, an engineered immunoglobulin monoclonal antibody targeting PD-L1, in Japanese patients with advanced solid tumors

(2016) Hidenori Mizugaki et al.   INVESTIGATIONAL NEW DRUGS

Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor

(2016) Rong Deng et al.   mAbs

Evaluation of Tumor Size Response Metrics to Predict Survival in Oncology Clinical Trials

(2014) R Bruno et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Exposure–Response Relationship of T-DM1: Insight Into Dose Optimization for Patients With HER2-Positive Metastatic Breast Cancer

(2014) J Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer

(2014) Thomas Powles et al.   NATURE

Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients

(2014) Roy S. Herbst et al.   NATURE

Oncology Meets Immunology: The Cancer-Immunity Cycle

(2013) Daniel S. Chen et al.   IMMUNITY

Molecular Pathways: Next-Generation Immunotherapy--Inhibiting Programmed Death-Ligand 1 and Programmed Death-1

(2012) D. S. Chen et al.   CLINICAL CANCER RESEARCH

The Combination of Exposure-Response and Case-Control Analyses in Regulatory Decision Making

(2012) Jun Yang et al.   JOURNAL OF CLINICAL PHARMACOLOGY