Shweta Vadhavkar
YOU?
Author Swipe
View article: Ethnic Sensitivity Assessment of Mosunetuzumab Pharmacokinetics and Pharmacodynamics in Chinese Patients With Relapsed or Refractory Follicular Lymphoma
Ethnic Sensitivity Assessment of Mosunetuzumab Pharmacokinetics and Pharmacodynamics in Chinese Patients With Relapsed or Refractory Follicular Lymphoma Open
Mosunetuzumab, a CD20 × CD3 T‐cell‐engaging bispecific antibody, redirects T cells to eliminate malignant B cells. The purpose of YO43555 was to assess the pharmacokinetics (PK), safety, tolerability, and efficacy of mosunetuzumab as a sin…
View article: A Novel Step‐Up Dosage Regimen for Enhancing the Benefit‐to‐Risk Ratio of Mosunetuzumab in Relapsed or Refractory Follicular Lymphoma
A Novel Step‐Up Dosage Regimen for Enhancing the Benefit‐to‐Risk Ratio of Mosunetuzumab in Relapsed or Refractory Follicular Lymphoma Open
Mosunetuzumab, a T‐cell engaging bispecific antibody targeting CD20xCD3, is approved for treating relapsed/refractory follicular lymphoma. This research supports the approved intravenous clinical dose regimen, summarizing the exposure–resp…
View article: Population pharmacokinetics and CD20 binding dynamics for mosunetuzumab in relapsed/refractory B‐cell non‐Hodgkin lymphoma
Population pharmacokinetics and CD20 binding dynamics for mosunetuzumab in relapsed/refractory B‐cell non‐Hodgkin lymphoma Open
Mosunetuzumab (Mosun) is a CD20xCD3 T‐cell engaging bispecific antibody that redirects T cells to eliminate malignant B cells. The approved step‐up dose regimen of 1/2/60/30 mg IV is designed to mitigate cytokine release syndrome (CRS) and…
View article: Population Pharmacokinetics and CD20 Binding Dynamics for Mosunetuzumab in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R NHL)
Population Pharmacokinetics and CD20 Binding Dynamics for Mosunetuzumab in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R NHL) Open
Introduction: Mosunetuzumab (Mosun) is a CD20xCD3 T-cell engaging bispecific antibody that redirects T cells to eliminate malignant B cells. Clinical data from GO29781 (NCT02500407), a Phase I/II, open-label, multicenter dose-escalation an…
View article: Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial
Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial Open
ClinicalTrials.gov Identifiers NCT02242942 and NCT02339181.
View article: Phase I and scintigraphy studies to evaluate safety, tolerability, pharmacokinetics, and lung deposition of inhaled GDC‐0214 in healthy volunteers
Phase I and scintigraphy studies to evaluate safety, tolerability, pharmacokinetics, and lung deposition of inhaled GDC‐0214 in healthy volunteers Open
Several inflammatory cytokines that promote inflammation and pathogenesis in asthma signal through the Janus kinase 1 (JAK1) pathway. This phase I, randomized, placebo‐controlled trial assessed the pharmacokinetics and safety of single and…
View article: Population Pharmacokinetics and Exposure‐Response Relationships of Astegolimab in Patients With Severe Asthma
Population Pharmacokinetics and Exposure‐Response Relationships of Astegolimab in Patients With Severe Asthma Open
Astegolimab is a fully human immunoglobulin G2 monoclonal antibody that binds to the ST2 receptor and blocks the interleukin‐33 signaling. It was evaluated in patients with uncontrolled severe asthma in the phase 2b study (Zenyatta) at dos…
View article: Pharmacokinetics and exposure-efficacy relationships of omalizumab in patients with nasal polyps
Pharmacokinetics and exposure-efficacy relationships of omalizumab in patients with nasal polyps Open
The anti-immunoglobulin E (IgE) antibody, omalizumab (Xolair), is approved in the United States for the treatment of allergic asthma and chronic spontaneous urticaria, and has recently been studied for the treatment of nasal polyposis foll…
View article: Pharmacokinetics and exposure–response analysis of venetoclax+obinutuzumab in chronic lymphocytic leukaemia: phase 1b study and phase 3 CLL14 trial
Pharmacokinetics and exposure–response analysis of venetoclax+obinutuzumab in chronic lymphocytic leukaemia: phase 1b study and phase 3 CLL14 trial Open
Aims: To investigate pharmacokinetics (PK) and exposure-response of the 400 mg once daily venetoclax dose regimen in combination with obinutuzumab in the phase 3 CLL14 study approved for the treatment of first-line (1L) chronic lymphocytic…
View article: Evaluation of atezolizumab immunogenicity: Clinical pharmacology (part 1)
Evaluation of atezolizumab immunogenicity: Clinical pharmacology (part 1) Open
Baseline patient characteristics and prognostic factors are important considerations in oncology when evaluating the impact of immunogenicity on pharmacokinetics (PK) and efficacy. Here, we assessed the impact of anti‐drug antibodies (ADA)…
View article: Population repeated time‐to‐event analysis of exacerbations in asthma patients: A novel approach for predicting asthma exacerbations based on biomarkers, spirometry, and diaries/questionnaires
Population repeated time‐to‐event analysis of exacerbations in asthma patients: A novel approach for predicting asthma exacerbations based on biomarkers, spirometry, and diaries/questionnaires Open
Identification of covariates, including biomarkers, spirometry, and diaries/questionnaires, that predict asthma exacerbations would allow better clinical predictions, shorter phase II trials and inform decisions on phase III design, and/or…
View article: Prediction of overall survival in patients across solid tumors following atezolizumab treatments: A tumor growth inhibition–overall survival modeling framework
Prediction of overall survival in patients across solid tumors following atezolizumab treatments: A tumor growth inhibition–overall survival modeling framework Open
The objectives of the study were to use tumor size data from 10 phase II/III atezolizumab studies across five solid tumor types to estimate tumor growth inhibition (TGI) metrics and assess the impact of TGI metrics and baseline prognostic …
View article: Atezolizumab and Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma: Pharmacokinetic and Safety Assessments Based on Hepatic Impairment Status and Geographic Region
Atezolizumab and Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma: Pharmacokinetic and Safety Assessments Based on Hepatic Impairment Status and Geographic Region Open
Introduction: Phase 1b GO30140 and phase 3 IMbrave150 studies evaluated first-line atezolizumab + bevacizumab for unresectable hepatocellular carcinoma (HCC). Here, we evaluated pharmacokinetics (PK) and safety by hepatic impairment status…
View article: Supplementary Material for: Atezolizumab and Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma: Pharmacokinetic and Safety Assessments Based on Hepatic Impairment Status and Geographic Region
Supplementary Material for: Atezolizumab and Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma: Pharmacokinetic and Safety Assessments Based on Hepatic Impairment Status and Geographic Region Open
Introduction: Phase 1b GO30140 and phase 3 IMbrave150 studies evaluated first-line atezolizumab + bevacizumab for unresectable hepatocellular carcinoma (HCC). Here, we evaluated pharmacokinetics (PK) and safety by hepatic impairment status…
View article: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden
Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden Open
We retrospectively investigated the pharmacokinetics and exposure‐efficacy/safety relationships of single‐agent atezolizumab based on tissue tumor mutational burden (tTMB) status (high vs low [≥16 vs <16 mutations/megabase]) in a pan‐tumor…
View article: Model-based clinical pharmacology profiling and exposure-response relationships of the efficacy and biomarker of lebrikizumab in patients with moderate-to-severe asthma
Model-based clinical pharmacology profiling and exposure-response relationships of the efficacy and biomarker of lebrikizumab in patients with moderate-to-severe asthma Open
Lebrikizumab is a humanized monoclonal antibody that binds to interleukin-13 and has been evaluated as a treatment for moderate-to-severe asthma. Objectives of this work were to characterize lebrikizumab pharmacokinetics (PK), identify inf…
View article: Population pharmacokinetics and exposure–response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2‐targeted regimens
Population pharmacokinetics and exposure–response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2‐targeted regimens Open
Aims We conducted population pharmacokinetic (PopPK) and exposure–response analyses for trastuzumab emtansine (T‐DM1), to assess the need for T‐DM1 dose optimization in patients with low exposure by using TH3RESA [A Study of Trastuzumab Em…