Lora Hamuro
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View article: Exposure–Response Analysis of Repotrectinib to Support the Dose Recommendation for Patients With <scp>ROS1</scp>‐Positive <scp>NSCLC</scp> or <scp>NTRK</scp>‐Positive Solid Tumors
Exposure–Response Analysis of Repotrectinib to Support the Dose Recommendation for Patients With <span>ROS1</span>‐Positive <span>NSCLC</span> or <span>NTRK</span>‐Positive Solid Tumors Open
To support the benefit–risk assessment and dose justification of repotrectinib for patients with c‐ros oncogene 1 ( ROS1 ) positive non‐small cell lung cancer (NSCLC) or neurotrophin receptor tyrosine kinase ( NTRK )‐positive solid tumors,…
View article: Administration of nivolumab plus ipilimumab: Infusion of the fixed‐ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800)
Administration of nivolumab plus ipilimumab: Infusion of the fixed‐ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800) Open
Background Immune checkpoint inhibitors can be coadministered as a fixed‐ratio combination (FRC) or administered as sequential infusions (ASI). Two randomized, open‐label trials compared nivolumab + ipilimumab as a FRC versus ASI in patien…
View article: A Novel Empirical Autoinduction Model to Characterize the Population Pharmacokinetics and Recommend Dose for Repotrectinib in Adult and Adolescents With Advanced Solid Tumors Harboring <scp>ALK</scp>, <scp>ROS1</scp>, or <scp>NTRK1</scp>‐3 Rearrangements
A Novel Empirical Autoinduction Model to Characterize the Population Pharmacokinetics and Recommend Dose for Repotrectinib in Adult and Adolescents With Advanced Solid Tumors Harboring <span>ALK</span>, <span>ROS1</span>, or <span>NTRK1</span>‐3 Rearrangements Open
Repotrectinib is approved in the US for treating ROS1‐positive non‐small cell lung cancer (NSCLC) and solid tumors harboring an NTRK gene fusion. A Population Pharmacokinetic (PopPK) model for repotrectinib was developed using data from 62…
View article: <scp>IQ</scp> Survey Results on Current Industry Practices: Part 2—Quantitative Evaluations of Immunogenicity Assessment
<span>IQ</span> Survey Results on Current Industry Practices: Part 2—Quantitative Evaluations of Immunogenicity Assessment Open
All biotherapeutics have the potential to induce an immunogenic response and generate anti‐drug antibodies (ADAs), especially when administered as multiple doses over prolonged periods. However, a clinically meaningful effect of ADAs can b…
View article: Pharmacokinetic and Exposure–Response Modeling Support Body Surface Area‐Based Dosing of Farletuzumab Ecteribulin in Japanese Patients with Solid Tumors
Pharmacokinetic and Exposure–Response Modeling Support Body Surface Area‐Based Dosing of Farletuzumab Ecteribulin in Japanese Patients with Solid Tumors Open
The first‐in‐human, Phase 1 Study 101 showed antitumor activity and a tolerable safety profile of farletuzumab ecteribulin in Japanese patients with platinum‐resistant ovarian and non‐small cell lung cancer. A pharmacometric assessment eva…
View article: Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors
Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors Open
Purpose BMS-986299 is a first-in-class, NOD-, LRR-, and pyrin-domain containing-3 (NLRP3) inflammasome agonist enhancing adaptive immune and T-cell memory responses. Materials and methods This was a phase-I ( NCT03444753 ) study that asses…
View article: The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy
The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy Open
NCT02145234, NCT02515669, NCT03039686.
View article: A Novel Empirical Drug Induced Autoinduction Model to Characterize the Population Pharmacokinetics of Repotrectinib with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
A Novel Empirical Drug Induced Autoinduction Model to Characterize the Population Pharmacokinetics of Repotrectinib with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements Open
View article: Exposure-Response Efficacy and Safety Analysis of Repotrectinib to Support the Dose Recommendation for Patients with ROS1-positive NSCLC
Exposure-Response Efficacy and Safety Analysis of Repotrectinib to Support the Dose Recommendation for Patients with ROS1-positive NSCLC Open
View article: Nivolumab and ipilimumab population pharmacokinetics in support of pediatric dose recommendations—Going beyond the body‐size effect
Nivolumab and ipilimumab population pharmacokinetics in support of pediatric dose recommendations—Going beyond the body‐size effect Open
Body size has historically been considered the primary source of difference in the pharmacokinetics (PKs) of monoclonal antibodies (mAbs) between children aged greater than or equal to 2 years and adults. The contribution of age‐associated…
View article: Pediatric model‐based dose optimization using a pooled exposure–response safety analysis for nivolumab and nivolumab plus ipilimumab combination in melanoma
Pediatric model‐based dose optimization using a pooled exposure–response safety analysis for nivolumab and nivolumab plus ipilimumab combination in melanoma Open
An exposure–response (E–R) safety analysis was conducted across adult and pediatric (<18 years) studies to evaluate the potential impact of higher nivolumab and/or ipilimumab exposures in adolescents (≥12 to <18 years) versus adults with m…
View article: Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Table from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Purpose:A benefit:risk assessment for a less-frequent nivolumab 480 mg every 4 weeks + cabozantinib 40 mg every day dosing regimen was predicted using modeling and simulation of clinical trial data from nivolumab monotherapy studies and fr…
View article: Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Purpose:A benefit:risk assessment for a less-frequent nivolumab 480 mg every 4 weeks + cabozantinib 40 mg every day dosing regimen was predicted using modeling and simulation of clinical trial data from nivolumab monotherapy studies and fr…
View article: Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Figure from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
View article: Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma Open
Supplementary Data from Exposure–Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma