tovetumab (MEDI-575) / AstraZeneca - LARVOL DELTA

A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2; N=99; Terminated; Sponsor: MedImmune LLC; Phase classification: P1/2 ➔ P1b/2; Completed ➔ Terminated; In conjunction with the overall risk-benefit assessment, study was terminated prematurely due to safety concerns.

Clinical • Combination therapy • Phase classification • Trial termination • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PDGFRA

A Novel Pharmacodynamic Biomarker and Mechanistic Modeling Facilitate the Development of Tovetumab, a Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha, for Cancer Therapy. (PubMed, AAPS J) - "By incorporating PDGFRα internalization kinetics, the model not only predicted the target receptor occupancy by tovetumab, but also the biologically active agonistic ligand-receptor complex. This work described a novel PD biomarker approach applicable for anti-receptor therapeutics and the first mechanistic model to delineate the in vivo tri-molecular system of a drug, its target receptor, and a competing endogenous ligand, which collectively have been used for optimal dose recommendation supporting clinical development of tovetumab."

Biomarker • Journal • PK/PD data • Oncology • PDGFRA

Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Patients With Previously Untreated Advanced Non-Small-Cell Lung Cancer. (PubMed, Clin Lung Cancer) - "The addition of MEDI-575 to CP chemotherapy as first-line treatment of advanced non-small-cell lung cancer did not improve efficacy and resulted in increased toxicity."

Clinical • Combination therapy • Journal • P1/2 data