AGS67E / Astellas, Pfizer - LARVOL DELTA

A first in human experience of the anti-CD37 antibody-drug conjugate AGS67E in lymphoid malignancies (ASCO 2016) - P1, N=30; NCT02175433; "Responses were noted in subjects dosed at 0.9 and 1.2 mg/kg; Specifically, 2 subjects with Diffuse Large B-Cell Lymphoma (DLBCL) experienced a complete remission (CR) and 2 subjects (Mycosis Fungoides and DLBCL) experienced a partial remission (PR)."

P1 data • Hematological Malignancies

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies (clinicaltrials.gov) - P1; N=85; Active, not recruiting; Sponsor: Agensys, Inc.; Suspended ➔ Active, not recruiting

Enrollment closed • Biosimilar • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies (clinicaltrials.gov) - P1; N=78; Completed; Sponsor: Astellas Pharma Global Development, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Aug 2021 ➔ Oct 2019; Trial primary completion date: Aug 2021 ➔ Oct 2019

Clinical • Monotherapy • Trial completion • Trial completion date • Trial primary completion date

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies (clinicaltrials.gov) - P1; N=78; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Jun 2019 ➔ Aug 2021; Trial primary completion date: Jun 2019 ➔ Aug 2021

Clinical • Monotherapy • Trial completion date • Trial primary completion date