Xencor to Present Data from Phase 1 Study of Vibecotamab in Acute Myeloid Leukemia at the 2020 ASH Annual Meeting
Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune disease, today announced that data from the ongoing Phase 1 dose-escalation study of vibecotamab (XmAb14045), a CD123 x CD3 bispecific antibody, in patients with relapsed/refractory acute myeloid leukemia (AML) will be presented in an oral session at the 2020 American Society of Hematology (ASH) Annual Meeting on Sunday, December 6, 2020.
"Data from the Phase 1 study of vibecotamab suggest that patients with AML having low baseline disease burden and specific T-cell signatures may be more likely to respond to treatment with vibecotamab. The primary toxicity, CRS, is generally mild-to-moderate in severity when observed and is manageable," said Allen Yang, M.D., Ph.D., senior vice president and chief medical offer at Xencor. "We continue to optimize dosing regimen in this study, and along with our partner Novartis, we are planning our next clinical trials to develop vibecotamab in patients, for whom an intermittently dosed, CD123-targeting antibody could be a needed therapeutic option."
Key Highlights from the Abstract
The accepted abstract is available on the ASH conference website.
- At data cut off for submitting the abstract, 104 patients with AML, one patient with B cell acute lymphoblastic leukemia and one patient with chronic myeloid leukemia had received vibecotamab. Patients had a median age of 63 years and were heavily pretreated, having a median of three prior therapies, and 30% (n=32/106) had undergone prior allogeneic stem cell transplantation.
- Patients received doses of vibecotamab ranging from 0.003 mcg/kg to 12 mcg/kg. The recommended initial priming dose was determined to be 0.75 mcg/kg. A maximum tolerated dose (MTD) was not reached.
- Cytokine release syndrome (CRS) was the most common toxicity occurring in 58% of patients (n=62), and 8% of patients (n=9) experienced CRS at Grade 3 or higher. The majority of CRS was observed on the first dose and was generally manageable with premedication. Additional adverse events consistent with CRS but not reported as such, including chills, fever, tachycardia and hypotension, were reported in an additional 24% of patients. No myelosuppression requiring dose modification or evidence of tumor lysis syndrome was observed.
- At dose levels of at least 0.75 mcg/kg (n=51), two patients achieved complete remission (CR), three patients achieved a CR with incomplete hematologic recovery, and two patients or morphologic leukemia-free state (ORR=14%).
- Patients with responses were characterized by lower disease burden and specific T-cell subtypes.