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Title: TG-1701, A selective Bruton Tyrosine Kinase (BTK) Inhibitor, as monotherapy and in combination with ublituximab and umbralisib (U2) in patients with B- Cell Malignancies.
Epworth Authors: Yannakou, Costas
Other Authors: Chan, Cheah
Wojciech, Jurczak
Lasica, Masa
Wickham, Nicholas
Wrobel, Tomasz
Andrzej, Jan
Cheung, Stanley
Lewis, Katharine
Długosz-Danecka, Monika
Giannopoulos, Krzysztof
Miskin, Hari
Tan, Jian-Ping
Normant, Emmanuel
O'Connor, Owen
Ricart, Alejandro
Tam, Constantine
Keywords: Chronic Lymphocytic Leukemia (CLL)
Relapsed/Refractory (R/R) CLL
Combination Therapies
Molecular Targeted Therapies
Selective Covalent BTK Inhibitor
Treatment Naïve (TN)
Dose Escalation
Phase 1 Study
Anti-CD20 mAb Ublituximab
PI3Kδ-CK1ϵ Inhibitor Umbralisib
Waldenstrom's (WM)
Mantle Cell Lymphoma (MCL)
Safety Profile Characterisation
Epworth Center for Immunotherapies and Snowdome Laboratories
Molecular Oncology and Cancer Immunology
Cancer Services Clinical Institute, Epworth Healthcare, Australia
Issue Date: 2021
Citation: Hematological Oncology (2021): 321-323
Conference Name: 16th International Conference on Malignant Lymphoma, Virtual Edition, 18–22 June, 2021
Conference Location: Virtual
Abstract: TG-1701 is a selective, covalent BTK inhibitor administered once daily (QD). Both the "U2" combination (anti-CD20 mAb ublituximab + the PI3Kδ-CK1ϵ inhibitor umbralisib) and BTK inhibition are highly active in treatment-naïve (TN) and relapsed/refractory (R/R) CLL, each having previously demonstrated superiority over standard chemoimmunotherapy. Patients with R/R CLL, MCL and Waldenstrom's (WM) were enrolled in an ongoing Ph1 study initially evaluating dose escalation (DE) of oral TG-1701 QD continuously administered in 28-day cycles (100, 200, 300, and 400 mg). After characterizing the safety profile of TG-1701 monotherapy, we implemented a parallel DE arm of TG-1701+U2. Select dose levels of TG-1701 monotherapy were expanded. All patients were treated until disease progression, unacceptable toxicity, or investigator/ patient decision to withdraw. TG-1701 exhibits an encouraging safety and efficacy profile. The combination of 1701+U2 has been well tolerated and dose escalation continues. The combination shows enhanced depth of response over TG-1701 monotherapy. Recruitment to this study (NCT03671590) continues.
DOI: 10.1002/hon.148_2880
Type: Conference Paper
Affiliated Organisations: Sir Charles Gairdner Hospital, Department of Haematology, Perth, Australia
Maria SklodowskaCurie National Research Institute ofOncology, Oncology Center, Krakow, Poland
St. Vincent Hospital and University of Melbourne, Haematology, Melbourne, Australia
Ashford Cancer Centre Research, Hematology, Adelaide, Australia
WroclawMedical University, Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw, Poland
Maria Sklodowska Curie National Research Institute of Oncology, Department of Lymphoid Malignancy, Warsaw, Poland
StJohn's Cancer Centre, Hematology Department, Lublin, Poland
TGTherapeutics, Oncology, New York, USA
Type of Clinical Study or Trial: Clinical Trial
Appears in Collections:Cancer Services

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