On June 20, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported data from four presentations, including three oral presentations and one poster presentation, at the 15thInternational Conference on Malignant Lymphoma (ICML), being held in Lugano, Switzerland (Press release, TG Therapeutics, JUN 20, 2019, View Source [SID1234537194]). Highlights from all presentations are included below.
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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are excited by the data presented today evaluating umbralisib in patients intolerant to currently approved BTK or PI3K therapies. We believe the data presented continue to show that there are many patients in need of alternative treatment options for whom umbralisib can provide meaningful benefit." Mr. Weiss continued, "We are also pleased to present data from the combination of ublituximab + umbralisib ("U2") plus pembrolizumab in patients with relapsed/refractory CLL and Richter’s transformation. It was encouraging to see that 5 of 6 BTK refractory patients responded to therapy, with 4 of those responders achieving a rapid response to U2 alone at the patient’s first efficacy assessment prior to the addition of pembrolizumab. We are eager to initiate our clinical study of U2 plus TG-1501, our PDL1 inhibitor, in the same patient population and believe the triplet may offer the opportunity for time limited therapy in CLL."
Highlights from the oral presentations include:
Oral Presentation Title: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy
This presentation includes data from patients with CLL who are intolerant to prior BTK or PI3K delta inhibitor therapy who were then treated with single agent umbralisib. To be eligible for the study patients had to have received prior treatment with a BTK inhibitor or a PI3K delta inhibitor and discontinued therapy due to intolerance. Fifty-one patients were evaluable for safety of which 50 were evaluable for Progression Free Survival (PFS).
Highlights:
Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK or PI3K delta therapy
Only 12% discontinued due to an umbralisib adverse event, of which only one patient discontinued due to a recurrent adverse event (AE) previously experienced with prior kinase inhibitor therapy
In this relapsed/refractory CLL population, 67% had a high-risk molecular / genetic marker and 6% had an ibrutinib resistance mutation, the estimated median progression free survival (PFS) was 23.5 months
Median overall survival (OS) has not been reached with a median follow-up of 14 months
As of the cut-off date, 58% of patients have been on umbralisib for a duration longer than their prior BTK or PI3k inhibitor
Oral Presentation Title: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation (RT)
This oral presentation includes data from patients with relapsed or refractory CLL or RT treated with the triple combination of ublituximab, umbralisib, and pembrolizumab. Patients with CLL received 2 cycles of the U2 regimen before pembrolizumab was added for an additional 4 cycles, followed by umbralisib maintenance. Patients with RT received U2 + pembrolizumab for the first 4 cycles, followed by U2 maintenance. Twenty patients were evaluable for safety (11 CLL patients and 9 RT patients) and 19 were evaluable for efficacy (11 CLL and 8 RT). Data highlights include:
The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone
In this heavily pre-treated cohort with a median of 2 (1-9) prior lines of therapy:
— 91% (10 of 11) Overall Response Rate (ORR) in patients with relapsed/refractory CLL
— 83% (5 of 6) ORR in BTK refractory CLL patients, with 4 of 5 responders achieving a response to U2 alone at the patient’s first efficacy assessment, prior to the addition of pembrolizumab
— 38% (3 of 8) ORR in RT, with two durable complete responses; 1 subject relapsed post-CAR-T in CR for 12 months and 1 subject relapsed post-transplant continuing on study in CR now 20+ months
Additionally, data from the UNITY-NHL MZL cohort and data from TG-1801, the Company’s first-in-class anti-CD47-CD19 bispecific antibody, will be presented during ICML. These presentations were recaps and have been previously presented. Links to full data presentations included below.
Oral Presentation Title: Umbralisib Monotherapy Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Registration Directed Phase 2 Study
Poster Presentation Title: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL
Full schedule of data being presented at ICML:
Oral Presentation: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy
— Session Date & Time: Thursday, June 20, 2019 13:45 – 15:15 CEST
– Presentation Time: 15:00 CEST
— Session Title: Session 3 – CLL
— Location: Palazzo dei Congressi, Room A – Main Hall
— Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center
Oral Presentation: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Rel/Ref CLL and Richter’s Transformation
— Session Date & Time: Thursday, June 20, 2019 17:05 – 18:05 CEST
– Presentation Time: 17:05 CEST
— Session Title: Focus on Non-Clinical and Early Clinical Data with New Combinations
— Location: Palazzo dei Congressi, Cinema Corso
— Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center
Oral Presentation: Umbralisib Monotherapy Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Registration Directed Phase 2 Study
— Session Date & Time: Saturday, June 22, 2019 10:15 – 11:15 CEST
– Presentation Time: 10:45 CEST
— Session Title: Focus on Indolent Non-Follicular Lymphoma
— Location: Palazzo dei Congressi, Room A and B
— Lead Author: Pierre-Luigi Zinzani, MD, University of Bologna, Institute of Hematology "L. e A. Seràgnoli"
Poster Presentation: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL
— Session Date & Time: Wednesday, June 19 (12:00-17:00 CEST), Thursday, 20 (9:00-17:00 CEST) and Friday, June 21 (9:00-18:30 CEST)
— Location: Palazzo dei Congressi, Marquee Parco Ciani
— Lead Author: Marcelo Lima Ribeiro, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Autonomous University of Barcelona, Barcelona, Spain
The data presentations are now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.