TG Therapeutics Announces Data Presentations at the 25th European Hematology Association (EHA) Annual Congress - Seite 2

Safety and efficacy highlights include:

• TG-1701 monotherapy exhibited an encouraging preliminary safety profile across all dose levels evaluated with only 3% (2/69) of patients having a dose reduction due to treatment-related adverse events (AEs), with no treatment discontinuations due to AEs in the monotherapy cohorts
• In the monotherapy dose escalation cohort (n=25), TG-1701 produced partial responses at all dose levels evaluated (100mg to 400mg once daily) in CLL, MCL, Waldenström’s macroglobulinemia (WM), and small lymphocytic lymphoma (SLL)
• In the monotherapy dose expansion cohort in which TG-1701 was administered at 200mg, 25 patients were evaluable for efficacy with a 92% overall response rate (ORR) observed in CLL patients (n=12), a 33% ORR in MCL patients (n=6), and a 86% ORR in WM patients (n=7)                                                
• The combination of TG-1701 plus U2 has been well tolerated and demonstrated encouraging clinical activity with a 77% ORR across all disease types (n=13), including complete responses in three patients; dose escalation continues

Presentation Title: Long term results of a Phase I/Ib study of ibrutinib in combination with umbralisib in patients with relapsed/refractory CLL or MCL

This presentation includes updated long term data from a Phase 1/1b study of patients with relapsed or refractory CLL or MCL treated with umbralisib in combination with ibrutinib. Data from this trial were previously published in Lancet Haematology in December 2018 (Davids et.al.). As of the updated data cutoff, 42 patients were evaluable for safety and efficacy (21 CLL patients and 21 MCL patients).

Safety and efficacy highlights include:

• With long term follow up (median follow-up of 43.5 months (range 8.4-61), there were no cumulative or recurrent late onset toxicities observed
• In relapsed/refractory CLL, the overall response rate was 95% including a 29% complete response (CR) rate, and the 4-year Progression-free Survival (PFS) and Overall Survival (OS) were 78% and 90%, respectively
• In relapsed/refractory MCL, the ORR was 71% with a 24% CR rate, and median PFS and OS were 10.8 and 30.7 months, respectively

The data presented is available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.