Dr. Cheah on the Safety Profile of TG-1701 With and Without Ublituximab/Umbralisib in CLL

Chan Cheah, MBBS, clinical professor, University of Western Australia (WA); consultant hematologist, lymphoma lead, fellowship program director, Sir Charles Gairdner Hospital, Pathwest Laboratory Medicine WA, Linear Clinical Research and Hollywood Private Hospital; and founder, Blood Cancer Research WA, discusses the toxicity profile of TG-1701 with and without ublituximab (TG-1101) and umbralisib (Ukoniq) in patients with chronic lymphocytic leukemia (CLL).

A phase 1 trial (NCT03671590) evaluated TG-1701 as monotherapy or plus ublituximab and umbralisib in patients with CLL. When given as a monotherapy, the BTK inhibitor was very well tolerated in this population, according to Cheah.

Most adverse effects (AEs) were low grade, and the most common AE was mild bruising or contusion and it was observed in 20% of patients. Moreover, 20% of the patients in the 200-mg cohort experienced diarrhea, Cheah adds. The addition of ublituximab and umbralisib to TG-1701 introduced more AEs that were expected with PI3K inhibitors, such as nausea and diarrhea. Infusion reactions related to ublituximab were also reported, Cheah concludes.