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, founder, Blood Cancer Research WA, discusses the investigation of BGB-11417 with or without zanubrutinib (Brukinsa) in chronic lymphocytic leukemia (CLL).

In a phase 1 study (NCT04277637), investigators evaluated the safety, tolerability, and maximum tolerated dose of BGB-11417 monotherapy and BGB-11417 in combination with zanubrutinib.

Investigators treated 159 patients, a majority of whom had CLL, Cheah says. Of these patients, 8 were treated with BGB-11417, and 71 patients were received BGB-11417 combination therapy, Cheah notes.

In terms of preliminary efficacy, patients in the monotherapy cohort had an overall response rate (ORR) of 67%, with 33% of responses being complete responses (CR), Cheah explains. In the combination cohort, ORR rates were 95% and 100% in the relapsed/refractory and treatment-naïve cohorts, respectively, Cheah says.

Notably, the combination cohorts had a much shorter duration of follow-up vs the monotherapy cohort, Cheah concludes.

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Chan Cheah, MBBS, discusses the investigation of BGB-11417 with or without zanubrutinib in chronic lymphocytic leukemia.


Dr. Cheah on the Investigation of BGB-11417 With or Without Zanubrutinib 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.

Chan Cheah, MBBS, discusses the toxicity profile of TG-1701 with and without ublituximab and umbralisib in patients with chronic lymphocytic leukemia.

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, founder, Blood Cancer Research WA, discusses the results of a study evaluating the efficacy and safety of TG-1701 alone and in combination with ublituximab (TG-1101) and umbralisib (Ukoniq; U2) in chronic lymphocytic leukemia (CLL). 

, findings from an ongoing phase 1 trial (NCT03671590) evaluating TG-1701, a selective BTK inhibitor, as monotherapy and in combination with U2 in patients with CLL were presented virtually. Single-agent TG-1701 demonstrated an objective response rate (ORR) of 83%. Additionally, the 3 patients who received the triplet regimen achieved an objective response, Cheah explains.

By disease-specific cohort, the ORR was 95% in patients who received 200 mg of TG-1701 and 100% in patients who received 300 mg of TG-1701 at a median follow-up of 19 months and 12 months, respectively. Ultimately, these findings indicate that TG-1701 is an effective BTK inhibitor alone or in combination with U2 in CLL, Cheah concludes.

Chan Cheah, MBBS, discusses the results of a study evaluating the efficacy and safety of TG-1701 alone and in combination with ublituximab and umbralisib in chronic lymphocytic leukemia.



Chan Cheah, MBBS

Articles

Dr. Cheah on the Investigation of BGB-11417 With or Without Zanubrutinib in CLL

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

Dr. Cheah on the Efficacy of TG-1701 Alone and in Combination With U2 in CLL