Orelabrutinib also revealed substantial response in patients with high prognostic risks: overall response rates of patients carrying positive TP53 mutational status or del(17p), del(11q)...In conclusion, Orelabrutinib demonstrated compelling efficacy as well as safety profiles, with a noteworthy number of patients obtaining complete response in refractory or relapsed CLL/SLL.

A total of 80 patients with R/R CLL/SLL were enrolled. All patients received ≥1 prior treatment with median age of 60.0 years. 70% of patients had Rai stage III–IV disease, 22.5% had del(17p) and/or TP53 mutation, 41.3% had unmutated immunoglobulin heavy chain variable region (IGHV) and 23.8% had del(11q). The median follow-up time was 31. 2 months, with 68.8% remaining on study treatment. This updated study result further confirms that orelabrutinib is efficacious in treating R/R CLL patients with significant higher CR rate than other BTK inhibitors, durable response and improved safety profiles. Orelabrutinib provides a favorable therapeutic choice for patients with R/R CLL/SLL and has great potential to be the best candidate for the combination therapy.

This is an open-label, multicenter, phase II study to evaluate the safety and efficacy following an oral daily administration of orelabrutinib....A total of 80 patients with r/r CLL/SLL were enrolled....The ORR was 100% in patients with Del(17p) and/or TP53 mutation....The ORR was 94.7% for Del(11q)) and 93.9% for unmutated IGHV....Orelabrutinib provides a favorable therapeutic choice for patients with r/r CLL/SLL.

Following a minimum of 12 cycles treatment, the ORR (PR-L or above) was 91.3% (95% confidence interval [CI]: 82.80～96.41%) with 10.0% of patients having complete response (CR), 63.8% PR and 17.5% PR-L….Patients with Del(17p) and/or TP53 mutation achieved 100% ORR. The ORR is 94.7% for Del(11q)) and 93.9% for unmutated IGHV.

The estimated 12-month DOR was 77.1% (95% CI: 62.50-86.60%), PFS 81.1% (95% CI: 70.53 - 88.13%) and OS 86.3% (95% CI: 76.55 - 92.14%). Patients with Del(17p) and/or TP53 mutation achieved 100% ORR. The ORR is 94.7% for Del(11q)) and 93.9% for unmutated IGHV...This updated and extended study further confirms that orelabrutinib is efficacious in treating r/r CLL patients with a higher CR rate, durable response and improved safety profiles. As a highly selective BTK inhibitor with favorable pharmacokinetic and pharmacodynamic properties, orelabrutinib provides a favorable therapeutic choice for patients with r/r CLL/SLL and a potential best candidate for combination therapy.