News & Events
The 18th Hematology Academic Conference of the Chinese Society of Hematology (CSH) was held from September 19 to 22, 2024, in Wuhan, China. The conference is the largest and most prestigious academic event in the field of hematology in China.
Lacutoclax is a novel, highly potent, orally bioavailable, and selective BCL-2 inhibitor. An update on the safety and efficacy results of Lacutoclax from a phase I study (LP-108-I-01) in patients with relapsed or refractory B-cell non-Hodgkin lymphomas (R/R B-NHL) was presented by Professor Wei Xu, from the First Affiliated Hospital of Nanjing Medical University, in the afternoon of September 21st at the Lymphoma Session.
The study results of LP-108-I-01 were initially reported at the European Hematology Association (EHA) Annual Congress in 2022 (Abstract NO.: P684, P635, P669). Since then, the data has been continuously updated as more patients have been enrolled.
By April 30, 2024, 63 patients with R/R B-NHL, including 33 with CLL/SLL, were enrolled and received treatment with Lacutoclax at doses ranging from 20 mg/day to 800 mg/day. Among these patients, 32 with CLL/SLL were treated at 200 mg/day or higher. The median age of the patients was 62 years (range: 34-84). The median number of previous lines of therapy that patients received was 2 (range: 1-7). Forty-two patients (66.7%) had received at least one type of BTK inhibitor (BTKi) treatment. At 200 mg/day or higher, 55 patients were evaluable for the efficacy. The overall response rate (ORR) was 60.0% (33 out of 55). The ORR for R/R CLL/SLL was as high as 74.2% (23 out of 31), among whom, 6 patients (19.4%) showed complete response (CR) or CR with incomplete bone marrow recovery (CRi) and 17 patients (54.8%) showed partial response (PR). For patients with R/R CLL/SLL who had previously received BTKi treatment, the ORR was 70% (14 out of 20), among whom, 4 patients were classified as CR/CRi and 10 patients as PR, most of these patients (85.7%, 12 out of 14) have been remained in remission at the time of data cutoff.
With a median follow-up time of 16.5 months, the median progression-free survival (PFS) and duration of response (DOR) have not yet been assessed; however, the 18-month PFS rate and DOR rate reached 87.9% and 87.0%, respectively. Dose-limiting toxicity (DLT) was not observed up to 800mg dose level. Grade 3 or 4 treatment‐related adverse events (TRAEs) were mainly hematological toxicity and manageable. There was no grade 5 TRAEs identified. Additionally, no clinical tumor lysis syndrome (TLS) occurred, even with the rapid daily dose ramp-up.
Lacutoclax has demonstrated promising and durable efficacy along with favorable tolerability in patients with various types of R/R B-NHL, including patients who had progressed during or after BTKi treatment and those who were intolerant to BTKi treatment.