BeiGene will report the ALPINE trial at the American Society of Hematology (ASH) 2022 Annual Meeting on the ALPINE trial. Compare Yike? Achieving progression-free survival (PFS) efficacy outcomes for oral presentation of a summary of the latest breakthroughs

BeiGene (NASDAQ: BGNE; HKEx code: 06160; SSE code: 688235) is a global biotechnology company
.
The company announced November 22 that it will present an oral summary of the latest breakthrough in the results of the end-of-life analysis of its ALPINE trial at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans
, USA.
ALPINE is a global Phase 3 clinical trial to evaluate the efficacy
of BRUKINSA ® (zebratinib) versus ibrutinib ® for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
The results will be presented
at a summary of the latest breakthrough on December 13 at 10:15 a.
m.
CET (December 14, 00:15 a.
m.
Beijing time) in Hall E of the Ernest N.
Morial Convention Center in New Orleans.

In the final PFS analysis of the trial, BRUKINSA ® achieved a superior effect over EKE ® (HR: 0.
65 [95% CI, 0.
49-0.
86], P = 0.
0024)
after evaluation by an independent review committee (IRC) and investigators.
According to IRC and investigator evaluations, BRUKINSA ® showed consistent PFS efficacy in the main predefined subgroups, including patients with different IGHV states and del(17p)/TP53 mutations
.

Mehrdad Mobasher, M.
D.
, Chief Medical Officer of BeiGene, Hematology, said, "BRUKINSA ® is currently the only BTK inhibitor
that has shown an efficacy advantage over ibrutinib in any therapeutic setting.
At the same time, the ALPINE test results also showed that BRUKINSA ® was superior to ibrutinib in both PFS and overall response rate (ORR) in patients with relapsed/refractory CLL/SLL patients
.
At nearly 30 months of follow-up since this trial began, we observed BRUKINSA ® to demonstrate a very stable safety and tolerability profile
.
We look forward to sharing the detailed results of
the final analysis at the ASH Annual Meeting.
" "

CLL is one of the most common types of leukemia, accounting for about a quarter
of new cases of leukemia[i].
The disease is characterized by recurrent relapses, and its response to treatment will ultimately determine clinical benefit
, including survival.

Analysis of pre-set outcomes at a median follow-up of 29.
6 months in this trial showed that BRUKINSA ® was generally well tolerated and its safety profile was consistent
with previous reports.
Compared with ibrutinib (41.
2%), the overall incidence of discontinuation (26.
3%) and the incidence of discontinuation due to adverse events (16.
2 vs.
22.
8%) or disease progression (7.
3 vs.
12.
9%) were lower
in the BRUKINSA ® group.

BRUKINSA also showed advantages in cardiac function-related safety measures in this analysis compared to ibrutinib: BRUKINSA ® ® (5.
2%) had a lower
incidence of atrial fibrillation/atrial flutter in the ibrutinib group (13.
3%).
Six grade 5 adverse events due to heart disease were reported in the ibrutinib group, while no such adverse events were reported
in the BRUKINSA ® group.