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Association details:
| Biomarker: | MYD88 mutation |
|---|---|
| Cancer: | Waldenstrom Macroglobulinemia |
| Drug: | Brukinsa (zanubrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
HEALTH-RELATED QUALITY OF LIFE IN PATIENTS (PTS) WITH WALDENSTRÖM MACROGLOBULINEMIA (WM) TREATED WITH ZANUBRUTINIB (ZANU) VS IBRUTINIB (IBR): RESULTS FROM THE PHASE 3 ASPEN TRIAL LONG-TERM FOLLOW-UP
Published date:
05/11/2023
Excerpt:
Health-related quality of life (HRQoL) outcomes were evaluated in Cohort 1 (pts with activating mutations inMYD88) in both the intention-to-treat (ITT) population and pts achieving a complete response or very good partial response (CR + VGPR)...In the ASPEN trial, treatment with ZANU was associated with greater improvements in HRQoL vs IBR in pts with WM and MYD88 mutations.
Trial ID:
Source:
Title:
ASPEN: Long-Term Follow-Up Results of a Phase 3 Randomized Trial of Zanubrutinib vs Ibrutinib in Patients With Waldenström Macroglobulinemia
Published date:
09/21/2022
Excerpt:
In cohort 1, patients with MYD88 mutations were randomized 1:1 to receive zanubrutinib 160 mg twice daily or ibrutinib 420 mg once daily; stratifi cations were CXCR4 mutations and prior lines of therapy….At a median follow-up of 43 months, zanubrutinib had higher CR+VGPR rates and clinically meaningful advantages in long-term safety/tolerability versus ibrutinib.
Trial ID:
Source:
Title:
ASPEN: Long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) versus ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM).
Published date:
05/26/2022
Excerpt:
Patients with MYD88 mutations were assigned to cohort 1 and randomized 1:1 to receive ZANU...The CR+VGPR rate by investigator was 36% with ZANU vs 22% with IBR (p= 0.02) in cohort 1, and 31% in cohort 2….ASPEN is the largest phase 3 trial with head-to-head BTKi comparison in WM. At a median follow-up of 43 months, ZANU was associated with higher CR+VGPR rate and demonstrated clinically meaningful advantages in long-term safety and tolerability vs IBR.
DOI:
10.1200/JCO.2022.40.16_suppl.7521
Trial ID:
Source:
Title:
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
Excerpt:
...Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT...
Trial ID:
