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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

ASPEN: Long-Term Follow-up Results of a Phase 3 Randomized Trial of Zanubrutinib (ZANU) vs Ibrutinib (IBR) in Patients (PTS) with Waldenström Macroglobulinemia (WM)

Published date:
07/22/2022
Excerpt:
ASPEN is an open‑label, multicenter, randomized phase 3 study of zanubrutinib vs ibrutinib in patients with WM….Patients were assigned to cohort 1 (MYD88MUT; randomized) or exploratory cohort 2 (MYD88WT or MYD88 unknown; nonrandomized)….In cohort 2 (MYD88WT), zanubrutinib demonstrated a CR in 1 patient with major response rate of 65% (including 31% CR+VGPR) overall (Figure 3B)....Event‑free rates of PFS and OS at 42 months were 53.8% (95% CI: 33.3, 70.6) and 83.9% (95% CI: 62.6, 93.7), respectively.
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial

Published date:
12/07/2020
Excerpt:
...7 of 26 MYD88WT patients (27%) had achieved a VGPR and 50% a major response (partial response or better); there were no CRs. At 18 months, the estimated PFS and OS rates were 68% and 88%, respectively, while the median DOR had not been reached. ...zanubrutinib monotherapy can induce high quality responses in patients with MYD88WT WM.
DOI:
https://doi.org/10.1182/bloodadvances.2020003010
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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: