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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Imbruvica (ibrutinib) (BTK inhibitor) + Briumvi (ublituximab-xiiy) (CD20 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial
Published date:
02/22/2021
Excerpt:
We did a randomised, phase 3, multicentre study (GENUINE) of patients aged 18 years or older with relapsed or refractory chronic lymphocytic leukaemia with at least one of 17p deletion, 11q deletion, or TP53 mutation....The addition of ublituximab to ibrutinib resulted in a statistically higher overall response rate without affecting the safety profile of ibrutinib monotherapy in patients with relapsed or refractory high-risk chronic lymphocytic leukaemia.
DOI:
10.1016/S2352-3026(20)30433-6
Trial ID:
Source:
Title:
Effect of adding ublituximab to ibrutinib on PFS, ORR, and MRD negativity in previously treated high-risk chronic lymphocytic leukemia: Final results of the GENUINE phase III study.
Published date:
05/28/2020
Excerpt:
Eligible pts having rel/ref CLL with centrally confirmed del17p, del11q, and/or a TP53 mutation, were randomized 1:1 to IB (420 mg QD) alone or with UTX….17p del was greater in the IB arm (50% vs 44%); bulky disease was greater in UTX + IB arm (47% vs 28%)....PFS was superior for UTX + IB vs. IB alone, driven primarily by pts with del17p/p53mut. No meaningful difference in PFS was observed for pts with del11q. Among pts treated with UTX + IB, MRD-neg was associated with significant improvement in PFS. OS at 4 yrs was 82% vs. 70% for UTX + IB vs. IB alone.
Trial ID:
