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Zanubrutinib beat chemoimmunotherapy in untreated CLL and delivered a 72% five-year progression-free rate in the hardest genetic subgroup.
SEQUOIA, trial NCT03336333 sponsored by BeOne, formerly BeiGene, published in Lancet Oncology in 2022 with five-year data in JCO in 2025, showed that zanubrutinib beats bendamustine and rituximab in previously untreated chronic lymphocytic leukaemia unsuitable for FCR, and delivered a high five-year progression-free rate in del(17p) disease. Cohort 1 randomised 479 patients and met its primary progression-free survival endpoint with a large effect maintained at five years, arm C treated 111 patients with del(17p) with most progression-free at five years, and arm D combined zanubrutinib with venetoclax with very high undetectable MRD rates, the basis of the January 2023 CLL approval. Whether the arm D doublet becomes a fixed-duration standard is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
590 enrolled.
Numbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (cohort 1)primary | Zanubrutinib | 241 | - | 0.42 (0.28 to 0.63) | <0.0001 | link |
| Bendamustine + rituximab | 238 | - | ||||
| Progression-free survival at 5 years, del(17p) (arm C) | Zanubrutinib | 111 | 72.2% | - | - | link |
| Overall survivalprimary | Pegilodecakin + FOLFOX | 283 | 5.8 months | 1.045 (0.863 to 1.265) | - | link |
| FOLFOX | 284 | 6.3 months |
One of the most cited trial reports Europe PMC returns for Zanubrutinib in Chronic lymphocytic leukaemia, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
ELEVATE-TN put a more selective BTK inhibitor into first-line CLL and, with the head-to-head ELEVATE-RR trial, showed it is as effective as ibrutinib with fewer cardiac side effects. Continuous acalabrutinib became one of the two main front-line options alongside fixed-duration venetoclax combinations. The trade-off is indefinite therapy and cost versus a time-limited course.
Shares BTK inhibitor + venetoclax, fixed duration, del(17p) / TP53 aberration in CLL, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares BTK inhibitor + venetoclax, fixed duration, Zanubrutinib, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares BTK inhibitor + venetoclax, fixed duration, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment, Venetoclax.
Shares Chronic lymphocytic leukaemia, first treatment, Eli Lilly (incl. Loxo), Rituximab, Chronic lymphocytic leukaemia.
Shares John Oyler, Zanubrutinib, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia.
Shares Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial, Zanubrutinib, Chronic lymphocytic leukaemia, first treatment, Venetoclax.
Shares BTK inhibitor + venetoclax, fixed duration, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment, Venetoclax.
Shares Pancreatic cancer: the failed and stopped programmes and why, BTK (Bruton tyrosine kinase), Metastatic pancreatic ductal adenocarcinoma, Small-molecule kinase inhibitors.