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Fifteen months of two oral drugs cut the risk of progression by nearly 80% versus chemoimmunotherapy in older patients, and later showed a survival advantage.
GLOW, trial NCT03462719 sponsored by Janssen and published in NEJM Evidence in 2022, showed that fifteen months of ibrutinib and venetoclax cut the risk of progression by nearly eighty percent versus chlorambucil plus obinutuzumab in older or comorbid patients with previously untreated chronic lymphocytic leukaemia without del(17p), and later showed a survival advantage. It randomised 211 patients, met its primary progression-free survival endpoint with far higher rates of undetectable MRD in marrow, and the four-year update showed improved overall survival; the European Union approved the regimen in 2022 but it is not FDA-approved. OnCo links it to chronic lymphocytic leukaemia, BTK and BCL-2 as targets, ibrutinib, venetoclax, obinutuzumab and the fixed-duration pairing, and CAPTIVATE, AMPLIFY and FLAIR support the approach. Whether the regimen reaches US patients 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.
211 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Ibrutinib + venetoclax | 106 | - | 0.216 (0.131 to 0.357) | <0.0001 | link |
| Chlorambucil + obinutuzumab | 105 | - | ||||
| Undetectable MRD in bone marrow at 3 months post-treatment | Ibrutinib + venetoclax | - | 51.9% | - | - | link |
| Chlorambucil + obinutuzumab | - | 17.1% |
Shares BTK inhibitor + venetoclax, fixed duration, AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients, Obinutuzumab, BTK (Bruton tyrosine kinase).
Shares BTK inhibitor + venetoclax, fixed duration, Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares Chronic lymphocytic leukaemia, first treatment, Ibrutinib, Johnson & Johnson, Venetoclax.
Shares BTK inhibitor + venetoclax, fixed duration, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment, Ibrutinib.
Shares AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients, Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, Venetoclax, Chronic lymphocytic leukaemia.
Shares Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, Venetoclax, Chronic lymphocytic leukaemia.
Shares Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, BCL-2, Venetoclax.