Six years on, most patients on acalabrutinib have still not progressed, and adding obinutuzumab also improved survival.
ELEVATE-TN, trial NCT02475097 sponsored by AstraZeneca and Acerta, published in the Lancet in 2020 with six-year results in Blood in 2025, showed that most previously untreated patients with chronic lymphocytic leukaemia on acalabrutinib have still not progressed six years on, and that adding obinutuzumab also improved survival over chemoimmunotherapy. It randomised 535 patients aged 65 or over or with comorbidities to acalabrutinib with or without obinutuzumab or to chlorambucil plus obinutuzumab, met its primary progression-free survival endpoint with the median not reached in either acalabrutinib arm, and showed a survival advantage for the combination with benefit in high-risk genetic subgroups. Whether obinutuzumab is worth adding for every patient 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.
535 enrolled.
Median not reached · Median not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (median, 6-year follow-up)primary | Acalabrutinib + obinutuzumab | 179 | Median not reached | - | - | link |
| Acalabrutinib | 179 | Median not reached | ||||
| Chlorambucil + obinutuzumab | 177 | 27.8 months | ||||
| Overall survival (A+O vs O+Clb) | Acalabrutinib + obinutuzumab | - | - | 0.62 | - | link |
| Chlorambucil + obinutuzumab | - | - |
Shares Acalabrutinib, Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia.
Shares Acalabrutinib, Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares Acalabrutinib, Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia.
Shares Acalabrutinib, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia.
Shares Acalabrutinib, Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia, AstraZeneca.
Shares Acalabrutinib, Chronic lymphocytic leukaemia, AstraZeneca, Small-molecule kinase inhibitors.
Shares Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia.