OnCo
trialsTrialPositive

ELEVATE-TN

Six years on, most patients on acalabrutinib have still not progressed, and adding obinutuzumab also improved survival.

At 74.5 months median follow-up: median PFS not reached (either acalabrutinib arm) vs 27.8 months; OS significantly longer for acalabrutinib-obinutuzumab vs chemoimmunotherapy (HR 0.62); benefit in del(17p)/TP53 and unmutated IGHV. Lancet 2020; Blood 2025 (6-year).

Setting
Previously untreated CLL, age ≥65 or with comorbidities: acalabrutinib ± obinutuzumab vs chlorambucil + obinutuzumab
Phase
Phase 3
Sponsor
AstraZeneca / Acerta
Registry
Headline result
6-year median PFS not reached vs 27.8 months; OS HR 0.62 (A+O).
Reported
2019
Enrolled
535
Replication
SEQUOIA (zanubrutinib) and RESONATE-2 (ibrutinib) show the same class effect of continuous BTK inhibition over chemoimmunotherapy in frontline.

Outcomes

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In plain words
What these results mean for people, not percentages
535 people took part
Progression-free survival (median, 6-year follow-up)primarysurrogate endpoint
  • Median 27.8 months with Chlorambucil + obinutuzumab.
  • Acalabrutinib + obinutuzumab: Median not reached.
  • Acalabrutinib: Median not reached.
  • "Not reached" means that, when the data were analysed, more than half of that group had not yet had the event, which is good news for that group.
  • A median is a midpoint: half the people did better than this and half did worse.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survival (A+O vs O+Clb)survival endpoint
  • The treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62).
  • The absolute difference, how many more people out of 100 were helped, is not reported here.
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Previously untreated CLL, age ≥65 or with comorbidities: acalabrutinib ± obinutuzumab vs chlorambucil + obinutuzumab. People in a different situation may not see the same effect.

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 participants enrolled.

Progression-free survival (median, 6-year follow-up)primary
Acalabrutinib + obinutuzumab
Median not reached
Acalabrutinib
Median not reached
Chlorambucil + obinutuzumab
27.8 mo

Median not reached · Median not reached

Source
Overall survival (A+O vs O+Clb)
HR 0.62

Numbers not yet public.

EndpointArmnValueHR (95% CI)pSource
Progression-free survival (median, 6-year follow-up)primaryAcalabrutinib + obinutuzumab179Median not reachedlink
Acalabrutinib179Median not reached
Chlorambucil + obinutuzumab17727.8 months
Overall survival (A+O vs O+Clb)Acalabrutinib + obinutuzumab0.62
Chlorambucil + obinutuzumab
Replication
SEQUOIA (zanubrutinib) and RESONATE-2 (ibrutinib) show the same class effect of continuous BTK inhibition over chemoimmunotherapy in frontline.

Key papers

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Connected

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