OnCo
trialsTrialPositive

CLL14

One year of two targeted drugs, then nothing: more than half of patients were still progression-free six years later, off all treatment.

Median PFS 76.2 vs 36.4 months (HR 0.40); 6-year PFS 53.1% vs 21.7%; time to next treatment 65.2% vs 37.1% at 6 years; uMRD at end of treatment 75.5% vs 35.2%; OS not significantly different. NEJM 2019; Blood 2024 (6-year). Established fixed-duration therapy as a CLL standard and uMRD as a predictor of durable remission.

Setting
Previously untreated CLL with coexisting conditions: 12 months of venetoclax + obinutuzumab vs chlorambucil + obinutuzumab
Phase
Phase 3
Sponsor
German CLL Study Group / Roche / AbbVie
Registry
Headline result
6-year PFS 53.1% vs 21.7%; HR 0.40.
Reported
2019
Enrolled
432
Replication
CLL13/GAIA (fit patients) reproduced venetoclax-obinutuzumab superiority over chemoimmunotherapy; real-world registries confirm ~2-year PFS >85%.

Outcomes

3top
In plain words
What these results mean for people, not percentages
432 people took part
Progression-free survival (median)primarysurrogate endpoint
  • Median 76.2 vs 36.4 months with Venetoclax + obinutuzumab compared with Chlorambucil + obinutuzumab; about 39.8 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 60 percent lower chance of the event at any given time (hazard ratio 0.4).
  • The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
Progression-free survival at 6 yearssurrogate endpoint
  • 53.1 vs 21.7 out of 100 alive without the cancer growing at 6 years with Venetoclax + obinutuzumab compared with Chlorambucil + obinutuzumab; 31.4 more per 100.
  • Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Undetectable MRD in blood at end of treatmentsurrogate endpoint
  • 75.5 vs 35.2 out of 100 had no detectable disease on sensitive tests with Venetoclax + obinutuzumab compared with Chlorambucil + obinutuzumab; 40.3 more per 100.
  • Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Be careful
  • 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.
  • These results apply to the people the trial enrolled: Previously untreated CLL with coexisting conditions: 12 months of venetoclax + 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.

432 participants enrolled.

Progression-free survival (median)primary
HR 0.4 · p <0.0001
Venetoclax + obinutuzumab
76.2 mo
Chlorambucil + obinutuzumab
36.4 mo
Source
Progression-free survival at 6 years
Venetoclax + obinutuzumab53.1 of 100
Chlorambucil + obinutuzumab21.7 of 100
Undetectable MRD in blood at end of treatment
Venetoclax + obinutuzumab75.5 of 100
Chlorambucil + obinutuzumab35.2 of 100
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (median)primaryVenetoclax + obinutuzumab21676.2 months0.4<0.0001link
Chlorambucil + obinutuzumab21636.4 months
Progression-free survival at 6 yearsVenetoclax + obinutuzumab53.1%
Chlorambucil + obinutuzumab21.7%
Undetectable MRD in blood at end of treatmentVenetoclax + obinutuzumab75.5%
Chlorambucil + obinutuzumab35.2%
Replication
CLL13/GAIA (fit patients) reproduced venetoclax-obinutuzumab superiority over chemoimmunotherapy; real-world registries confirm ~2-year PFS >85%.

Key papers

1top

Connected

11top

Pages like this

not linked directly; found by shared links