GLOW
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.
PFS HR 0.216 (95% CI 0.131-0.357); uMRD in marrow 51.9% vs 17.1%; 4-year OS HR 0.487 (2023 update). NEJM Evidence 2022. EU approval of the fixed-duration regimen 2022; not FDA-approved in the US.
Setting
Previously untreated CLL, age ≥65 or with comorbidities, no del(17p)/TP53: fixed-duration ibrutinib + venetoclax vs chlorambucil + obinutuzumab
Phase
Phase 3
Sponsor
Janssen
Registry
Headline result
PFS HR 0.216; OS HR 0.487 (4-year).
Reported
2021
Enrolled
211
Replication
CAPTIVATE (single-arm, younger) and AMPLIFY (acalabrutinib-venetoclax) support BTKi + BCL2i fixed duration; FLAIR (UK, ibrutinib-venetoclax vs FCR) also positive.
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- The treated group had about 78 percent lower chance of the event at any given time (hazard ratio 0.216).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
Undetectable MRD in bone marrow at 3 months post-treatmentsurrogate endpoint
- 51.9 vs 17.1 out of 100 had no detectable disease on sensitive tests with Ibrutinib + venetoclax compared with Chlorambucil + obinutuzumab; 34.8 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.
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, age ≥65 or with comorbidities, no del(17p)/TP53: fixed-duration ibrutinib + venetoclax vs chlorambucil + obinutuzumab. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (17p); the result should not be assumed for people whose cancer does not have it.
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 participants enrolled.
Undetectable MRD in bone marrow at 3 months post-treatment
Ibrutinib + venetoclax51.9 of 100
Chlorambucil + obinutuzumab17.1 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Ibrutinib + venetoclax | 106 | — | 0.216 (0.131–0.357) | <0.0001 | link |
| Chlorambucil + obinutuzumab | 105 | — | ||||
| Undetectable MRD in bone marrow at 3 months post-treatment | Ibrutinib + venetoclax | — | 51.9% | — | — | — |
| Chlorambucil + obinutuzumab | — | 17.1% |
Replication
CAPTIVATE (single-arm, younger) and AMPLIFY (acalabrutinib-venetoclax) support BTKi + BCL2i fixed duration; FLAIR (UK, ibrutinib-venetoclax vs FCR) also positive.