ATLANTIS
Lurbinectedin's confirmatory trial missed its survival goal, but the drug stayed on the market because the combination tested was not the approved monotherapy dose.
OS 8.6 vs 7.6 months (HR 0.97, not significant); better tolerability than control. The accelerated 2020 monotherapy approval (ORR 35% in a basket cohort) was maintained; the FDA later accepted IMforte and the LAGOON trial as confirmatory routes.
Setting
Relapsed SCLC after one platinum line: lurbinectedin + doxorubicin vs topotecan or CAV
Phase
Phase 3
Sponsor
PharmaMar / Jazz
Registry
Headline result
OS HR 0.97, not significant.
Reported
2021
Enrolled
613
Replication
Monotherapy activity supported by single-arm data and by IMforte in maintenance; head-to-head second-line superiority unproven.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 8.6 vs 7.6 months with Lurbinectedin + doxorubicin compared with Topotecan or CAV; about 1 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 3 percent lower chance of the event at any given time (hazard ratio 0.97, likely range 0.82 to 1.15).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Relapsed SCLC after one platinum line: lurbinectedin + doxorubicin vs topotecan or CAV. 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.
613 participants enrolled.
Overall survivalprimary
HR 0.97 (0.82–1.15)
Lurbinectedin + doxorubicin
8.6 mo
Topotecan or CAV
7.6 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Lurbinectedin + doxorubicin | 307 | 8.6 months | 0.97 (0.82–1.15) | — | link |
| Topotecan or CAV | 306 | 7.6 months |
Replication
Monotherapy activity supported by single-arm data and by IMforte in maintenance; head-to-head second-line superiority unproven.