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IMforte

IMforte produced the first maintenance treatment ever approved for extensive-stage small-cell lung cancer, adding lurbinectedin to the immunotherapy that continues after chemotherapy.

Randomised after four cycles of carboplatin-etoposide-atezolizumab without progression. OS 13.2 vs 10.6 months from randomisation (HR 0.73); PFS HR 0.54. FDA approval 2 October 2025. Presented ASCO 2025 plenary; Lancet 2025. Adds myelosuppression and fatigue.

Setting
First-line maintenance after induction chemo-immunotherapy in ES-SCLC: lurbinectedin + atezolizumab vs atezolizumab
Phase
Phase 3
Sponsor
Roche / Jazz / PharmaMar
Registry
Headline result
OS 13.2 vs 10.6 months (HR 0.73); PFS HR 0.54.
Reported
2025
Enrolled
483
Replication
Single phase 3; the maintenance concept is being tested with tarlatamab (DeLLphi-305) and I-DXd.

Outcomes

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In plain words
What these results mean for people, not percentages
483 people took part
Overall survivalprimarysurvival endpoint
  • Median 13.2 vs 10.6 months with Lurbinectedin + atezolizumab compared with Atezolizumab; about 2.6 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 27 percent lower chance of the event at any given time (hazard ratio 0.73, likely range 0.57 to 0.95).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Progression-free survival (IRF)primarysurrogate endpoint
  • Median 5.4 vs 2.1 months with Lurbinectedin + atezolizumab compared with Atezolizumab; about 3.3 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 46 percent lower chance of the event at any given time (hazard ratio 0.54, likely range 0.43 to 0.67).
  • 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.
Be careful
  • These results apply to the people the trial enrolled: First-line maintenance after induction chemo-immunotherapy in ES-SCLC: lurbinectedin + atezolizumab vs atezolizumab. 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.

483 participants enrolled.

Overall survivalprimary
HR 0.73 (0.57–0.95)
Lurbinectedin + atezolizumab
13.2 mo
Atezolizumab
10.6 mo
Source
Progression-free survival (IRF)primary
HR 0.54 (0.43–0.67)
Lurbinectedin + atezolizumab
5.4 mo
Atezolizumab
2.1 mo
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryLurbinectedin + atezolizumab24213.2 months0.73 (0.57–0.95)link
Atezolizumab24110.6 months
Progression-free survival (IRF)primaryLurbinectedin + atezolizumab5.4 months0.54 (0.43–0.67)
Atezolizumab2.1 months
Replication
Single phase 3; the maintenance concept is being tested with tarlatamab (DeLLphi-305) and I-DXd.

Connected

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