OnCo
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LIBRETTO-431

Proved that a RET pill is better than chemotherapy with or without immunotherapy as first treatment for RET-fusion lung cancer.

261 patients. PFS 24.8 vs 11.2 months (HR 0.46); intracranial responses in 82% vs 58%. Reinforces the rule that oncogene-addicted NSCLC should receive targeted therapy before immunotherapy.

Setting
First-line RET-fusion advanced NSCLC: selpercatinib vs platinum-pemetrexed ± pembrolizumab
Phase
Phase 3
Sponsor
Eli Lilly
Registry
Headline result
PFS HR 0.46.
Reported
2023
Enrolled
261
Replication
Consistent with the single-arm LIBRETTO-001 (ORR 84% treatment-naive); pralsetinib (ARROW) supports the RET class.

Outcomes

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In plain words
What these results mean for people, not percentages
261 people took part
Progression-free survival (BICR), ITT-pembrolizumab populationprimarysurrogate endpoint
  • Median 24.8 vs 11.2 months with Selpercatinib compared with Platinum-pemetrexed ± pembrolizumab; about 13.6 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 54 percent lower chance of the event at any given time (hazard ratio 0.46, likely range 0.31 to 0.7).
  • 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: First-line RET-fusion advanced NSCLC: selpercatinib vs platinum-pemetrexed ± pembrolizumab. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (RET); 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.

261 participants enrolled.

Progression-free survival (BICR), ITT-pembrolizumab populationprimary
HR 0.46 (0.31–0.7) · p <0.001
Selpercatinib
24.8 mo
Platinum-pemetrexed ± pembrolizumab
11.2 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (BICR), ITT-pembrolizumab populationprimarySelpercatinib12924.8 months0.46 (0.31–0.7)<0.001link
Platinum-pemetrexed ± pembrolizumab8311.2 months
Replication
Consistent with the single-arm LIBRETTO-001 (ORR 84% treatment-naive); pralsetinib (ARROW) supports the RET class.

Connected

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