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Proved that a RET pill is better than chemotherapy with or without immunotherapy as first treatment for RET-fusion lung cancer.
LIBRETTO-431, trial NCT04194944 sponsored by Eli Lilly and reported in 2023, proved that the RET inhibitor selpercatinib is better than platinum-pemetrexed chemotherapy, with or without pembrolizumab, as first treatment for RET-fusion advanced non-small-cell lung cancer. It randomised 261 patients, met its primary progression-free survival endpoint by blinded review with a large effect, and produced more intracranial responses than the chemotherapy-based arm. OnCo links it to RET as a target, to LIBRETTO-531 in thyroid cancer, and to the pairing that places targeted therapy before immunotherapy in driver-positive lung cancer, a rule this trial reinforced; the result is consistent with LIBRETTO-001 and with pralsetinib in ARROW. Whether resistance after selpercatinib can be met by next-generation RET inhibitors is the open question. Selpercatinib has its own page.
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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR), ITT-pembrolizumab populationprimary | Selpercatinib | 129 | 24.8 months | 0.46 (0.31 to 0.7) | <0.001 | link |
| Platinum-pemetrexed ± pembrolizumab | 83 | 11.2 months |
Shares LIBRETTO-531, Selpercatinib, RET, Small-molecule kinase inhibitors.
Shares Selpercatinib, RET fusion-positive non-small-cell lung cancer, Eli Lilly (incl. Loxo), Small-molecule kinase inhibitors.
Shares A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRET, Selpercatinib, RET fusion-positive non-small-cell lung cancer.
Shares Selpercatinib, RET fusion-positive non-small-cell lung cancer, RET, Small-molecule kinase inhibitors.
Shares ARROW (thyroid cohorts), Selpercatinib, RET fusion-positive non-small-cell lung cancer, RET.
Shares RET fusion-positive non-small-cell lung cancer, RET, Non-small-cell lung cancer.
Shares Selpercatinib, Eli Lilly (incl. Loxo), Small-molecule kinase inhibitors.
Shares Selpercatinib, Eli Lilly (incl. Loxo), Small-molecule kinase inhibitors.