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The first randomised trial of a KRAS drug: better than chemotherapy on progression, not on survival.
CodeBreaK 200, trial NCT04303780 sponsored by Amgen and reported in 2022, was the first randomised trial of a KRAS drug, comparing sotorasib with docetaxel in previously treated KRAS G12C-mutant non-small-cell lung cancer. It randomised 345 patients, met its primary progression-free survival endpoint by blinded review and showed a higher response rate, but overall survival was no different, a result confounded by crossover and dropout, and an FDA advisory committee questioned the benefit in 2023 so that full approval was not granted on this trial alone. OnCo links it to KRAS as a target, to Ferdinandos Skoulidis and to the bottleneck of undruggable drivers, and its findings are consistent with KRYSTAL-12 for adagrasib. Whether a progression benefit without a survival benefit justifies a new standard is the question the trial forced the field to confront. Sotorasib 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.
345 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Sotorasib | 171 | 5.6 months | 0.66 (0.51 to 0.86) | 0.0017 | link |
| Docetaxel | 174 | 4.5 months | ||||
| Overall survival | Sotorasib | - | 10.6 months | 1.01 | - | link |
| Docetaxel | - | 11.3 months |
Shares KRAS G12C-mutant non-small-cell lung cancer, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall, KRAS & RAS inhibitors, The undruggable drivers.
Shares Sotorasib, KRAS G12C-mutant non-small-cell lung cancer, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall, KRAS & RAS inhibitors.
Shares Sotorasib, Amgen, KRAS G12C-mutant non-small-cell lung cancer, KRAS & RAS inhibitors.
Shares Ferdinandos Skoulidis, CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug, Sotorasib, KRAS G12C-mutant non-small-cell lung cancer.
Shares CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug, Sotorasib, Amgen, KRAS & RAS inhibitors.
Shares Sotorasib, KRAS G12C-mutant non-small-cell lung cancer, KRAS & RAS inhibitors, Non-small-cell lung cancer.
Shares Sotorasib, KRAS G12C-mutant non-small-cell lung cancer, KRAS & RAS inhibitors, KRAS.
Shares CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug, Sotorasib, Amgen, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall.