Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01843062 ASTRA | — | Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set At 18 months post-RAI treatment | Placebo + RAI | 38.5 Percentage of participants |
| Selumetinib 75 mg BD + RAI | 40.0 Percentage of participants | |||
| NCT01933932 SELECT-1 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI) | Placebo + Docetaxel | 2.8 Months |
| Selumetinib + Docetaxel | 3.9 Months | |||
| NCT01974752 SUMIT | Neoplasm Metastasis | Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1. From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 | Placebo + Dacarbazine 1000 mg/m2 | 24 number of progression events |
| Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 82 number of progression events | |||
| NCT04924608 KOMET | Neurofibromatosis 1 | Confirmed Partial and Complete Response Rate (ORR) by End of Cycle 16 Using Volumetric MRI Analysis as Determined by ICR (Per REiNS Criteria) in Participants With NF1 Who Have Symptomatic, Inoperable PN. From first dose up until progression (if it occurs prior to the end of Cycle 16), or the last evaluable assessment up to and including the end of Cycle 16, excluding MRI during prolonged study intervention interruption (defined as interruption >= 28 days) | Placebo | 5.4 Percentage |
| Selumetinib 25 mg/m2 | 19.7 Percentage |