Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olomorasib · 5 trials · 3 indications
DFS by Investigator Assessment
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
PK: Area Under the Concentration Versus Time Curve (AUC) of olomorasib
PK: Cmax of Olomorasib
PK: AUC(0-tlast) of Olomorasib
PK: AUC(0-∞) of Olomorasib
PK: Cmax of Olomorasib
PK: Cmax of Olomorasib
PK: AUC0-inf of Olomorasib
| Arm | Type | Description |
|---|---|---|
| Part A: Olomorasib + Pembrolizumab | EXPERIMENTAL | Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment. |
| Part A: Placebo + Pembrolizumab | PLACEBO_COMPARATOR | Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment. |
| Part B: Olomorasib + Durvalumab | EXPERIMENTAL | Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment. |
| Part B: Placebo + Durvalumab | PLACEBO_COMPARATOR | Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment. |
| Olomorasib + Fluconazole | OTHER | Administered orally |
| Olomorasib | OTHER | Administered orally |
| Olomorasib Test (Part A) | EXPERIMENTAL | Olomorasib test formulation administered orally with or without food. |
| Olomorasib Reference (Part B) | EXPERIMENTAL | Olomorasib reference formulation administered orally with or without food. |
| Olomorasib Test (Part B) | EXPERIMENTAL | Olomorasib test formulation administered orally with or without food. |
| Olomorasib - (Test Formulation 1) | EXPERIMENTAL | Olomorasib administered orally |
| Olomorasib - (Test Formulation 2) | EXPERIMENTAL | Olomorasib administered orally |
| Olomorasib - (Reference Formulation) | ACTIVE_COMPARATOR | Olomorasib administered orally |
| Olomorasib (Mild Hepatic Impairment) | EXPERIMENTAL | Olomorasib administered orally. |
| Olomorasib (Moderate Hepatic Impairment) | EXPERIMENTAL | Olomorasib administered orally. |
| Olomorasib (Severe Hepatic Impairment) | EXPERIMENTAL | Olomorasib administered orally. |
| Olomorasib (Normal Hepatic Function) | EXPERIMENTAL | Olomorasib administered orally. |
| Name | Type | Description |
|---|---|---|
| Olomorasib | DRUG | Administered orally. |
| Pembrolizumab | DRUG | Administered intravenously (IV). |
| Durvalumab | DRUG | Administered IV. |
| Placebo | DRUG | Administered orally. |
| Fluconazole | DRUG | Administered orally |
Inclusion Criteria: * Histological or cytological confirmation of NSCLC. * Part A 1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible. 2. Patholo...
Olomorasib is an investigational small molecule being studied for use in non-small cell lung cancer, specifically in participants with resected or unresectable KRAS G12C-mutant disease. It is also being studied in healthy participants and those with hepatic insufficiency to evaluate its safety and pharmacokinetics.
Olomorasib is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company is conducting clinical trials of this investigational drug across multiple countries.
Olomorasib is in Phase 3 clinical development for non-small cell lung cancer. It has received Breakthrough Therapy designation from the FDA. The drug remains investigational and has not been approved for any use.
Olomorasib is being studied in a Phase 3 trial (NCT06890598) combining it with standard of care in KRAS G12C-mutant non-small cell lung cancer, currently recruiting 700 participants. Completed Phase 1 trials include NCT06719128 in hepatic impairment and healthy participants, NCT07044271 in healthy participants, and NCT07124013 in healthy Japanese participants.
Yes, Olomorasib is also known as LY3537982. Clinical trial records use both names interchangeably, with LY3537982 appearing in the official study titles for the drug's trials.
Olomorasib targets the KRAS G12C mutation, a specific genetic alteration found in certain cancers. The drug is being evaluated in non-small cell lung cancer patients whose tumors harbor this KRAS G12C mutation.