Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Olomorasib test, LY3537982
Olomorasib · 6 trials · 9 indications
DFS by Investigator Assessment
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
PK: Cmax of LY3537982
PK: AUC of LY3537982
Measured by the number of patients with dose-limiting toxicities (DLTs)
Measured by the number of patients with dose-limiting toxicities (DLTs)
Measured by TEAEs
| 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. |
| Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab | EXPERIMENTAL | LY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab | EXPERIMENTAL | LY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum | EXPERIMENTAL | LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Part A: LY3537982 plus Pembrolizumab | EXPERIMENTAL | LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Part A: Placebo plus Pembrolizumab | PLACEBO_COMPARATOR | Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum | EXPERIMENTAL | LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum | PLACEBO_COMPARATOR | Placebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Part C: LY3537982 plus Pembrolizumab | EXPERIMENTAL | LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Olomorasib + Cetuximab + mFOLFOX6 | EXPERIMENTAL | Olomorasib administered orally; Cetuximab, fluorouracil, leucovorin \& oxaliplatin administered intravenously (IV) |
| LY3537982 (Normal renal function) | EXPERIMENTAL | LY3537982 administered orally. |
| LY3537982 (Severe renal impairment) | EXPERIMENTAL | LY3537982 administered orally. |
| LY3537982 (Moderate renal impairment) | EXPERIMENTAL | LY3537982 administered orally. |
| LY3537982 | EXPERIMENTAL | LY3537982 administered orally. |
| LY3537982 (Dose Escalation) | EXPERIMENTAL | LY3537982 administered orally. |
| LY3537982 (Dose Expansion) | EXPERIMENTAL | LY3537982 administered orally either alone or with another investigational agent. |
| LY3537982 (Dose Optimization) | EXPERIMENTAL | LY3537982 administered orally either alone or with another investigational agent |
| Name | Type | Description |
|---|---|---|
| Olomorasib | DRUG | Administered orally. |
| Pembrolizumab | DRUG | Administered intravenously (IV). |
| Durvalumab | DRUG | Administered IV. |
| Placebo | DRUG | Administered orally. |
| LY3537982 | DRUG | Administered orally. |
| Cisplatin | DRUG | Administered IV. |
| Carboplatin | DRUG | Administered IV. |
| Pemetrexed | DRUG | Administered IV. |
| Cetuximab | DRUG | Administered IV |
| Oxaliplatin | DRUG | Administered IV |
| Leucovorin/levofolinate calcium | DRUG | Administered IV |
| 5-fluorouracil | DRUG | Administered IV |
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 developed for KRAS G12C-mutant cancers, specifically non-small cell lung cancer and colorectal neoplasms. It is being studied in patients with resected or unresectable KRAS G12C-mutant non-small cell lung cancer and in advanced colorectal cancer with a KRAS G12C mutation. It is not yet approved for any indication.
Olomorasib targets KRAS G12C, a specific mutation of the KRAS protein. By inhibiting this mutant form, the drug aims to block signaling that drives tumor growth in cancers harboring the KRAS G12C alteration. The trials are biomarker-selected, enrolling only participants with this mutation.
Olomorasib is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is the sponsor of the clinical trials evaluating the drug in KRAS G12C-mutant solid tumors.
Olomorasib is in Phase 3 clinical development. The Phase 3 trial is evaluating the drug in combination with standard of care in participants with resected or unresectable KRAS G12C-mutant non-small cell lung cancer. A Phase 2 trial in advanced colorectal cancer is also planned.
Olomorasib is being studied in two registered trials. NCT06890598 is a Phase 3 trial in KRAS G12C-mutant non-small cell lung cancer, recruiting 700 participants across many countries. NCT07814417 is a Phase 2 trial in advanced colorectal cancer with a KRAS G12C mutation, planning to enroll 50 participants in the United States, China, and Spain.
Olomorasib test is an alternative name for olomorasib, also known by the development code LY3537982. All refer to the same investigational small molecule being developed by Eli Lilly and Company for KRAS G12C-mutant cancers.