Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Olomorasib, Olomorasib test, Olomorasib reference
LY3537982 · 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...
LY3537982 is an investigational oral therapy being studied in advanced solid tumors, including KRAS G12C-mutant non-small cell lung cancer, colorectal, endometrial, ovarian, pancreatic, and biliary tract cancers. It is also being evaluated in a dedicated Phase 1 study in participants with renal insufficiency. It is not approved for any indication.
LY3537982 targets KRAS G12C, a specific mutation in the KRAS protein. By binding to this mutant form, the drug is designed to inhibit signaling that drives tumor growth in cancers harboring the KRAS G12C alteration. It is a small molecule and is being developed as a targeted therapy.
LY3537982 is being developed by Eli Lilly and Company (ticker: LLY). Lilly is running multiple clinical trials of the drug, including a Phase 3 study in first-line KRAS G12C-mutant non-small cell lung cancer and Phase 1 studies in advanced solid tumors and renal insufficiency.
LY3537982 is in Phase 1 and Phase 3 clinical development. The Phase 3 trial (NCT06119581) is evaluating first-line olomorasib plus pembrolizumab with or without chemotherapy in advanced KRAS G12C-mutant non-small cell lung cancer. Phase 1 studies include NCT04956640, NCT06235983, and NCT07137689. The drug is investigational and not approved.
LY3537982 is being studied in several trials. NCT06119581 is a recruiting Phase 3 trial in first-line KRAS G12C-mutant non-small cell lung cancer. NCT04956640 is an active Phase 1 trial in KRAS G12C-mutant solid tumors. NCT06235983 and NCT07137689 are completed Phase 1 studies in Chinese participants with advanced solid tumors and in participants with renal insufficiency, respectively.
Yes, LY3537982 is also known as olomorasib. The two names refer to the same investigational KRAS G12C inhibitor being developed by Eli Lilly and Company. Clinical trial records and publications may use either name interchangeably.