Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adagrasib · 7 trials · 10 indications
ORR evaluation of subjects treated with adagrasib 600 mg BID without regard to food versus 400 mg BID with food having NSCLC with KRAS G12C mutation (Study Population) will be completed per blinded independent central radiology (BICR) review. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of adagrasib until last dose of adagrasib.
Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival
Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC∞)
Maximum observed plasma concentration (Cmax)
Time to reach Cmax (tmax)
Elimination half-life (t1/2)
Apparent total plasma clearance (CL/F)
Apparent volume of distribution (Vz/F)
| Arm | Type | Description |
|---|---|---|
| Adagrasib | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm A1 | EXPERIMENTAL | - |
| Arm A2 | EXPERIMENTAL | - |
| Arm B1 | EXPERIMENTAL | - |
| Arm B2 | EXPERIMENTAL | - |
| Arm B3 | EXPERIMENTAL | - |
| Arm B4 | EXPERIMENTAL | - |
| Arm C1 | EXPERIMENTAL | - |
| Arm C2 | EXPERIMENTAL | - |
| Arm C3 | EXPERIMENTAL | - |
| Arm C4 | EXPERIMENTAL | - |
| Adagrasib 600mg BID | EXPERIMENTAL | Adagrasib 600mg BID without regard to food |
| Adagrasib 400mg BID | EXPERIMENTAL | Adagrasib 400mg BID with food |
| Phase 2 Cohort 1a: PD-L1 TPS <1% | EXPERIMENTAL | Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab |
| Phase 2 Cohort 1b: PD-L1 TPS <1% | EXPERIMENTAL | Cohort 1b: Adagrasib BID monotherapy |
| Phase 2 Cohort 2: PD-L1 TPS ≥1% | EXPERIMENTAL | Cohort 2: Adagrasib BID in combination with pembrolizumab |
| Phase 3 Cohort 3 Investigational Arm | EXPERIMENTAL | Adagrasib BID in combination with pembrolizumab |
| Phase 3 Cohort 4 Comparator Arm | ACTIVE_COMPARATOR | Pembrolizumab |
| Adagrasib sequence A | EXPERIMENTAL | - |
| Adagrasib sequence B | EXPERIMENTAL | - |
| Treatment A | ACTIVE_COMPARATOR | Treatment A: A single oral dose of adagrasib 400 mg (2 × 200-mg tablets) on Day 1; |
| Treatment B | ACTIVE_COMPARATOR | Treatment B: A single oral dose of eltrombopag 75 mg (1 × 75-mg tablet) plus adagrasib 400 mg (2 × 200-mg tablets) on Day 8. |
| Name | Type | Description |
|---|---|---|
| Adagrasib | DRUG | Specified dose on specified days |
| Pembrolizumab | DRUG | Specified dose on specified days |
| Carboplatin | DRUG | Specified dose on specified days |
| Pemetrexed | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
| Cisplatin | DRUG | Specified dose on specified days |
| Cetuximab | DRUG | Specified dose on specified days |
| Docetaxel | DRUG | Specified dose on specified days |
| Irinotecan | DRUG | Specified dose on specified days |
| Leucovorin | DRUG | Specified dose on specified days |
| Oxaliplatin | DRUG | Specified dose on specified days |
| Fluorouracil | DRUG | Specified dose on specified days |
| Eltrombopag + adagrasib | DRUG | Eltrombopag + adagrasib |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA). * Locally advanced or metastatic disease. * Measurable disease via computed tomography (CT) or...
Adagrasib is an investigational small molecule being studied for the treatment of advanced cancer, solid tumors, and advanced non-small cell lung cancer. It is being evaluated in patients with KRAS G12C mutations. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
Adagrasib targets the KRAS G12C mutation, a specific genetic alteration found in certain cancers. It is designed to inhibit the mutant KRAS protein, which plays a role in tumor growth. The drug is being studied in non-small cell lung cancer and other solid tumors with this mutation.
Adagrasib is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
Adagrasib is in Phase 2 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials. There are active Phase 2 trials recruiting patients with solid tumors and advanced non-small cell lung cancer.
Adagrasib is being studied in several clinical trials, including NCT05853575, a Phase 2 trial of two dosing regimens in NSCLC with KRAS G12C mutation, and NCT07415031, a long-term treatment study for solid tumor patients. Additional Phase 1 trials assess drug interactions and pharmacokinetics in healthy volunteers.
Yes, Adagrasib is also known as BMS-986503. This alternative name appears in clinical trial documentation, such as the pharmacokinetic study NCT07723118, which evaluates single-dose Adagrasib (BMS-986503) in healthy participants of Japanese descent.