Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MRTX849 · 5 trials · 8 indications
Defined as time from date of randomization to date of death due to any cause.
Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Number of participants with treatment emergent adverse events
Plasma concentration
Number of patients with dose limiting toxicity
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Number of participants with treatment related adverse events
Blood plasma concentration
Number of participants with treatment related adverse events
Blood plasma concentration
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
| Arm | Type | Description |
|---|---|---|
| MRTX849 + Cetuximab | EXPERIMENTAL | - |
| mFOLFOX6 or FOLFIRI | ACTIVE_COMPARATOR | - |
| MRTX849 | EXPERIMENTAL | - |
| Docetaxel | ACTIVE_COMPARATOR | - |
| Dose Escalation | EXPERIMENTAL | Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination. |
| Dose Expansion | EXPERIMENTAL | Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib. |
| Phase 1 Dose Exploration | EXPERIMENTAL | Dose escalation of TNO155 to determine maximum tolerated dose of TNO155 in combination with MRTX849 |
| Phase 1b Expansion | EXPERIMENTAL | Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with TNO155 to recommend Phase 2 regimens |
| Phase 2 | EXPERIMENTAL | Separate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity to evaluate clinical activity of MRTX849 and TNO155 in combination |
| Pilot Phase 1b Combination with Pembrolizumab | EXPERIMENTAL | Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC |
| Pilot Phase 1b Combination with Cetuximab | EXPERIMENTAL | Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC |
| Pilot Phase 1b Combination with Afatinib | EXPERIMENTAL | Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC |
| Phase 2 Combination with Cetuximab | EXPERIMENTAL | Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC |
| Pilot Phase 1b Combination with Cetuximab in NSCLC | EXPERIMENTAL | Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC |
| Pilot Phase 1b Combination with Cetuximab in PDAC | EXPERIMENTAL | Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC) |
| Name | Type | Description |
|---|---|---|
| MRTX849 | DRUG | 28 Day Cycle |
| Cetuximab | BIOLOGICAL | 28 Day Cycle |
| mFOLFOX6 Regimen | DRUG | * Fluorouracil * Oxaliplatin * Folinic acid |
| FOLFIRI Regimen | DRUG | * Fluorouracil * Irinotecan * Folinic acid |
| Docetaxel | DRUG | 21 day cycles |
| Palbociclib | DRUG | CDK 4 and 6 inhibitor |
| TNO155 | DRUG | SHP2 Inhibitor |
| Pembrolizumab | DRUG | Pembrolizumab is administered as an intravenous infusion once every 3 weeks |
| Afatinib | DRUG | Afatinib will be administered orally once a day in a continuous regimen |
Inclusion Criteria: * Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue. * Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically docume...
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MRTX849, also known as adagrasib, is an investigational small molecule being studied for the treatment of advanced solid tumors, advanced cancer, advanced colorectal cancer, and metastatic non-small cell lung cancer. It is currently in Phase 1 clinical development for these oncology indications.
MRTX849 targets the KRAS G12C mutation, a specific genetic alteration found in certain cancers. As a small molecule inhibitor, it is designed to bind to the mutant KRAS G12C protein, potentially blocking its activity in tumor cells.
MRTX849 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with KRAS G12C-mutated cancers.
MRTX849 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in treating advanced cancers.
MRTX849 is being studied in several clinical trials, including NCT03785249 (KRYSTAL-1), a Phase 1/2 study in patients with KRAS G12C mutations, and NCT04330664 (KRYSTAL 2), a Phase 1 combination study with TNO155. These trials are investigating the drug's effects in advanced and metastatic cancers.
Yes, MRTX849 is also known as adagrasib. The drug is referred to by both names in clinical research and development contexts, with adagrasib being the generic name and MRTX849 the investigational code.