Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LGH447 · 4 trials · 3 indications
Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients
Using a Bayesian logistic regression model (BLRM) to guide dose escalation and predict MTD or determine the RP2D for LGH447 in combination with BYL719 in relapsed and refractory multiple myeloma. The frequency and characteristics of DLTs will be assessed.
The proportion of patients with a confirmed best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as assessed by Investigators using the International Myeloma Working group (IMWG) Criteria with modifications. End of Study (defined as the time when all patients have completed at least 6 cycles of treatment or discontinued treatment, or have been lost to follow up, whichever occurs first.
Frequency and characteristics of dose limiting toxicities
Incidence rate of dose limiting toxicity
| Arm | Type | Description |
|---|---|---|
| LGH447 | EXPERIMENTAL | LGH447, QD |
| Phase Ib: LGH447 + BYL719 | EXPERIMENTAL | Dose-escalation, LGH447 in combinatinon with BYL719 |
| Phase II: LGH447 + BYL719 | EXPERIMENTAL | LGH447 + BYL719 (dosing according to MTD/RP2D from Phase Ib portion of the study) |
| Phase II: LGH447 alone | EXPERIMENTAL | LGH447 alone (dosing according to single-agent RDE) |
| LGH447 monotherapy arm | EXPERIMENTAL | LGH447 monotherapy in patients with AML or MDS |
| LGH447 + midostaurin combination arm | EXPERIMENTAL | LGH447 + midostaurin in patients with AML |
| LGH447 and midazolam | EXPERIMENTAL | Eligible patients will receive midazolam on two separate days, the first dose will be administered prior to the start of LGH447 and the second will be co-administered with LGH447. After that, the patients will continue to be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| LGH447 | DRUG | LGH447, QD |
| BYL719 | DRUG | PI3K-alpha inhibitor |
| LGH447 + midostaurin | DRUG | LGH447 + midostaurin in patients with AML |
| midazolam | DRUG | - |
Inclusion Criteria: -Confirmed diagnosis of relapsed and/or refractory MM for which no standard effective treatment options exist. Exclusion Criteria: -Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within t...
LGH447 is an investigational small molecule being studied for the treatment of multiple myeloma, relapsed and refractory multiple myeloma, acute myeloid leukemia (AML), and high risk myelodysplastic syndrome (MDS). It is an oral therapy developed by Novartis AG for patients with these hematologic malignancies.
LGH447 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is an oral small molecule in Phase 1 clinical development for multiple myeloma, AML, and high risk MDS.
LGH447 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All four clinical trials for LGH447 are Phase 1 studies that have been completed, with a total enrollment of 92 patients across the trials.
LGH447 has been studied in four completed Phase 1 trials. NCT01456689 evaluated LGH447 in relapsed and/or refractory multiple myeloma with 79 patients. NCT02078609 studied it in AML and high risk MDS with 70 patients. NCT02144038 tested LGH447 combined with BYL719 in relapsed and refractory multiple myeloma with 20 patients. NCT02160951 was a dose escalation study in Japanese patients with hematologic malignancies.
No, LGH447 is not the same as BYL719. They are distinct investigational drugs that have been studied together in a combination trial for relapsed and refractory multiple myeloma. The trial NCT02144038 evaluated the safety and effectiveness of LGH447 and BYL719 when used together in patients with this condition.