Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Asciminib and Trastuzumab
Asciminib · 6 trials · 6 indications
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR.
MMR is defined as BCR::ABL1IS ≤ 0.1%. A patient will be counted as having achieved MMR at 12 month if he/she meets the MMR criterion at 12 month.
Evaluate the major molecular response rate at 24 weeks in asciminib arm
The AUC from time zero to the last measurable concentration sampling time (tlast) (ng\*h/mL)
The AUC from time zero to infinity (ng\*h/mL)
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (ng/mL)
The total body clearance of drug from the plasma (L/h)
Determine the MTD and/or RDE of ABL001 as single agent in CML and Ph+ ALL, and in combination with either nilotinib or imatinib or dasatinib in CML patients
| Arm | Type | Description |
|---|---|---|
| Asciminib | EXPERIMENTAL | Participants received asciminib 80 mg once a day (QD). |
| Nilotinib | ACTIVE_COMPARATOR | Participants will receive nilotinib 300 mg BID |
| Bosutinib | ACTIVE_COMPARATOR | Patients were randomized to bosutinib 500mg QD |
| asciminb arm | EXPERIMENTAL | Patients will receive asciminib (40 mg BID continuous) |
| best available treatment arm | EXPERIMENTAL | Patients will receive best available therapy chosen by investigator |
| Normal renal function | EXPERIMENTAL | healthy volunteers with normal renal function |
| Severe renal impairment | EXPERIMENTAL | subjects with severe renal impairment |
| Moderate renal impairment | EXPERIMENTAL | subject with moderate renal impairment |
| Mild renal impairment | EXPERIMENTAL | subjects with mild renal impairment |
| Asciminib in CML patients | EXPERIMENTAL | Dose escalation study estimated the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of asciminib in adult patients with chronic myeloid leukemia (CML). |
| Asciminib+Nilotinib in CML patients | EXPERIMENTAL | Dose escalation study estimated the MTD and/or RDE of asciminib in combination with Nilotinib in adult CML patients |
| Asciminib in Ph+ ALL patients | EXPERIMENTAL | Dose escalation study estimated the MTD and/or RDE of asciminib in adult patients with Ph positive ALL patients |
| Asciminib+Imatinib in CML patients | EXPERIMENTAL | Dose escalation study to estimate the MTD and/or RDE of asciminib in combination with imatinib in adult CML patients |
| Asciminib+dasatinib in CML patients | EXPERIMENTAL | Dose escalation study estimated the MTD and/or RDE of asciminib in combination with dasatinib in adult CML patients |
| Name | Type | Description |
|---|---|---|
| Asciminib | DRUG | Asciminib 80 mg QD administered under fasting conditions. |
| Nilotinib | DRUG | Nilotinib 300 mg twice a day (BID) was administered under fasting conditions. |
| Bosutinib | DRUG | 500 mg tablets was taken orally once daily (QD) |
| best available treatment | OTHER | Best available treatment will be based on investigator's choice identified prior to randomization. Dose and frequency will depend on label and institutional guidelines for various BAT |
| Asciminib (ABL001) | DRUG | Asciminib was be administered orally in a dose escalation schedule. |
| Imatinib | DRUG | Asciminib and imatinib was administered orally in CML patients |
| Dasatinib | DRUG | Asciminib and dasatinib was administered orally in CML patients |
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female patients ≥ 18 years of age. * Patients with CML-CP within 3 months of diagnosis. * Diagnosis of CML-CP (European Leukemia Network \[ELN\] 2020 criteria) with cytogenetic confirma...
Asciminib is an investigational small molecule being studied for chronic myelogenous leukemia, including Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, and for HER2+ metastatic breast cancer. It is also being studied in patients with renal impairment. Asciminib is not approved and remains in clinical development.
Asciminib is a kinase inhibitor, belonging to the -nib class of drugs. It is being studied in chronic myelogenous leukemia and other conditions where kinase signaling plays a role. The specific molecular target is not disclosed in available information.
Asciminib is developed by Novartis AG, a pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials of Asciminib across multiple countries.
Asciminib has completed Phase 1, Phase 2, and Phase 3 trials. A Phase 3 study compared Asciminib to bosutinib in patients with chronic myelogenous leukemia previously treated with two or more tyrosine kinase inhibitors. Asciminib remains investigational and is not FDA approved.
Asciminib has been studied in several completed trials. NCT02081378 was a Phase 1 study in chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. NCT03106779 was a Phase 3 trial versus bosutinib. NCT03605277 examined pharmacokinetics in renal impairment, and NCT04795427 was a Phase 2 study in China.
Asciminib is not the same as Trastuzumab. Asciminib is a small molecule kinase inhibitor, while Trastuzumab is a different type of agent. Asciminib is being studied for chronic myelogenous leukemia and HER2+ metastatic breast cancer, though the two drugs are distinct.