Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AB-106, DS-6051b
Taletrectinib · 6 trials · 3 indications
Measure Description: Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence) by investigator's assessment.
Progression-Free-Survival, The time between the beginning of treatment and the occurrence of disease progression or death. Assessed by the blinded Independent Review Committee (BIRC), per RECIST v1.1
Confirmed ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by an independent radiology review committee (IRC)
Best overall response (BOR) based on independent radiology review by Independent Review Committee(IRC) according to RECIST 1.1
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
| Arm | Type | Description |
|---|---|---|
| Taletrectinib Active Arm | ACTIVE_COMPARATOR | Active Arm |
| Placebo Arm | PLACEBO_COMPARATOR | Placebo Arm |
| Taletrectinib | EXPERIMENTAL | 97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm A and treated with talerectinib |
| Crizotinib | ACTIVE_COMPARATOR | 97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm B and treated with Crizotinib |
| AB-106 （DS-6051b） | EXPERIMENTAL | Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106 |
| Itraconazole cohort | EXPERIMENTAL | - |
| Rifampicin cohort | EXPERIMENTAL | - |
| digoxin cohort | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Taletrectinib | DRUG | Intervention Label: Taletrectinib Intervention Name: Taletrectinib Dosage Formulation: Capsule Unit Dose Strength(s): 200 mg Dosage Level (s): 400 mg QD Route of Administration: Oral Use: Experimental IMP and NIMP/AxMP : IMP Former Name(s) or Alias(es): AB-106. |
| Placebo | DRUG | Intervention Label: Placebo Intervention Name: Placebo Type: Drug Dosage Formulation: Capsule Unit Dose Strength(s): 200 mg Dosage Level(s): 400 mg QD Route of Administration: Oral Use: Placebo Comparator IMP and NIMP/AxMP: IMP Former Name(s) or Alias(es): Placebo |
| Crizotinib | DRUG | Approximately 194 ROS-1TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms: Arm A: Taletrectinib monotherapy at 600 mg once daily (QD); Arm B: Crizotinib monotherapy at 250 mg twice daily (BID). Each cycle duration will be 28 days. Participants will be treated until they experience progressive disease (PD) assessed by the blinded Independent Review Committee (BIRC), intolerable toxicity, or another discontinuation criterion is met. Crossover from control group (crizotinib) to taletrectinib is also permitted, at the Investigator's discretion with the Sponsor's approval, for qualifying participants who have experienced objective progression confirmed by the BIRC. |
| AB-106 | DRUG | Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients Stage 2: 600mg QD |
| AB-106, Itraconazole | DRUG | single dose AB-106 at Day1, Itraconazole QD at Day14\~Day28, single dose AB-106 at Day17 |
| AB-106, Rifampicin | DRUG | single dose AB-106 at Day1, Itraconazole QD at Day14\~Day32, single dose AB-106 at Day21 |
| AB-106, digoxin | DRUG | Period 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin |
Inclusion Criteria: 1. Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging. 2. Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories. 3. Adequate tissue is...
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Taletrectinib is an investigational oral therapy being studied for ROS1 positive non-small cell lung cancer (NSCLC) and solid tumors. It is in Phase 3 development for locally advanced or metastatic ROS1 positive NSCLC and is also being evaluated as adjuvant therapy in ROS1 positive NSCLC. It has received FDA Breakthrough Therapy, Priority Review, and Orphan Drug designations.
Taletrectinib is a small molecule inhibitor that targets ROS1 and the NTRK family kinases NTRK1, NTRK2, and NTRK3. By inhibiting these targets, it is designed to block signaling pathways that drive tumor growth in cancers harboring ROS1 or NTRK alterations.
Taletrectinib is being developed by Nuvation Bio Inc., which trades on the New York Stock Exchange under the ticker NUVB. The company is the sponsor of the clinical development program for this asset.
Taletrectinib is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes four trials in total, with two completed Phase 1 studies and two active Phase 3 studies. The FDA has granted Breakthrough Therapy, Priority Review, and Orphan Drug designations.
Taletrectinib is being evaluated in two active Phase 3 trials: NCT07154706 (TRUST-IV), comparing taletrectinib to placebo as adjuvant therapy in ROS1 positive NSCLC, and NCT06564324, comparing taletrectinib with standard therapy in ROS1 positive locally advanced or metastatic NSCLC. Two completed Phase 1 trials, NCT05357911 and NCT05357820, assessed drug interactions in healthy volunteers.
Yes, Taletrectinib is also known as AB-106. The two names refer to the same investigational drug. The Phase 1 trials NCT05357911 and NCT05357820 used the AB-106 designation, while the Phase 3 trials use the taletrectinib name.