Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Taletrectinib · 3 trials · 2 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)
| 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 |
| 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. |
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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