Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JSB462 Dose 1 QD, JSB462 Dose 1
JSB462 · 3 trials · 3 indications
Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between.
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
The duration of exposure in weeks to study treatment and for each study treatment component (JSB462, abiraterone and enzalutamide) will be summarized for each study treatment component by means of descriptive statistics using the SAS.
Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
A dose-limiting toxicity (DLT) is defined as a treatment-related adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the first 28 days of treatment with JSB462 and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose regimen decisions, DLTs will be considered.
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics.
JSB462 pharmacokinetic (PK) samples will be obtained and evaluated to assess single dose and steady-state plasma Pharmacokinetic (PK) of JSB462 and its metabolite ARV-767 and summarized using descriptive statistics.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) will be listed and summarized using descriptive statistics.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | JSB462 100 mg QD + abiraterone 1000 mg QD |
| Arm 2 | EXPERIMENTAL | JSB462 300 mg QD + abiraterone 1000 mg QD |
| Arm 3 | ACTIVE_COMPARATOR | abiraterone 1000 mg QD or enzalutamide 160 mg QD |
| Name | Type | Description |
|---|---|---|
| JSB462 | DRUG | JSB462 is administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision. |
| Abiraterone | DRUG | Abiraterone 1000 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision. |
| Enzalutamide | DRUG | Enzalutamide 160 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision. |
| AAA617 | DRUG | administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision |
Key Inclusion Criteria: * An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2 * Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible * High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non...
JSB462 is an investigational small molecule being developed for prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC). It is studied in combination with other agents, such as abiraterone or lutetium (177Lu) vipivotide tetraxetan, in adult male patients.
JSB462 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in clinical trials for prostate cancer indications.
JSB462 is in Phase 2 clinical development for metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer. A Phase 1 study in Japanese patients with metastatic prostate cancer is also active. It is investigational and not yet approved by regulatory authorities.
JSB462 is being studied in several active trials. NCT06991556 is a Phase 2 study combining JSB462 with abiraterone in mHSPC. NCT07047118 is a Phase 2 study combining JSB462 with lutetium (177Lu) vipivotide tetraxetan in mCRPC. NCT07174063 is a Phase 1 study in Japanese patients with metastatic prostate cancer.
Yes, JSB462 is also known as Luxdegalutamide. In clinical trial titles, it is referred to as JSB462 (Luxdegalutamide). The drug is being investigated under these names in prostate cancer studies.