Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADXS31-142 · 1 trial · 2 indications
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Adverse events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication were considered "treatment emergent".
| Arm | Type | Description |
|---|---|---|
| Part A: ADXS31-142 | EXPERIMENTAL | Participants received ADXS31-142 1 × 10\^9 colony-forming units (CFU), 5 × 10\^9 CFU, or 1 × 10\^10 CFU intravenously (IV) every 3 weeks (Q3W) in a 12-week cycle for up to 24 months or until disease progression or discontinuation. |
| Part B: ADXS31-142 + Pembrolizumab | EXPERIMENTAL | Participants received ADXS31-142 1 × 10\^9 CFU) IV Q3W (in a 12-week cycle) in combination with 200 mg pembrolizumab IV Q3W for three times, with a fourth pembrolizumab dose 3 weeks later (in 12 week-cycles) for up to 24 months or until disease progression or discontinuation. |
| Name | Type | Description |
|---|---|---|
| ADXS31-142 | DRUG | ADXS31-142 IV infusion |
| Pembrolizumab | DRUG | Pembrolizumab IV infusion |
Inclusion Criteria: 1. Have progressive mCRPC, on androgen deprivation therapy, based on at least one of the following criteria: 1. Prostate-specific antigen (PSA) progression, defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirm...
Top 2 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |