Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARV-110
Bavdegalutamide · 2 trials · 1 indication
DLT was defined as: Grade \>=3 hematologic parameters, Grade ≥ 3 neutropenia with infection, Grade 4 neutropenia lasting \> 5 days, Febrile neutropenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 thrombocytopenia, any toxicity requiring dose interruption for \>=14 days; Grade \>=3 non-hematologic toxicities considered clinically significant and non-clinically significant Grade \>=3 toxicities requiring dose interruption for \>=10 days that determined by the investigator to be clinically relevant. Severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Dose limiting toxicities in first 4 weeks of the study combination treatment assessed to determine the dose of bavdegalutamide associated with acceptable safety and tolerability.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE is an AE occurring on/after the date of first dose of bavdegalutamide and on-study abiraterone and within 30 days of the last dose of bavdegalutamide and on-study abiraterone. TEAEs included both Serious TEAEs and non-serious TEAEs.
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
PSA response rate per PCWG3.
Overall RECIST response rate in patients with measurable disease at baseline.
To evaluate the clinical anti-tumor activity (PSA response rate per PCWG3, Overall RECIST RR, rPFS, and PFS) of ARV-110 in patients with mCRPC in different subgroups of patients with mCRPC with predefined tumor genomic and molecular profiles or based on prior therapy.
| Arm | Type | Description |
|---|---|---|
| Bavdegalutamide + Abiraterone (Safety Lead-in) | EXPERIMENTAL | Male participants received 420 milligrams (mg) bavdegalutamide (3\*140 mg tablets) orally once daily with food and continued taking abiraterone orally once daily at the same dose they were taking before enrolling in the study, on an empty stomach (at least 1 hour before or 2 hours after a meal), along with a corticosteroid of the investigator's choice, per the local guidelines or product label in initial safety lead-in phase until disease progression, an adverse event (AE) leading to discontinuation of the study treatment, death, withdrawal of consent, or any criteria were met for discontinuation. |
| Bavdegalutamide + Abiraterone (Expansion Phase) | EXPERIMENTAL | After the Recommended Phase 2 Dose (RP2D) was determined, additional male participants were enrolled and participants from safety lead-in phase continued to receive 420 mg bavdegalutamide (3\*140 mg tablets) orally once daily with food and continued taking abiraterone orally once daily at the same dose they were taking before enrolling in the study, on an empty stomach (at least 1 hour before or 2 hours after a meal), along with a corticosteroid of the investigator's choice, per the local guidelines or product label until disease progression, an AE leading to discontinuation of the study treatment, death, withdrawal of consent, or any criteria were met for discontinuation. |
| ARV-110 | EXPERIMENTAL | Part A: Oral tablet(s), once or twice daily in 28 day cycles Part B: Oral tablet(s), once or twice daily in 28 day cycles |
| Name | Type | Description |
|---|---|---|
| Bavdegalutamide | DRUG | Bavdegalutamide oral tablets daily in 28 day cycles. |
| Abiraterone | DRUG | Abiraterone oral tablets daily at the same dose they were on prior to study enrollment with a concomitant corticosteroid of Investigator's choice as per local label/guidelines. |
| ARV-110 | DRUG | Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A |
Inclusion Criteria: 1. Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate. 2. Ongoing treatment with stable doses of abiraterone (on an empty stomach) and a concomitant corticosteroid for mCRPC or for metastatic castration sensitive prostate cancer (mCS...
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Bavdegalutamide is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial involving patients with metastatic prostate cancer.
Bavdegalutamide is being developed by Arvinas, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ARVN. The company is conducting clinical research on this investigational drug for the treatment of metastatic prostate cancer.
Bavdegalutamide is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The drug is being studied for the treatment of metastatic prostate cancer in an early-stage clinical trial that has been completed.
Bavdegalutamide has been studied in one clinical trial with the identifier NCT05177042. This Phase 1 trial, titled "Trial of ARV-110 and Abiraterone in Participants With Metastatic Prostate Cancer," enrolled 45 participants and has been completed. The trial was conducted in the United States, Canada, France, and the United Kingdom.
Bavdegalutamide is also known as ARV-110. The clinical trial NCT05177042, which studied Bavdegalutamide, is titled "Trial of ARV-110 and Abiraterone in Participants With Metastatic Prostate Cancer," confirming that these names refer to the same investigational drug.