Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARV-471 · 2 trials · 1 indication
Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected. Ki-67 expression was assessed by immunohistochemical staining in a central laboratory. The log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates. The treatment effects were back transformed into geometric means and their Confidence Intervals. The percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1 - geometric mean ratio between Ki-67 at C1D15 and Ki-67 at baseline).
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.
Clinical benefit response rate based on the summation of CRs, PRs and stable disease of 24 weeks duration or longer
First cycle dose-limiting toxicities and determination of a maximum tolerated dose (MTD) if applicable among the doses evaluated
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
| Arm | Type | Description |
|---|---|---|
| Arm A: ARV-471 (Experimental) | EXPERIMENTAL | Participants received 200 mg ARV-471 (2\*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than Cycle 6 Day 18 \[C6D18\] + 14 days). |
| Arm B: Anastrozole | ACTIVE_COMPARATOR | Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days). |
| ARV-471 | EXPERIMENTAL | Parts A and B: ARV-471 administered once daily (QD) or twice daily (BID) for 28 day cycles. |
| ARV-471 and palbociclib (IBRANCE®) | EXPERIMENTAL | Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days. |
| Name | Type | Description |
|---|---|---|
| ARV-471 | DRUG | 100 mg tablet |
| Anastrozole | DRUG | 1 mg tablet |
| Surgical resection of breast tumor | PROCEDURE | Surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days) |
| ARV-471 in combination with palbociclib (IBRANCE®) | DRUG | Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days |
Inclusion Criteria: * Post-menopausal females ≥ 18 years. * Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment). ER and HER2 status must be documented: * ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by immunohistochemistry (IHC) per America...
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ARV-471 is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in patients with ER+/HER2- locally advanced or metastatic breast cancer, as well as in post-menopausal women with breast cancer prior to surgery. The drug is in clinical development and is not yet approved.
ARV-471 is a small molecule designed to target and degrade the estrogen receptor. By targeting the estrogen receptor, the drug aims to disrupt estrogen receptor signaling, which is relevant in ER+ breast cancer. The mechanism is being investigated in clinical trials for breast cancer.
ARV-471 is being developed by Arvinas, Inc., a biopharmaceutical company. Arvinas is publicly traded under the ticker symbol ARVN. The company is conducting clinical trials to evaluate the safety and efficacy of ARV-471 in breast cancer.
ARV-471 is in Phase 2 clinical development. It has completed a Phase 1/2 trial and a Phase 2 trial. The drug is investigational and has not been approved by regulatory authorities. Its development is ongoing, with completed trials providing data for further evaluation.
ARV-471 has been studied in two completed clinical trials. NCT04072952 is a Phase 1/2 trial of ARV-471 alone and in combination with palbociclib in ER+/HER2- locally advanced or metastatic breast cancer. NCT05549505 is a Phase 2 trial comparing ARV-471 to anastrozole in post-menopausal women with breast cancer prior to surgery.
ARV-471 is also known as vepdegestrant. The drug is being developed by Arvinas, Inc. under the name ARV-471, and vepdegestrant is an alternative name for the same investigational compound. Both names refer to the same small molecule being studied in breast cancer.