Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARV-471
ARV-471 in combination with Everolimus · 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).
Dose limiting toxicities in the first 35 days of the study combination treatment characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), 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 combination
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), 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 and Everolimus | EXPERIMENTAL | ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles |
| 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 Everolimus | DRUG | ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles |
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 has been evaluated in clinical trials involving post-menopausal women with breast cancer prior to surgery and in patients with advanced or metastatic ER+, HER2- breast cancer. It is not yet approved for any indication.
ARV-471 targets the estrogen receptor (ER), a receptor protein that drives growth in certain breast cancers. By binding to ER, ARV-471 is designed to degrade the receptor, thereby reducing estrogen signaling that promotes tumor growth. This mechanism is being investigated in ER+ breast cancer.
ARV-471 is being developed by Arvinas, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ARVN. Arvinas is focused on targeted protein degradation and is the sponsor of the clinical trials evaluating ARV-471 in breast cancer.
ARV-471 is in Phase 2 clinical development. It has completed two trials: a Phase 2 trial in post-menopausal women with breast cancer prior to surgery and a Phase 1 trial in combination with everolimus for advanced or metastatic ER+, HER2- breast cancer. It is investigational and not approved.
ARV-471 has been studied in two completed clinical trials: NCT05549505, a Phase 2 trial comparing ARV-471 to anastrozole in post-menopausal women with breast cancer prior to surgery, and NCT05501769, a Phase 1 trial of ARV-471 in combination with everolimus for advanced or metastatic ER+, HER2- breast cancer.