Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 104

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 104
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 trial who would meet eligibility criteria for Phase 3 VERITAC-2 trial (no prior fulvestrant, no prior chemotherapy for locally advanced or metastatic disease), CBR was 62.5% or 5 of 8 patients, PFS was 19 months or four of eight events and the ORR was 29% or two confirmed responses in seven evaluable patients. 

Part C: In 2021 we initiated a Phase 1b cohort to evaluate vepdegestrant in combination with palbociclib. 

In the second quarter of 2023, we evaluated and announced preliminary results from the Part C dose escalation portion of the Phase 1b/2 clinical trial. Preliminary results from the Part C dose escalation trial, announced in the first quarter of 2023, (November 2022 data cut-off from the Phase 1b combination of vepdegestrant with palbociclib at 125 mg) demonstrated an observed CBR (rate of confirmed complete response, confirmed partial response, or stable disease ≥24 weeks) of 60.7% (95% CI, 40.6 – 78.5) across all dose cohorts (17 of 28 CBR-evaluable patients; patients are CBR-evaluable if they received their first dose >24 weeks prior to the cut-off). In particular, as announced in the second quarter of 2023, 85.7% of the 28 CBR-evaluable patients had received CDK4/6 inhibitor therapy prior to study entry. These data showed an increase in palbociclib exposure relative to historical palbociclib pharmacokinetic data. A similar overall safety profile was observed compared with that reported in our previous palbociclib and endocrine therapy combination studies, except for a higher incidence of grade 3/4 neutropenia, which was managed by monitoring and dose modification per the palbociclib label. Patients were started on palbociclib 125 mg irrespective of dose reduction during prior CDK4/6 inhibitor therapy.

In the fourth quarter of 2023, at the 2023 SABCS, we, along with Pfizer, presented preliminary data from the Phase 1b cohort of the first-in-human ARV-471-mBC-101 trial evaluating vepdegestrant in combination with palbociclib. Data from this clinical trial (data cut-off of June 6, 2023