Company: ARVN
Filing Date: 2025-12-08
Form Type: 8-K
Source: 0001628280-25-055682
Chunk: 1

Company: ARVINAS, INC.
Filing Date: 2025-12-08
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

On December 6, 2025, the Company issued a press release announcing preclinical data for ARV-393, a PROTAC BCL6 degrader, in combination with glofitamab, a CD20× CD3 bispecific antibody. These preclinical data were presented in a poster at the 67th ASH® Annual Meeting and Exposition in Orlando, Florida.

These preclinical data showed that in a humanized high-grade B-cell lymphoma ("HGBCL") cell line - derived xenograft ("CDX") model, the combination of ARV-393 and glofitamab resulted in significantly enhanced tumor growth inhibition ("TGI") and increased rates of tumor regression compared with either agent alone. These preclinical data suggest mechanistic synergies between BCL6 degradation with ARV-393 and T-cell engagement.

Specifically, key highlights from the poster presentation included the following:

• In a humanized HGBCL CDX model, ARV-393 (3 mg/kg) combined with glofitamab (0.15 mg/kg) achieved 81 percent TGI with concomitant dosing and 91 percent TGI with sequential dosing (ARV-393 followed by glofitamab), versus 38 percent for single-agent ARV-393 and 36 percent for glofitamab alone.

• At a higher ARV-393 dose (6 mg/kg) combined with glofitamab (0.15 mg/kg), an increase in tumor regressions was observed with concomitant (10 of 10 mice) and sequential dosing (7 of 8 mice) versus single-agent ARV-393 (5 of 11 mice) or glofitamab (0 of 11 mice).

• RNA sequencing and biomarker analyses revealed that ARV-393 upregulated CD20 expression and genes that promote interferon signaling and antigen presentation, while downregulating proliferation-associated gene sets. These collective effects likely contributed to the observed synergistic antitumor activity.

ARV-393 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma and the Company plans to share clinical data from this trial at a medical congress in 2026. Additionally, the Company plans to add a glofitamab combination cohort in patients with diffuse large B-cell lymphoma in the ongoing Phase 1 clinical trial of ARV-393 in 2026.

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