Acrivon Therapeutics (ACRV) European Society of Gynecological Oncology (ESGO) Congress 2026 summary

Key clinical data and trial design

• ACR-368 demonstrated a 39% overall response rate (ORR) and 81% disease control rate in biomarker-positive endometrial cancer patients, with higher efficacy in serous subtypes and a favorable safety profile compared to standard therapies.

• In serous endometrial cancer, response rates reached 52% with a disease control rate of 74% and clinical benefit rate of 65% at 16 weeks, with manageable hematologic toxicity and minimal severe adverse events.

• Subjects with ≤2 prior lines of therapy showed improved ORR: 44% in BM+ and 26% in BM- arms.

• The trial allows prior exposure to ADCs and immune checkpoint inhibitors, addressing a population with high unmet need and limited effective options after standard therapies.

• Arm 3 of the ongoing trial enrolls serous histology patients regardless of biomarker status, aiming for rapid recruitment by removing the biopsy requirement and expanding to over 20 sites in Europe.

Safety profile and adverse events

• ACR-368 demonstrated a favorable safety profile, with limited, transient, mechanism-based hematological adverse events.

• No fatal treatment-related adverse events were reported; notable absence of GI toxicities, ILDs, stomatitis, ocular toxicity, and peripheral neuropathy.

• G-CSF support is encouraged or mandated depending on treatment arm.

• ADCs present toxicity challenges such as interstitial lung disease and neurotoxicity, while ACR-368 offers a more manageable safety profile.

• In serous endometrial cancer, toxicity was manageable with minimal severe adverse events.

Unmet need and clinical context

• Serous endometrial cancer represents only 10% of cases but accounts for over 40%–50% of deaths, highlighting a disproportionate burden and urgent need for new therapies.

• Standard second- and third-line therapies yield response rates around 15%, making the observed efficacy of ACR-368 particularly notable.

• IO after IO is not supported by data or reimbursement, reinforcing the need for alternative agents like ACR-368 in recurrent settings.

• The removal of biopsy requirements and expansion into Europe are expected to accelerate trial enrollment and facilitate broader access.

• The ongoing study includes an exploratory arm for biopsy-independent serous all-comers and aims to complete enrollment by late 2026.