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 (52% ORR, 74% disease control rate).

• The trial included patients relapsed after platinum-based chemotherapy and checkpoint inhibitor therapy, with both biomarker-positive and -negative cohorts evaluated.

• Subjects with ≤2 prior lines of therapy showed improved ORR: 44% in BM+ and 26% in BM- arms; serous endometrial cancer patients with ≤2 prior lines had an ORR of 52%, compared to 22% in non-serous cases.

• The OncoSignature biomarker test identified serous endometrial cancer as particularly sensitive to ACR-368, supporting a tumor-agnostic approach and stratifying patients into biomarker-positive and -negative cohorts.

• The study is expanding to over 20 sites in four major EU countries, with Arm 3 enrolling serous histology patients without biopsy requirement and targeting up to 90 patients; enrollment completion is targeted for Q4 2026.

Safety profile and adverse events

• ACR-368 demonstrated a favorable safety profile, with manageable hematologic adverse events and minimal GI, lung, or neurotoxicities compared to other therapies.

• 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.

Unmet need and clinical context

• Serous endometrial cancer, though only 10% of cases, accounts for over 40–50% of deaths and recurrences, highlighting a major unmet need.

• Standard second- and third-line therapies yield response rates around 15% and PFS of ~3.4 months, making the observed efficacy of ACR-368 highly significant.

• Current options like immunotherapy and chemotherapy offer limited and short-lived benefits, with rapid resistance and few alternatives after progression.

• ADCs are emerging but present challenges with toxicity and sequencing, and are not curative in this setting.

• IO after IO is not supported by data or reimbursement, reinforcing the need for novel agents in recurrent disease.