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 a 52% ORR in serous subtypes and favorable safety profile, notably lacking severe GI or neurotoxicities.

• The trial included patients relapsed after platinum-based chemotherapy and checkpoint inhibitor therapy, with both biomarker-positive and -negative groups showing clinical benefit, especially when treated earlier.

• The OncoSignature biomarker test identified serous endometrial cancer as highly sensitive to ACR-368, driving patient selection and stratifying into biomarker-positive and -negative cohorts.

• Arm 3 of the study, enrolling serous histology patients regardless of biomarker status, aims to rapidly expand in Europe and the U.S. without requiring pre-treatment biopsy, targeting up to 90 patients.

• The study's primary endpoint is overall response rate, with duration of response approaching five months and lower confidence interval bounds already exceeding historical standards.

Clinical data and efficacy results

• In the biomarker-positive cohort, ACR-368 achieved an ORR of 39% (95% CI, 24-56) and a disease control rate of 80.6%.

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

• Serous endometrial cancer patients with ≤2 prior lines had an ORR of 52%, compared to 22% in non-serous cases.

• The clinical benefit rate at 16 weeks was 61.3% in biomarker-positive and 65% in serous all-comers.

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.