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

Key clinical data and trial design

• ACR-368 demonstrated a 52% overall response rate and 74% disease control rate in serous endometrial cancer, with a favorable safety profile and manageable hematologic toxicity, and minimal non-hematologic adverse events.

• The Phase 2 ACR-368-201/GOG-3082 study enrolled relapsed endometrial cancer patients post-platinum and checkpoint inhibitor therapy, using the OncoSignature biomarker to stratify biomarker-positive and -negative cohorts.

• Arm 3, enrolling in Europe and the US, removes the biopsy requirement and focuses on serous histology, aiming for rapid recruitment and broader access, with expansion to over 20 sites in four major EU countries and enrollment completion targeted for Q4 2026.

• Both arms 1 and 3 are of registrational intent, with ongoing prospective enrollment and active FDA dialogue for potential accelerated approval.

• The conference featured a KOL panel with leading oncologists and researchers discussing the trial and its design.

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 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 clinical benefit rate at 16 weeks was 61.3% in BM+ 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 and minimal non-hematologic toxicity.

• 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.