Acrivon Therapeutics Reports 52% ORR and 74% DCR in Serous Endometrial Cancer
Acrivon Therapeutics reported a 52% overall response rate, 74% disease control rate and 65% benefit at 16 weeks in serous endometrial cancer patients treated with ACR-368 in its Phase 2B registrational study. The company plans a 90-patient, biopsy-independent serous expansion across 20+ European sites starting Q2 with completion targeted by Q3.
1. Phase 2B Data Highlights
ACR-368 achieved a 52% overall response rate, 74% disease control rate and 65% clinical benefit at 16 weeks in uterine serous endometrial cancer, compared with a 22% response in non-serous tumors. These outcomes follow treatment of patients after platinum chemotherapy and checkpoint inhibitor therapy.
2. OncoSignature Biomarker Strategy
The trial used Acrivon’s OncoSignature protein-based test to prospectively select patients: biomarker-positive individuals received ACR-368 monotherapy at 105 mg/m2 biweekly and showed a 39% ORR and 81% DCR, while biomarker-negative patients treated with ACR-368 plus ultra-low-dose gemcitabine demonstrated a 26% ORR.
3. Arm 3 Serous Expansion Plans
A biopsy-independent serous cohort (Arm 3) will enroll up to 90 patients with ≤2 prior therapy lines, opening at over 20 European sites in Q2. Enrollment is expected to finish by the end of Q3, and the company remains in active dialogue with regulators to confirm biomarker findings.
4. Safety Profile and Competitive Context
ACR-368 exhibited a favorable safety profile with limited, transient mechanism-based hematologic adverse events (30–40% grade 3/4), considered manageable compared to antibody-drug conjugate toxicities such as interstitial lung disease and neurotoxicity. Panel experts highlighted this profile as an advantage in clinical management.