Acrivon (NASDAQ: ACRV) shows ACR-368 activity in endometrial cancer
Rhea-AI Filing Summary
Acrivon Therapeutics described interim Phase 2b data for its CHK1/2 inhibitor ACR-368 in endometrial cancer during a company-sponsored key opinion leader panel held at the ESGO Congress. The trial uses the ACR-368 OncoSignature biomarker to prospectively select patients predicted to benefit.
In the biomarker-positive Arm 1, ACR-368 monotherapy showed an objective response rate of 39% (95% CI, 24–56) in 31 treated subjects, with disease control rate of 80.6% and 16‑week clinical benefit rate of 61.3%. Across arms, better response rates were observed in patients with ≤2 prior lines of therapy, including serous and non‑serous histologies.
Safety data showed mainly hematologic adverse events such as thrombocytopenia, anemia, leukopenia and neutropenia, with no fatal treatment-related events and a notable absence of common non‑hematologic toxicities. The study is expanding to additional U.S. and European sites, with enrollment completion for the serous all‑comer cohort targeted in Q4 2026.
Positive
- None.
Negative
- None.
Insights
Interim Phase 2b data show ACR-368 activity and manageable safety in heavily pretreated endometrial cancer.
The trial tests ACR-368, a CHK1/2 inhibitor, in endometrial cancer patients pretreated with platinum chemotherapy and anti–PD-(L)1 therapy. A proprietary OncoSignature biomarker stratifies patients into biomarker‑positive and biomarker‑negative cohorts to prospectively predict benefit.
In the biomarker‑positive arm, monotherapy produced a 39% objective response rate with high disease control and clinical benefit rates, which appears notable in a late‑line setting. Serous endometrial cancer, a high‑mortality subtype with limited effective options, showed meaningful responses in both biomarker‑positive and biomarker‑negative tumors.
Safety was mainly hematologic, with Grade 3/4 thrombocytopenia, anemia, leukopenia and neutropenia but no fatal treatment‑related events and few non‑hematologic toxicities. The study’s expansion to >20 European sites and planned enrollment completion by Q4 2026 set clear milestones, while future datasets will need to clarify durability of responses and performance versus current standard chemotherapy outcomes cited in the presentation.
8-K Event Classification
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code:
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 7.01 | Regulation FD Disclosure |
On February 27, 2026, a live webcast of a company-sponsored key opinion leader (KOL) panel of Acrivon’s ACR-368 Phase 2b registrational-intent trial was held during the European Society of Gynecological Oncology (ESGO) Congress taking place in Copenhagen, Denmark, with speakers participating both on-site from the meeting as well as virtually. The discussion included an overview and assessment of the interim ACR-368 clinical data from the registrational intent arms, future plans and the views of the KOL panel participants on the potential of ACR-368 to address unmet patient need in endometrial cancer, particularly in the serous sub-type.
A copy of the slides presented as part of the discussion are attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit Number |
Description | |
| 99.1 | KOL Panel Slides | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Acrivon Therapeutics, Inc. | ||||||
| Date: February 27, 2026 | By: | /s/ Peter Blume-Jensen | ||||
| Name: | Peter Blume-Jensen, M.D., Ph.D. | |||||
| Title: | Chief Executive Officer and President | |||||
KOL PANEL DISCUSSION ACR-368 ENDOMETRIAL CANCER TRIAL February 27, 2026 Exhibit 99.1
Forward-looking statements Certain information contained in this presentation and related webcast includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Our forward-looking statements are based primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and results of operations. The outcome of the events described in the forward-looking statements is subject to risks and uncertainties, including the factors described in our filings with the U.S. Securities and Exchange Commission. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this presentation. The results, events, and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events, or circumstances could differ materially from those described in the forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, including those made by the participants of today’s KOL panel, which are made only as of the date of this event. We undertake no obligation to update any forward-looking statements or to reflect new information or the occurrence of unanticipated events, except as required by law.
Today’s agenda Welcome Adam Levy, Ph.D., M.B.A., CFO Introduction Peter Blume-Jensen, M.D., Ph.D., CEO ACR-368 Clinical Data Overview Brian Slomovitz, M.D. Q&A and Discussion Moderator: Mansoor Raza Mirza, M.D., CMO KOL Panelists: Ramez Eskander, M.D. Robert Coleman, M.D. Domenica Lorusso, M.D., Ph.D. Brian Slomovitz, M.D. Audience Q&A All Adjourn Peter Blume-Jensen, M.D., Ph.D., CEO
Today’s Participants Robert Coleman, M.D. GOG Partners, Special Advisor to the President; GOG Foundation, Vice President; Texas Oncology, US Oncology Network; CMO, Vaniam group Brian Slomovitz, M.D. Member of the Board of Directors, GOG Foundation and the Uterine Cancer Lead, GOG Partners; Director of Gynecologic Oncology and Co-chair of the Cancer Research Committee at Mount Sinai Medical Center; Professor of Obstetrics and Gynecology at Florida International University Domenica Lorusso, M.D., Ph.D. Chair, the MITO (Multicenter Italian Trials in Ovarian Cancer and Gynecological Malignancies) Group; Member of ENGOT (European Network of Gynecological Oncological Trial groups); Director of Gynecological Oncology unit at Humanitas Hospital San Pio X, Milan; Professor of Obstetrics and Gynecology, Humanitas University, Rozzano Ramez Eskander, M.D. Julie St. John Endowed chair in Gynecologic Oncology, Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Clinical Trials Medical Director, Fellowship Director – Gynecologic Oncology, UCSD Health, Rebecca and John Moores NCI Designated Comprehensive Cancer Center Mansoor Raza Mirza, M.D. Chief Medical Officer, Acrivon Therapeutics, Former Chief Oncologist at Copenhagen Univ. Hospital; Honorary Congress President of the European Society of Gynecological Oncology (ESGO) Peter Blume-Jensen, M.D., Ph.D. Chief Executive Officer, President and Co-Founder, Acrivon Therapeutics; Inventor of the AP3 Platform
CLINICAL ACTIVITY OF ACR-368 IN PATIENTS WITH ENDOMETRIAL CARCINOMA PROSPECTIVELY SELECTED BY ONCOSIGNATURE A PHASE 2 STUDY - ACR-368-201/GOG3082 (NCT05548296) Panagiotis Konstantinopoulos1, Mihae Song2, Ramez N Eskander3, Daniela Matei4, Ira Winer5, William H Bradley6, Lindsay Brubaker7, Michael Guy8, Donna Mcnamara9, Rachael Turner10, Chrisann Kyi11, Robert L Coleman12, Stephanie Blank13, David M. O'Malley14, Bradley J. Monk15, Katherine Harris16, Monica Phadnis16, Erick Gamelin16, Mansoor Raza Mirza16, Brian Slomovitz17 1Dana-Farber Cancer Institute, Boston, MA, United States, 2City of Hope Comprehensive Cancer Center – Duarte, Duarte, CA, United States, 3UC San Diego Health, San Diego, CA, United States, 4Northwestern Medicine, Chicago, IL, United States, 5Wayne State University/ Karmanos Cancer Institute, Detroit, MI United States, 6Medical College of Wisconsin, Milwaukee, WI, United States, 7University of Colorado Cancer Center, Aurora, CO, United States, 8Miami Valley Hospital South, Centerville, OH, United States, 9John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ, United States, 10University of Rochester Medical Center, Rochester, NY, United States, 11Memorial Sloan Kettering Cancer Center, New York, NY, United States, 12Texas Oncology - The Woodlands, The Woodlands, TX, United States, 13Mount Sinai Hospital, New York, NY, United States, 14The Ohio State University Comprehensive Cancer Center - James, Columbus, OH, United States, 15Florida Cancer Specialists & Research Institute, West Palm Beach, FL, United States, 16Acrivon Therapeutics Inc., Watertown, MA, United States, 17Mount Sinai Medical Center, Miami Beach, FL, United States
BM-Stratified Cohorts with Prospective Response Prediction Subjects with high-grade EC ≤3 lines of prior therapy Background, Study Rationale & Design ACR-368-201/GOG-3082 presented by Panagiotis Konstantinopoulos The ACR-368 OncoSignature™ is a tumor agnostic, functional Biomarker (BM) test designed to prospectively predict benefit from ACR-368 (prexasertib), a potent, selective CHK1/2 inhibitor. It is composed of 3 protein biomarkers that measure the tumor’s addiction to CHK1/2-mediated DNA repair independent of genetic alterations. Screening with Acrivon’s OncoSignature BM test across routine-processed (FFPE) human tumor types, predicted endometrial cancer (EC) to be particularly sensitive to ACR-368. Subjects relapsed after prior platinum-based chemotherapy and one prior line of anti-PD-(L)1 therapy Arm 1 (BM+) ACR-368 (105mg/m2 iv q14d) (N=71) Arm 2 (BM-) ACR-368 (105mg/m2 iv q14d) + ULDG* sensitization (10mg/m2 iv q14d) (N=~150) Primary endpoint ORR: RECIST 1.1 *ULDG = ultra low dose gemcitabine Exploratory Arm
ACR-368-201/GOG-3082 presented by Panagiotis Konstantinopoulos Subject Demographics Arm 1 (BM+) N = 40 Arm 2 (BM-) N = 48 Median Age (range) 66.0 (40, 77) 66.0 (49, 80) Race, n (%) White 29 (72.5) 29 (60.4) Black/African American 6 (15) 10 (20.8) Asian 1 (2.5) 4 (8.3) American Indian or Alaska Native 0 0 Native Hawaiian or other pacific islander 1 (2.5) 0 Other 1 (2.5) 4 (8.3) Unknown 2 (5) 1 (2.1) Stage, n (%) III 10 (25) 18 (37.5) IV 30 (75) 29 (60.4) Unknown 0 1 (2.1) Histology, n (%) Serous 20 (50) 16 (33.3) Clear-cell carcinoma 2 (5) 4 (8.3) Carcinosarcoma 6 (15) 10 (20.8) Endometroid, G3 9 (22.5) 15 (31.3) Other 3 (7.5) 3 (6.3) ECOG Status at Baseline, n (%) 0 20 (50) 25 (52) 1 20 (50) 23 (48) Subject Demographics Arm 1 (BM+) N = 40 Arm 2 (BM-) N = 48 Median (Mean) Number of Prior Lines 2 (2) 2 (2) Best Overall Response to Last Prior Line Refractory 9 (22.5) 15 (31.3) Relapsed disease 31 (77.5) 33 (68.7) Unknown 0 (0) 0 (0) MMR Status, n (%) pMMR 28 (70) 29 (60.4) dMMR 1 (2.5) 6 (12.5) Unknown 11 (27.5) 13 (27.1) TP53 Status, n (%) Mutant 24 (60) 15 (31.3) Wildtype 6 (15) 11 (22.9) Unknown 10 (25) 22 (45.8) Prior exposure to PD-1/PD-L1, n (%) Yes 39 (97.5) 46 (95.8) No 1 (2.5) 2 (4.2) Prior exposure to Pembro/Len, n (%) Yes 19 (47.5) 20 (41.7) No 21 (52.5) 28 (58.3) Non QC’ed data based on EDC data extract as of 01/13/2026 Demographics and baseline characteristics
Significant Response in Arm 1 (BM+) ITT Population Treated with ACR-368 ACR-368-201/GOG-3082 presented by Panagiotis Konstantinopoulos * Best of BICR and/or PI # Unconfirmed PR Non QC’ed data based on EDC data extract as of 12/04/2025 # # ORR = 39% (95% CI, 24 - 56) n = 31 DCR: 80.6%, CBR (16 weeks): 61.3% BOR by RECIST 1.1 on study treatment* Best overall response (BOR) DCR: Disease Control Rate (CR+PR+SD) CBR: Clinical Benefit Rate [(CR+PR)+(SD >16 weeks)]
# # # Better ORR Observed in Subjects with ≤2 Prior lines of Therapy ACR-368-201/GOG-3082 presented by Panagiotis Konstantinopoulos n = 25 n = 35 ORR = 26% (95% CI, 14 - 42) ORR = 44% (95% CI, 27 - 63) Arm 1 (BM+) ACR-368 ARM 2 (BM-) ACR-368 + ULDG BOR by RECIST 1.1 on study treatment* * Best of BICR and/or PI # Unconfirmed PR Non QC’ed data based on EDC data extract as of 12/04/2025
Significant ORR in Serous All-Comer Population with ≤ 2 Prior Lines of Therapy ACR-368-201/GOG-3082 presented by Panagiotis Konstantinopoulos # # # n = 23 n = 37 Serous (≤ 2 Prior Lines) Non-Serous (≤ 2 Prior Lines) ORR = 22% (95% CI, 11 - 37) ORR = 52% (95% CI, 33 - 71) DCR: 74%, CBR (16 weeks): 65% BOR by RECIST 1.1 on study treatment* * Best of BICR and/or PI # Unconfirmed PR Non QC’ed data based on EDC data extract as of 12/04/2025
Favorable Safety Profile ACR-368-201/GOG-3082 presented by Panagiotis Konstantinopoulos Treatment-Related Adverse Events N = number of subjects (%) Arm 1 (ACR-368) N=40 Grades 3/4 Arm 2 (ACR-368 + ULDG) N=48 Grades 3/4 Thrombocytopenia 9 (22) 17 (34) Anemia 11 (27) 22 (46) Leukopenia 6 (15) 11 (23) Neutropenia 10 (25) 16 (33) Febrile neutropenia 2 (5) 4 (8) Acute kidney injury 2 (5) 0 TRAEs with Grades 3/4 percentages ≥5% for either group are included in this table. No fatal TRAE in either group. G-CSF is encouraged for ACR-368 monotherapy and mandated for ACR-368 + ULDG Limited, transient, mechanism-based hematological AEs Notable Absence of GI toxicities, ILDs, stomatitis, ocular toxicity, peripheral neuropathy, etc. Data-cut of 01/13/2026
Conclusions ACR-368-201/GOG-3082 presented by Panagiotis Konstantinopoulos Subjects relapsed after prior platinum-based chemotherapy and one prior line of anti-PD-(L)1 therapy Arm 1 BM+ N=71 ACR-368 Arm 2 BM- N= up to ~150 ACR-368 with ULDG sensitization Biopsy-Independent Serous Cohort (US + EU) Subjects with ≤2 lines of prior therapy Arm 3 Serous All-Comer N= up to ~90 ACR-368 with ULDG sensitization Enrollment completion Q4 2026 >20 selected sites in 4 major EU countries BM-Stratified Cohorts with Prospective Response Prediction (US only) Subjects with ≤3 lines of prior therapy Primary endpoint ORR by RECIST 1.1 ACR-368 is active in BM+ EC Serous EC shows particularly high ORR in both BM+ and BM- tumors ACR-368 has a favorable safety profile Arm 3 is evaluating ACR-368 with ULDG in serous EC all-comer (biopsy-independent) population with ≤2 prior LoT The study is being expanded to >20 EU sites Primary endpoint ORR by RECIST 1.1 Exploratory Arm LoT: Lines of Therapy
Serous endometrial cancer - a significant unmet need Disproportionate Mortality Accounts for ~40% of all endometrial cancer deaths.5 Limited Effective Treatment Options Only moderate benefit from immunotherapy Chemotherapy responses short-lived. Rapid resistance, early recurrence. HER2-targeting benefits smaller proportion, no TP53-directed therapies Almost all serous patients progress to ≥2nd line of therapy SOC in ≥2nd line post-IO/platinum ~15% ORR and ~3.4 months PFS (single agent chemotherapy)5, 6 Serous EC is characterized by high-grade aplasia and aggressive histological features Nakayama, K.; Nakayama, N.; Ishikawa, M.; Miyazaki, K. Cancers 2012, 4, 799-807. 1SEER database 2https://pmc.ncbi.nlm.nih.gov/articles/PMC9445918 3Concin, C. et al, ESGO–ESTRO–ESP 2025 Guidelines; Lian Y., Luo P. Annals of Global Health (2025). 4Based on internal estimates of approximately 2.4% serous in the prevalence pool given survival approximations 5Bogani et al, Gynecol Oncol. 2021 July ; 162(1): 226–234. doi:10.1016/j.ygyno.2021.04.029. 6Makker et al, NEJM; 2022; 386:437-48 7KOL estimates EC Mortality (US + EU) = ~44K1, 3 Serous EC Mortality 40-50% ~18-22K/year2, 3,7 EC Prevalence ~2.4M patients1, 3 ~58,800 serous EC4