On the opening day of ASCO 2025, Professor Huang Huiqiang from Sun Yat-sen University Cancer Center delivered an oral presentation showcasing the latest results from the SCENT Study 2.0. The study evaluated Chidamide in combination with PD-1 therapy for patients with untreated NK/T-cell lymphoma, revealing outstanding results, Highlighting strong efficacy data. Key study highlights:

Sintilimab (anti-PD-1 antibody) combined with chidamide (an oral subtype-selective HDACi) followed by P-GemOx regimen in patients with treatment-naive extranodal natural killer/T cell lymphoma (TN-ENKTL):  A multicenter, open-label, single-arm, phase II study (SCENT-2 trial)

 

Abstract Number: 7006

 

Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Presentation Time: May 30, 2:45 PM-5:45 PM (NACST); May 31, 3:45 AM-6:45 AM (Beijing Time)

 

Primary Author: Huang Huiqiang, Sun Yat-sen University Cancer Center

 

Key Findings:

Extranodal NK/T-cell lymphoma (ENKTL) is a highly aggressive form of non-Hodgkin lymphoma, with a higher incidence in Asia. The P-GemOx regimen is the current standard first-line treatment. SCENT 1.0 demonstrated that Chidamide (SC) combined with Sintilimab is both safe and effective for patients with relapsed or refractory ENKTL. For treatment-naïve patients, the SC regimen has the potential to improve outcomes further. SCENT 2.0 is a prospective study designed to evaluate the efficacy and safety of Chidamide (SC) in combination with P-GemOx in newly diagnosed ENKTL patients.

 

From August 2022 to December 2024, the study enrolled a total of 47 eligible patients. Patients initially received two cycles of the standard-dose SC regimen (Part A). Those who achieved a complete response (CR) or partial response (PR) then proceeded to two cycles of the P-GemOx regimen (Part B). Among the 46 patients evaluable for efficacy after Part A, 78.2% achieved a response, with 60.3% attaining a complete response. Following Part B, among the 42 efficacy-evaluable patients, the complete response rate increased to 95.2%, and the overall objective response rate reached 97.6%. At one year, the disease control rate, progression-free survival rate, and overall survival rate were 96.2%, 97.5%, and 95.3%, respectively.

 

Adverse Events: The most common hematologic adverse events were neutropenia (97.8%), lymphopenia (89.4%), anemia (74.5%), and thrombocytopenia (58.7%). Non-hematologic adverse events included anorexia (38.3%), nausea (38.3%), and elevated lipase (31.9%). Most toxicities were associated with the P-GemOx regimen. The preliminary results from the SCENT-2 trial surpassed expected efficacy outcomes. For this patient population, the regimen may represent a promising chemotherapy-reduced approach with manageable toxicity, meriting further investigation.

 

Previously, the SCENT 1.0 study, led by Professor Huang, demonstrated remarkable results in relapsed/refractory NK/T-cell lymphoma. The combination of Chidamide and PD-1 therapy extended median survival in advanced relapsed patients from 6 months to 32.9 months—a more than five-fold increase—while achieving a cure rate of 48.6%. SCENT 2.0, focusing on treatment-naïve patients, showed that Chidamide can significantly enhance the tumor microenvironment and overcome resistance to immunotherapy, providing clinical validation for this treatment regimen.

 

 

At this year’s ASCO Annual Meeting, Chidamide’s therapeutic outcomes were highlighted across multiple indications, including advanced urothelial carcinoma, soft tissue sarcoma, biliary tract cancer, pancreatic cancer, and breast cancer.

Poster 1

 

Final Results of a Phase II Study of the HDAC Inhibitor Chidamide in Combination with a PD-1 Inhibitor for Advanced Urothelial Carcinoma After Platinum Therapy.

 

Abstract Number: 4563

 

Presentation Time: June 2, 9:00 AM-12:00 PM (NACST); June 3, 10:00 AM-1:00 PM (Beijing Time)

 

Lead Author: Liu Zhuowei, Sun Yat-sen University Cancer Center

 

Key Findings:

Epigenetic dysregulation plays a key role in the development and progression of urothelial carcinoma. Preliminary studies have shown that Chidamide combined with Tislelizumab is well tolerated and demonstrates meaningful antitumor activity in patients with advanced or metastatic urothelial carcinoma (mUC), achieving a confirmed objective response rate (ORR) of 41.7% and a median progression-free survival (PFS) of 4.6 months. This report presents the final analysis of these results.

 

From January 2021 to October 2023, Sun Yat-sen University Cancer Center enrolled 45 patients. As of the data cutoff in August 2024, the median follow-up was 23.2 months (95% CI: 17.2–31.9). The median age of participants was 63 years (IQR: 57–68). The confirmed objective response rate (ORR) was 44.4% (12 complete responses, 8 partial responses; 95% CI: 29.6–60.0%), and the disease control rate (DCR) was 60% (27/45; 95% CI: 44.3–74.3%). The duration of response (DOR) was not reached (95% CI: 8.8–NE). Median progression-free survival (PFS) was 7.0 months (95% CI: 2.4–10.3), and median overall survival (OS) was 20.3 months. (95% CI: 10.7–NE). The most common treatment-emergent adverse events (TEAEs) included anemia, decreased appetite, thrombocytopenia, neutropenia, leukopenia, fatigue, and hypoalbuminemia. Grade ≥3 TEAEs with an incidence of ≥10% included neutropenia (24.4%), thrombocytopenia (20.0%), and anemia (13.3%). No treatment-related deaths were reported.

 

This study is the first to demonstrate both the feasibility and significant efficacy of combining an HDAC inhibitor with a PD-1 monoclonal antibody in metastatic urothelial carcinoma (mUC). Chidamide plus Tislelizumab may offer a promising new treatment option for this patient population.

 

Poster 2

 

A phase II, multicenter trial of the combination of chidamide and toripalimab in patients with advanced soft tissue sarcoma: Efficacy updates

 

Abstract Number: 11560

 

Presentation Time: May 31, 9:00 AM-12:00 PM (NACST); June 1, 10:00 AM-1:00 PM (Beijing Time)

 

Lead Author: Zhang Xing, Sun Yat-sen University Cancer Center

 

Key Findings:

Chidamide is an oral, subtype-selective histone deacetylase (HDAC) inhibitor with proven efficacy in hematologic malignancies, and it has been shown to enhance the effectiveness of immune checkpoint blockade while modulating host immune responses. The research team previously reported preliminary results of Chidamide combined with Toripalimab in patients with soft tissue sarcoma. The latest findings show that a 21-day dosing regimen of Chidamide plus Toripalimab is well tolerated and demonstrates promising antitumor activity in patients with advanced soft tissue sarcoma.

 

As of the data cutoff in January 2025, 69 patients with advanced soft tissue sarcoma were enrolled. The median age was 47 years (range: 16–68), and patients had received a median of 2 prior lines of therapy (range: 0–5). The major subtypes included leiomyosarcoma (29%), well-differentiated/dedifferentiated liposarcoma (36.2%), undifferentiated sarcoma (7.2%), myxoid/round cell liposarcoma (4.3%), and osteosarcoma (4.3%). Among the 69 efficacy-evaluable patients, the overall response rate (ORR) was 29%, and the disease control rate (DCR) was 73.9%. The median time to first response was 5 months (95% CI: 3–7), with a median progression-free survival (mPFS) of 7.1 months (95% CI: 4.0–10.2). Median overall survival (OS) has not yet been reached.

 

The treatment was generally well tolerated. The most common grade 1–2 adverse events included anemia (55.1%), hypothyroidism (44.9%), leukopenia (33.3%), thrombocytopenia (30.4%), neutropenia (24.6%), nausea/vomiting (24.6%), and fatigue (15.9%). The most frequent grade 3–4 adverse events were neutropenia (27.5%), thrombocytopenia (23.2%), leukopenia (14.5%), nausea/vomiting (10.1%), and anemia (1.4%).

 

 

Online Abstract 1

 

Dalpiciclib combined with Chidamide and letrozole as neoadjuvant therapy for HR-positive，HER2-negative early or locally advanced breast cancer: A single-arm, prospective, exploratory clinical study.

 

 

Abstract No.: e12593

 

Lead Author: Shi Yuan, Anyang Tumor Hospital

 

Key Findings:

Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) typically shows low pathological complete response (pCR) and objective response rates (ORR) to neoadjuvant therapy, underscoring the urgent need for more effective treatment options. Dalpiciclib is a novel CDK4/6 inhibitor, while Chidamide is an oral, selective histone deacetylase inhibitor. This study was designed to evaluate the efficacy and safety of combining Dalpiciclib, Chidamide, and Letrozole as neoadjuvant therapy for HR+/HER2- breast cancer.

 

The study enrolled 23 patients, all with ER expression ≥50%, and 74% (17/23) had Ki67 expression ≥20%. Among the 12 patients who completed neoadjuvant therapy and underwent surgery, the residual cancer burden (RCB) 0/I rate was 25% (95% CI: 5.5%–49.5%), with a total pathological complete response (tpCR) rate of 25% (95% CI: 5.5%–49.5%) and an overall response rate (ORR) of 92% (95% CI: 61.5%–100%). Among the 20 patients who completed two treatment cycles and were evaluable for efficacy, the ORR was 75% (95% CI: 50.9%–94.0%).

 

The most common adverse events were neutropenia (100%) and leukopenia (86%). Grade ≥3 adverse events included neutropenia (82%) and leukopenia (55%), while most other events were primarily grade 1–2. These results suggest that the triple combination of Dalpiciclib, Chidamide, and Letrozole shows promising potential in HR+/HER2- breast cancer, with long-term benefits requiring validation in larger-scale studies.

 

Online Abstract 2

 

Dalpiciclib plus chidamide in HR+/HER2- advanced breast cancer following CDK4/6 inhibitor treatment failure: Final results of a phase Ib trial.

 

 

Abstract No.: e13071

 

Primary Author: Wang Tao, The Fifth Medical Center of the Chinese PLA General Hospital

 

Key Findings:

This single-arm, Phase Ib dose-escalation trial used a Bayesian optimal interval design to evaluate the efficacy and safety of Dalpiciclib combined with Chidamide in HR+/HER2- advanced breast cancer patients who had progressed on prior CDK4/6 inhibitor therapy.

 

A total of 22 patients with locally recurrent or metastatic HR+/HER2- breast cancer previously treated with CDK4/6 inhibitors were enrolled. Eligible patients had received no more than one line of chemotherapy for recurrent or metastatic disease. Participants were assigned to four treatment groups: Group A: Dalpiciclib 125 mg/day + Chidamide 25 mg BIW; Group B: Dalpiciclib 125 mg/day + Chidamide 20 mg BIW; Group C: Dalpiciclib 100 mg/day + Chidamide 25 mg BIW; Group D: Dalpiciclib 100 mg/day + Chidamide 20 mg BIW. The primary endpoint was the maximum tolerated dose (MTD). Three dose-limiting toxicities were observed; all grade 4 thrombocytopenia. The overall objective response rate (ORR) was 9.1%, with Group C achieving 16.7%. Median progression-free survival (PFS) was 5.8 months overall and 12.3 months in Group C. Next-generation sequencing (NGS) identified PIK3CA mutations in 8 of 14 patients (57%), ESR1 mutations in 4 (29%), and TP53 mutations in 4 (29%). Patients with wild-type genes showed a trend toward longer PFS compared to those with mutations. Group C (Dalpiciclib 100 mg/day + Chidamide 25 mg BIW) was determined to be the maximum tolerated dose (MTD). Grade 3–4 adverse events were primarily neutropenia (100%), leukopenia (64%), and thrombocytopenia (32%).

 

These results suggest that this combination regimen may represent a viable therapeutic option for HR+/HER2- breast cancer patients following progression on prior CDK4/6 inhibitor therapy.

 

 

Online Abstract 3

 

Envafolimab and chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (Benefits/ScOG-B001): A single-arm, exploratory, phase II trial

 

 

Abstract No.: e16231

 

Principal Author: Li Wei, The First Affiliated Hospital of Soochow University

 

Key Findings:

Biliary tract cancer (BTC) is a group of rare, aggressive malignancies associated with poor prognosis. Envafolimab is a light-chain-deficient PD-L1 monoclonal antibody, and Chidamide is a subtype-selective histone deacetylase (HDAC) inhibitor.

 

This single-arm, multicenter, prospective Phase II clinical trial (ChiCTR2400080783) evaluated the efficacy and safety of first-line treatment with Envafolimab plus Chidamide combined with the GEMOX regimen in advanced BTC. The study demonstrated significant short-term efficacy, with an objective response rate (ORR) of 51.43% (18/35) and a disease control rate (DCR) of 77.14% (27/35). Median progression-free survival (PFS) reached 8.13 months, showing a trend toward superior survival compared with traditional GEMOX monotherapy (median PFS ~6 months). Overall survival (OS) data are not yet mature. Safety analyses showedthat all patients (100%) experienced treatment-related adverse events (TRAEs), with 68.57% (24/35) experiencing grade≥3 toxicities, primarily hematologic, including thrombocytopenia (48.57%), anemia (37.14%), and leukopenia (37.14%). Non-hematologic adverse events were mainly grade 1–2 gastrointestinal reactions (e.g., nausea, diarrhea) and fatigue, and overall tolerability was manageable.

 

This study is the first to validate the synergistic potential of combining a PD-L1 inhibitor with an epigenetic agent and chemotherapy in advanced BTC, providing a promising new treatment option for patients.

 

 

Online Abstract 4

Efficacy of adebrelimab with chidamide, gemcitabine, and S-1 in locally advanced or metastatic pancreatic cancer: A phase II study

 

 

Abstract No.: e16365

 

Principal Authors: Liu Xiufeng - Eastern Theater Command General Hospital; Li Jianping - Yancheng First People’s Hospital

 

Key Findings:

Chidamide, a subtype-selective HDAC inhibitor, exhibits synergistic activity with chemotherapy, immunotherapy, and endocrine therapy, demonstrating clinical efficacy across multiple tumor types.

 

As of December 27, 2024, 13 patients with locally advanced or metastatic pancreatic cancer received first-line treatment with Adebrelimab, Chidamide, Gemcitabine, and Tegafur. The regimen achieved an objective response rate (ORR) of 62% and a disease control rate (DCR) of 92%. Median time to response (TTR) was 1.66 months, median progression-free survival (PFS) was 9.0 months, and median overall survival (OS) was 14.2 months. Notably, all patients with ≥40% reduction in CA199 levels achieved an objective response. Grade ≥3 treatment-related adverse events included leukopenia (23%) and thrombocytopenia (15%). All adverse events were managed with supportive care, and no patients discontinued treatment due to toxicity.

 

These results suggest that Chidamide combination therapy can significantly enhance the efficacy of immunotherapy and chemotherapy, offering superior outcomes compared with chemotherapy alone or standard chemo-immunotherapy regimens, while maintaining a favorable safety profile.