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SHR2554 in patients with R/R PTCL: Results from a phase I trial

By Dylan Barrett

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Aug 7, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in peripheral T-cell lymphoma.



In patients with peripheral T-cell lymphoma (PTCL), inhibiting enhancer of zeste homolog 2 (EZH2), a key histone methyltransferase, is a rational treatment approach.1 SHR2554 is an oral, small-molecule, selective EZH2 inhibitor.1 A multicenter, two-part, phase I trial (NCT03603951) investigated the safety and efficacy of SHR2554 in patients with relapsed/refractory (R/R) lymphoma.1 In part 1, the recommended dose of SHR2554 350 mg twice daily demonstrated antitumor activity across several lymphoma types, including R/R PTCL.1 Part 2 assessed the safety and efficacy of SHR2554 in 67 patients aged 18–70 years with R/R PTCL following prior chemotherapy and ≥1 novel agent approved in China.1

During the European Hematology Association (EHA) 2025 Congress, June 12–15, 2025, Milan, IT, Yuqin Song presented results from Part 2 of this trial. The primary endpoint was the overall response rate (ORR).1 Key secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. The median follow-up was 15.2 months.1

Key learnings

The primary endpoint was met: the ORR was 64.2%, with a CR rate of 32.8%. The ORR benefit was observed across PTCL subtypes (AITL, 70.3%; PTCL-NOS, 57.1%; ENKTL-NT, 50.0%; ALCL, ALK−, 42.9%; ALCL, ALK+, 50.0%; MEITL, 100%).

The median DoR, PFS, and OS were 18.7 months, 10.0 months, and not reached, respectively. 

Any-grade TEAEs and Grade ≥3 TEAEs occurred in 92.5% and 61.2% of patients, respectively. The most common Grade ≥3 TEAEs were decreased platelet count (28.4%), decreased neutrophil count (26.9%), decreased WBC count (25.4%), and anemia (23.9%).

SHR2554 demonstrated efficacy and a manageable safety profile across PTCL subtypes, making it a potentially new therapeutic option for this challenging-to-treat population. A phase III study comparing SHR2554 vs tucidinostat for R/R PTCL is currently ongoing (NCT06122389).

AITL, angioimmunoblastic T-cell lymphoma; ALCL, ALK-, anaplastic large-cell lymphoma, anaplastic lymphoma kinase-negative; ALCL, ALK+, ALCL, ALK-positive; CR, complete response; DoR, duration of response; EHA, European Hematology Association; ENKTL-NT, extranodal NK/T-cell lymphoma nasal type; EZH2, enhancer of zeste homolog 2; MEITL, monomorphic epitheliotropic intestinal T-cell lymphoma; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PTCL, peripheral T-cell lymphoma; PTCL-NOS, PTCL-not otherwise specified; R/R, relapsed/refractory; TEAE, treatment-emergent adverse event.

References

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