Soquelitinib Monotherapy Shrank Tumors in Pretreated T-Cell Lymphoma

Soquelitinib, an investigational oral drug that blocks interleukin-2-inducible T cell kinase (ITK), led to lasting tumor responses in some patients with relapsed or refractory T cell lymphoma, according to final results from a phase 1 trial published in Blood.

The trial included 75 patients with T cell lymphoma whose disease had returned or stopped responding to treatment. Soquelitinib was evaluated for safety, its ability to block ITK and its antitumor activity. The findings showed that responses were concentrated among patients who had received fewer prior lines of treatment.

“Despite advances in the molecular characterization of mature T and NK cell lymphomas, outcomes for these patients [are] poor especially [for patients] with relapsed/refractory disease,” the study authors wrote.

How effective was soquelitinib for relapsed or refractory T cell lymphoma?

Among patients who received 200 milligrams of soquelitinib twice daily and had received one to three prior therapies, 37% experienced a complete or partial response, meaning their cancer disappeared or shrank. No responses occurred among patients who had received more than three prior therapies.

The responses were seen across several types of T cell lymphoma and some lasted for more than two years, according to the study and accompanying news release.

The investigators also evaluated how long patients lived without their disease worsening and how long they survived overall.

Among patients who received one to three prior therapies, median progression-free survival, the midpoint amount of time patients lived without their disease worsening, was 6.2 months. Median duration of response was 18.5 months.

Among all patients treated with 200 milligrams twice daily, median overall survival, the midpoint amount of time patients lived after starting treatment, was 28.1 months. At 24 months, 66% of patients were alive.

How does soquelitinib work in T cell lymphoma?

Soquelitinib is designed to selectively block ITK, an enzyme involved in T-cell signaling and the development of different types of immune cells.

Blood and tumor samples collected during the trial suggested that blocking ITK shifted T cells toward a type known as Th1 cells while blocking the development of Th2 cells. The investigators also observed reductions in markers associated with T-cell exhaustion, a state in which T cells become less effective at carrying out their immune functions.

The findings suggest that soquelitinib may act in more than one way, affecting malignant T cells while also changing the activity of normal immune cells surrounding the tumor, according to the study authors.

Who participated in the phase 1 soquelitinib trial?

The phase 1 trial enrolled 75 patients with relapsed or refractory T cell lymphomas and included a dose-escalation portion followed by a dose-expansion portion.

Patients received oral soquelitinib at increasing doses to evaluate safety and determine how effectively different doses blocked ITK. The doses evaluated included 100, 200, 400 and 600 milligrams twice daily.

The study established more than 80% ITK target occupancy at the 200-milligram twice-daily dose, meaning the drug was binding to most of its intended targets. The dose was then evaluated in an expanded group of patients.

Patients enrolled in the trial had several types of T cell lymphoma, including peripheral T cell lymphoma not otherwise specified, cutaneous T cell lymphoma and other subtypes.

What side effects occurred with soquelitinib in T cell lymphoma?

No dose-limiting side effects were reported at doses up to 600 milligrams twice daily, according to the published findings.

In the earlier analysis presented at the 2025 American Society of Hematology Annual Meeting, grade 3 or higher side effects occurred in 29% of patients. The most common grade 3 or higher side effects, occurring in at least 5% of patients, included itching and anemia, although investigators did not consider them related to soquelitinib.

What is next for soquelitinib in peripheral T cell lymphoma?

Soquelitinib is being evaluated in a randomized phase 3 registration trial for patients with relapsed or refractory peripheral T cell lymphoma who have received one to three prior therapies.

The trial is comparing soquelitinib with the investigator's choice of belinostat or pralatrexate.

The phase 3 study is intended to further evaluate whether the responses observed during early-stage testing translate into benefit in a larger group of patients.

References

1. Miller RA, Ding N, Reneau JC, et al. “Phase 1 Trial with Soquelitinib, a Selective ITK Inhibitor for Treatment of Relapsed/Refractory T Cell Lymphomas.” Blood. Published Aug. 25, 2026.
2. “Corvus Pharmaceuticals Announces Publication in Blood of Final Phase 1 Data from the Soquelitinib Phase 1/1b T Cell Lymphoma Trial.” News release. Corvus Pharmaceuticals, Inc. Published Aug. 27, 2026.
3. “Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-Cell Lymphoma Not Otherwise Specified, Follicular Helper T-Cell Lymphomas, or Systemic Anaplastic Large-Cell Lymphoma.” ClinicalTrials.gov. NCT06561048.

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