Golidocitinib, an orally available, JAK1-selective inhibitor, demonstrated promising antitumor activity and durable responses in patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL), according to research at the ASCO Annual Meeting 2023.
The findings were from the primary analysis of efficacy and safety of the multinational, open-label, phase 1/2 JACKPOT8 study of golidocitinib monotherapy in R/R PTCL. The primary endpoint was CT-based objective response rate (ORR) assessed by an independent review committee.
A total of 112 patients (median age, 58 years; 65.2% male) with R/R PTCL received golidocitinib (150 mg) once daily until disease progression or discontinuation. The primary subtypes observed were PTCL not otherwise specified (NOS; 45.5%), angioimmunoblastic T-cell lymphoma (AITL; 14.3%) and anaplastic large-cell lymphoma (ALCL; 9.8%). Patients had a median of 2 prior lines of therapy.
At data cutoff (February 16, 2023), 88 patients were evaluable for efficacy. The ORR was 44.3%, with 21 patients (23.9%) achieving a complete response. Tumor response was observed in other subtypes, including AITL (56.3%), PTCL NOS (46.0%), and ALCL (10%).
At a median follow-up of 6.3 months, the median duration of response (DOR) has not been reached. The longest DOR is 16.8 months, and the patient is still responding.
The researchers found golidocitinib was tolerable and reported that most treatment-related adverse events (TRAEs) were reversible or manageable. Grade ≥3 TRAEs occurred in 55.4% of patients; the most common were hematological TRAEs, including neutrophil count decreased (24.1%), white blood cell count decreased (23.2%), platelet count decreased (17.0%) and lymphocyte count decreased (16.1%).
“Consistent to earlier studies, golidocitinib demonstrated strong and durable anti-tumor efficacy [and] can be a treatment option for patients with R/R PTCL,” concluded study presenter Qingqing Cai, PhD, deputy chief of the department of medical oncology for the Sun Yat-sen University Cancer Center in Guangzhou, China.
Disclosure: This research was supported by Dizal Pharmaceutical. Please see the original reference for a full list of disclosures.
Cai Q, Zhu J, Song Y. Golidocitinib in treating refractory or relapsed peripheral T-cell lymphoma: Primary analysis of the multinational pivotal study results (JACKPOT8). ASCO 2023. June 2-6, 2023. Abstract 7503.