Results from JACKPOT8 presented during the 2022 EHA Congress show that golidocitnib has encouraging anti-tumor efficacy and tolerable safety in patients with relapsed or refractory peripheral T-cell lymphoma.
New data of the selective, oral JAK1 inhibitor, golidocitnib (DZD4205), for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) will be reported in an oral presentation during the European Hematology Association (EHA) 2022, according to a press release from Dizal.1
Results come from the ongoing phase 1/2 trial JACKPOT8 study (NCT04105010) evaluating the safety, tolerability and anti-tumor efficacy of golidocitnib as monotherapy in patients with PTCL, who have relapsed from or are refractory/intolerant to standard systemic treatment. Previously, golidocitnib was granted fast track designation by the FDA for the treatment of r/r PTCL in February 2022, after phase 1 findings showed a 42.9% tumor response rate in patients with relapsed/refractory PTCL.
By the cutoff date of May 31, 2022, 49 patients completed 1 or more post-treatment Lugano assessments with 21 achieving tumor response. Median duration of treatment (DOR) was not reached, and the longest DOR was > 14 months.
In regard to safety, 39.2% of patients (n = 20) experienced grade 3 treatment-emergent adverse events (TEAEs), a majority of which were reversible or clinically manageable with dose modification and possibly related to golidocitnib.
These clinical data, which will be presented at EHA, show golidocitnib to demonstrate good safety and promising anti-tumor efficacy in this patient population.
"We are thrilled to share the updated results from the phase I/II study of golidocitnib in patients with r/r PTCL at 2022 EHA." stated Xiaolin Zhang, MD, chief executive officer of Diesel, in the press release. "This, along with FDA's recent decision to grant fast track designation, strengthens our belief that golidocitnib has enormous potential for PTCL patients."
Within JACKPOT8, 47 patients with histologically confirmed, measurable, relapsed/refractory PTCL were enrolled, with a median age of 62 years (range, 29-79). Those enrolled in the trial received a median of 2 prior lines of therapy (range, 1-8), and had diverse histologic subtypes.2
Enrollment in JACKPOT8, was open to patients with measurable disease according to Lugano criteria, who were transplant-ineligible, and who had adequate bone marrow and organ system functions. The primary outcome of the study is evaluating objective response rate (ORR) with secondary end points of incidence of AEs, peak plasma concentration, and area under the plasma concentration versus time curve of golidocitinib.
During the 2021 International Conference of Malignant Lymphoma, preliminary findings from the JACKPOT8 clinical trial were presented, showing tumor responses to 150 mg or 250 mg of golidocitinib in 14 patients to have achieved an ORR of 51.9%, and complete responses responses were observed in 22.2% of patients. At this time, the median duration of response was not reached, but the longest DOR was greater than 12 months.
All patients were assessed for safety in which 87.2% experienced TEAEs. Grade 3 or higher TEAEs occurred in 51.1% of patients, with 34% of the high-grade TEAEs possibly related to the study drug. The most common TEAEs which were grade 3 or higher seen in patients included thrombocytopenia (23.4%), neutropenia (17.0%), and pneumonia (12.8%).3
The ongoing JACKPOT8 study is actively recruiting patients at 51 locations in the United States, Australia, China, and the Republic of Korea.
Based on these findings, investigators predict that golidocitinib may be safe with anti-tumor efficacy in relapsed/refractory PTCL with the potential to fill an unmet medical need for a new therapeutic option.