Dizal Pharmaceutical's golidocitinib, a Janus kinase 1 (JAK1) inhibitor, is currently undergoing evaluation in a pivotal global multicenter study for relapsed/refractory peripheral T-cell lymphoma (R/R PTCL). Encouraging results from the Phase I clinical trial, known as JACKPOT8 Part A, have demonstrated promising clinical activity and a favorable safety profile among R/R PTCL patients. The primary analysis of Phase II multinational pivotal study, JACKPOT8 Part B, was recently presented at the ASCO 2023 conference.
The analysis included a cohort of 112 patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL), all of whom received a minimum of one daily dose of golidocitinib at 150 mg. The independent review committee (IRC) evaluated the overall response rate (ORR) and found positive results in 88 PTCL patients, with 21 achieving complete responses (CRR) accounting for 23.9% of the total. The study revealed promising anti-tumor efficacy across various subtypes of PTCL. The median duration of response (mDoR) has not yet been determined, indicating that the length of response is still ongoing. Notably, the longest duration of response recorded thus far is 16.8 months, and the patient continues to exhibit a positive response to the treatment.
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Golidocitinib exhibited a favorable safety profile, with no significant concerns. The majority of adverse events related to the treatment (known as treatment-related adverse events or TRAEs) were related to blood-related conditions and could be effectively monitored and managed within the clinical setting. The median relative dose intensity was 100%, indicating that patients were able to tolerate and adhere to the prescribed dosage. The longest treatment duration recorded was 18 months, demonstrating the sustained administration of golidocitinib over an extended period.
KOL insights
“Patients with r/r PTCL have limited treatment options and a poor prognosis. Golidocitinib has demonstrated superior efficacy compared to current treatment options for r/r PTCL, with an ORR of 44.3% and a complete response rate of 23.9%. These findings validate earlier research results and suggest golidocitinib as a potential therapeutic option to improve patients’ survival outcomes” –Expert Opinion.
“Moreover, the favorable safety profile of golidocitinib suggests that highly selective JAK1 inhibitors may address the limitations of non-selective inhibition of JAK/STAT signaling pathway, thus offering a novel and effective targeted approach for treating PTCL.” –Expert Opinion.
Conclusion
Golidocitinib continues to shine according to the compelling results of the pivotal Phase II study, JACKPOT8. Building on earlier research, this study showcased the golidocitinib’s remarkable and sustained anti-tumor efficacy. The independent review committee (IRC) evaluated the overall response rate (ORR) and found it to be an impressive 44.3%, indicating a significant positive impact on patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL). Notably, the longest duration of response (DoR) recorded was an impressive 16.8 months, affirming the drug's ability to deliver enduring benefits. In terms of safety, golidocitinib proved to be a reliable ally in the fight against R/R PTCL. Its safety profile was deemed acceptable, ensuring that patients could confidently undergo treatment without major concerns. Furthermore, the US FDA recognized the potential of this groundbreaking therapy by granting it Fast Track Designation for the treatment of R/R PTCL
