Golidocitinib NDA Under NMPA Review for Relapsed/Refractory PTCL

The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has accepted the new drug application (NDA) seeking the approval of golidocitinib (AZD4205) for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).¹

The application was supported by data from part B of the phase 1/2 JACKPOT8 trial (NCT04105010). At a data cutoff date of February 16, 2023, findings showed that golidocitinib elicited an overall response rate (ORR) of 44.3% per independent review committee assessment. Patients experienced a complete response (CR) rate of 23.9%, with more than 50% of patients with tumor remission achieving a CR.

Responses were observed across different PTCL subtypes and irrespective of prior treatment history.

Regarding safety, most treatment-related adverse effects (TRAEs) were monitored and well managed in the clinic.

“We are thrilled that our NDA for golidocitinib has been accepted, marking our second successful NDA submission in 2023,” Xiaolin Zhang, PhD, chairman and chief executive officer of of Dizal Pharamceutical, stated in a news release. “Golidocitinib, as a first-in-class JAK1-only inhibitor, has demonstrated a superior efficacy and safety profile. We believe it will provide a much-needed treatment option for patients with this challenging disease. At Dizal, we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases.”

JACKPOT8 is an open-label, multicenter study enrolling patients at least 18 years of age with histologically confirmed PTCL per the 2016 revision of the World Health Organization classification of lymphoid neoplasms that is relapsed or refractory/intolerant to at least 1 but no more than 3 prior systemic therapies for PTCL.² Patients are required to have measurable disease per Lugano criteria, be transplant ineligible upon study entry, and have adequate bone marrow reserve and organ function.

Exclusion criteria include any unresolved toxicities greater than grade 1 (with the exception of alopecia); active infections, including active or latent tuberculosis; severely decreased lung function; a history of heart failure or QT interval prolongation; central nervous system or leptomeningeal lymphoma; a history of treatment with JAK or STAT3 inhibitors; and any prior allogeneic stem cell transplant or prior autologous stem cell transplant within 6 months of enrollment.

In the phase 1 portion of the study, patients were enrolled to 1 of 2 dose-ascending cohorts. Phase 2 is assessing golidocitinib at the recommended phase 2 dose.

ORR is serving as the trial’s primary end point. Secondary end points include incidence of AEs and pharmacokinetics.

In February 2022, the FDA granted fast track designation to golidocitinib for the treatment of patients with relapsed/refractory PTCL.³

References

1. Dizal announces China CDE acceptance of new drug application for golidocitinib for relapsed or refractory PTCL. News release. Dizal Pharmaceutical. September 14, 2023. Accessed September 14, 2023. http://www.dizalpharma.com/news/detail?id=62
2. Assessing an oral janus kinase inhibitor, AZD4205 as monotherapy in patients who have PTCL (JACKPOT8). ClinicalTrials.gov. Updated September 13, 2023. Accessed September 14, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04105010
3. Dizal Pharmaceutical receives US FDA fast track designation for DZD4205 (golidocitinib) for the treatment of refractory or relapsed peripheral T-cell lymphoma. News release. Dizal Pharmaceutical. February 18, 2023. Accessed September 14, 2023. http://www.dizalpharma.com/news/detail?id=20