China’s NMPA Accepts NDA for Golidocitinib in Peripheral T-Cell Lymphoma

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Data from the phase 2 JACKPOT8 PARTB study support the new drug application for golidocitinib as a treatment for relapsed/refractory peripheral T-cell lymphoma in China.

In the open-label, multi-center phase 1/2 JACKPOT8 study, patients with relapsed/refractory PTCL received golidocitinib as an oral capsule once a day until disease progression or unacceptable AEs.

In the open-label, multi-center phase 1/2 JACKPOT8 study, patients with relapsed/refractory PTCL received golidocitinib as an oral capsule once a day until disease progression or unacceptable AEs.

A new drug application (NDA) for golidocitinib (DZD4205) as a treatment for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) has been accepted by the National Medical Products Administration’s Center for Drug Evaluation in China, according to a press release from Dizal.1

Supporting data for the NDA came from the phase 2 JACKPOT8 PARTB study (NCT04105010). As of the data cutoff date of February 16, 2023, the objective response rate (ORR) by independent central review in patients treated with golidocitinib was 44.3%, which included a complete response (CR) rate of 23.9%. Additionally, investigators reported that over half of the patients with tumor remission experienced a CR. Patients with different PTCL subtypes appeared to derive benefit from study treatment.

Most treatment-related adverse effects (TRAEs) observed in the JACKPOT PARTB study were manageable 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 at Dizal, said in the press release. “We believe [golidocitinib] 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.”

Golidocitinib was designed as an orally available JAK1-specific inhibitor. According to the press release, the JAK/STAT signaling pathway is believed to be instrumental in the pathogenesis and progression of hematologic diseases such as T-cell malignancies, and golidocitinib appears to demonstrate promise in impeding tumor growth by targeting this pathway.

In the open-label, multi-center phase 1/2 JACKPOT8 study, patients with relapsed/refractory PTCL received golidocitinib as an oral capsule once a day until disease progression or unacceptable AEs.

The study’s primary end point was ORR per Lugano criteria. Secondary end points included AEs, peak plasma concentration of golidocitinib, and area under the plasma concentration.

Patients 18 years and older with histologically confirmed PTCL according to 2016 World Health Organization criteria for lymphoid neoplasms were able to enroll on the trial. Additional eligibility criteria included having measurable disease based on Lugano criteria, being transplant-ineligible, having refractory disease after 1 but no greater than 3 lines of systemic therapy, and adequate bone marrow reserve and organ system functions.

Those with any unresolved toxicities from prior lines of anti-cancer therapy, active infections, or active or latent tuberculosis were unable to enroll on the study. Patients were also unable to enroll if they had severely decreased lung function, a history of heart failure, central nervous system or leptomeningeal lymphoma, or treatment with JAK or STAT3 inhibitors.

The FDA granted fast track designation to golidocitinib as a treatment for those with relapsed/refractory PTCL in February 2022.2

“Relapsed or refractory [PTCL] is an aggressive and rare type of non-Hodgkin lymphoma. Patients with [relapsed/refractory] PTCL often [have a] poor prognosis,” Zhang said in a press release at the time of the fast track designation.2 “The FDA fast track designation for [golidocitinib] is an important milestone and we look forward to working closely with the FDA to potentially bring this treatment to our patients.”

References

  1. Dizal announces China CDE acceptance of new drug application for golidocitinib for relapsed or refractory PTCL. News release. Dizal. September 14, 2023. Accessed September 15, 2023. https://shorturl.at/yFOWZ
  2. Dizal Pharmaceutical receives U.S. FDA fast track designation for DZD4205 (golidocitinib) for the treatment of refractory or relapsed peripheral T-cell lymphoma. News release. Dizal. February 18, 2022. Accessed September 15, 2023. https://shorturl.at/jlCE0
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