Breakthrough Treatment for Relapsed T-Cell Lymphoma Approved in China

Introduction to Golidocitinib

Golidocitinib, developed by Dizal, is a new medication that has just received approval in China for treating adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It stands out as the first Janus kinase 1 (JAK1) selective inhibitor approved for this use worldwide. This approval marks a significant advancement for patients who have not responded to previous treatments.

What is Peripheral T-Cell Lymphoma?

Peripheral T-cell lymphoma is a group of aggressive cancers that affect T-cells and natural killer (NK) cells, and are classified under non-Hodgkin lymphomas (NHL). Patients diagnosed with PTCL often face a high likelihood of the disease returning even after initially successful treatments. The survival rate for those whose cancer has returned or not responded to treatment is very low, with only 23% living for three years and a median survival time of just under six months.

Current Treatments and Their Limitations

Although there are a few medications that have received conditional approval to treat relapsed or refractory PTCL, their effectiveness has been limited. With typically less than 30% objective response rates (ORRs), these treatments offer modest benefit to patients.

Study and Approval of Golidocitinib

The approval of golidocitinib is based on the JACKPOT8B study, a pivotal international trial that examined its effectiveness and safety as a standalone treatment for relapsed or refractory PTCL. The study’s main goal was to determine the ORR, which was reviewed by an independent committee. The complete findings were published in The Lancet Oncology and presented at the 65th American Society of Hematology Annual Meeting and Exposition.

Results of the JACKPOT8B Study

The study showcased golidocitinib's remarkable and lasting results in terms of tumor reduction and patient safety. As of August 31, 2023, the drug achieved an ORR of 44.3%, including a complete response rate of 23.9%. These responses were observed across various subtypes of PTCL, and the median duration of response was 20.7 months, with more than half of the patients continuing to respond to the treatment.

The Significance of Golidocitinib

Dr. Jun Zhu, a leading researcher in the study, emphasized golidocitinib’s novel mechanism and design, making it the first oral JAK1 inhibitor for treating relapsed or refractory PTCL. With an ORR of 44.3% and a median response duration of over 20 months, the drug offers a new and much-needed option for PTCL patients.

Dizal's Pioneering Work

Dizal was the first to identify the JAK/STAT pathway as a potential treatment target for PTCL, which led to the development of golidocitinib. The drug exhibits high selectivity for JAK1 over other JAK family members, resulting in potent antitumor effects coupled with a favorable safety profile.

Global Implications

Dizal plans to further expedite the development and approval of golidocitinib on a global scale, with efforts already underway in the United States, where the drug has received Fast Track designation from the FDA for treating relapsed or refractory PTCL.

Recognition from Medical Community

Golidocitinib has gained significant recognition at major international medical conferences, with multiple oral presentations over several years. The results of the JACKPOT8 study have been widely published, reinforcing the treatment's credibility within the medical community.

About Dizal

Dizal is a biopharmaceutical company devoted to discovering and developing unique treatments for cancer and immunological disorders. With a strong focus on molecular design and translating scientific discoveries into treatments, the company aims to address unmet medical needs worldwide.