Golidocitinib Plus PD-1 Antibodies Being Explored in Lung Cancer Subset

Among patients with non-small cell lung cancer (NSCLC), treatment with the Janus kinase 1 (JAK1)-only inhibitor golidocitinib with PD-1 antibodies following progression on anti-PD-1 therapy elicited responses in 44.3% of patients.

New findings on golidocitinib administered in combination with PD-1 antibodies for patients with NSCLC whose disease has progressed on anti-PD-1 therapy were announced in a news release issued by biopharmaceutical company Dizal, with details of the trial design and clinical results expected to be presented later this month at the 2025 European Lung Cancer Congress (ELCC) in Paris.

As of a data cut-off of Aug. 31, 2023, golidocitinib had resulted in an objective response rate of 44.3%, with more than half of the patients who experienced tumor remission experiencing a complete response, with a complete response rate of 23.9%, according to the news release. The median duration of response was 20.7 months, the news release stated.

"Immunotherapy alone or with chemotherapy is commonly used as front line treatment for [patients with] NSCLC without driver mutations. Unfortunately, resistance is inevitable and once the disease progresses, the prognosis is poor and treatment option is limited." said Xiaolin Zhang, CEO of Dizal. "The findings we are presenting at ELCC 2025 highlight the potential for golidocitinib-based combination regimen to delay or overcome the resistance. The preliminary results are very promising and justify further clinical validation."

Golidocitinib, as defined by the National Cancer Institute on its website, has potential antineoplastic activity, meaning it may block the formation of growths that may become cancer. The drug may result in an inhibition of cellular proliferation of JAK1-overexpressing tumor cells.

Golidocitinib received fast track designation from the Food and Drug Administration (FDA) for the treatment of r/r PTCL in February 2022, according to the news release. The GOLDEN trial, currently being conducted at The University of Texas MD Anderson Cancer Center in Houston, is a phase 2 trial studying how well golidocitinib works with or without cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in the treatment of patients with PTCL, according to the National Cancer Institute. 

Fast track, according to the FDA’s website, fda.gov, is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to patients earlier.

The drug has already been approved for the treatment of relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) in China, according to the news release, which stated that preclinical studies have shown that the combination of golidocitinib and a PD-1 antibody has the synergistic potential for anti-tumor effects.

An exploratory phase 1B clinical study combining golidocitinib and PD-1 antibodies was designed in order to explore these synergistic effects among patients with NSCLC whose disease had progressed on anti-PD-1-containing regimens. The study, according to the news release, will enroll 30 patients with locally advanced or metastatic NSCLC who have previously received either anti-PD-1 monotherapy or anti-PD-1 therapy with platinum-containing chemotherapy.

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