#China #Shanghai #NSCLC #Dizal #Golidocitinib

Dizal's Golidocitinib: An Innovative Approach to Overcoming NSCLC Resistance

Dizal, a biopharmaceutical firm based in Shanghai, is paving the way for innovative cancer treatments with their lead candidate, golidocitinib. This compound is a selective JAK1 inhibitor specifically designed to tackle the challenges of treatment resistance seen in non-small cell lung cancer (NSCLC). Recent findings highlight its promising capabilities in combination with PD-1 antibodies for patients who have shown resistance to standard immune checkpoint inhibitors. Findings from ongoing studies will be showcased at the upcoming European Lung Cancer Congress (ELCC) in Paris, set for March 26-29, 2025.

Understanding the Mechanism

Recent research has unveiled that the dysregulated JAK/STAT signaling pathway plays a pivotal role in fostering resistance to immune therapies. In cancer immunotherapy, the continued activation of this pathway leads to excessive interferon gamma (IFN-γ) release, eventually resulting in the failure of treatments. Dizal's studies indicate that combining JAK inhibitors like golidocitinib with PD-1 therapy can potentially reverse or postpone this resistance by regulating the JAK/STAT pathway. This innovative combination therapy has already shown remarkable clinical efficacy, evidenced by its prior approval for relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) in China.

The Exploratory Phase Ib Study

In light of these compelling preclinical results, Dizal established a phase Ib exploratory study that examines the effectiveness of golidocitinib alongside PD-1 antibodies in a carefully selected cohort: 30 NSCLC patients with either locally advanced or metastatic disease who have previously undergone anti-PD-1 treatments. The study aims to evaluate whether this combined approach can enhance anti-tumor responses even in the face of previous treatment failures.

Xiaolin Zhang, PhD, the CEO of Dizal, emphasized the urgency of finding effective alternatives given the limited prognosis for patients experiencing treatment resistance. "The findings we are presenting at ELCC 2025 highlight the potential for Golidocitinib-based combination regimen to delay or overcome the resistance," said Zhang. Preliminary results from the study have been described as promising, warranting deeper exploration into this combination therapy.

Additional Studies to be Presented

In conjunction with insights from golidocitinib, Dizal will also disclose findings from a phase II study analyzing sunvozertinib in combination with Anlotinib. Aimed at effectively treating NSCLC patients with specific EGFR mutations that have not benefited from existing therapies, this combination therapy demonstrated encouraging anti-tumor activity and manageable safety profiles. In this heavily pre-treated group, the objective response rate (ORR) was 33.3% alongside a disease control rate (DCR) of 100%, underscoring the need for continued innovation in NSCLC treatment regimens.

About Golidocitinib

Designated DZD4205, golidocitinib has exhibited strong anti-tumor activities that led to its approval in China after demonstrating an ORR of 44.3% and remarkable durability of response. Its accomplishment in achieving a 23.9% complete response rate among patients with tumor remission solidifies its standing as a formidable contender in therapeutic strategies for r/r PTCL and beyond. Following its approval, golidocitinib was granted Fast Track Designation by the U.S. FDA for the same indication, showcasing its broad relevance across various regulatory landscapes.

Commitment to Innovation

As a company, Dizal is committed to addressing significant unmet medical needs through the discovery and development of novel therapeutics. With a focused portfolio that balances both approved products and multiple assets under development, their aim remains clear: to transform the treatment landscape for cancer and immunological conditions worldwide. For more information about Dizal and its innovative therapies, visit Dizal's website.

Conclusion

With golidocitinib, Dizal stands on the cusp of potentially reshaping how resistant NSCLC is treated. As ongoing studies advance, the anticipated findings at ELCC 2025 could herald a new era in combating persistent challenges within immuno-oncology.