#China #Chengdu #Sacituzumab #NSCLC #EGFR-TKI

Results of Phase III OptiTROP-Lung04 Study Published

The New England Journal of Medicine recently featured groundbreaking results from the Phase III OptiTROP-Lung04 study, which focused on sacituzumab tirumotecan (sac-TMT). This study aimed to investigate the effectiveness of sac-TMT for patients with advanced non-small cell lung cancer (NSCLC) who developed resistance to EGFR-tyrosine kinase inhibitors (TKIs). Conducted in collaboration with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., the study highlights significant improvements in patient outcomes compared to traditional chemotherapy options.

Study Background

The OptiTROP-Lung04 study was led by Professor Zhang Li and witnessed participation from numerous medical centers. The research focused on adult patients suffering from locally advanced or metastatic EGFR-mutant NSCLC. These individuals had previously undergone treatment with EGFR TKIs but experienced disease progression. The primary objective was to evaluate Progression-Free Survival (PFS) and Overall Survival (OS) rates, crucial indicators in the treatment of cancer.

Key Findings

After a median follow-up period of 18.9 months, results demonstrated that patients receiving sac-TMT experienced a median PFS of 8.3 months, compared to just 4.3 months in the chemotherapy group, yielding a hazard ratio (HR) of 0.49. This signified a profound improvement in disease management for those receiving sac-TMT. Moreover, OS rates similarly favored sac-TMT, with a HR of 0.60 indicating significantly longer survival compared to traditional therapies.

Safety Profile

While the introduction of sac-TMT showcased noteworthy improvements, it was also essential to understand its safety implications. The study reported a higher incidence of stomatitis among participants but noted that most cases were mild, and serious events were rare. Correspondingly, the occurrence of ocular-surface toxicities, interstitial lung disease (ILD), or pneumonitis remained low, suggesting a manageable safety profile for sac-TMT.

Regulatory Approvals

Following these promising results, sac-TMT has been approved for clinical use in China by the National Medical Products Administration (NMPA). It stands as a unique treatment option for patients experiencing progression after EGFR TKIs, now positioned as an essential therapy in the landscape of EGFR-mutant NSCLC.

Expert Commentary

Dr. Michael Ge, the CEO of Kelun-Biotech, expressed enthusiasm regarding the study's findings, emphasizing that such results fundamentally change the treatment protocol for lung cancer patients. He articulated a commitment to advancing sac-TMT's clinical pathways as they seek to broaden its application and efficacy in treating diverse cancer types.

In addition, Professor Shengxiang Ren stressed the importance of the study's contributions, stating, “The application of third-generation EGFR-TKIs has significantly improved patients' prognosis; however, resistance development necessitates innovative approaches like sac-TMT.” This study establishes sac-TMT not only as a viable treatment post-resistance to TKIs but also as a potential new standard of care in managing advanced lung cancer.

Conclusion

As the OptiTROP-Lung04 findings speed the development of sac-TMT as a cornerstone therapy for advanced EGFR-mutant NSCLC, it opens up avenues for further research and expansion into additional indications. Together with ongoing trials and the collaboration with partners like MSD, the future looks promising for non-small cell lung cancer patients facing treatment-resistant challenges.