#China #Chengdu #Kelun-Biotech #TROP2 ADC #Sac-TMT

Kelun-Biotech's Sac-TMT Receives Third Indication Approval

On October 11, 2025, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced a significant regulatory milestone with the approval of their innovative drug, sacituzumab tirumotecan (Sac-TMT, also known as SKB264/MK-2870), by the National Medical Products Administration (NMPA). This approval marks the third indication for Sac-TMT, specifically for adult patients suffering from non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations who have shown progression after treatment with EGFR-tyrosine kinase inhibitors (TKI).

The Importance of This Approval

Sac-TMT is distinguished as the first and only antibody-drug conjugate (ADC) globally that demonstrates an overall survival (OS) advantage over traditional platinum doublet chemotherapy for this demographic. This marks an important advancement in treatment options for NSCLC, particularly for patients who have limited choices after TKI therapy, which is a common first-line treatment that often results in resistance.

In a clinical setting, satisfying treatment outcomes are critical. The approval of Sac-TMT is based on a robust Phase III study known as OptiTROP-Lung04, which has been presented as a late-breaking abstract at the prestigious European Society for Medical Oncology (ESMO) Congress 2025. This study emphasizes the significant improvement in progression-free survival (PFS) and overall survival (OS) for patients treated with Sac-TMT compared with those receiving the conventional platinum-based chemotherapy regimen.

Efficacy and Safety of Sac-TMT

The OptiTROP-Lung04 trial focused on comparing the safety and efficacy of Sac-TMT administered as a monotherapy against a control group treated with pemetrexed plus platinum chemotherapy. The results from this randomized, multi-center study suggest that Sac-TMT is effective in extending survival outcomes for patients whose condition has become resistant to TKI therapy, thus addressing critical unmet medical needs in this patient population.

Notably, the regular clinical practice often involves switching to platinum-based therapies following TKI-induced resistance, which may not yield optimal survival benefits. This new approval provides an additional treatment alternative that is not reliant on platinum compounds, which could significantly improve the quality of life for patients in advanced stages of NSCLC.

Broader Impact on the NSCLC Landscape

Lung cancer remains the leading cause of cancer-related deaths in China, with statistics indicating around 1.06 million new cases diagnosed each year, predominantly non-small cell lung cancer (NSCLC). Among these cases, the prevalence of EGFR mutations is significant, accounting for 40-50% of NSCLC, underscoring the necessity for treatments like Sac-TMT that can target these specific mutations effectively.

Dr. Michael Ge, the CEO of Kelun-Biotech, expressed his enthusiasm for the approval, describing it as a crucial step forward in expanding treatment options for NSCLC patients with EGFR mutations. He highlighted the enormous challenges faced by patients once they develop resistance to existing therapies, thus reinforcing the need for innovative solutions like Sac-TMT.

Looking forward, Kelun-Biotech is also advancing research into combining Sac-TMT with osimertinib for first-line treatment, which could further enhance treatment effectiveness for EGFR-mutant NSCLC patient populations.

Conclusion

The recent approval of Sac-TMT is anticipated to contribute significantly to the fight against lung cancer, offering hope to a demographic that has historically faced poor outcomes following TKI therapy. With ongoing clinical trials and a committed vision towards innovative biological drug development, Kelun-Biotech is poised to define the future landscape of cancer treatment in China and globally. The company signals its dedication to revolutionizing how NSCLC is treated with promising advancements in drug development.

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