Kelun-Biotech’s TROP2 ADC combined with immunotherapy as first-line treatment for NSCLC succeeds in Phase III study

On May 25, Kelun-Biotech announced that in the global first Phase III OptiTROP-Lung05 study of a TROP2 ADC combined with immunotherapy as first-line treatment for patients with PD-L1 positive, driver gene-negative advanced non-small cell lung cancer (NSCLC), the median progression-free survival (PFS) shows a statistically significant and clinically meaningful improvement, and the study also observes a favorable trend in overall survival (OS).

This landmark achievement will be presented as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract No. 8506), marking that the novel “ADC + immunotherapy” treatment model officially enters the core stage of first-line lung cancer therapy and is expected to reshape the current standard of care.

Non-small cell lung cancer (NSCLC) is the most common histological type of lung cancer, accounting for approximately 85% of all lung cancer cases. For patients with driver gene-negative advanced NSCLC, PD-1/PD-L1 inhibitor monotherapy or combination with chemotherapy is the current standard first-line treatment.

However, the objective response rate (ORR) of immunotherapy alone is typically only 20% to 45%, meaning more than half of patients do not benefit from monotherapy. While immunotherapy combined with chemotherapy improves efficacy, chemotherapy-related toxicities (myelosuppression, gastrointestinal reactions, hair loss, etc.) significantly reduce patients’ quality of life.

For the large patient population with PD-L1 positive (TPS ≥ 1%), which accounts for more than 60% of advanced NSCLC cases, achieving “chemotherapy-free” treatment while improving efficacy has become a critical clinical challenge in lung cancer therapy. The success of the OptiTROP-Lung05 study directly addresses this unmet need, offering patients a new treatment option with “high efficacy and low toxicity.”