Kelun-Biotech Achieves World-First Approval for TROP2 ADC in NSCLC

What's Happening?

Kelun-Biotech has received approval from the National Medical Products Administration (NMPA) for its TROP2-targeting antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT), for treating EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) in China. This marks the third indication for sac-TMT and its second world-first approval for a TROP2 drug. The approval is based on the OptiTROP-Lung04 study, which demonstrated improvements in progression-free survival and overall survival. Sac-TMT is the first ADC globally to show an overall survival benefit compared to platinum doublet chemotherapy for NSCLC that has progressed after TKI therapy.

Why It's Important?

The approval of sac-TMT is a significant advancement in lung cancer treatment, offering a new option for patients who have developed resistance to EGFR-TKI therapy. EGFR mutations are a common driver in NSCLC, and resistance to current treatments leaves patients with few effective options. Sac-TMT provides a targeted therapy that could improve survival outcomes for a larger patient population. This approval also strengthens Kelun-Biotech's position in the competitive ADC market, challenging larger companies like AstraZeneca and Gilead Sciences.

What's Next?

Kelun-Biotech is conducting a Phase III trial in China to test sac-TMT in combination with osimertinib for first-line treatment of EGFR-mutant NSCLC. The company is also collaborating with Merck & Co. on global clinical trials for sac-TMT and other ADCs. These efforts may lead to further approvals and expanded use of sac-TMT in other cancer types, potentially enhancing its market presence and impact on cancer treatment.

Beyond the Headlines

The approval of sac-TMT highlights the potential of ADCs in oncology, offering targeted therapy that minimizes damage to healthy cells. This approach could lead to more effective treatments with fewer side effects, transforming cancer care. Kelun-Biotech's success may encourage further investment and innovation in ADC technology, driving advancements in cancer treatment.