What's Happening?
Kelun-Biotech has achieved a significant milestone with the approval of its TROP2-targeting antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT), for treating non-small cell lung cancer (NSCLC) in China. The National Medical Products Administration (NMPA) has authorized sac-TMT for patients with EGFR-mutant locally advanced or metastatic NSCLC, whose disease has progressed following first-line EGFR tyrosine kinase inhibitor (TKI) treatment. 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. Kelun's sac-TMT is the first ADC globally to show an overall survival benefit compared to platinum doublet chemotherapy for advanced NSCLC that has progressed after TKI therapy.
Why It's Important?
The approval of sac-TMT is a significant advancement in lung cancer treatment, particularly for patients with EGFR mutations, which are prevalent in non-squamous NSCLC cases in China. This development provides a new therapeutic option for patients who have developed resistance to standard first-line therapies, addressing a critical gap in treatment. The partnership between Kelun and MSD, known as Merck & Co in the US and Canada, highlights the global interest in innovative cancer treatments and the potential for sac-TMT to impact markets outside China. The approval positions Kelun as a competitive player against larger pharmaceutical companies in the TROP2 ADC category, such as AstraZeneca/Daiichi Sankyo and Gilead Sciences.
What's Next?
Kelun is actively testing sac-TMT in combination with AstraZeneca's EGFR-TKI Tagrisso for first-line treatment of EGFR-mutant NSCLC, with a phase 3 trial in China already fully enrolled. The results of this trial could further expand the use of sac-TMT in lung cancer treatment. Additionally, the collaboration with MSD may lead to broader international approvals and market expansion, potentially influencing treatment protocols globally. The ongoing research and development efforts by Kelun and its partners are likely to continue driving innovation in cancer therapeutics.
Beyond the Headlines
The approval of sac-TMT not only represents a breakthrough in lung cancer treatment but also underscores the growing role of Chinese biotech companies in the global pharmaceutical industry. This development may encourage further investment and collaboration between Western and Chinese firms, fostering innovation and competition in the ADC market. The success of sac-TMT could also inspire other companies to pursue similar strategies, potentially leading to more effective treatments for various cancers.
