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Kelun Wins World’s First TROP2 ADC Approval In Lung Cancer

 
• By Dexter Jie Yan

While diverging from partner Merck & Co. in its study dosage of sacituzumab tirumotecan, Kelun has garnered the world’s first approval, in China, for a TROP2-targeting antibody-drug conjugate, for the treatment of lung cancer.

Merck/Kelun and AstraZeneca/Daiichi Sankyo are locked in a race to win lung cancer labels for their TROP2 ADCs. (Shutterstock)

Sichuan Kelun Pharmaceutical has won an approval in China for its Merck & Co.-partnered sacituzumab tirumotecan (sac-TMT), a TROP2-targeting antibody-drug conjugate (ADC), which becomes the world’s first in the class to be cleared for the treatment of lung cancer.

While originator Kelun retains the Greater China rights to sac-TMT under a tie-up with Merck signed in 2022, its development strategy for the agent in the

Key Takeaways
  • Kelun has won approval in China for its Merck & Co.-partnered sacituzumab tirumotecan (sac-TMT), a TROP2-targeting antibody-drug conjugate, as the world’s first in the class to be cleared for lung cancer.
  • The approval was based on positive PFS and OS results from the Phase II OptiTROP-Lung03 trial with sac-TMT as monotherapy versus docetaxel in Chinese EGFR-mutated NSCLC patients who had failed on an EGFR inhibitor and platinum-based chemotherapy

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