Kelun hits dato-dxd while it's down

Even though the country in question is China rather than the US, the first approval of Keluln's sacituzumab tirumotecan is significant: the drug has jumped ahead of AstraZeneca/Daiichi Sankyo's datopotamab deruxtecan to become the second marketed anti-TROP2 ADC. Primarily, saci-T will compete against Gilead's Trodelvy in third-line triple-negative breast cancer, where China's NMPA has greenlit it on the back of the OptiTROP-Breast01 study that impressed at this year's ASCO. But the more significant competitor is dato-dxd, which had been due a decision next month regarding US approval for second-line non-squamous lung cancer, but whose filing Astra/Daiichi had to withdraw after failing to get FDA support for a subgroup analysis of the Tropion-Lung01 study. True, there is still much to play for, both for dato-dxd, which is now targeting breast and other lung cancer settings, and saci-T, which Kelun licensed to Merck & Co, has yet to be filed in the US, and has yet to receive any approvals in lung cancer. But the withdrawal of dato-dxd's US filing was a body blow, and in being beaten into third place won't help sentiment.

Selected late-stage trials of anti-TROP2 ADCs

Notes: *post-PD-(L)1 therapy; **EGFRm, post TKI therapy. Source: OncologyPipeline.