|Totally agree on the late breaker portending good data at ESMO. Not only would they not get an oral presentation on a late breaker with negative data, they would never submit a late breaker if the data wasn't positive. Who would want to go out of their way and rush to break bad news?|
But I think saying the Daiichi data on 1062 was just "somewhat" disappointing understates how far the data fell short. In June, 1062 looked phenomenal. Daiichi was pushing through 10mg on dose expansion, moving forward to 12mg, and they were already at 4/4 PR at 10mg. No talk of any safety signal. But 3 months later, they have multiple ILDs, and they are still doing follow up. Lung scarring is the type of AE that can stop development of a drug. I listened to Daiichi's call yesterday, and to me the presenter sounded like he was trying to understate the impact of this issue.
Beyond the safety signal, the presentation also revealed that the small sample was skewed toward patients with high Trop2 expression. IMMU will soon be recruiting to TROPICS-03, the enriched basket study. Since DS-1062 was unintentionally enriched, TROPICS-03 might be a better comparitor to this DS-1062 data than the NSCLC cohort from the 132 all-comer basket study that only yielded a 19% response.