The Drug Developers: We project negative overall survival for AZN/DS's AVANZAR, TL-07 & TL-08 - blocking SMMT plus Datroway NSCLC combo

The fourth note in our series The Drug Developers: Bringing the Bench to the Buy Side continues to highlight our significant skepticism of an FDA-approved treatment regimen with Datroway and Ivonescimab in NSCLC (AZN/DS covered by Smith/Sogi). The FDA requires the trial sponsor to demonstrate the contribution of components or clinical activity of each drug in the experimental regimen. Therefore, the Ph3 trials for Datroway (either AVANZAR, TL-07 or TL-08) and Ivonescimab (HARMONi-3) must both have statistically significant OS to support an FDA-label enabling trial in 1L non-sq NSCLC. As stated previously, our base case is a positive HARMONi-3 for Ivonescimab in squamous NSCLC given China-only HARMONi-6 results. However, clinical development of the combination is not possible in squamous NSCLC because Datroway lacks efficacy in this histology. Non-squamous histology is the lone NSCLC patient population for investigating the Datroway and Ivonescimab combination. This note focuses on TROP