If we look at the more mature phase 2 data now available for Amgen’s sotorasib (AMG 510) in KRAS G12C driven lung cancers, we learn there are quite a few nuances and subtleties at play. These aren’t always obvious in top line press releases or even in presentations until we consider the broader niche in which they are competing.
Amgen submitted the sotorasib applications to both the US and EMA health authorities in December. With breakthrough designation status and clinical evidence of activity in an area of high unmet medical need, it’s hard to believe the approval won’t be forthcoming sooner rather than later, at least in the US.
Mirati is expected to showcase their phase 2 data later this year, so I would highly encourage people to hold off with cross-trial comparisons until we see how their more robust data look at the RP2D.
In the meantime, we can take a careful look at the latest Amgen data. We do those not only from a BSB review but also through the lens of a company perspective and consider some of the key strategic issues we need to start thinking about…