Commenting on the recent "data".....
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William Gerber is concerned that, despite statsig, the failure to report actual PFS numbers reflects poorly on the absolute difference between margetuximab plus chemo versus control. I agree with him, but absolute numbers would have sparked the usual debate about cost versus benefit.... why would anyone pay an enormous sum for a few extra weeks of survival?
My point is that the company wished to avoid that time-worn debate, given that the objective is to move upstream, to test margetuximab plus pertuzumab versus trastuzumab plus pertuzumab in patients who are metastasis-free.
There is only one way to get there (SOPHIA), so mgnx is stuck with modest PFS differences in a very sick population of patients.
Why spark that debate? Instead, they waited a week to launch their secondary. They didn't seek funding during the gut-wrench trip to 30, letting the interpretation of PFS stats spread among veteran investors. There are different routes to arriving at class-act.
I am hoping that there will also be a statsig difference in MST. But the rationale behind the "prespecified 158F subgroup (HR=0.68, p=0.005) is tight". Given preliminary SOPHIA results, I'm hoping that margetuximab will have a pronounced effect on survival time in early-stage patients.
Aside.... the SOPHIA PFS stats reflect positively on enoblituzumab, also Fc-modified. B7-H3 has its own issues, of course.
My position is small, but my interest in Fc modification is big. Maybe my position will catch up with interest, maybe not. |
