Biotech Values

[DewDiligence]

The ONJ rate of ~2% in the D-mab arm vs ~1% in the Zometa arm is somewhat worrisome; however, ONJ is clearly a more acceptable SAE in a trial for metastatic cancer than in a trial for, say, osteoporosis. Hence, I’m inclined to think the ONJ numbers won’t derail D-mab’s approval in metastatic cancer or derail its commercial uptake in this setting.

One observation from the D-mab data in HRPC is that it seems to make little difference whether one measures the time to the first skeletal-related event or one measures the rate of multiple SRE’s. The former metric had HR=0.82 (for D-mab relative to Zometa) with a 95% CI of [0.71,0.95], while the latter metric had HR=0.82 with a 95% CI of [0.71,0.94]—an almost identical outcome.