NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

God,these ICI's really are pretty poor, as well as being highly toxic and often life-shortening.

Researchers at MD Anderson (including Vivek Subbiah) reviewed the data from a series of PI dose escalation studies of ICI's conducted at their institution. and made public their findings in a poster presentation at ASCO.

http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.3077

Their summary:-

Despite a dose-dependent increase in irAE, we identify no improvement in PFS, OS, or DCR with escalating doses of ICI administered in phase I trials but do detect an improvement in ORR. Prospective dose-/exposure-response relationships and biomarker-driven RP2D are warranted on all ICI dose-escalation phase 1 trials. Lower doses may reduce toxicity and cost without compromising disease control or survival.

They should have added; 'even lower doses may further reduce toxicity and cost.'

So as they increased the dose they saw increasing toxicity in the shape of increased immune-related adverse events, but no improvement in PFS or OS. They did detect a dose-related improvement in ORR, which just goes to show that ORR is completely irrelevant to patient wellbeing because it doesn't correlate with PFS or OS!

Amazingly, immune-related adverse events were reduced to zero if a zero dose was given. Unfortunately, the researchers did not record how much PFS and OS were improved by not giving any of the drug.