Merck And AstraZeneca Quietly Halt LYNK-003 Combo Study

To be certain, there is to be no shame, here. Keytruda^® (pembrolizumab) works wonders in many other solid organ / tumors / cancers. And Lynparza^® (olaparib) works well in several specified ovarian oncology settings, to be sure. But it would seem that there is no incremental benefit over standard course therapies, in combining the two -- for colorectal cancers.

Again, this is the way life-science (immuno-oncology) advances -- we learn with tiny, halting steps. . . most of the time. Here's that end of day confirmation, from Rahway:

. . .[Merck and AstraZeneca] will stop for futility the Phase 3 LYNK-003 trial investigating LYNPARZA with or without bevacizumab for the treatment of patients with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. This action follows the recommendation of an independent Data Monitoring Committee (DMC), after the DMC reviewed the data from a planned interim analysis. LYNPARZA is a PARP inhibitor that is being co-developed and co-commercialized with AstraZeneca.

At the pre-specified interim analysis for progression-free survival, the efficacy of LYNPARZA as a monotherapy and in combination with bevacizumab relative to control met the criteria for futility by the DMC and accordingly, both experimental arms will be discontinued. No new safety signals were observed with LYNPARZA in this trial, and the safety profiles of both LYNPARZA monotherapy and LYNPARZA combined with bevacizumab in this trial were generally consistent with that observed in previously reported studies. Merck will inform study investigators of the recommendation from the DMC and will advise patients in the trial to speak to their physician regarding treatment options. Data from this study will be shared in a future scientific forum. . . .

I mention it mostly to highlight that there are many very expensive, legitimately ground-breaking, and ultimately. . . dead end alleys, in advancing the frontier of clinical practice in a complicated set of high burden diseases, like cancers. And so, not all pharma runs a Shkreli shell-game, pretending to do clinical research. In point of fact, most large pharma concerns spend deep into the tens of billions of dollars each year, on just this sort of science advancing research.

It does seem that the overall spend peaked in 2021, however according to PhRMA (though that may yet turn out to be a by-product of COVID-19 slowdowns in recruitment for new studies). That is, this may reverse, as people now move about more freely, and will agree to be enrolled in new clinical trial protocols. We shall see.

Be excellent to one another -- and enjoy the summer. . . smile.

नमस्ते