Should Lilly also take on Merck in lung cancer?

How many companies are bold enough to pit another anti-PD-1 antibody against Keytruda in first-line non-small cell lung cancer? For latecomers such a strategy is surely the only way to compete seriously against Merck & Co, and this is precisely what Merck KGaA is doing with its bispecific fusion protein bintrafusp alfa. Lilly could also consider such a move after today buying global rights to Tyvyt, an anti-PD-1 antibody jointly developed with Innovent for China. US approvals will now be pursued, and NSCLC looks like the lead indication: World Lung recently featured the phase III Orient-11 study pitting Tyvyt against chemo, and on PFS the numbers looked competitive to Keytruda's similar Keynote-189 trial; OS has yet to mature. The study was run in China so might not suffice for the US FDA, and running a front-line NSCLC trial in the US against chemo looks questionable. However, Sanofi/Regeneron recently tested Libtayo front-line versus chemo in countries where Keytruda was not widely available, and hope that this will provide an easy US filing path. If Lilly decides to consider an active comparator this does not have to be Keytruda, of course, and Bristol Myers Squibb’s Opdivo could provide an easier target.

Cross-trial comparison of first-line NSCLC studies with anti-PD-(L)1 agents

Dr Misako Nagasaka & World Lung 2020.

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