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In Another Lung Cancer Setback, Bristol Yanks FDA App For Drug Combo

(Xconomy New York) Jan 24, 2019 - Bristol-Myers Squibb has lost yet more ground in its ongoing cancer immunotherapy battle with rival Merck. Along with its earnings, the pharma firm reported Thursday that it has pulled a key approval application to use a combo regimen of its already approved immunotherapies, nivolumab (Opdivo) and ipilimumab (Yervoy), in a portion of patients with newly diagnosed, advanced non-small cell lung cancer (NSCLC). Specifically, Bristol said that, upon discussions with the FDA, it needs more data to support the approval filing. The problem: Bristol needs to provide additional evidence for “the relationship between [tumor mutational burden] and PD-L1”—two biomarkers meant to help identify patients who might respond to immunotherapy—to really tell if the Bristol regimen is helping patients live longer.

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H. Jack West, MD (Posted: January 24, 2019)

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We are not privy to the data that the FDA have, but based on the TMB data that are publicly available, I think this is a very appropriate guidance by the FDA. We need more and stronger data to support TMB use for clinical decision-making. First, we need to see a survival benefit by using it; second, we need to see that the survival benefit is predicated on using the TMB test.

I think it is more likely than not that TMB will be a useful biomarker, but not the only one, in a few years. However, the data we've seen from CheckMate-227 are not sufficient to warrant using it.

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