Two Approaches To PD-1 Blocker Pediatric Studies Could Help Clarify Biomarker’s Role
Merck plans to enrich its Phase II study for MK-3475 with patients whose tumors express PD-L1; Bristol would take all comers in its Phase I/II trial of nivolumab.
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Merck’s oncology build-up is continuing, even as it tightens focus and squeezes spending in other parts of its business as part of an ongoing “reshaping” that CFO Peter Kellogg said will help to maximize “core in-line assets and key pipeline programs” that are critical for growth.
Bristol-Myers Squibb’s launch of a new Phase III lung cancer study of nivolumab monotherapy in those with high expression of PD-L1 lung cancer patients raises questions about the role of the biomarker and the possibility of combination therapy with Yervoy. The PD-L1 biomarker is still being evaluated and strategies are likely to differ depending on drug and tumor type.
The New York pharma talked about its anti-PD-1 drug for most of its year-end conference call, but managed to say very little about the success of the drug so far in clinical trials, disappointing analysts and investors.