This is a long race -- not a sprint -- and Merck looks to be in good form here -- perhaps even reaching market first in melanoma. However, I still think nivolumab will ultimately emerge as the leader in the largest burden-of-disease cancers -- the largest markets. We shall see -- a bit from the Whitehouse Station presser, then:
. . . .Merck today announced the first presentation of early findings from a Phase 1b study (KEYNOTE-012) evaluating pembrolizumab (MK-3475), Merck’s investigational anti-PD-1 antibody, as a single-agent (monotherapy) in patients with PD-L1 positive, advanced head and neck cancer. Early data showed a best overall response rate of 20 percent (confirmed and unconfirmed) (n=11/56) (95% CI, 10.2- 32.4) with 29 percent of patients having stable disease as measured by RECIST criteria (n=16/56) (95% CI, 17.3-42.2). Similar overall response rates were observed in Human papillomavirus (HPV)-positive and HPV-negative patients – HPV infection is a risk factor for some types of head and neck cancer. In the study, tumor shrinkage was demonstrated in 51 percent of evaluable patients who had measurable disease with one post baseline scan, per RECIST criteria (n=26/51). . . .
Merck's KEYNOTE-012 study is an ongoing multi-center, non-randomized Phase 1b trial evaluating the safety, tolerability and anti-tumor activity of pembrolizumab monotherapy in patients with advanced triple negative breast cancer (TNBC), advanced head and neck cancer, advanced urothelial cancer, or advanced gastric cancer. . . .
So the battle is joined -- there will be plenty of market opportunity for both nivolumab and pembrolizumab -- but which drug will clear FDA in the biggest burden cancers, first? My money is still on BMS, here.
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