Pembrolizumab KEYNOTE-001: an adaptive study leading to accelerated approval for two indications and a companion diagnostic

The landscape of cancer treatment has undergone a vast change over the past four decades [1, 2]. Discovery of the heterogeneous molecular features of tumors and the associated microenvironment has led to the development of novel classes of targeted therapeutics [3–5], the two main types of which are small-molecule inhibitors and monoclonal antibodies (mAbs) [1–3]. These targeted drugs have furthered the development of personalized therapeutic regimens in oncology.

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