Author: Michael Ramirez
Publisher: Datamonitor Healthcare
PDR001 (Novartis) is a fully humanized monoclonal antibody designed to inhibit the negative immunoregulatory receptor programmed death-1 (PD-1). PDR001 blocks the interaction between PD-1 and its ligands, programmed death-ligand 1 (PD-L1) and PD-L2; the signaling elicited by this interaction inhibits T-cell activation. Therefore, disrupting the interaction allows T-cells to become activated, and mount cytotoxic effects against cancer cells.
PDR001 is being tested in several combinations in addition to as a monotherapy across various cancer types, including in combination with mitogen-activated protein kinase (MAPK) inhibitors Tafinlar (dabrafenib; Novartis) and Mekinist (trametinib; Novartis/Japan Tobacco) in previously untreated unresectable or metastatic BRAF V600-mutant melanoma. Although PDR001 faces steep competition from established marketed PD-1 inhibitors Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) and Keytruda (pembrolizumab; Merck & Co), it may benefit from the fact that these drugs are not in development in combination with MAPK inhibitors. However, pipeline drug Tecentriq (atezolizumab; Roche/Chugai), a PD-L1 inhibitor, is in a Phase III trial in a triple combination with MAPK inhibitors Zelboraf (vemurafenib; Roche/Chugai/Daiichi Sankyo) and Cotellic (cobimetinib; Exelixis/Roche) for BRAF V600-mutant unresectable locally advanced or metastatic melanoma. If approved, this combination could compete strongly with PDR001.
4 Drug Overview
5 Product Profiles
5 PDR001 : Melanoma
LIST OF FIGURES
8 Figure 1: PDR001 for melanoma – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of PDR001 for melanoma
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of PDR001 for melanoma
12 Figure 4: PDR001 sales for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: PDR001 drug profile
7 Table 2: PDR001 ongoing late-phase trial in melanoma
13 Table 3: PDR001 sales for melanoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
15 Table 4: PDR001 patient numbers for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
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