Polatuzumab vedotin (Roche) is an antibody-drug conjugate (ADC) that combines a humanized immunoglobulin (Ig)-G1 monoclonal antibody (MAb) targeting human B-cell surface antigen cluster of differentiation (CD)79b and antimitotic agent monomethyl auristatin E (MMAE). The CD79b MAb delivers the antimitotic agent to the malignant cell surface where it ultimately binds to tubulin, disrupts the microtubule network, and promotes apoptosis. Approximately 12–23% of DLBCL patients, predominantly with the activated B-cell (ABC) subtype, express levels of CD79b that may confer sensitivity to treatment with an anti-CD79b-MMAE drug conjugate.
Polatuzumab vedotin (Roche) is currently being trialed in combination with rituximab-cyclophosphamide, doxorubicin, and prednisone (R-CHP) against rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for previously untreated cluster of differentiation (CD)20-positive diffuse large B-cell lymphoma (DLBCL) patients in the Phase III POLARIX trial (ClinicalTrials.gov identifier: NCT03274492). Approval as an add-on therapy to standard rituximab-based regimens is a potentially lucrative treatment strategy that could help Roche to maintain revenues in DLBCL as rituximab biosimilars continue to gain uptake. However, polatuzumab vedotin will have to demonstrate significant efficacy and a strong tolerability profile to justify the added cost to front-line treatment. Although polatuzumab vedotin has demonstrated signs of efficacy in early-phase trials, peripheral nephropathy is an area of concern. Roche is hoping to minimize this adverse event by limiting treatment in the Phase III POLARIX trial to six cycles of polatuzumab vedotin, as all grade 2 and 3 instances of peripheral nephropathy have occurred at cycle five or later in early-phase trials.
4 Drug Overview
5 Product Profiles
5 polatuzumab vedotin : NHL: Diffuse large B-cell lymphoma (DLBCL)
LIST OF FIGURES
11 Figure 1: Polatuzumab vedotin for diffuse large B-cell lymphoma – SWOT analysis
12 Figure 2: Datamonitor Healthcare’s drug assessment summary for polatuzumab vedotin in diffuse large B-cell lymphoma
13 Figure 3: Datamonitor Healthcare’s drug assessment summary for polatuzumab vedotin in diffuse large B-cell lymphoma
15 Figure 4: Polatuzumab vedotin sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Polatuzumab vedotin drug profile
8 Table 2: Polatuzumab vedotin ongoing pivotal trial in diffuse large B-cell lymphoma
10 Table 3: Early-phase data for polatuzumab vedotin in diffuse large B-cell lymphoma
16 Table 4: Polatuzumab vedotin sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
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