Betalutin is a first-in-class antibody-radionucleotide conjugate targeted to CD37, an alternative to CD20, which is widely targeted in non-Hodgkin’s lymphoma. CD37 is highly expressed in B cells and B-cell lymphomas. The 177-Lu payload emits beta particles, leading to the formation of double-strand breaks in cells in the vicinity of the bound antibody (including cells that do not express CD37), and subsequent cell death.
Although Nordic Nanovector’s first-in-class cluster of differentiation (CD)37-directed antibody-radionucleotide conjugate Betalutin (177-Lu-lilotomab satetraxetan) represents a novel treatment option for follicular lymphoma (FL), the drug faces several hurdles in becoming commercially viable. Firstly, the pivotal Phase IIb PARADIGME trial has suffered enrollment issues, and the planned readout and filing for Betalutin has been delayed from the second half of 2019 to the first half of 2020. Secondly, Betalutin is projected be the fourth drug in the FL market to be approved in the third-line setting, following Zydelig (idelalisib; Gilead), Aliqopa (copanlisib; Bayer), and Copiktra (duvelisib; Verastem/Infinity/Yakult Honsha Co). Zydelig has been approved for third-line FL treatment since 2014 and has limited market share, but Aliqopa and Copiktra were recently approved, in 2017 and 2018 respectively, and could gain significant market share before Betalutin’s potential approval, currently slated for 2021. Finally, Betalutin’s potential in this indication is negatively affected by logistical and economic issues associated with its administration. Similar issues have markedly impacted the only other radioactive antibody approved for FL, Zevalin (ibritumomab tiuxetan; Acrotech Biopharma/Mundipharma), which has subsequently gained little uptake in this market. With these issues in mind, demonstration of high efficacy and low toxicity will be crucial for Betalutin’s future uptake.
LIST OF FIGURES
10 Figure 1: Betalutin for follicular lymphoma – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Betalutin for follicular lymphoma
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Betalutin for follicular lymphoma
14 Figure 4: Betalutin sales for follicular lymphoma across the US and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Betalutin drug profile
7 Table 2: Betalutin ongoing pivotal clinical trial in follicular lymphoma
9 Table 3: Betalutin clinical trial data in follicular lymphoma
15 Table 4: Betalutin sales for follicular lymphoma across the US and five major EU markets, by country ($m), 2017–26
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