The US Food and Drug Administration (FDA) approved Coherus BioSciences and Shanghai Junshi Biosciences’ Loqtorzi (toripalimab-tpzi) for treating metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC).
The drug is marketed as Tuoyi in China.
The drug has been approved as a first-line therapy in combination with chemotherapy and as a monotherapy in recurrent, unresectable, or metastatic NPC patients with disease progression on or after platinum-containing chemotherapy.
Following the news on 27 October, Coherus stock was up by more than 20% in pre-market trading today. The company has a market cap of $280.8m.
Coherus acquired the marketing rights for Loqtorzi in the US and Canada in February 2021. As per the agreement, Junshi received $150m and the option to receive an additional $380m in milestone-based payments.
Loqtorzi is an anti-programmed cell death protein 1 (PD-1) monoclonal antibody. The drug is expected to generate $195m in global sales in 2029, as per GlobalData.
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The FDA approval of Loqtorzi was based on the Phase II and III trial data (NCT02915432 and NCT03581786). The Phase III study showed an improvement in progression-free survival (PFS) and a reduction in the risk of disease progression or death by 48% in patients on combination therapy of Loqtorzi and chemotherapy compared to chemotherapy alone.
The safety profile of the combination therapy was similar to that seen with chemotherapy alone in terms of Grade 3 adverse events. However, 54.1% of the patients reported immune-related adverse events in the combination arm compared to 21.7% in the chemotherapy-only arm.
Last month, Coherus acquired Surface Oncology to expand its immuno-oncology pipeline for approximately $66.9m. Other drugs in Coherus’ portfolio include the vascular endothelial growth factor (VEGF) inhibitor, Cimerli (ranibizumab), which generated $26.7m in sales in Q2 2023, as per the company’s financials.
Coherus catalogue also includes biosimilars such as Yusimry, a biosimilar of AbbVie’s Humira (adalimumab), and Udenyca, a biosimilar for Amgen’s Neulasta (pegfilgrastim).
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