Coherus, Junshi’s PD-1 blocker Loqtorzi aces Phase III liver cancer trial
Coherus, Junshi’s PD-1 blocker Loqtorzi aces Phase III liver cancer trial
Published: Jun 13, 2024
By Tristan Manalac
BioSpace
Junshi Biosciences and Coherus BioSciences on Wednesday unveiled data from the Phase III HEPATORCH study, showing that its PD-1 inhibitor Loqtorzi (toripalimab)—when used with bevacizumab—significantly improved survival in patients with advanced hepatocellular carcinoma.
The partners did not provide specific data in their announcement, only revealing that the Loqtorzi-based combination regimen significantly improved progression-free and overall survival when used in the first-line setting.
Loqtorzi plus bevacizumab also met key secondary endpoints, such as objective response rate and time to progression. In terms of safety, HEPATORCH found no new signals of concern and Loqtorzi’s overall adverse event profile was consistent with what had been established in prior studies.
According to the companies, Loqtorzi “has met the pre-defined efficacy boundary.” Junshi plans to file a supplemental New Drug Application to seek approval for advanced hepatocellular carcinoma (HCC) “in the near future.”
HEPATORCH is a randomized, open-label and active-controlled study comparing Loqtorzi plus bevacizumab versus the current standard treatment sorafenib in patients with unresectable or metastatic advanced HCC. Junshi and Coherus will present complete findings and analysis from HEPATORCH at an upcoming international academic congress.
Jianjun Zou, CEO and general manager of Junshi, in a statement said that HEPATORCH’s latest readout underscores Loqtorzi’s potential “as a cornerstone of immuno-oncology, significantly improving survival rates for patients with advanced HCC.”
“We will actively communicate with regulatory authorities to expedite the approval of relevant indications, and we hope our efforts will benefit more patients with advanced liver cancer,” Zou said.
Loqtorzi is a PD-1 receptor inhibitor which works by blocking the pathway that tumor cells use to avoid being detected and attacked by the immune system. The therapeutic monoclonal antibody won its first FDA approval in October 2023 for the treatment of nasopharyngeal carcinoma. Loqtorzi is the first Chinese PD-1 blocker to enter the U.S. market.
However, in China, Loqtorzi has the distinction of being the first domestic PD-1 inhibitor approved for use and is sold under the brand name Touyi. It can be used for eight indications, including unresectable or metastatic melanoma, recurrent or metastatic nasopharyngeal carcinoma and locally advanced or metastatic urothelial carcinoma.
Loqtorzi was initially discovered and developed by Junshi. Coherus bought the U.S. and Canadian rights to the PD-1 inhibitor in February 2021 for $150 million upfront plus up to $380 million in certain milestone payments. As part of the licensing deal, Coherus also gained option rights to several earlier-stage cancer candidates from Junshi.
Source: BioSpace
