The next China-developed immuno-oncology therapy to cross the FDA's desk has been hit with bad news. Still, it will be half a year at least before Coherus BioScience and Junshi Bioscience get another crack at U.S. approval of their cancer PD-1 inhibitor, toripalimab.
The FDA has turned away Coherus’ Junshi-licensed prospect for head and neck cancer, coming after the FDA snubbed sintilimab, a China-developed PD-1 inhibitor from Eli Lilly and Innovent Biologics. Currently, there are no approved head and neck cancer immunotherapies in the U.S., which the FDA has noted warrants "flexibility" for toripalimab's approval decision, Coherus and Junshi said.
The agency’s complete response letter asked the companies to make a quality process change that Junshi and Coherus think is “readily addressable.” The partners will link up with the FDA directly and expect to refile their toripalimab application by the middle of the summer, they noted.
But it will take the FDA six months to weigh the resubmitted application, which it blamed on inspection difficulties posed by COVID-19 travel restrictions in China. Throughout the pandemic, the FDA has accrued a sizable backlog of manufacturing inspections, derailing multiple approval timelines in the process.
Junshi boasts two manufacturing sites, in Shanghai and the nearby city of Suzhou. At the moment, Shanghai is under lockdown amid an omicron-fueled COVID-19 outbreak. In fact, the drug’s prospects of pulling off its April 30 FDA decision date started to dim in late March when it became clear the FDA still hadn’t scheduled an inspection of the drug’s manufacturing site.
In terms of the trial design challenges that Lilly and Innovent have to contend with, much like the ORIENT-11 trial used for their sintilimab application, toripalimab’s JUPITER-02 trial was run predominantly in China. In the case of Lilly and Innovent’s March rejection, the regulator recommended the partners tee off additional global studies to show that the combination of sintilimab—marketed in China as Tyvyt—and chemotherapy works at least as well as standard of care in helping in newly diagnosed non-small cell lung cancer patients live longer.
The FDA essentially criticized Lilly and Innovent for losing sight of trial diversity and flagged the study's comparator arm and overall design. In commenting on Lilly and Innovent's decision to compare the drug to chemo, the regulator pointed out that PD-1 therapy had already become the standard of care in the U.S.
Coherus and Junshi, however, noted that the FDA has told them the toripalimab data on hand support its submission and suggested the indication—technically known as nasopharyngeal carcinoma—warrants “regulatory flexibility” on the acceptance of China-only data.
Toripalimab, which is approved in China across multiple cancer indications as Tuoyi, is one of four drugs Coherus hopes could reach combined sales of more than $1.2 billion by 2026. The other three meds are Udenyca, a biosimilar to Amgen’s neutropenia drug Neulasta, plus Humira and Lucentis copycats.