After the FDA snubbed Eli Lilly and Innovent Biologics’ cancer immunotherapy sintilimab because of China-only data, all eyes have turned to the next China-developed PD-1 therapy in line at the FDA. But an FDA decision on that may be delayed.
With a regulatory decision just one month away, the FDA has yet to schedule an inspection of the manufacturing site for toripalimab, the PD-1 inhibitor Coherus BioSciences licenses from China’s Junshi Biosciences, because of COVID-19 travel restrictions, Theresa LaVallee, Coherus’ chief development officer said during an investor event Tuesday.
Based on the timeline, Mizuho analyst Salim Syed figured the drug’s April 30 target date in nasopharyngeal carcinoma may lapse. But Syed pointed out that a reason for optimism is that Coherus said toripalimab's review is a “high priority” item at the FDA.
Coherus didn’t confirm nor rule out the possibility of a virtual inspection, Syed said in a note Tuesday. Junshi currently lists two manufacturing sites in Shanghai and the nearby city of Suzhou. Shanghai is under lockdown amid a COVID-19 outbreak caused by omicron.
Toripalimab has been approved in China across multiple cancer indications including nasopharyngeal carcinoma and is marketed under the brand name Tuoyi.
The FDA’s rejection of Lilly and Innovent's sintilimab is adding a slight wrinkle to toripalimab’s application. Similar to the China-only Orient-11 trial that the companies used for sintilimab’s submission for newly diagnosed non-small cell lung cancer, toripalimab's JUPITER-02 study is conducted predominantly in China.
But Coherus and industry watchers believe toripalimab’s current application is different. As LaVallee pointed out, the FDA denied sintilimab “regulatory flexibility” because several PD-1/L1 inhibitors are already available in front-line NSCLC. By comparison, no PD-1/L1 drug has been allowed in the U.S. for nasopharyngeal carcinoma.
Nasopharyngeal carcinoma is a rare cancer type that disproportionately affects the Asian population. The disease is often coded as head and neck cancer in the U.S., Paul Reider, Coherus’ chief commercial officer, said during the event. Using the head and neck cancer sales from Merck & Co.’s PD-1 inhibitor Keytruda, Reider suggested that toripalimab’s nasopharyngeal carcinoma indication could represent a $100 million opportunity.
If approved, toripalimab will be managed by Coherus’ current sales team for Udenyca, a biosimilar to Amgen’s neutropenia drug Neulasta, Reider said. Prescribers of PD-1 inhibitors and Udenyca have a roughly two-third overlap, he noted.
In JUPITER-02, toripalimab showed its addition to chemotherapy could pare down the risk of disease progression or death by 48% compared to chemo alone as first-line treatment in advanced nasopharyngeal carcinoma, according to data presented during the plenary session at last year’s ASCO annual meeting. The therapy also reduced the risk of death by 40%.
Toripalimab has its own front-line NSCLC trial, dubbed Choice-01, which was also a China-only study. But during LaVallee’s presentation, front-line NSCLC didn’t appear in the slide about “potential opportunities for U.S. registration.”
Still, Syed said he would keep a close eye on the potential inclusion of toripalimab in guidelines and subsequent off-label usage and reimbursement in lung cancer.
Toripalimab and Udenyca are among four drugs that Coherus hopes could together grow to more than $1.2 billion sales by 2026 as the former biosimilar specialist pivots to oncology. The other two meds are copycats to AbbVie’s Humira and Roche and Novartis’ eye med Lucentis.
Editor's note: A previous version of the story stated that JUPITER-02 is conducted solely in China, the clinical trial is actually run predominantly in the country.