- Coherus Biosciences and China's Junshi Biosciences on Wednesday said their experimental immunotherapy succeeded in a Phase 3 trial in non-small cell lung cancer and that they aim to seek approval of the drug in the U.S., China and elsewhere.
- Interim results show the drug toripalimab, when combined with chemotherapy, kept tumors from spreading for a median of 8.3 months, versus 5.6 months for chemotherapy alone. The trial hasn't gone on long enough to prove the combination helped patients live longer, though the trend currently favors treatment with the Junshi and Coherus drug.
- The results could position Coherus, best known as a maker of copycat biologic drugs, to become the next entrant in oncology's most competitive market. Its commercial prospects are unclear, however, as Merck & Co.'s Keytruda has become the standard of care for most patients and drugs from Roche, partners Regeneron and Sanofi and others are fighting for market share.
After spending years developing biosimilars, Coherus broadened its ambitions in February. Using the profits generated from a copycat version of Amgen's Neulasta, the company bought partial rights to Junshi's drug, marking its first foray into innovative medicines.
Coherus executives signaled the deal was part of a transition to "Coherus 2.0," using its biosimilar cash to fund a pipeline of experimental cancer immunotherapies. Toripalimab, a so-called checkpoint inhibitor that works similarly to Keytruda, Bristol Myers Squibb's Opdivo and others, is meant to be the linchpin of that effort.
Already approved in China for melanoma, the drug is in testing for a dozen different tumor types, among them cancers of the breast, lung and liver. Coherus aims to use toripalimab, along with options for other Junshi oncology assets or deals with other companies, to develop multi-drug combinations. Its first step is a U.S. approval filing in nasopharyngeal carcinoma, a submission that is currently underway. With the results disclosed Wednesday morning, lung cancer might be next.
Toripalimab's U.S. arrival could, in theory, represent an opportunity to launch a lower-priced checkpoint inhibitor, which have six-figure annual price tags even though there are now seven available. Costs could keep rising, too, as multiple checkpoint inhibitors are progressing from their original approvals in advanced disease to earlier lines of care, where many existing treatments are generic and cheap.
Coherus hasn't specifically divulged its pricing plans, though some analysts expect the company to undercut others. "We believe ... Coherus is really going to make the PD-1 game about access and working with providers differently," wrote Mizuho analyst Salim Syed, in February, "in part [with] price cuts."
But Coherus' drug has to pass muster with U.S. regulators first, and that's not a certainty. The trials supporting its use in nasopharyngeal carcinoma and lung cancer were each run in China. Coherus doesn't expect to need to run "bridging studies" to secure approval, though management acknowledged such a requirement depends on the FDA and hasn't been discussed yet, Syed wrote in July.
Coherus plans to meet with the FDA "to discuss a potential submission," the company said in a statement Wednesday.
Syed wrote that Junshi's drug "seems to line up fairly well" against Merck's Keytruda given the Phase 3 result. But it's unclear how the two exactly compare. Regulators first approved the Keytruda-chemotherapy combination in 2018. Junshi's lung cancer trial began afterwards, but tested toripalimab and chemotherapy against an outdated comparator — a strategy for which Regeneron, whose drug Libtayo was approved in lung cancer this year, has already drawn criticism.
Coherus shares climbed 7% in early trading Wednesday.