Two months after CRL, FDA accepts Coherus, Junshi's resubmission for PD-1 studied in China
China-only clinical data has not fared well before the FDA this year. But in one case, the regulatory agency might be willing to budge a little.
Coherus BioSciences, the US partner for Junshi Biosciences, announced Wednesday morning that the FDA has accepted a BLA resubmission for its PD-1 drug two months after a CRL. The companies are seeking a nod for toripalimab plus chemotherapy in first-line advanced recurrent or metastatic nasopharyngeal carcinoma (NPC), plus toripalimab alone for second-line and later recurrent or metastatic NPC after platinum-containing chemotherapy.
Set for a final action date of Dec. 23, the FDA said last month that the timeline for the review would be six months, saying that on-site inspections would be required. If the FDA gives Coherus the green light, the biotech plans to launch toripalimab in the US in Q1 of 2023.
The drug was approved in 2018 in China, where it is marketed as Tuoyi.
A biosimilars player, Coherus spent $150 million last year to license the PD-1 candidate from Junshi, joining three other major US companies at the time (Eli Lilly, EQRx and Novartis) that promised to undercut the high-priced market for PD-1 inhibitors by bringing in Chinese drugs and selling them well below the price of Merck’s Keytruda or Bristol Myers Squibb’s Opdivo. Lilly dished out $200 million to Innovent, EQRx doled out $150 million to Cstone, and Novartis paid BeiGene $650 million, with the latter duo expecting a decision next week on tislelizumab.
However, the FDA rebuked Eli Lilly back in February for trying to get its PD-1 candidate sintilimab approved based on Chinese data alone, which initially suggested that Coherus and other competitors might not be able reach market.
In the aftermath of the sintilimab rejection, Chinese biotech Hutchmed got thrown a CRL for its small inhibitor candidate over similar concerns of data mostly from China. Junshi also said at the time that it received a CRL from US regulators, which it claimed had nothing to do with data. Rather, Junshi said it was “a quality process change.”
Interestingly, with Coherus and Junshi’s two Phase II studies from which the original BLA was based, both were mainly done in China, with the second study including some sites in Singapore and Taiwan.
“We believe toripalimab addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and the FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of single country clinical data,” Coherus CEO Denny Lanfear had said at the time.
Lanfear said today in a statement that “the toripalimab resubmission is one of several key development and commercialization milestones we are sharply focusing on over the next twelve months, and we are pleased with the Company’s execution and progress on all of them.”
Following potential approval, Coherus added Wednesday in a release that its next steps include looking at the drug in broader indications or in combo with other cancer drugs or immunotherapies, keeping co-development agreements on the table. Junshi and Coherus already teased broader indications last December, showcasing positive results from an interim analysis of the drug plus chemo in more than 400 patients with advanced squamous and non-squamous NSCLC. That analysis said the drug combination demonstrated statistically significant improvement in overall survival.
Coherus’ stock price went up slightly after the markets opened, with $CHRS up 2.5%.