Korean biotech HLB and its China-based partner Jiangsu Hengrui Pharmaceuticals said Friday that the FDA rejected their drug combination for the most common form of liver cancer.
The FDA rejected the pairing of rivoceranib and camrelizumab as a first-line treatment for patients with unresectable hepatocellular carcinoma. The US regulator had set a decision deadline of this month for the small molecule tyrosine kinase inhibitor rivoceranib and the anti-PD-1 camrelizumab. China’s health authorities greenlit the combo in early 2023.
Yang Gon JinHLB’s stock price fell about 30% in response to the news. The company’s chairman, Yang Gon Jin, delivered the news via a Youtube video, according to local outlet Korea Biomedical Review.
Elevar Therapeutics, a US-based majority-owned subsidiary of HLB, inked a global licensing deal with Hengrui last year to obtain rights to market and develop the combo worldwide, save for China and Korea. The New Jersey biotech said last October it would pay up to $600 million in sales milestones and double-digit royalties on net sales of camrelizumab. The 10-year payout could reach $1 billion, the companies said at the time.
Saeho Chong“We are deeply disappointed by the FDA’s decision and were not anticipating this response based on our positive communications with the FDA over the past year and through our late-cycle meeting, which occurred in March. Elevar was in label discussions with the FDA as recently as the past week,” Elevar CEO Saeho Chong said in an emailed statement to Endpoints News. “In the CRL, the FDA did not indicate issues with our HCC clinical data.”
An Elevar spokesperson said the FDA’s complete response letter cited two issues.
The agency was unable to complete all bioresearch monitoring clinical inspections during the review cycle because of “restrictions on travels.” The spokesperson said the FDA’s inspections would be “delayed until resubmission.”
“Additionally, the FDA cited that because the safety and effectiveness of rivoceranib has only been established in combination with camrelizumab, the FDA will not approve rivoceranib until a regulatory approval action is issued for camrelizumab,” the spokesperson wrote in an email.
Elevar said HLB and Hengrui have “communicated their commitments to resubmissions.”
“Elevar and HLB are committed to working closely with Hengrui to understand the open manufacturing deficiencies for camrelizumab. The FDA did not cite any manufacturing issues related to Hengrui’s manufacturing facility for rivoceranib,” the spokesperson added.
Data from CARES-310, a Phase 3 trial testing the combination, were published in The Lancet last year. The biotech previously said it plans to present the “final overall survival analysis” at this year’s meeting of the American Society of Clinical Oncology in Chicago on June 1.
Elevar has been developing rivoceranib since 2009, according to a description in the bio of HLB’s chairman.
Bristol Myers Squibb is also working on expanding the label for its Opdivo-Yervoy combination to include advanced hepatocellular carcinoma. In March, the large pharma said the duo met its primary goal of overall survival in a Phase 3. Meanwhile, Exelixis’ cancer drug Cabometyx has been approved for HCC for about five years. Merck’s megablockbuster Keytruda has also been on the market for HCC since 2018.