As Elevar Therapeutics and Hengrui Pharmaceuticals await an FDA decision on their combination therapy for newly diagnosed unresectable liver cancer—approved in China back in February—the partners are lining up a new global commercialization pact.
Under the deal, Elevar is set to pay China’s Hengrui up to $600 million in milestones—plus potential royalties—to market the VEGFR rivoceranib combined with the PD-1 inhibitor camrelizumab worldwide. The deal excludes the greater China region and Korea, the companies said.
The total estimated 10-year payout could approach $1 billion, Elevar said in a press release.
The move comes after the partners submitted their application for the combo therapy to the FDA in May, teeing up a regulatory action date for May 16, 2024. The liver cancer combo therapy was approved for first-line use in China in February and, if approved in the U.S., would go toe-to-toe with Roche’s own PD-1/VEGF combo of Tecentriq and Avastin.
The partners are angling for an approval in unresectable hepatocellular carcinoma (uHCC). Each year, liver cancer causes more than 830,000 deaths worldwide, according to the companies. HCC is the most common form of the disease and typically has a poor prognosis because of a lack of treatment options, Elevar and Hengrui said.
The combo therapy aside, Hengrui in 2020 scored China approval for rivoceranib monotherapy under the brand name Aitan in second-line treatment for advanced HCC.
Separately, camrelizumab, under the commercial moniker AiRuiKa, is approved as a monotherapy in China across eight indications, including second-line HCC, relapsed or refractory classic Hodgkin’s lymphoma and esophageal squamous cell carcinoma.
Back in May 2022, Hengrui said the combination therapy hit its goal in newly diagnosed patients of liver cancer, with rivoceranib and camrelizumab besting Bayer’s Nexavar at extending patients’ lives and preventing disease progression or death.
If approved in the U.S., Hengrui’s cocktail will have to duke it out with Roche’s Tecentriq and Avastin, which scored an FDA approval in first-line liver cancer in 2020.
Hengrui is just one of many Chinese drugmakers who’ve attempted to bring a PD-1/L1 inhibitor to the U.S. market.
Not all those efforts have resulted in success. Look no further than Innovent Biologics and Eli Lilly’s failed attempt to bring Tyvyt, or sintilimab, to the U.S. market in non-small cell lung cancer. In that case, the FDA lambasted the companies for using a pivotal trial conducted solely in China—and for comparing the experimental therapy against an outdated standard of care.
In Hengrui and Elevar’s case, the partners' phase 3 trial was conducted at 121 sites, including several in the U.S., Belgium, Italy, Spain and other countries. As for the trial's comparator arm, Nexavar was the standard of care until Tecentriq came along, but Hengrui's clinical study started a year before Tecentriq's first-in-class nod.
One possible hangup for Elevar and Hengrui? Neither camrelizumab nor rivoceranib is approved in the U.S. Therefore, it could be argued that there’s no telling of each drug’s contribution to the regimen. It may prove difficult to ask for a combo therapy approval that effectively includes two new drug applications.