- EQRx, which aims to bring new medicines to market at "radically lower" prices, said the experimental lung cancer drug it co-owns with Chinese biotech CStone Pharmaceuticals extended patients' lives in a late-stage clinical trial.
- The Phase 3 study compared a combination of chemotherapy and the drug, known as sugemalimab, against chemotherapy alone. A previously published analysis in the Lancet found the two-drug regimen bested chemotherapy at holding tumors in check. Now, sugemalimab has also helped patients live longer, though EQRx didn't disclose specifics in a statement released Tuesday.
- The findings help reinforce EQRx's case for sugemalimab, which the company hopes could win approval in lung cancer. But should EQRX seek Food and Drug Administration clearance, its application would become another test case for U.S. regulators, who have expressed concern about granting an OK to drugs developed and exclusively tested in China.
EQRx is looking to shake up the cancer immunotherapy market and take on blockbuster medications such as Merck & Co.'s Keytruda, which had sales of over $14 billion in 2020. Like Keytruda, sugemalimab is part of the checkpoint inhibitor class, which also includes Roche’s Tecentriq and Bristol Myers Squibb’s Opdivo and works to rev up the body's immune system to fight cancer.
Yet, EQRx is getting ready to enter the regulatory process at a time when the FDA is casting a more skeptical eye on cancer immunotherapies. And the company may face a particular challenge in the U.S. market because its pivotal study was conducted in China.
Last April, the FDA convened a panel of outside experts to review six approvals for cancer immunotherapies because follow-up research didn't succeed after initially positive results. While the committee recommended maintaining the approvals in four cases, multiple companies ultimately decided to withdraw their drugs for the indications considered by the panel.
These kinds of medicines have had "powerful effects on patients’ lives," but their rapid growth has led to a "Wild West of drug development" that needs examination and coordination, FDA officials Julia Beaver and Richard Pazdur wrote in the New England Journal of Medicine recently. The agency is advocating for cooperation between drugmakers and trials that test checkpoint inhibitors against one another.
The FDA is also concerned about studies conducted exclusively in China, Beaver and Pazdur said. It's likely that a head-to-head study showing that the drug works as well or better than an approved checkpoint inhibitor would be needed in the U.S., they said.
Eli Lilly and partner Innovent Biologics will soon test the FDA's stance on the issue, as they face an advisory panel next month for their drug sintilimab, marketed in China as Tyvyt. Lilly has also suggested it may undercut rivals on pricing if it wins approval for the treatment in the U.S.
EQRx, meanwhile, does plan to run a head-to-head study comparing sugemalimab with approved treatments at multiple sites including some in the U.S., according to the company’s CEO, Melanie Nallicheri. Though she didn’t offer much detail, Nallicheri said the study would start this year.