- An experimental cancer immunotherapy co-owned by Chinese biotech CStone Pharmaceuticals and startup EQRx succeeded in a Phase 3 trial in early lung cancer, positioning the two companies to potentially bring to market a lower-cost alternative to top-selling drugs like Merck & Co.'s Keytruda.
- Without disclosing details, the two companies said their drug sugemalimab, a type of medicine known as a checkpoint inhibitor, kept tumors from spreading in Stage 3 non-small cell lung cancer patients who have just received chemotherapy. The drug already succeeded in a study in advanced lung cancer patients, meaning sugemalimab could soon compete with multiple checkpoint blockers, led by Keytruda, in one of oncology's most competitive fields.
- C-Stone and EQRx now plan to seek regulatory approvals in multiple countries. Authorization would make sugamelimab the ninth checkpoint inhibitor to market, but potentially the first to compete on price given EQRx's plan to undercut branded medicines. Typical checkpoint therapy can cost more than $100,000 per patient, per year.
Checkpoint inhibitors helped change the standard of care for a number of tumor types over the past decade. And in the process, they've become a very big business for drugmakers. Keytruda alone generated $14.4 billion in 2020, making it one of the world's best-selling medicines. Similar drugs from Bristol Myers Squibb, Roche and AstraZeneca also make billions of dollars every year.
But despite the fact that there are now eight checkpoint inhibitors approved, competition hasn't yet brought down cost. GlaxoSmithKline's Jemperli, which just came to market last month for endometrial cancer, has an average monthly wholesale cost of $15,000, which is slightly higher than the monthly cost of Keytruda and Opdivo for other tumors. 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.
The "market is becoming more crowded, but the constant debate around pricing without action is to the detriment of patients," said Alexis Borisy, CEO of EQRx, in a statement.
All of which makes the progress of sugemalimab worth watching. EQRx, which partnered with China's CStone last year to develop the drug, was formed with the unusual goal of developing lower-cost alternatives to branded medicines. The biotech's plan is to show that drugs it acquires or makes in-house are just as good or better than similar, proven medicines, and then price them at a fraction of the cost.
EQRx has already taken important steps toward that goal, amassing a pipeline of drugs meant to mimic some of the industry's top-sellers. Recently, the company disclosed positive Phase 3 results for one of them, a targeted lung cancer drug similar to AstraZeneca's blockbuster medicine Tagrisso. EQRx president Melanie Nallicheri said the plan is to price the drug "significantly lower" than the competition, though she didn't provide specifics.
Sugemalimab could be next. The drug has now succeeded in two late-stage trials in China in Stage 3 and Stage 4 non-small cell lung cancer, one of oncology's most competitive and lucrative fields. The companies plan to begin discussions with regulators in multiple countries, including the U.S., in both settings.
The results EQRx and CStone reported Friday could position their drug as a threat to AstraZeneca's Imfinzi, which is currently the only checkpoint inhibitor approved for use in Stage 3 cancer. That may depend, however, not only on sugemalimab's ability to keep tumors from spreading, but extend lives. In the Phase 3 Pacific study, for example, Imfinzi reduced the risk of death by 32%, a benefit that has largely held up over four years, according to results published in a peer-reviewed journal earlier this month.
Survival results for sugemalimab aren't available yet, and detailed study results will be disclosed at a future medical meeting.
EQRx and Cstone's drug could also challenge other checkpoint blockers as well. The drug is in a mid-stage trial in lymphoma, while two other Phase 3 studies in gastric and esophageal cancer — tumor types in which Opdivo and Keytruda, respectively, were recently approved — are underway. Advanced lung cancer, meanwhile, accounts for the bulk of Keytruda's yearly revenue.
Checkpoint inhibitors are the "backbone of cancer treatment," Borisy said, and sugemalimab could help lower "the overall costs of immunotherapy options."
EQRx has rights to sugemalimab everywhere outside of China.