Regeneron Pharmaceuticals unveiled what it calls "paradigm-shifting" test results for a drug that could prevent an asymptomatic disease from ever becoming multiple myeloma.
Multiple myeloma is a blood cancer that's considered incurable. Patients can live for years, but usually while undergoing multiple rounds and types of treatments. Roughly 62% of patients live for five years following their multiple myeloma diagnosis, according to the American Cancer Society.
But Regeneron says it might be able to prevent some patients from ever developing multiple myeloma. The company tested its drug, linvoseltamab, in patients with high-risk smoldering multiple myeloma, a precursor to the cancer.
Every patient in the 19-person study responded to treatment. Almost 84% of patients had a complete response, meaning all signs of their disease disappeared. All 12 of the patients who could be evaluated with a blood test, showed no molecular signs of their cancer.
"This is remarkable," Andres Sirulnik, Regeneron's head of hematology, told Investor's Business Daily. "This is unprecedented for a single agent."
Regeneron Vs. Johnson & Johnson
Though high-risk smoldering multiple myeloma can progress quickly into full-blown multiple myeloma, there's no approved treatment for it. The Food and Drug Administration is currently deciding whether it will approve Johnson & Johnson's Darzalex for the condition.
Darzalex and Regeneron's linvoseltamab, under the brand name Lynozyfic, are already approved to treat multiple myeloma.
Sirulnik acknowledged there have been no head-to-head studies pitting linvoseltamab and Darzalex in patients with high-risk smoldering multiple myeloma. In Phase 3 testing, 63.4% of patients responded to treatment with Darzalex. But J&J said it couldn't determine the complete response.
He said the molecular testing results are particularly promising. Using minimal residual disease tests, or MRD tests, doctors can now determine which patients still have cancer DNA circulating in their blood well before the cancer shows up on traditional scans. Patients who have circulating cancer DNA are likely to later relapse.
But all 12 of the patients Regeneron testing following treatment with linvoseltamab were free of cancer DNA in their blood.
"We are very encouraged by the data and we believe we have the opportunity to bring to patients a paradigm-shifting treatment in high-risk smoldering multiple myeloma and in other stages of the disease," Sirulnik said.
Regeneron Stock Is Rising
The news could give Regeneron stock a boost. Shares have climbed almost 7% this week, as of midday Thursday. That helped them retake their 50-day moving average, according to MarketSurge.
Still, shares have a low IBD Digital Relative Strength Rating of 12. This means Regeneron stock ranks in the lowest 12% of all stocks when it comes to 12-month performance.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.