A radiopharmaceutical drug from Novartis helped stave off prostate cancer progression for longer than further treatment with standard medicines in a late-stage study, positive results that could support wider use of the Swiss pharmaceutical company’s therapy.
In a statement Monday, Novartis said its drug, called Pluvicto, outperformed androgen-blocking medicines among people with metastatic prostate cancer that’s resistant to castration. The difference in radiographic progression-free survival — a measure that describes how long patients go without evidence of their cancer advancing on scans — was both statistically significant and “clinically meaningful,” Novartis said.
The company did not observe any unexpected side effects and plans to discuss potential approval with the Food and Drug Administration next year.
Pluvicto was approved in the U.S. earlier this year for castration-resistant metastatic prostate cancer following treatment with androgen-blocking medicines and with chemotherapy.
The study that Novartis read out results from on Monday tested Pluvicto earlier, before patients received a type chemotherapy known as taxanes. Company executives have said the “pre-taxane” setting is three to four times larger than Pluvicto’s current market.
“We look forward to discussing the data with healthcare authorities in order to bring this innovative new early treatment option to many more prostate cancer patients sooner after their diagnosis,” said Shreeram Aradhye, Novartis’ chief medical officer, in the company’s statement.
Pluvicto is what’s known as a radiopharmaceutical, or radioligand, therapy. The drug consists of a targeting compound called a ligand bound to a radioactive particle. The ligand shepherds the toxic particle to cells expressing a specific target, in this case a protein called PSMA that’s expressed on prostate cancer cells. Once delivered, the radioactive payload damages the cancer cells, causing them to die.
It’s a powerful treatment option, but one that’s hard to make. Earlier this year, Novartis halted production of Pluvicto and another radiopharmaceutical over “potential quality issues” it had identified in its manufacturing process. The company restarted production and delivery of the therapies about two months later.
Novartis is now working on expanding the number of centers that offer Pluvicto treatment, as well as on increasing its manufacturing capacity by adding new factories in New Jersey, Indiana and Italy.
The company eventually expects annual sales of Pluvicto to exceed $2 billion, a lofty target that Monday’s results could make easier to reach.
Novartis did not disclose specific data in its statement Monday, indicating that those results would be presented at an upcoming medical meeting. Still, news of the study’s success helped raise the company’s share price by 1.5% in Monday morning trading on the New York Stock Exchange.
Novartis is also testing Pluvicto in a large Phase 3 trial of patients with hormone-sensitive prostate cancer. Results from that study are expected in 2024.