Novartis' Pluvicto hits goal in earlier prostate cancer amid radiotherapy production expansion

Novartis got a clinical data boost that could support its radiotherapy Pluvicto’s $2 billion-plus peak sales ambition.

Pluvicto helped patients with previously treated PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) live longer without radiographic disease progression. The improvement was over an androgen-receptor inhibitor such as Astellas and Pfizer’s Xtandi and it was “statistically significant and clinically meaningful,” Novartis said in a Monday press release.

The results came from the phase 3 PSMAfore trial, in which all patients had previously received an androgen-receptor inhibitor but didn’t get taxane-based chemotherapy. It marks an earlier treatment setting than Pluvicto’s existing FDA approval, which is in post-chemotherapy mCRPC.

A positive readout in the pre-taxane setting would triple to quadruple the number of patients that Pluvicto could target, Novartis CEO Vas Narasimhan said during the company’s third-quarter earnings call in October.

Novartis will discuss the PSMAfore data with the FDA next year for a potential approval, and detailed results will be shared at a future medical meeting, according to the release.

Novartis has high hopes for Pluvicto, having put its peak sales estimate at above $2 billion. The projection is dependent on positive readouts from PSMAfore and another phase 3 called PSMAaddition, which is slated to report data next year in metastatic hormone-sensitive prostate cancer.

In anticipation of the expansion of Pluvicto and the company’s entire radiotherapy efforts, Novartis has recently started building up its production footprint. The company is increasing capacity at its radioligand site in Millburn, New Jersey, which is coming off a recent manufacturing hiccup and temporary production halt. It also expects a new plant at Indianapolis’ Purdue Research Park to become operational mid-2023, Narasimhan told investors during the October conference call.

Once the Millburn facility comes back online, Novartis would be “well-positioned” for the chemo-naïve mCRPC indication expansion and its demand surge, Narasimhan said. And the Indianapolis facility would give Novartis two manufacturing plants, while its European facilities will focus on Europe and other ex-U.S. markets as Novartis looks to add additional capacity in Asia over time, he added.

For now, Novartis has enough capacity to supply for the post-chemo indication to the more than 120 designated treatment centers, but the plan is to eventually reach 350 to 400 centers, Narasimhan said. The prescription volume would be even higher if Novartis “were to completely unconstrain the number of centers,” the CEO said. Pluvicto generated $80 million in sales in the third quarter, its first full quarter on the market.

Pluvicto is among eight marketed products, each holding multibillion-dollar sales potential, that Novartis is counting on for growth as its top-selling heart failure drug Entresto nears the patent cliff. Novartis is in the process of spinning off its generics business, Sandoz, to focus on innovative drugs. Radioligand therapy and solid tumors are within the company’s focus in terms of technology platforms and therapeutic areas.