A phase 3 prostate cancer clinical trial of Novaris’ targeted radioligand therapy 177Lu-PSMA-617 has met both its primary endpoints. The result tees Novartis up to seek approval for a drug it picked up in its $2.1 billion acquisition of Endocyte.
Investigators in the phase 3 VISION study randomized 831 patients with PSMA-positive metastatic castration-resistant prostate cancer to receive either just investigator-chosen best standard of care or that regimen plus up to six infusions of 177Lu-PSMA-617. The drug is designed to bind to cells that express PSMA, a protein found in prostatic tissue, and expose them to radioisotope emissions that disrupt replication and cause cell death.
Tuesday, Novartis reported overall survival and radiographic progression-free survival were significantly better in patients who received 177Lu-PSMA-617. Novartis is yet to share the results but is sufficiently encouraged by the data to start preparing to seek approvals in the U.S. and EU later this year.
Analysts at Jefferies expect use of 177Lu-PSMA-617 to be limited to patients with high expression of PSMA. However, as 60% to 80% of patients have high-grade prostate cancer, the PSMA limitation will still leave Novartis with a substantial market to target. The Jefferies analysts forecast peak sales of $600 million, although that figure could swell if the phase 3 data are strong and Novartis is able to expand into earlier lines of treatment.
Endocyte took 177Lu-PSMA-617 into phase 3 patients previously treated with drugs such as Pfizer’s Xtandi and Johnson & Johnson’s Zytiga in 2018, shortly before accepting Novartis’ buyout bid. The success of the phase 3 gives Novartis a shot at generating a return on its outlay and provides a boost for its radiopharmaceutical strategy and broader business.
“Pipeline wins are sorely needed to boost sentiment in the shares, as Novartis remains out of favor in most of our investor discussions,” Jefferies analysts wrote in a note to investors. “The positive VISION study readout has added importance as it is one of the first pivotal studies for Novartis' radioligand platform beyond Lutathera.”
Novartis acquired Lutathera in its $3.9 billion takeover of Advanced Accelerator Applications before going on to snap up Endocyte. The takeovers gave Novartis radiopharmaceutical platforms to add to its existing expertise in cell and gene therapy, targeted therapy and immunotherapy. Novartis has continued to increase its exposure to radiopharmaceuticals through deals such as its investment in Aktis Oncology.