The discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.
Novartis has quietly scrapped a mid-stage radioligand therapy that had been under development for breast cancer and other solid tumors.
The investigational asset, called 177Lu-NeoB, was listed on the pharma’s pipeline in its first quarter presentation but no longer appears on the company’s most recent investor update posted Tuesday. A Novartis spokesperson confirmed the discontinuation of 177Lu-NeoB to BioSpace via email, noting that the decision was made because “early clinical data did not support advancing it to the next stage of development.”
The termination was not due to safety concerns, the spokesperson added. “Novartis remains committed to exploring opportunities in radioligand therapies to advance cancer care.”
Novartis is currently the leading player in the radiopharma space. The company has two approved products: Lutathera, approved in 2018 for gastroenteropancreatic neuroendocrine tumors, and Pluvicto, indicated for metastatic castration-resistant prostate cancer.
Pluvicto has become the cornerstone of Novartis’ radiopharma portfolio, surging 43% year-on-year to bring in $651 million in the second quarter. Lutathera, meanwhile, showed an 8% uptick in sales to hit $225 million.
The pharma continues to build up Pluvicto’s therapeutic profile and presented additional data from the Phase 3 PSMAddition trial in May, focusing on patients with metastatic hormone sensitive prostate cancer (mHSPC). Data at the time showed that Pluvicto significantly lowered the risk of prostate-specific antigen progression, a key indicator of disease resistance, as compared with standard of care.
The FDA is reviewing Pluvicto for mHSPC, with a decision expected in the third quarter, according to Novartis’ earnings presentation on Tuesday.
Like Pluvicto and Lutathera, 177Lu-NeoB makes use of a lutetium-based radioactive payload. As lutetium deteriorates, it emits small and highly energetic beta particles, which in turn bombard the tumor, ultimately leading to its destruction. Novartis was hoping to harness this mechanism to treat various solid tumors, for which 177Lu-NeoB was in mid-stage development, according to the company’s Q1 presentation.
Novartis was also running a Phase 1/2 study of the asset in breast cancer. The trial is listed as active on a federal clinical trials database, with a primary completion date in 2031. Participants will “continue as per protocol,” the company spokesperson told BioSpace in an email.
Novartis has other radiopharma candidates in the works, including the actinium-based 225Ac-PSMA-617, in late-stage development for patients with mCRPC who had undergone prior lutetium-based treatment. The pharma’s other radioligand therapy candidates are in early- or mid-stage studies for solid tumors.
