Novartis has dropped a phase 2-stage radioligand therapy (RLT) after the candidate disappointed in the clinic.
The Swiss pharma had been evaluating the gastrin-releasing peptide receptor (GRPR)-targeting therapy, called Lutetium-NeoB or Lu-NeoB, in a phase 1 study for breast cancer, plus a phase 2 study for various solid tumors.
The phase 2 study was testing Lu-NeoB in combination with chemotherapy and had been due to wrap up in 2031, according to the federal trials database.
But Novartis confirmed to Fierce this morning that it has discontinued all studies of Lu-NeoB as “early clinical data did not support advancing it to the next stage of development.”
“This decision was not based on any new or unexpected safety concern and patients participating continue as per protocol,” a spokesperson said. “Novartis remains committed to exploring opportunities in radioligand therapies to advance cancer care.”
Novartis’ radiotherapy portfolio is led by PSMA-targeted Pluvicto and SSTR-aimed Lutathera. Pluvicto sales jumped 43% to $651 million in the second quarter, which the company attributed to strong demand in the pre-taxane metastatic castration-resistant prostate cancer setting in the U.S., as well as expanded access in other countries.
Behind those approved meds, the company has a new PSMA-targeting RLT in late-stage development for prostate cancer in the form of Ac-PSMA-617. There are also RLTs targeting DLL3, HER2 and FAP, respectively, in phase 1 development, as well as another FAP-focused candidate in phase 2.
In a call with journalists this morning, Novartis CEO Vas Narasimhan told Fierce that the company’s “commitment to RLT remains completely unchanged.”
“I think we're excited by the portfolio of RLTs beyond Pluvicto and Lutathera,” he added. “We're moving now through the clinic, both with actinium and lutetium-based therapies.”
Back in 2024, Narasimhan told Fierce that the company’s focus on radioligands was one of the reasons Novartis remained one of the few pharmas not to dabble in antibody-drug conjugates (ADCs).
When asked by Fierce this morning why Novartis had changed its strategy enough to pay $1.1 billion for ADC biotech Myricx Bio earlier this month, Narasimhan said the company acknowledged that “certain cancer types … could be better served by ADCs, or served in different ways than they could be by RLTs.”
‘No big changes’ to workforce
In May, Novartis confirmed that it was laying off a “select number of employees” from the company’s biomedical research organization.
When asked by Fierce this morning if Novartis should expect a more significant restructure in the near-term, Narasimhan said “no big changes” are planned.
“Right now, we would expect just the normal kind of adjustments that we make for our workforce on an ongoing basis,” he told Fierce. “So nothing major.”
“We're always looking—particularly in our field organizations—when we need to make adjustments, and we do those as a normal course of business,” the CEO added. “But nothing else major planned at this time.”