ClinicalNovartis Lets Go of Phase 2 Radioligand Therapy Following...

Novartis Lets Go of Phase 2 Radioligand Therapy Following Clinic Disappointment

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Novartis has ended development of one of its radioligand therapy (RLT) candidates after less-than-stellar clinical results halted its progress.

The Swiss drugmaker had been studying Lutetium-NeoB (Lu-NeoB), a gastrin-releasing peptide receptor (GRPR)-targeting radioligand therapy, in a Phase 1 trial for breast cancer and a Phase 2 study involving multiple solid tumors.

The Phase 2 trial was evaluating Lu-NeoB in conjunction with chemotherapy and had been scheduled to continue until 2031, according to federal clinical trial records.

A Novartis spokesperson confirmed that all clinical studies involving Lu-NeoB have now been discontinued because the early clinical findings did not justify advancing the therapy into the next stage of development. The spokesperson added that the decision was unrelated to any new or unexpected safety issues and that patients enrolled in the studies would continue to be managed according to the trial protocols. The company also emphasized that it remains committed to advancing radioligand therapies as part of its strategy to improve cancer treatment.

Novartis’ commercial RLT portfolio is anchored by Lutathera, which targets somatostatin receptors (SSTR), and the PSMA-directed therapy Pluvicto. During the second quarter, Pluvicto generated $651 million in sales, an increase of nearly 45%, driven by strong demand in the U.S. among patients with pre-taxane metastatic castration-resistant prostate cancer, as well as broader access in international markets.

Beyond its marketed products, Novartis continues to advance several experimental radioligand therapies. Its late-stage pipeline includes the PSMA-targeting candidate Ac-PSMA-617 for prostate cancer, while earlier-stage programs include therapies directed at HER2, DLL3, and FAP in Phase 1 development, along with another FAP-targeted candidate that has progressed to Phase 2.

Speaking during a media briefing, Novartis Chief Executive Officer Vas Narasimhan said the company’s commitment to radioligand therapies remains the same. He explained that Novartis is encouraged by the pipeline extending beyond Pluvicto and Lutathera and is continuing to advance both lutetium- and actinium-based therapies through clinical development.

Addressing Novartis’ recent $1.1 billion acquisition of ADC developer Myricx Bio, Narasimhan said the company recognizes that certain cancers may be better treated with antibody-drug conjugates (ADCs) or may benefit from approaches that differ from radioligand therapies. His comments contrast with the company’s earlier position, when Novartis had cited its emphasis on radioligand therapies as a reason for not pursuing significant investments in ADCs.

Earlier this year, Novartis confirmed it had reduced its biomedical research workforce by laying off a limited number of employees. Narasimhan said the company is not planning any major restructuring in the near future, adding that only routine workforce adjustments are expected as part of normal business operations, with no broader organizational changes currently anticipated.

In other news for the firm, it reported second-quarter earnings that exceeded market expectations while leaving its 2026 guidance unchanged, a move analysts interpreted as a sign that some expenses may have been deferred to the second half of the year.

Shares of the company climbed 3% after it posted core operating profit of nearly $6 billion for the quarter, comfortably ahead of analyst estimates of roughly $5.3 billion.

Novartis has decided to discontinue the development of one of its investigational radioligand therapies after disappointing Phase 2 clinical trial results. The decision reflects the company’s strategy of focusing resources on programs with the strongest scientific evidence and the highest potential to improve patient outcomes. While setbacks are common in drug development, Novartis continues to maintain one of the industry’s broadest oncology research pipelines.

Novartis Discontinues Phase 2 Radioligand Therapy

The Phase 2 study evaluated an experimental radioligand therapy designed to target cancer cells with precision while limiting damage to surrounding healthy tissue. According to Novartis, the trial failed to generate the clinical outcomes necessary to justify further development. As a result, the company has elected to end the program and redirect investment toward more promising pipeline candidates.

Why the Clinical Results Fell Short

Clinical trials must demonstrate meaningful improvements in efficacy and safety before advancing to later development stages. In this case, Novartis concluded that the investigational therapy did not achieve the desired clinical objectives, making continued investment difficult to justify. Decisions like these are a routine part of pharmaceutical research and help companies prioritize programs with the greatest likelihood of success.

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