adobe stock photos - Michael Derrer Fuchs

Novartis drops Phase 2 radioligand therapy

Novartis has discontinued development of Lu-NeoB, an experimental radioligand therapy targeting the gastrin-releasing peptide receptor, after early clinical data failed to support further development.

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Why it matters: The Swiss pharma told Fierce Biotech that it had stopped all studies of Lu-NeoB, although patients already participating would continue according to their trial protocols.

  • Lu-NeoB was part of Novartis’ effort to expand radioligand therapy beyond the prostate and neuroendocrine cancers addressed by its approved products Pluvicto and Lutathera.
  • The setback removes one of the company’s more advanced attempts to target a new tumour-associated receptor with the modality. However, it does not appear to have changed Novartis’ wider commitment to radioligand drugs.

Zoom in: Lu-NeoB used lutetium-177 to deliver radiation to tumours expressing GRPR, a receptor found at elevated levels in some breast cancers and other solid tumours.

  • Novartis had been studying the candidate across several trials, including a Phase 1 breast cancer study combining Lu-NeoB with ribociclib and fulvestrant and a Phase 1/2 study combining the therapy with the chemotherapy capecitabine in metastatic ER-positive, HER2-negative breast cancer.

Yes, but: Novartis did not disclose the efficacy results that prompted the decision. A spokesperson told Fierce that the discontinuation was not caused by a new or unexpected safety issue.

The bigger picture: Novartis’ commitment to radioligand therapy remained unchanged. Its pipeline still includes radioligands targeting PSMA, DLL3, HER2 and fibroblast activation protein.

  • The company is also adding another targeted drug-delivery modality through its planned acquisition of London-based antibody-drug conjugate specialist Myricx Bio for up to $1.5 billion.

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