Novartis Terminates Phase 1 Trial of Radioligand Therapy [177Lu]Lu-FF58 in Solid Tumors

Recently, according to the ClinicalTrials.gov website, Novartis terminated the Phase 1 clinical study of [177Lu]Lu-FF58 in solid tumors. The reason for termination is unclear, with only the indication “not based on any safety concerns.”

According to the report, a spokesperson for Novartis cited "Careful evaluation of available clinical data"As a result, and added that all patients had either stopped treatment or been safely followed up.

Lu-FF58

FF58 is aIntegrated Diagnosis and TreatmentRadioligand therapy, composed of integrin-coupled radionuclides 177Lu or 68Ga (177Lu for therapeutic purposes and 68Ga for diagnostic purposes).

Lu-FF58 was originally developed by PeptiDream and then licensed to Novartis. This is part of a nearly $3 billion collaboration between Novartis and PeptiDream reached in April 2024.

The phase 1 clinical trial of Lu-FF58, which has been terminated, aimed to evaluate the safety and dosage of Lu-FF58 in patients with advanced or metastatic solid tumors expressing integrins (αvβ3 and αvβ5), as well as to assess the safety of the imaging agent Ga-FF58 and its ability to identify tumor lesions.

The study described in detail that the research would conclude when at least 80% of the patients in the extended portion completed disease follow-up or discontinued the study for any reason, and all patients had finished treatment and the 36-month long-term follow-up, or if the study was terminated early. In such cases, all patients would also undergo safety follow-up.

However, Novartis did not specify the reason for terminating the study, only indicating that it was unrelated to safety.

Although there is no explicit statement confirming the failure of this clinical trial, the signal accompanying the termination of the trial — "all patients have either stopped treatment or been safely followed up" — makes Lu-FF58 appear less optimistic.

Novartis: Leader in Nuclear Medicine

Currently, Novartis is undoubtedly the leading company in the field of radioligand therapy.

NovartisChinaIn 2017, it acquired Advanced Accelerator Applications (A), a pioneer in the field of nuclear medicine.AA). 2018,NovartisAcquired Endocyte for $2.1 billion, bringing both Lutathera and Pluvicto under its wing in one move.

It is precisely becauseThe commercial success of Pluvicto and Lutathera, with their rapidly growing salesStimulated Novartis' further investment in nuclear medicine.

Novartis has subsequently entered into high-value collaborations on radiopharmaceuticals with multiple companies, including a partnership with Japanese company PeptiDream.

In addition, Novartis also acquired Mariana Oncology for $1 billion in May 2024, strengthening its leading position in nuclear medicine.

Summary

In fact, since 2023, the attention to nuclear medicine within the pharmaceutical industry has been increasing.

In 2023, Eli Lilly and Bristol-Myers Squibb made substantial acquisitions of their respective desired radiopharmaceutical companies, entering the field of radioactive drug development. Additionally, Johnson & Johnson, Merck, Sanofi, and Bayer have also established layouts through BD collaborations.

Continuing the high interest of pharmaceutical giants in radiopharmaceuticals from 2023, this type of drug remained a focal point in 2024, attracting another pharmaceutical giant, AstraZeneca, as well as multiple collaborations related to nuclear medicine.

Jefferies analyst Andrew Tsai commented: "These deals indicate that large pharmaceutical companies view radiopharmaceuticals as commercially viable for hard-to-treat cancers and potentially even as a (first-line) therapy."

Nuclear medicine will likely remain a key investment theme next year.