Sanofi and Orana Med’s radiopharmaceutical candidate has met all its primary endpoints in a Phase II trial, meaning the former’s €320m bet on the therapy looks to be paying off.
In the ongoing ALPHAMEDIX-02 study (NCT05153772), AlphaMedix, an investigational somatostatin receptor (SSTR)-targeted alpha therapy using the lead-212 isotope, met its primary endpoint of objective response rate (ORR), as evaluated by Response Evaluation Criteria in Solid Tumours (RECIST).
Key secondary endpoints, including progression-free survival (PFS) and overall survival (OS), also saw benefit and maintained a manageable safety profile.
This was seen in both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients with unresectable or metastatic SSTR-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Chief medical officer at Orano Med, Dr Volker Wagner, said: "The positive results from the ALPHAMEDIX-02 study represent a pivotal movement for the Orano Med 212Pb-based platform and underscore the profound potential of lead-212-based radiopharmaceuticals in addressing critical unmet needs for patients with GEP-NETs.”
AlphaMedix was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of PRRT-naïve patients with unresectable or metastatic, progressive SSTR-expressing GEP-NETs in February 2024.
Dr Christopher Corsico, Global Head of Development at Sanofi, added: “These data, demonstrating clinically meaningful activity and a manageable safety profile, underscore our unrelenting commitment to developing innovative therapies for patients with difficult-to-treat cancers.”
Corisco added that Sanofi is looking to advance AlphaMedix in the clinic as part of its partnership with Orano Med.
The study is ongoing, with the data set to be presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
Sanofi gained global rights to commercialise AlphaMedix in September 2024. The French drugmaker paid €100m upfront to Oroano Med, with a further €220m outlaid in milestone payments.
A month later, Sanofi returned to Orano Med with a €300m investment. The deal saw the two companies create a new entity tasked with developing new radioligand therapies using lead-212 alpha-emitting isotopes.
Radiopharmaceutical landscape growing
The radiopharmaceutical space is growing, with Novartis at the helm with its two approved therapies, Pluvicto (lu-177 vipivotide tetraxetan) and Lutathera (lu-177 dotatate). GlobalData analysis shows that the drugs brought in $1.4bn and $724m in 2024, respectively.
Other major pharmaceutical companies in the space include Johnson & Johnson (J&J) with its prostate cancer radiotherapy JNJ-6420; however, there is concern over four patient deaths reported in the study.
ITM Radiopharma’s candidate ITM-11 met its primary endpoint, demonstrating a statistically significant benefit in PFS when compared to standard-of-care (SOC) Novartis’ Afinitor (everolimus) in GEP-NETs.
GlobalData analysis also shows that 2024 had the highest number of deals in the space in the past decade, with an average deals value or just over $290m. GlobalData is the parent company of Clinical Trials Arena.
