Sanofi Challenges Novartis in Radioligand Therapy with Promising Pancreatic Tumor Data

Sanofi and partner Orano Med have made a significant stride in the field of radioligand therapy, potentially positioning themselves as formidable competitors to Novartis, the current leader in this therapeutic modality. The companies recently announced positive results from their Phase II ALPHAMEDIX-02 study, evaluating the targeted radioligand therapy AlphaMedix in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

AlphaMedix Achieves Primary Endpoints in Phase II Trial

The mid-stage ALPHAMEDIX-02 study met all primary efficacy endpoints, including overall response rate (ORR), in patients with GEP-NETs who had received prior treatment. While specific data points were not disclosed, Sanofi and Orano Med described the results as "clinically meaningful." The companies also reported benefits in key secondary endpoints such as progression-free survival and overall survival.

Volker Wagner, Chief Medical Officer at Orano, expressed optimism about the therapy's potential, stating, "These data reinforce our belief that delivering highly potent alpha-emitters directly to cancer cells could potentially offer a meaningful new treatment option for people living with GEP-NETs."

The safety profile of AlphaMedix was described as "manageable," though detailed safety data were not provided in the initial announcement. Full results from the ALPHAMEDIX-02 study are expected to be presented at the upcoming European Society for Medical Oncology (ESMO) Congress.

Implications for the Radioligand Therapy Landscape

Sanofi's entry into the radioligand therapy space represents a significant challenge to Novartis, which has dominated the field with its approved therapies Lutathera for GEP-NETs and Pluvicto for prostate cancer. Novartis reported impressive sales figures for both drugs in 2024, with Lutathera generating $724 million (a 20% year-over-year increase) and Pluvicto achieving blockbuster status with $1.4 billion in sales.

The partnership between Sanofi and Orano Med, established in October 2024 through a $326 million equity deal, focuses on developing new alpha therapies using lead-212 alpha-emitting isotopes. AlphaMedix, the lead candidate from this collaboration, is a lead-212 targeted radioligand therapy specifically designed for GEP-NETs.

As the radioligand therapy market continues to expand, other major pharmaceutical companies have also made strategic moves to enter the space. Bristol Myers Squibb acquired RayzeBio, while Eli Lilly purchased Point Biopharma, both aiming to establish a foothold in this promising therapeutic area.

The positive results from the ALPHAMEDIX-02 study may lead to discussions with health authorities, potentially paving the way for future regulatory submissions. However, Sanofi and Orano Med have not yet provided specific details on their regulatory strategy or timeline.