Sanofi’s Orano Med-partnered radioligand therapy AlphaMedix achieved all primary efficacy endpoints, which included a measure of overall response rate, in the mid-stage ALPHAMEDIX-02 study.
Watch out Novartis: another Big Pharma has finally entered the radiopharma ring. Sanofi and partner Orano Med’s targeted radioligand therapy achieved a “clinically meaningful” overall response against an advanced type of pancreatic tumor in a Phase II clinical trial.
While the companies did not detail specifics in their Wednesday release, the therapy, called AlphaMedix, achieved all primary efficacy endpoints, which included a measure of overall response rate (ORR), in the mid-stage ALPHAMEDIX-02 study. The trial was testing the somatostatin receptor (SSTR)-targeted alpha therapy in patients with difficult to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who had received prior treatment.
Benefits were also observed on key secondary endpoints including progression-free survival and overall survival. The therapy had a “manageable safety profile,” the companies said.
“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,” Volker Wagner, chief medical officer at Orano, said in a statement.
The study is continuing on. Sanofi pledged to reveal full results at the upcoming European Society for Medical Oncology (ESMO) Congress later this month. The ALPHAMEDIX-02 data will also “form the basis of discussions with health authorities,” although the companies did not provide details.
Sanofi and Orano’s results are a shot across the bow at Novartis’ radioligand enterprise, which comprises Lutathera for GEP-NETs and Pluvicto for prostate cancer. Long the leader in the modality, Novartis began to see competition encroaching in recent years as other pharmas made major plays.
But until now, the data have been slow to build a case for more entrants. Sanofi joined up with Orano in October 2024 in a $326 million equity deal to develop new alpha therapies using lead-212 alpha-emitting isotopes. But the star of the deal was AlphaMedix, a lead-212 targeted radioligand therapy that was under development for GEP-NETs.
Lutathera was approved for GEP-NETs in January 2018. At the time, the FDA noted that patients with these rare tumors had limited options after the cancer advances following initial treatment.
GEP-NETs occur in the pancreas and in other parts of the gastrointestinal tract from hormone-producing neuroendocrine cells. They can sometimes excrete hormones and cause issues or remain silent until the growth begins to cause problems. The tumors are typically removed by surgery, but radioligand therapies have become a key second-line treatment option since Lutathera’s approval.
Novartis reported net sales of $724 million for Lutathera in 2024, a 20% change over the previous year. Pluvicto, meanwhile has crossed into blockbuster status with $1.4 billion in sales.
Also in the radioligand game are Bristol Myers Squibb and Eli Lilly, which bought into the modality via the acquisitions of RayzeBio and Point Biopharma, respectively.
