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ASCO conference: Progenics' radiation therapy benefits patients with rare tumors

Progenics Pharmaceutical Inc. said its radiation therapy Azedra to treat patients with rare tumors achieved positive results in a mid-stage study.

The phase 2 trial involved patients with aggressive, recurrent and surgically irremovable forms of pheochromocytoma and paraganglioma — tumors that can be benign or malignant and form in the hormone-producing adrenal glands and along nerve pathways in the head, neck and spine.

The study showed Azedra helped patients reduce intake of antihypertensive medication — a class of drugs that are used to treat hypertension — by 50% or more for at least six months.

In addition, the study showed favorable results for its secondary goal, which was to assess the percentage of patients whose tumors shrank by a predefined amount and for a minimum amount of time. The results showed that 92.2% of patients taking Azedra saw their tumors shrink by a predefined amount within 12 months.

The average length of time patients lived after starting the treatment was 37 months — 44 months for those taking two doses and 18 months for one dose.

Results from the study also showed potential for Azedra to extend the lives of patients with liver or lung metastasis, a condition where the cancer has spread to other parts of the body.

The phase 2 study was conducted under a special protocol assessment with the U.S. Food and Drug Administration.

The company filed a new drug application in November 2017 for Azedra, or iobenguane I 131. The FDA granted the drug priority review and has set an action date of July 30 under the Prescription Drug User Fee Act.

"We are eagerly anticipating the FDA's decision on Azedra, as we believe it has the potential to be a breakthrough treatment option for patients with these deadly, ultra-rare neuroendocrine cancers," Progenics Pharmaceutical CEO Mark Baker said.

There are no approved therapies in the U.S. for pheochromocytoma and paraganglioma patients.

New York-based Progenics Pharmaceuticals is a biotechnology company, which develops medicines and other technologies to target and treat cancer.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on site and an additional 3,350 abstracts to be published online.