Ferring Pharmaceuticals Initiates Three New Clinical Trials in Bladder Cancer

Privately-held specialty pharmaceutical group, Ferring Pharmaceuticals, has initiated three new US-based clinical trials evaluating ADSTILADRIN in patients with non-muscle invasive bladder cancer (NMIBC), and plans to expand select clinical trials outside of the US later in 2024.

ADSTILADRIN was approved by the FDA in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS).

Bipin Dalmia, Senior Vice President, Global Head, Uro-Oncology Franchise, Ferring Pharmaceuticals, commented, “Embarking on a broad research and geographic expansion program is yet another demonstration of our commitment to the uro-oncology community, together with our significant manufacturing investments that recently enabled full availability of ADSTILADRIN to every appropriate U.S. patient who needs it.”

NMIBC is a form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body. More than 50% of patients with high-risk NMIBC who receive initial treatment with intravesical BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.

Ferring’s clinical trials

ABLE-22 is a Phase 2, randomized, multi-center, open label clinical study to evaluate the safety and efficacy of ADSTILADRIN alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in adult patients with high-grade BCG-unresponsive NMIBC.

ABLE-32 is a Phase 3b randomized, controlled clinical study to evaluate the safety and efficacy of ADSTILADRIN versus observation in patients with intermediate-risk NMIBC.

ABLE-42 is a Phase 4, multi-center, open-label clinical study to evaluate the efficacy of retreatment with ADSTILADRIN in previously-treated patients with high-grade BCG-unresponsive NMIBC with CIS with or without papillary tumors who had not responded to the product at the first three-month assessment.

“ADSTILADRIN is an established monotherapy treatment option for patients with BCG-unresponsive NMIBC disease, an area where patients’ treatment options have been severely limited for decades,” said Pierre-Yves Berclaz, M.D., Ph.D., Executive Vice President and Chief Science and Medical Officer, Ferring Pharmaceuticals. “These new trials underscore Ferring’s commitment to create solutions for patients by enlarging the body of evidence for this novel nonreplicating gene therapy.”

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.

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Ferring Pharmaceuticals Initiates Three New Clinical Trials in Bladder Cancer

Catie Corcoran

Biotech Editor