ImmunityBio secured exclusive U.S. rights to develop and commercialize Tokyo-172 BCG for bladder cancer following Phase III SWOG S1602 results showing non-inferiority versus TICE BCG in BCG-naïve high-grade NMIBC.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
ImmunityBio announced an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory to develop, import, and commercialize intravesical Tokyo-172 BCG in the United States for bladder cancer treatment.
The agreement follows positive Phase III results from the SWOG S1602 study, sponsored by the National Cancer Institute (NCI), which demonstrated non-inferiority of Tokyo-172 BCG versus TICE BCG in patients with BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC). Tokyo-172 BCG remains investigational in the United States and is not FDA approved.
SWOG S1602 (NCT03091660) enrolled 1,000 patients, including 984 eligible participants, randomized to receive intravesical TICE BCG, Tokyo-172 BCG, or intradermal priming followed by Tokyo-172 BCG. The study evaluated high-grade recurrence-free survival (HGRFS) with a pre-specified non-inferiority margin of hazard ratio (HR) 1.34.
At a median follow-up of 4.6 years, Tokyo-172 BCG met the primary endpoint of non-inferiority in high-grade recurrence-free survival versus TICE BCG (HR 0.82; 95.8% CI, 0.63–1.08). Secondary endpoints included complete response rates in carcinoma in situ at six months (66.4% vs. 70.2%) and progression-free survival, which was similar across groups. Estimated five-year HGRFS rates favored Tokyo-172 BCG (64% vs. 58%).
ImmunityBio said it plans to engage with the FDA on a potential U.S. approval pathway and would serve as the sole Biologics License Application (BLA) applicant and future Marketing Authorization Holder if approved. The company is also discussing a Data Use Agreement with the SWOG Cancer Research Network, the NCI, and Fred Hutchinson Cancer Research Center to support a planned BLA submission.
Japan BCG Laboratory President Seiichi Inoue said the partnership aims to bring the Tokyo strain of BCG to U.S. patients while supporting ImmunityBio’s FDA engagement.
Patrick Soon-Shiong, Founder and Chief Scientific and Medical Officer of ImmunityBio, said the SWOG S1602 findings support expanding treatment access and strengthening BCG supply options in the United States.
ImmunityBio added that its ongoing partnership with the Serum Institute of India will continue supporting access to investigational recombinant BCG through the FDA Expanded Access Program.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting