Bladder cancer patients who have an early but aggressive form of the disease that’s unresponsive to the standard of care now have a new treatment option, an implanted Johnson & Johnson drug/device combination product that enables extended local delivery of its drug payload to the organ.
The J&J product, known in development as TAR-200, will be commercialized under the brand name Inlexzo.
Inlexzo was developed for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), which is cancer confined to the lining of the bladder. This cancer may or may not have papillary tumors, which are finger-like growths that form in the tissue lining the inside of the bladder. Standard treatment for this type of bladder cancer is Bacillus Calmette-Guérin (BCG), bacteria that prompt an immune response to the cancer. When bladder cancer does not respond to this type of immunotherapy, the next treatment option is surgical removal of the bladder. The Inlexzo approval announced after Tuesday’s market close covers the treatment of adults whose bladder cancer is unresponsive to BCG.
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Inlexzo administers gemcitabine, a chemotherapy. The product package includes a urinary catheter and slender probe for insertion of this delivery system into the bladder. J&J’s regulatory submission was based on a single-arm Phase 2b study that enrolled 83 patients. Study participants received the delivery system every three weeks for six months, then once every 12 weeks for up to 18 months. After each treatment period, Inlexzo was removed from the bladder.
Trial results showed the complete response rate to the therapy was 82%; 51% of patients had a duration of response of 12 months or longer. The most common adverse events included urinary frequency, urinary tract infection, and pain or discomfort while urinating. Inlexzo is not recommended for patients who have a perforated bladder.
Inlexzo traces its origins to Taris Biomedical, which J&J acquired in 2019 for an undisclosed sum. Since then, another immunotherapy has become available for patients with bladder cancer that’s unresponsive to BCG. Last year, the FDA approved ImmunityBio’s Anktiva, a fusion protein designed to enhance the activity of cancer-killing immune cells. Another therapy is in development from CG Oncology, which went public last year. The biotech is currently in Phase 3 testing with an oncolytic virus called cretostimogene. Last week, CG said it expects to submit a biologics license application to the FDA in the fourth quarter of this year.
Leerink Partners spoke with clinicians over the summer about emerging therapies for bladder cancer. Analyst David Risinger said in a July research note that these clinicians expressed support for both the J&J and CG therapies, but said the J&J treatment may have a logistical advantage. Dosing of the CG therapy requires pre-washes and a biosafety level 2 hood, a partially enclosed space that protects the clinician, the surrounding environment, and the materials inside the space.
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By contrast, the J&J therapy can be administered in a logistically less complex procedure. Cross-trial comparisons give CG’s therapy a slight safety edge, but the clinicians told Leerink that they do not believe these differences are enough to drive physician preference.
“Instead, factors like cost, profitability, and logistical ease will likely be the key drivers of uptake,” Risinger said in the note. “Given its convenience, TAR-200 may hold an edge in community settings. Additionally, TAR-200 is the only therapy being evaluated in a head-to-head trial against BCG.”
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