J&J and ImmunityBio Compete in Bladder Cancer Treatment Arena

Johnson & Johnson (J&J) and ImmunityBio are vying for dominance in the treatment of non-muscle-invasive bladder cancer (NMIBC), with both companies presenting updated data at the American Urological Association's 2025 annual meeting in Las Vegas. The competition centers on J&J's TAR-200 and ImmunityBio's Anktiva, each offering unique approaches to treating this challenging disease.

J&J's TAR-200 Shows Promise in Phase 2b Trial

J&J's TAR-200, an intravesical system designed to deliver gemcitabine directly into the bladder, has demonstrated impressive results in the phase 2b SunRISe-1 trial. Updated data from cohort 2 revealed a complete response (CR) rate of 82.4% among 85 patients with BCG-unresponsive high-risk NMIBC carcinoma in situ (CIS). This CR rate surpasses those of currently available therapies, including ImmunityBio's Anktiva (62%), Merck & Co.'s Keytruda (41%), and Ferring Pharmaceuticals' Adstiladrin (51%).

Mark Wildgust, VP of oncology global medical affairs for J&J Innovative Medicine, highlighted the significance of these results, stating, "TAR-200's CR rate is the highest recorded among currently available therapies."

The durability of response for TAR-200 is also noteworthy, with 52.9% of responders still in remission at one year and 86.6% avoiding bladder removal. Among 11 patients who completed two years of treatment, nine remained in response, with a median duration of response of 25.8 months.

ImmunityBio Touts Anktiva's Durability of Response

While J&J leads in CR rates, ImmunityBio is emphasizing Anktiva's superior duration of response. In an update from the QUILT-3.032 trial, 51% of complete responders to the Anktiva-BCG regimen remained tumor-free at 45 months, with a median duration of complete response of 45.4 months.

Patrick Soon-Shiong, executive chairman and chief scientific and medical officer of ImmunityBio, stated, "There's nobody [who] has a median of [complete response] of over 45 months like Anktiva does."

ImmunityBio also highlighted Anktiva's favorable tolerability profile, with only 3% of patients experiencing grade 3 treatment-related adverse events and no grade 4 or 5 events reported in a combined cohort of 180 patients.

Expanding Indications and Future Prospects

Both companies are seeking to expand their drugs' indications beyond BCG-unresponsive NMIBC CIS. ImmunityBio has submitted an FDA application for Anktiva plus BCG in papillary disease, based on data from the QUILT-3.032 trial. The company reported that 81.8% of patients with papillary disease avoided bladder removal after three years.

J&J is taking a more cautious approach, planning a randomized phase 3 trial (SunRISe-5) to test TAR-200 against chemotherapy in the papillary population. The company is also conducting the phase 3 SunRISe-3 trial, comparing TAR-200 alone or in combination with cetrelimab against BCG in BCG-naïve NMIBC patients.

As the bladder cancer treatment landscape evolves, the competition between J&J's TAR-200 and ImmunityBio's Anktiva promises to drive innovation and potentially improve outcomes for patients with this challenging disease.