Johnson & Johnson's TAR-200 vs. ImmunityBio's Anktiva: The Battle for Dominance in Bladder Cancer Treatment.

The race to revolutionize the treatment of non-muscle invasive bladder cancer (NMIBC) has become more competitive with major players such as Johnson & Johnson (J&J) and ImmunityBio vying for dominance in a space traditionally dominated by Bacillus Calmette-Guérin (BCG) therapy. At the center of this heated competition is J&J’s TAR-200, a new intravesical chemotherapy system currently under FDA review, and ImmunityBio’s Anktiva, a cutting-edge immunotherapy already making waves in the field.

As J&J positions its TAR-200 as a game-changer for treating high-risk NMIBC, it directly competes with ImmunityBio’s Anktiva, which has garnered attention for its remarkable long-term results. With both companies presenting their latest findings at the American Urological Association’s 2025 meeting, the upcoming months will be critical as these two heavyweights go head-to-head in both efficacy and market potential.

J&J’s Bold Strategy:

J&J’s TAR-200, which delivers chemotherapy directly to the bladder, has shown encouraging results in clinical trials. In the SunRISe-1 Phase 2b trial, as of March 2025, TAR-200 achieved a complete response (CR) in 82.4% of patients with BCG-unresponsive high-risk NMIBC with carcinoma in situ (CIS). The results demonstrate a promising remission rate, with 52.9% of patients still in remission at one year. Among those who completed two years of treatment, 82% maintained a response, and the median duration of response was 25.8 months. These statistics position TAR-200 as one of the most effective treatments currently available in this field.

TAR-200’s design offers patients and physicians a significant advantage in terms of convenience. The device is inserted into the bladder via a quick cystoscopy procedure, a standard practice among urologists, requiring only one to two minutes. This ease of use makes it a preferred option for physicians, particularly compared to therapies that demand long hours of in-clinic observation and monitoring.

Given these results, J&J is optimistic about the long-term market potential of TAR-200. “In all the research that we have done, I have absolutely no reason to believe that they will use anything else but us once they fail BCG,” said Bilijana Naumovic, president of J&J’s U.S. solid tumor business. However, she acknowledges that the drug won’t immediately capture the entire market share.

ImmunityBio's Counterattack: Focusing on Durability:

While J&J highlights TAR-200's high CR rates, ImmunityBio counters by emphasizing the durability of Anktiva's responses. Anktiva, an IL-15 receptor agonist used in combination with BCG, has shown a remarkable median duration of response, with 51% of patients remaining tumor-free for 45 months. Furthermore, in a broader group of 100 patients with BCG-unresponsive NMIBC CIS, 84% of responders avoided bladder removal after three years.

ImmunityBio's executive chairman, Patrick Soon-Shiong, underscores the importance of long-term efficacy in treating bladder cancer. “There’s nobody who has a median of over 45 months for complete response like Anktiva does,” he stated, highlighting the competitive edge of Anktiva’s extended response duration.

In addition to its impressive durability, Anktiva boasts a favorable safety profile. In the QUILT-3.032 trial, treatment-related adverse events of grade 3 or higher occurred in only 3% of patients, with no grade 4 or 5 events. This contrasts with TAR-200, where about 13% of patients experienced severe adverse events.

Soon-Shiong also argues that Anktiva’s mechanism of action, which preserves the activation of key immune cells like NK and CD8+ T cells while avoiding the upregulation of immune-suppressive Treg cells, is a crucial factor in its extended efficacy. This immunological approach is central to ImmunityBio’s strategy to prove that immunotherapy can outperform traditional chemotherapy in terms of both response rates and long-term outcomes.

The Road Ahead for Both Companies:

While both J&J and ImmunityBio are focused on BCG-unresponsive NMIBC, both companies are also eyeing broader indications. J&J is running Phase 3 trials to explore TAR-200’s efficacy in BCG-naïve patients and to test it in combination with its PD-1 inhibitor cetrelimab. Meanwhile, ImmunityBio has submitted an FDA application for Anktiva plus BCG in the NMIBC papillary disease population, expanding its reach in a market that represents about 90% of NMIBC cases.

The battle for the future of bladder cancer treatment is far from over, with both companies positioning their therapies to address unmet needs. J&J is banking on the convenience and effectiveness of TAR-200, while ImmunityBio is betting on the durability and safety profile of Anktiva. As both therapies continue to progress through clinical trials, the field of NMIBC treatment is set to undergo significant transformation, offering new hope for patients with this challenging disease.

As the stakes continue to rise, only time will tell whether J&J’s innovative device or ImmunityBio’s immunotherapy will ultimately secure their place as the new standard of care in bladder cancer.

Source:https://www.fiercepharma.com/pharma/jj-aims-fundamentally-change-how-bladder-cancer-type-treated-immunitybio-plays-defense

This is non-financial/medical advice and made using AI so could be wrong.