Adstiladrin Phase IIIb Results in Japan
Ferring announced results from an ongoing Phase IIIb trial of Adstiladrin (nadofaragene firadenovec) in BCG (Bacillus Calmette-Guérin)-unresponsive CIS (carcinoma in situ) ± high-grade Ta/T1 patients (n=20) in Japan. At 3 months, 75% (15/20) of patients achieved a complete response. Overall, 80% of participants experienced a drug–related AE, all of which were either Grade 1 (84.2%) or Grade 2 (15.8%).
The pivotal Phase III results for Alstiladrin from SUO-CTC, the independent real-world results from Mayo Clinic, and our interim Japanese Phase IIIb results, all continue to build a consistent body of evidence for efficacy, safety and tolerability of Adstiladrin . To date, there have been no severe AEs (Grade 4 or 5) reported in clinical trials.
With Adstiladrin, Ferring is redefining the future of NMIBC (non-muscle invasive bladder cancer ). Patients who do not respond to BCG now have another option – a well-tolerated, effective, convenient (dosed once every 3 months), localized treatment that provides durable bladder preservation with rare risk of muscle-invasive disease progression.
Ferring has a steadfast dedication to science and an unwavering commitment to the bladder cancer community. Therefore, our work has not stopped with the approval and launch of Adstiladrin. We continue to explore the full potential of Adstiladrin in bladder cancer with several ongoing clinical trials. We are hopeful that these additional studies will further build on the growing body of evidence that, we believe, would continue to support the emerging role of Adstiladrin as the new standard of care and the backbone therapy for NMIBC patients.
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