Dr. Necchi on findings from SunRISe-1 study of TAR-200 for high-risk NMIBC

In this video, Andrea Necchi, MD, shares findings from the SunRISe-1 trial (NCT04640623) of TAR-200 in patients with high-risk NMIBC, which he presented at the 2023 Euopean Society for Medical Onology (ESMO) Annual Congress in Madrid, Spain. Necchi is an associate professor of oncology at the Vita-Salute San Raffaele University and the director of GU medical oncology at San Raffaele Hospital in Milan, Italy.

Video Transcript:

This data that have been disclosed at the ESMO meeting this year are related to this portion of TAR-200 monotherapy cohort, so cohort 2 this time, with the TAR-200 monotherapy. TAR-200 was cycled every 3 weeks for the first 24 weeks, and then every 12 weeks until week 96. The primary end point of the study is the complete response. Again, there is an important thing to highlight related to the definition of complete response in this study, which is quite stringent and quite rigorous. It allows the centralized assessment of the urine cytology and biopsies and cystoscopy at 2 different time points, at 24 weeks and 48 weeks. So, a centralized assessment of a tumor and urine at 2 different time points to define complete response. This is something that is quite more stringent as compared to other studies, so the definition of CR from other studies.

The data reported here at the meeting are related to the first 54 patients that have been included in the ITT analysis. Out of them, 30 patients were available for the efficacy [analysis]. So, we reported the safety data on the 54 patients, and the efficacy data on the first 30 evaluable patients. The general population is quite consistent with other studies. Most of the patient presented with CIS alone as just a minority with CIS and papillary disease. The median time from last BCG therapy installation to CIS relapse on persistent disease was just 3 months. So, a quite high-risk patient population.

In terms of our results in terms of primary end point, CR rate was centrally reported to be 76.7%. So, quite high rate. In particular, it was quite consistent with the locally evaluated CR rate, which was 80% in 24 patients out of the first 30 patients. There were quite consistent numbers and a quite high proportion in the special populations compared to similar other studies. The duration of complete response was also considered quite intriguing. There was a median follow-up time of 12 months, so pretty decent follow-up. And 11 patients had a duration of response of at least 6 months, and 6 patients were continuous responders at least 12 months of follow-up. All of these responses are ongoing. The projected Kaplan Meier curves of duration of complete response at 1 year are just over 80% at 84%. So, potentially quite higher as compared to the data reported with systemic immune therapy. The safety profile was quite consistent with previous studies with TAR-200. Very few grade 3/4 treatment-related adverse events, 7% of the cases. Quite a few patients had interrupted treatment due to side effects, less than 4%. There were no cases with treatment-related deaths, and none of the complete responders underwent radical cystectomy thus far. Overall, the risk to benefit ratio is quite in favor of using TAR-210 monotherapy in this patient population. TAR-210 is set to become a potentially new option for this patient population after failure of BCG treatment.

This transcription has been edited for clarity.