Commentary

Video

Dr Necchi on Responses With TAR-200 According to PD-L1 Status in NMIBC

Andrea Necchi, MD, discusses treatment with TAR-200 by PD-L1 expression in BCG-unresponsive, high-risk non–muscle-invasive bladder cancer with CIS.

Andrea Necchi, MD, associate professor, oncology, Vita-Salute San Raffaele University, director, Genitourinary Medical Oncology, IRCCS San Raffaele Hospital and Scientific Institute, discusses treatment with TAR-200 by PD-L1 expression in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), as seen in an updated dataset from the phase 2 SunRISe-1 trial (NCT04640623).

Data presented at the 2024 ESMO Congress provides further insights into the efficacy of TAR-200 monotherapy and its use in combination regimens for patients with NMIBC. At the data cutoff on January 2, 2024, 85 patients had received TAR-200 monotherapy. Among the 58 efficacy-evaluable patients, the complete response (CR) rate was 83% (95% CI, 71%-91%). Notably, among 31 patients with available PD-L1 scores, CR rates of 91% were observed in patients with a combined positive score (CPS) of at least 10, and 85% in those with CPS less than 10. Overall, high clinical responses to TAR-200 monotherapy were observed in patients with NMIBC regardless of PD-L1 status.

Previously reported results had already demonstrated the clinically meaningful efficacy and favorable benefit-risk profile of TAR-200 monotherapy in this population, and the updated data both confirm and improve upon these findings, Necchi asserts. These results suggest that TAR-200, which is delivered through an intravesical system, may minimize the risk of toxicities associated with checkpoint inhibitors and improve a patient's chance of being cured, he explains.

In December 2023, the FDA granted breakthrough therapydesignation to TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk NMIBC who are not candidates for or choose not to undergo radical cystectomy. This decision was supported by findings from the SunRISe-1 study. Accordingly, updated safety data and confirmed activity presented at the 2024 ESMO Congress reinforce the FDA's decision, highlighting TAR-200's potential as a viable alternative to more invasive treatment options for this patient population, Necchi concludes.

Disclosures: Dr Necchi reports receiving institutional grants/research funding from AstraZeneca, Bristol Myers Squibb, Gilead, Ipsen, and Merck; reciving consulting/advisory fees from Astellas, AstraZeneca, Bristol Myers Squibb, Catalym, Gilead, Johnson & Johnson, Samsung Bioepis, Bicycle Therapeutics, and Merck; serving in a leadership role for the Global Society of Rare Genitourinary Tumors; and serving as an Associate Editor for the Journal of Clinical Oncology.

Related Videos
Andrea Wolf, MD, MPH
Suzanne Lentzsch, MD, PhD
Jacob Sands, MD
Martin H. Voss, MD
Amitkumar Mehta, MD
Sunil Adige, MD
Nitin Jain, MD
Kimmie Ng, MD, MPH
Marina Chiara Garassino, MD
Elias Jabbour, MD, professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center