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

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.