Educational content on VJOncology is intended for healthcare professionals only. By visiting this website and accessing this information you confirm that you are a healthcare professional.

Share this video  

GU Cancers 2023 | KEYNOTE-057 Cohort B: pembrolizumab for BCG-unresponsive, high-risk NMIBC

Andrea Necchi, MD, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy, provides an overview of the Phase II KEYNOTE-057 trial (NCT02625961) and discusses results from Cohort B. The aim of the trial was to evaluate pembrolizumab for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG). The primary endpoint was a 12-month disease-free survival, which was met by 43% of patients in Cohort B. No new safety signals were identified and patient quality of life was reported to be good. This interview took place at the ASCO GU Cancers Symposium 2023 in San Francisco, CA.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

Transcript (edited for clarity)

The KEYNOTE-057 study Cohort B was a Phase II study of pembrolizumab monotherapy in patients with the BCG-unresponsive, high-risk non-muscle invasive disease, whose disease was characterized by a papillary tumor, pTa or T1, without CIS component.

The results from Cohort A of the same study, including a CIS component, resulted in a CR rate of 40% at 3 months and resulted in the approval by the US FDA of pembrolizumab as monotherapy in this patient population...

The KEYNOTE-057 study Cohort B was a Phase II study of pembrolizumab monotherapy in patients with the BCG-unresponsive, high-risk non-muscle invasive disease, whose disease was characterized by a papillary tumor, pTa or T1, without CIS component.

The results from Cohort A of the same study, including a CIS component, resulted in a CR rate of 40% at 3 months and resulted in the approval by the US FDA of pembrolizumab as monotherapy in this patient population.

We now focused on the Cohort B, so the patients without any carcinoma in situ component, which is a very, very unmet medical need perceived by the community, because for this patient, there is actually no standard of care established in the literature and established by the community. The study provided the same treatment paradigm of pembro monotherapy every 3 weeks for up to 2 years in case of no disease recurrence or progression.

The primary endpoint was a 12-month disease-free survival rate for high-risk disease recurrence, and provided a rate of 43% at 1 year, which was compelling. Also, when considering the fact that there were no new safety signals in this cohort, the safety data actually recapitulate that the data that had been already gathered in various disease settings with pembro monotherapy, including the Cohort A of the same study. Also, the quality of life parameters and the quality of life’s course revealed a stability or an improvement over time in patients who continued pembrolizumab without any recurrence.

So, overall, the study may justify a potential newer indication or expanded indication of pembrolizumab beyond the CIS component constraints.

Read more...