Ronnie Shapira-Frommer, MD, on Characteristics of Responders With Vulvar Squamous Cell Carcinoma Treated on the KEYNOTE-158 Trial

CancerNetwork® spoke with Ronnie Shapira-Frommer, MD, during the Society of Gynecological Oncology 2021 Virtual Annual Meeting on Women’s Cancer about patients with vulvar cancer who were responders to pembrolizumab monotherapy.

CancerNetwork® sat down with Ronnie Shapira-Frommer, MD, to discuss characteristics of responders to pembrolizumab monotherapy in previously treated vulvar squamous cell carcinoma on the phase 2 KEYNOTE-158 trial (NCT02628067).

In a presentation at the Society of Gynecological Oncology (SGO) 2021 Virtual Annual Meeting on Women’s Cancer, Shapira-Frommer presented data showing objective responses were achievable in this patient subgroup with the PD-1 inhibitor.


As we look at the baseline characteristics of the patients, the majority of [them had a performance status of] 1. They had asymptomatic disease and the majority of them had M1 disease, so metastatic or pelvic lymph node disease. Most of them received at least 1 prior treatment line. Therefore, we can say we saw responses in this cohort of patients who are heavily [pretreated] or who had lack of evidence-based standard of care.

Maybe the only differentiating characteristics was high tumor mutational burden. Patients with high tumor mutational burden had a better chance of response than patients with very low tumor mutational burden, [which] was evaluated by the FoundationOne [CDx] test, with over 10 mutations per megabase being the threshold for high tumor mutational burden.


Frommer RS, Mileshkin L, Manzyuk L, et al. Pembrolizumab for Vulvar Squamous Cell Carcinoma: Results From the Phase 2 KEYNOTE-158 Study. Abstract presented at: Society of Gynecological Oncology 2021 Virtual Annual Meeting on Women’s Cancer; March 19-21, 2021; Virtual. Abstract 11603.

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