Ronnie Shapira-Frommer, MD, on the Rationale for the KEYNOTE-158 Trial in Patients With Vulvar Squamous Cell Carcinoma

CancerNetwork® sat down with Ronnie Shapira-Frommer, MD, to discuss the rationale for the phase 2 KEYNOTE-158 trial (NCT02628067), which examined pembrolizumab (Keytruda) monotherapy in patients with advanced solid tumors.

At the Society of Gynecological Oncology (SGO) 2021 Virtual Annual Meeting on Women’s Cancer, Shapira-Frommer presented data on a cohort of patients with vulvar cancer treated on the trial. Results showed that patients with previously treated vulvar squamous cell carcinoma who received single-agent pembrolizumab experienced durable responses across PD-L1 expression levels.

Transcription:

The KEYNOTE-158 study was a multicohort, phase 2 study in [multiple tumor types], and vulvar cancer is one of them. Endometrial cancer, cervical cancer, mesothelioma, and other cohorts were included in the study. Vulvar cancer is a rare cancer, it’s very difficult to enroll patients. Usually, they are elderly patients with multiple diseases [aside from cancer]. It’s also quite hard to evaluate disease since it’s pelvic disease [with] local spreading of disease.

Vulvar cancer was one of the cohorts of the study, and it’s also important to know that vulvar cancer, in most cases, is related to HPV [human papillomavirus] infection. As we know in cervical cancer, the role of pembrolizumab was proven in another cohort of the KEYNOTE-158 study, and it was this study led to the approval by the FDA for this cohort of patients with cervical cancer [that is] PD-L1 positive. Therefore, vulvar cancer was included as well.

References

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.