3/2/2024 0 Comments Keynote 158 trialTwo phase 3 clinical trials ascertained the role of PD-L1 status in cervical cancer: KEYNOTE-826 (NCT03635567) and EMPOWER-Cervical1/GOG-3016/ENGOT-cx9 (NCT03257267). Both investigators agreed that PD-L1 expression is an imperfect biomarker, but this was where their arguments diverged. Oaknin noted that both combined positive score and tumor proportion score are used in clinical trials to measure PD-L1 expression. Oaknin, who is also principal clinical investigator of the Gynecological Malignancies Group at Vall d’Hebron Institute of Oncology in Barcelona, also emphasized these challenges, pointing out that PD-L1 expression has spatial and temporal heterogeneity and can be altered with exposure to prior therapies. 4 Despite the regulatory approval, challenges continue with its use, including variability in preanalytical conditions, the use of different antibodies and staining platforms, and the lack of an unequivocal scoring system. Seeking to clarify the discussion further, Colombo emphasized that the better question is whether PD-L1 is the right biomarker to predict response to immunotherapy in cervical cancer, considering that both the FDA and European Medicines Agency recommended choosing patient candidates for immunotherapy based on companion testing for PD-L1 expression. For example, PD-L1 is less common in adenocarcinomas, whereas TMB is more common, and MSI is more common in adenosarcomas. Although overlap exists between these 3 biomarkers regarding their presence in cervical cancer histology, there are potential gaps. ![]() 1īoth investigators agreed that the crux of the matter revolves around having a reliable, specific, and sensitive biomarker to predict benefit from immunotherapy in cervical cancer.Ĭolombo, who argued for the use of immunotherapy, noted that there are currently 3 potential biomarkers undergoing evaluation in cervical cancer-PD-L1 expression, tumor mutational burden (TMB), and microsatellite instability (MSI). ![]() Nicoletta Colombo, MD, PhD, director of gynecologic cancer medical treatments at the European Institute of Oncology and an associate professor of obstetrics and gynecology at the University of Milano-Biococca in Milan, Italy, and Ana Oaknin, MD, PhD, head of the Gynecological Tumor Unit and leader of the Gynaecological Cancer Program at the Institute of Oncology in Barcelona, Spain, provided a lively discussion on whether all patients with cervical cancer, regardless of biomarker status, should receive immunotherapy, during the European Society for Medical Oncology (ESMO) Gynaecological Cancers Congress 2022. Like other cancers, the use of immunotherapy in the treatment of locally advanced, recurrent, or metastatic cervical cancer has emerged over the past few years to include the frontline setting however, there remains an unmet need for biomarkers to identify patients who may or may not respond.
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