Bradley J. Monk, MD, FACS, FACOG, discusses the phase 3 KEYNOTE-A18 study of pembrolizumab with chemoradiotherapy for the treatment of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.
Bradley J. Monk, MD, FACS, FACOG, a professor in the Division of Gynecologic Oncology at the University of Arizona College of Medicine in Tucson and the medical director of the US Oncology Research Network–Gynecologic Program, discusses the phase 3 KEYNOTE-A18 study (NCT04221945) of pembrolizumab (Keytruda) added to external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy for the treatment of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.
With a median follow-up 17.9 months (range, 0.9-31.0), the median progression-free survival (PFS) was not yet reached (NR) among patients treated with pembrolizumab plus chemoradiotherapy (n = 528) or patients given placebo plus chemoradiotherapy (n = 530; HR, 0.70; 95% CI, 0.55-0.89; P = .0020). At 24 months, the PFS rates in these arms were 67.8% (95% CI, 61.8%-73.0%) vs 57.3% (95% CI, 51.2%-62.9%), respectively.
According to Monk, the OS data not yet mature refer to less than 43% of the information fraction. These data come from the first interim analysis of the trial which were recently presented during the 2023 ESMO Congress.
0:10 | First of all, there was a reduction of progression-free survival and death. Overall survival was immature, but there was an important trend in the right direction. And I would like to venture and say that there's no detriment, but with 43% of the informational fraction, meaning 43% of the patients that you need for maturity, not 43% of the patients that have died, but 43% of the patients that you need for maturity, there's a 27% hazard ratio reduction 0.73 in overall survival. So we'll continue to watch this.
0:45 | The P value or the alpha and the PFS now is carried forward of overall survival. This was the final PFS result at this interim analysis as [presented] at ESMO 2023 in Madrid, Spain.