The KEYNOTE-A18 study

Dr Laure-Anne Teuwen, medical oncologist at the University hospital of Antwerp, underscores the significance of the KEYNOTE-A18 study, which assesses the efficacy and safety of pembrolizumab in combination with concurrent chemoradiotherapy for patients with newly diagnosed, locally advanced cervical cancer. Eligibility for the study was irrespective of PD-L1 status. Patients were randomly assigned in a one-to-one ratio to receive either pembrolizumab with concurrent chemoradiotherapy or placebo along with concurrent chemoradiotherapy.

An initial protocol-specified interim analysis was conducted in January 2023, when a median follow-up duration of 17.9 months was attained. At this juncture, the combination of pembrolizumab with concurrent chemoradiotherapy demonstrated a statistically significant enhancement in PFS compared to placebo plus concurrent chemoradiotherapy, with a hazard ratio of 0.70. However, OS outcomes were still pending maturity at this initial interim analysis. The safety profile observed was in line with the established profiles of the individual treatment components, and no novel safety concerns emerged within this cohort. Furthermore, there were no discernible disparities in QoL as assessed by the EORTC QLQ C30 scale.

Based on the favourable PFS results, the FDA approved pembrolizumab in patients with newly diagnosed stage 3-4A cervical cancer in January of this year.

Recently, a press release announced that pembrolizumab, when combined with concurrent chemoradiotherapy, exhibited a statistically significant enhancement in OS compared to concurrent chemoradiotherapy alone. The official results have not yet been released, so it’s too early to draw conclusions. Nonetheless, once the OS results are disclosed, this trial has the potential to significantly influence clinical practice.