FDA grants Keytruda limited approval in newly-diagnosed cervical cancer

2024-01-15

临床结果临床3期上市批准免疫疗法

Merck & Co. announced that the FDA broadened the cervical cancer label for its PD-1-targeting immunotherapy Keytruda (pembrolizumab), but stopped short of including the overall population represented in a pivotal Phase III study. This new indication – the third for Keytruda in cervical cancer – is for use in combination with chemoradiotherapy (CRT) as treatment for newly-diagnosed patients with FIGO 2014 Stage III-IVA disease.

The decision was based on results from the KEYNOTE-A18 trial, which enrolled 1060 patients with high-risk, locally advanced cervical cancer who had not previously received any definitive surgery, radiation or systemic therapy for their disease. Subjects were roughly split between those with FIGO 2014 Stage III-IVA cervical cancer with either node-positive or node-negative disease, and those with FIGO 2014 Stage IB2-IIB cervical cancer with node-positive disease.

PFS benefit driven by later-stage cohort

Results demonstrated a significant improvement in progression-free survival (PFS) in the overall study population, although an exploratory analysis among the earlier-stage cohort suggested most of that benefit was derived from the 56% of trial participants who had Stage III-IVA disease. In this later-stage cohort, there was a PFS benefit of 41% with Keytruda versus placebo plus CRT, whereas the benefit was only 9% for the earlier-stage group. Merck noted that overall survival data were not mature at the time of the PFS analysis.

"Keytruda plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the US for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression," noted Gursel Aktan, vice president of global clinical development at Merck Research Laboratories.

The drug was already approved in two other cervical cancer indications in the US. These included Keytruda plus chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥1). It is also approved as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumours express PD-L1 (CPS ≥1).

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