Data support pembrolizumab regimen as ‘new standard’ for advanced cervical cancer
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Key takeaways:
- Pembrolizumab plus chemoradiotherapy significantly improved OS for certain women with advanced cervical cancer.
- The FDA previously approved the regimen based on PFS data.
The combination of pembrolizumab and chemoradiotherapy significantly improved OS for women with high-risk locally advanced cervical cancer, according to results of a randomized phase 3 trial presented at ESMO Congress.
Pembrolizumab (Keytruda, Merck) plus chemoradiotherapy should be considered the “new standard of care for this population,” Domenica Lorusso, MD, PhD, director of the gynecologic oncology unit and professor of obstetrics and gynecology at Humanitas San Pio X in Italy, and colleagues wrote.
Background and methods
The FDA approved pembrolizumab plus chemoradiotherapy in January for treatment of women with stage III to stage IVA cervical cancer based on PFS results of the double-blind NGOT-cx11/ GOG-3047/KEYNOTEA18 study.
The study enrolled 1,060 women with cervical cancer — either stage IB2 to stage IIB with lymph node-positive disease, or stage III to IVA with or without lymph node-positive disease — who had not previously received definitive surgery, radiation or systemic therapy.
Researchers randomly assigned 529 women to receive 200 mg IV pembrolizumab every 3 weeks for five cycles concurrent with 40 mg/m2 IV cisplatin for five cycles with radiotherapy, followed by 400 mg IV pembrolizumab every 6 weeks for 15 cycles. The other 531 women received placebo instead of pembrolizumab.
PFS and OS served as dual primary endpoints.
OS Results
Previously released results showed a statistically significant improvement in PFS with pembrolizumab (HR = 0.59; 95% CI, 0.43-0.82).
At ESMO, Lorusso and colleagues presented OS results based on median follow-up of 29.9 months (range, 12.8-43).
Results showed a significantly higher 36-month OS rate with pembrolizumab than placebo (82.6% vs. 74.8%; HR = 0.67; 95% CI, 0.5-0.9).
Median OS had not been reached in either group.
The benefit appeared “generally consistent” across all prespecified subgroups, according to investigators. These included patients with International Federation of Gynecology and Obstetrics stage IB2 to stage IIB disease (HR = 0.89; 95% CI, 0.55-1.44), and those with stage III to stage IVA disease (HR = 0.57; 95% CI, 0.39-0.83).
The pembrolizumab regimen exhibited a “manageable” safety profile, Lorusso and colleagues wrote. A higher percentage of women assigned pembrolizumab developed grade 3 or higher treatment-related adverse events (69.1% vs. 61.3%).
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Lorusso D, et al. Abstract 709O. Presented at: European Society for Medical Oncology Congress; Sept. 13-17, 2024; Barcelona, Spain.
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