A study coordinated by Italy may change, for the first time in 25 years, the treatment for high-risk, locally advanced cervical cancer. A new analysis of the Keynote-A18 study – led by Sunday Lorussoprofessor of Obstetrics and Gynecology at Humanitas University – has in fact demonstrated that the combination of immunotherapy and chemo-radiotherapy increases overall survival in a statistically significant and clinically relevant way compared to chemo-radiotherapy alone.
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Immunotherapy for cervical cancer
Already in 2023, the Keynote-A18 study had demonstrated that the addition of the immunotherapy pembrolizumab increases the time to progression: the data were presented at the 2023 Congress of the European Society for Medical Oncology (ESMO) and supported approval in Use the combination, received last January, for those with stage III-IVA disease at diagnosis.
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The new analysis discussed today was conducted by an independent Data Monitoring Committee: the results will be presented soon during a scientific conference and will be shared with regulatory authorities worldwide. “These results are important for both patients and the medical community and reinforce previous data from the Keynote-A18 study, now showing that this regimen also prolongs the lives of patients with high-risk locally advanced cervical cancer, which is one of the most symptomatic and painful neoplasms that can affect a woman – explains Lorusso – For the first time after 25 years, we are able to change the standard of care.
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Cervical cancer
The tumor originates from the cells that line the lower part of the uterus. All women are at risk and the diagnosis is most common between the ages of 35 and 44. Every year, in Italy, there are an estimated 2,500 new diagnoses, and the cause is almost always HPV, the human papillomavirus, the most frequent sexually transmitted infection. Against which, however, we have various prevention tools available: vaccination and screening. Now, after a long time, the possibilities of cure are also increasing: “Chemo-radiotherapy is the current standard and in itself is curative in 60% of patients – continues Lorusso – and on this basis, already very high, adding pembrolizumab will it helps heal a greater proportion of patients.”
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Pembrolizumab
Pembrolizumab is an anti-PD-1 immunotherapy drug already used in many tumors, and is currently approved for two other indications in cervical cancer: both in the USA and in the EU (by the European Medicines Agency – EMA) for the treatment of patients with persistent, recurrent or metastatic cervical cancer (with PD-L1 expression ≥1) in combination with chemotherapy, with or without bevacizumab; only in the USA for the treatment of recurrent or metastatic cervical cancer with disease progression during or after chemotherapy (with PD-L1 expression ≥1). “This is the first Phase 3 study in which an immunotherapy-based regimen has shown an improvement in overall survival compared to chemoradiotherapy alone – he concludes Gursel AktanVice President, global clinical development, Merck Research Laboratories – The results highlight our commitment to exploring the role of pembrolizumab in different types of cancers in the early stages of disease, where the potential for better outcomes is greatest.”