2023-12-11 14:06:00
In the treatment of adult patients with advanced or recurrent primary endometrial cancer with a genetic condition known as mismatch repair deficiency (dMMR)/MSI-H, high level of microsatellite instability) and candidates for systemic therapy, the European Commission (EC) has granted marketing authorization for dostarlimab in combination with carboplatin-paclitaxel chemotherapy. This was announced by the pharmaceutical company GSK in a note released today, which at the same time informs of the conversion into full approval by the EC of the previous conditional approval for dostarlimab as monotherapy in second line for the same indications.
With current standards of care, “typically, people living with this type of endometrial cancer experience disease progression and poor long-term outcomes,” says Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D at GSK. . With this approval we can expand the number of patients who can potentially benefit from the treatment in Europe, including patients who are at the beginning of their journey. We are proud of the recent approvals as we believe dostarlimab continues to transform the landscape of front-line endometrial cancer treatment and shows promise as a cornerstone immuno-oncology therapy.”
The approval just obtained, adds Mansoor Raza Mirza, chief oncologist at Copenhagen University Hospital (Denmark) and principal investigator of the Ruby pivotal study, “is important news because I believe it will define a new standard of care for some patients with breast cancer advanced or recurrent endometrium. The results of the Ruby study, which led to this approval, underline the potential of dostarlimab, capable of changing the clinical practice of these patients”.
The European green light for dostarlimab is in fact based on the results of the Ruby study which demonstrated a solid median duration of follow-up ≥ 25 months and a statistically and clinically significant benefit in dMMR/MSI-H patients treated – reports a note – with a 72% reduction in the risk of disease progression or death compared to chemotherapy alone. In a prespecified exploratory analysis of overall survival, the addition of dostarlimab to chemotherapy resulted in a 70% reduction in the risk of death compared to chemotherapy alone. The findings were previewed at the virtual plenary meeting of the European Society of Medical Oncology (Esmo) and the annual meeting of the Society of Gynecological Oncology (Sgo) last March. and simultaneously published in the ‘New England Journal of Medicine’.
In a subsequent planned analysis, the Ruby study achieved its other primary endpoint of overall survival, demonstrating a statistically and clinically significant benefit in the overall patient population. The safety and tolerability profile of the combination therapy was consistent with known safety profiles. The most common adverse reactions (≥ 10%) were rash, hypothyroidism (underactive thyroid), increased alanine aminotransferase or increased aspartate aminotransferase (increased levels of liver enzymes in the blood), fever, and dry skin.
Endometrial cancer is the most common gynecological cancer in developed countries. Every year, around the world, there are an estimated 417 thousand new cases. An estimated 20-29% of all endometrial cancers are dMMR/MSI-H. In the EU (France, Germany, Italy and Spain), approximately 3,000 people are diagnosed with advanced or recurrent primary endometrial cancer dMMR/MSI-H every year. Looking ahead, incidence rates are expected to grow by nearly 40% between 2020 and 2040. Approximately 15-20% of patients will be diagnosed with advanced disease.
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