The Minister of Health, Olivier Véran, announced it recently. Trodelvy, a promising new treatment against a aggressive form of breast cancer, is available, since Monday, November 1, for the patients who need it the most. This new therapy does not yet have a European marketing authorization. Only nominative temporary authorizations for use (ATU) had thus been granted in France, benefiting only a few dozen women. Here is what you need to know about this treatment that gives hope to hundreds of patients.
Who is this therapy for?
This new therapy, manufactured by the American laboratory Gilead, consists of an antibody treatment combined with chemotherapy. It is aimed at women with particularly aggressive breast cancer, called “triple negative”, metastasized and considered “in therapeutic failure” after receiving two other treatments.
Triple negative cancer affects about 15% of patients, or 9,000 new cases per year, and treatments are “rare and often ineffective”, report the High Authority for Health. Its characteristic: it does not present any marker (hormone receptors or HER2 protein) on the surface of cancer cells, likely to respond to an existing targeted therapy. In affected patients, often younger than average (40% are under 40), the risk of recurrence is high, around 30% within three years of diagnosis.
In the event of recurrence with metastases, Trodelvy can therefore now be offered. A hope for the patients because in the metastatic state, the prognosis of this cancer has not improved over the past 20 years, for lack of effective therapies. Like other tumors, metastatic triple negative breast cancer cannot be cured. He has a five-year survival rate of 11.3% and an overall median survival of 14 and a half months, according to the HAS.
What does this treatment allow?
Trodelvy helps to extend the short-term survival of patients, as scientific research shows. Among them, the international phase 3 clinical study Ascent, conducted on 468 patients and coordinated by the Institut Curie. It shows that the median progression-free survival was 5.6 months for patients treated with Trodelvy compared to 1.7 months for those treated with chemotherapy. In addition, as the Institute underlines, the study revealed a benefit in terms of overall survival since it reached 12.1 months against 6.7 months with chemotherapy. “This is real progress, we had never had such good results in this situation for metastatic triple negative breast cancer”, greets Delphine Loirat, medical oncologist at the Curie Institute and principal investigator of the Ascent study.
For Claude Coutier, of the #Mobilisationtriplettes collective, the Trodelvy therefore represents a “huge hope“. “Doubling life expectancy is to give hope to have time to see a new treatment arrive. It is priceless”, she explains to franceinfo, insisting on the need to “[continuer] research and mobilization to access innovative treatments that will make it possible to live longer with this disease, while waiting one day for a cure. “
Are there other ways to treat this form of breast cancer?
Among the programs underway in France, the Mondrian clinical trial of the Institut Curie was launched to be able to quickly estimate whether or not triple negative breast cancer responds to chemotherapy and thus save time. The Institut Gustave-Roussy, for its part, initiated the Compass program, the objective of which is to assess the effectiveness of different combinations of innovative treatments.
Studies have also shown that immunotherapy (a therapeutic approach that acts on the immune system) improves the overall survival of some women with triple-negative metastatic breast cancer. “We are asking for more inclusions in clinical trials as well as better knowledge of the clinical trials that exist for ‘triplets'”, adds Claude Coutier.
How many women have already had access to this treatment?
While nominative temporary authorizations for use (ATU) had been granted in France pending a marketing authorization (AMM) by the European Medicines Agency, France had encountered a supply problem. The Gilead laboratory ensured that it did not have sufficient production capacity to supply European patients. As the president of Gilead France reported to franceinfo, “a few thousand bottles” had all the same been taken from the American production to give access to the Trodelvy to a handful of patients who were in emergency.
From June, “78 patients were able to access it”, says Claude Coutier. “So you’re going to tell me, compared to 600 women who need it, it’s ridiculous, but at the same time, it’s 78 lives. It’s priceless.”
In early September, the High Authority for Health (HAS) announced that patients with this cancer could exceptionally receive this new treatment, thanks to an early access authorization. “From November 1, oncologists will be able to make prescriptions via the early access device. All patients who need it will therefore be able to benefit from it”, rejoices Claude Coutier. In total, his group has counted 600 patients who need it urgently.
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