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Metastatic breast cancer, a targeted therapy for the most aggressive cases

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Metastatic breast cancer, a targeted therapy for the most aggressive cases

We had three drugs that target one of the most aggressive breast cancers – the one called Her2-positive – and now we have five. Two new “weapons” have in fact been added in this last year for the metastatic phase, especially for those who have already tried many therapies or for those with active brain metastases, among the most feared by oncologists and patients. In particular, one of the two new treatments, tucatinib, shows a two-year survival of 51%, and 48.5% in those with brain metastases. The conference “Research Generators – Widening options in HER2 + metastatic breast cancer” which opened today in Milan, promoted by Seagen, is dedicated to the recent progress in advanced breast cancer: for two days, in the Lombard city, the most important breast cancer specialists, with the aim of promoting dialogue between the academic and clinical world, patient associations and industry.

Her2-positive stage IV breast cancer

In Italy, every year, more than 3,800 women receive a diagnosis of metastatic breast cancer and an overall estimate is between 37,000 and 50,000 patients living with stage IV breast cancer. Of these, about 20% have an increase in receptors 2 for human epidermal growth factor (Her2) on cancer cells. “We have known that HER2 has been an important target since the early 1980s,” he explains Lucia Del Mastro, director of the Clinic of Medical Oncology of the Irccs Ospedale Policlinico San Martino and full professor of Medical Oncology at the University of Genoa: “In the HER2CLIMB study, which will be discussed in the conference and which was published in Annals of Oncology, the oral drug tucatinib, in addition to the chemotherapy capecitabine, also oral, and trastuzumab, it has been shown to be effective after two lines of anti HER2 therapy, including a conjugated antibody drug: therefore in already treated women, where the standard of care offers little benefit. In addition to the ease of administration, it is important to underline that this combination is well tolerated and does not cause hair loss: a side effect particularly feared by patients “.

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The data of the study

The final analysis of the HER2CLIMB data demonstrates that the already highlighted benefits of tucatinib are maintained after more than 29 months and that this targeted therapy helps to live longer. 51% are alive compared to 40% with trastuzumab and capecitabine alone, and the median overall survival was 24.7 months compared to 19.2 months: the benefit obtained with tucatinib was therefore 5.5 months. Not only. Progression-free survival is also moving forward, which at one year stands at 29% compared to 14%.

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“HER 2 has always been a much feared neoplasm, because it is characterized by a greater aggressiveness and probability of recurrence, compared to HER2-negative breast cancers”, he adds. Giuseppe Curigliano, Professor of Medical Oncology at the University of Milan, Director of the Development Division of New Drugs for Innovative Therapies at the IEO in Milan and Scientific Director of the Milan Conference: “About half of patients with advanced disease develop brain metastases, which make it much more difficult the treatment. For the first time in the world, the HER2CLIMB study also evaluated many patients – almost half – with active brain metastases, that is, not pretreated with radiotherapy, so far excluded from the trials. Tucatinib is such a small molecule that it crosses the blood brain barrier and reaches the brain, blocking the proliferation stimulus of the HER2 protein ”.

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Pending reimbursement

In Italy, the therapy is currently available in CNN class, i.e. not reimbursed by the health system, and reimbursement is being discussed at the Italian Medicines Agency (AIFA). “To date, patients are being treated with this drug thanks to compassionate use, so the company makes it available at a cost of one euro per pack,” he says. Saverio Cinieri, National President of the Italian Association of Medical Oncology (AIOM) “. It will be like this until July 31, the date on which Seagen hopes to conclude the negotiation. In any case, those already under treatment will continue to receive the drug from 1 August. “The dossier – remembers Cinieri – was submitted to Aifa in February 2021. There is a delay on the part of the agency that has been trying to fill for years”.

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The company has involved more than 40 clinical research centers in Italy: “We are building partnerships with the Italian oncology excellence to find solutions to still unsatisfied clinical needs, ensuring access to new therapeutic opportunities for patients”, he concludes. Rodrigo Fernandez-Baca, General Manager Seagen Italy: “The ‘Research Generators’ conference offers us the opportunity to present our commitment and to make a joint reflection between institutions and industry on access to innovation in our country”.

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