Abemaciclib is the first and only inhibitor of the enzymes responsible for regulating the cell cycle (CDK 4 and CDK 6) approved in the European Union with a continuous dose scheme (twice a day), indicated for the treatment of women with cancer. locally advanced or metastatic breast, positive for the hormone receptor (HR) and negative for receptor 2 of the human epidermal growth factor (HER2), in combination with an aromatase inhibitor or fulvestrant as initial hormone therapy or in women who have received hormone therapy previous. In pre or perimenopausal women, hormone therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
It is an oral drug, marketed as Verzenios by Lilly, which has just been included in the pharmaceutical benefit of the National Health System.
Its development has been possible thanks to an international team of researchers in which, for the first time, Spanish professionals have participated from its inception to its commercialization, and has had the collaboration of the Lilly R & D center in Madrid.
In the words of one of the researchers who collaborated, Miguel Martín Jiménez, head of the Medical Oncology Service of the General University Hospital Gregorio Marañón and president of the GEICAM Group of Breast Cancer Research, “abemaciclib has a pharmacological profile that is close to the ideal of medical treatment capable of contributing to chronic breast cancer “. In his opinion, “we are faced with some simple pills capable of controlling the disease in a way never seen before in patients with hormonal tumors, with very few side effects and very well tolerated. This type of data really changes the management of metastatic breast cancer. “
A breakthrough
Abemaciclib has been evaluated in metastatic breast cancer through the clinical trials MONARCH 2 and MONARCH 3, showing a significant improvement in the main parameters of efficacy against standard treatment. In the first study, the combination of abemaciclib with fulvestrant achieved a median progression-free survival of more than 16 months, compared with 9.3 months with the fulvestrant combination and placebo. In the second, the combination of abemaciclib with an aromatase inhibitor achieved a median progression-free survival greater than 28 months, compared to 14.8 months obtained with the combination of an aromatase inhibitor and placebo.
Abemaciclib benefits patients suffering from the type called luminal, a phenotype developed by 70 percent of patients with breast cancer and who have positive hormone receptors. According to Eva Ciruelos, from the Medical Oncology Service of the University Hospital 12 de Octubre and president of the SOLTI group of Breast Cancer Research, “in these patients, the therapy contributes with excellent efficacy, comfort and tolerability. Besides, it prolongs the benefit with acceptable toxicity during a median of more than two years. This translates into a prolonged control of symptoms and the delay in the start of other more toxic drugs. “
During the presentation of the new drug, this Monday in Madrid, Maria José Lallena, director of the R & D center of Lilly in Spain, who recalled an important fact: since the 2000s, the development of new medicines has made deaths from cancer in the population were reduced by 50 percent. “For the team that has participated in the research, it is a source of pride that an innovation of this kind reaches patients. The fact that a single patient can benefit from these 20 years of effort and hard work is a dream, “he said.
For his part, Nabil Daoud, CEO of Lilly Spain, Portugal and Greece, highlighted during the ceremony the objective and commitment of this laboratory to provide oncologists and health professionals with the evidence and therapeutic options necessary to care for their patients.