Merck and Pfizer announce that the Italian Medicines Agency has admitted reimbursement avelumab (trade name: Bavencio), for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial cancer without progression after chemotherapy based on platinum. The drug had received approval for this indication from the FDA in July 2020 and from the EMA in January 2021.
Avelumab is the first and only immunotherapy – the companies report – to have demonstrated a significant benefit on overall survival in the first-line setting, as demonstrated by the Phase III clinical trial Javelin Bladder 100, which shows that avelumab therapy at the end of the first line, compared to the “observation” of the patient alone, increased overall survival by 8.8 months (Asco Gu 2022 update), with the patient’s condition maintained or improved, thanks to the limited toxicity of the drug.
“Bladder cancer is a disease that affects 313,600 subjects in Italy (of which 80% are men). In over 90% of cases the tumor originates from the urothelium, that is the epithelium that lines the bladder, but also other organs of the urinary tract such as the renal pelvis, the ureter and the urethra, and is therefore defined, more Generally, urothelial carcinoma – says Roberto Iacovelli, medical director at the Medical Oncology Unit of the Agostino Gemelli Irccs University Polyclinic Foundation – In 2021 this neoplasm was diagnosed in 25,500 people and caused over 6,000 deaths. This tumor initially develops in the inner lining of the bladder (urothelium), and can later spread to the surrounding muscle wall and reach the lymph nodes, or other organs such as lungs, liver, bones. For this reason, timely diagnosis is fundamental, because it influences future survival, as well as the therapeutic approach which, depending on the stage of the tumor, involves combined interventions between surgery, chemotherapy, radiotherapy and immunotherapy “.
“Until now, standard first-line treatment of advanced urothelial carcinoma has been characterized by platinum-based chemotherapy alone, usually for up to 6 cycles. In patients with at least stable disease at term of chemotherapy, followed by a period of clinical and instrumental observation to identify early the new progression of the disease to be followed by a new treatment, this time second line. Until now – adds Iacovelli – there was not sufficient scientific evidence to propose a therapy pharmacological maintenance with the aim of maintaining the results achieved by the first line of chemotherapy, delaying the progression, and finally the evolution of the disease “.
Avelumab is, therefore, the answer to a therapeutic need, that of maintenance, for which up to now there were no solutions. Immunotherapy represents a relatively new therapeutic approach in oncology, and is considered the “new weapon” for cancer treatment after surgery, chemotherapy and radiotherapy. It reactivates and strengthens the patient’s immune system, prompting it to attack diseased cells.
“Avelumab is a monoclonal antibody that binds to the so-called PD-L1 checkpoint protein, a specific target that allows some cancer cells to evade the activity of the immune system – says Sergio Bracarda, director of the Department of Oncology and of the SC of Medical Oncology and translational of the Santa Maria di Terni hospital and incoming President of Siuro (Italian Society of Uuro-oncology) – The drug inactivates Pd-L1, present on the surface of tumor cells, blocking this protective effect and allowing our Immune System to fight the tumor “.
“For urothelial tumors, after almost three decades without substantial ‘novelties’, avelumab really represents a turning point in clinical practice – underlines Bracarda -. The drug has not only proved effective in controlling the disease, and with results in survival. increased compared to those previously communicated, but it is also well tolerated. This is an element of extreme importance, in light of the type of patients treated, often elderly and suffering from many other pathologies “.
The most recent update of the results of the Javelin Bladder 100 study, presented at Asco-Gu 2022, relating to a median follow-up of 38 months (data cut off: June 4, 2021, 19 months longer than the initial primary analysis ) demonstrated a further increase in Overall Survival to 23.8 months (95% Ci, 19.9 to 28.8) in patients treated with avelumab plus best supportive care (Bsc – Best Supportive Care) in the first-line maintenance setting, compared to a median Os of 15.0 months (95% CI, 13.5 to 18.2) in cases treated with Bsc alone (HR 0.76; 95% CI, from 0.631 to 0.915), with a further increase, therefore, in the median of Os from approximately 7 initial months to current 8.8 months in cases treated with avelumab.
Based on these results, the frontline maintenance regimen with avelumab was strongly recommended in the guidelines Nccn – National Comprehensive Cancer Network, Esmo – European Society for Medical Oncology, Eau – European Association of Urology and Aiom – Italian Medical Oncology Association. .
“The introduction in Italy of avelumab in clinical practice for people with locally advanced or metastatic urothelial cancer allows us to respond to an urgent unmet therapeutic need – declared Jan Kirsten, president and managing director, Healthcare, Merck Italia – of the alliance with Pfizer, we are very pleased to be able to provide health professionals and their patients with a therapeutic solution capable of bringing about an important change in the natural history of such a severe disease. This is certainly a further impetus to continue with passion Merck’s commitment to cancer research, to be able to offer more and more cutting-edge solutions capable of significantly improving and extending people’s lives “.
“As part of our broader research and development program in oncology, Pfizer has been engaged in urogenital cancer for more than fifteen years, with a focus on kidney cancer that has led to the development of drugs that have helped change the natural history of this pathology – stated Alberto Stanzione, Oncology Director of Pfizer Italy – With avelumab we extend our commitment to advanced urothelial carcinoma, a form of cancer that is characterized by high recurrence and progression rates, proposing in alliance with Merck a innovative drug capable of changing the treatment paradigm and establishing, for the first time in this tumor, maintenance therapy as a new standard of care, with unprecedented efficacy results. The alliance on this drug is therefore fully in line with Pfizer’s mission to propose innovations that change the lives of patients, and we are proud to be able to offer people with urothelial carcinoma and their doctors a new therapeutic option aimed at significantly improve their care path “.
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