A new immunotherapy drug arrives in Italy for the first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma capable of increasing overall survival by almost nine months. It is avelumab, developed by Merck and Pfizer, and which has just received reimbursement from the Italian Medicines Agency for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma without progression after a chemotherapy-based of platinum.
Bladder cancer in Italy
In 2021, this cancer was diagnosed in 25,500 people and caused over 6,000 deaths. It affects 313,600 subjects in Italy, of which 80% are men. “In over 90% of cases – he explains Roberto Iacovellimedical director at the Medical Oncology Unit of the Agostino Gemelli Irccs University Polyclinic Foundation – the tumor originates from the urothelium, i.e. the epithelium that lines the bladder, but also other organs of the urinary system such as the renal pelvis, ureter and the urethra, and is therefore more generally defined as urothelial carcinoma “.
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The risk of affecting other organs
This tumor can also spread to the muscle wall that surrounds it and reach the lymph nodes, or other organs such as lungs, liver, bones. “For this reason – continues Iacovelli – 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”.
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Treatment of advanced urothelial carcinoma
Until now, standard first-line treatment of advanced urothelial carcinoma has been characterized by platinum-based chemotherapy alone, usually for up to six cycles. “In patients in whom at least one stability of the disease was observed at the end of chemotherapy – continues Iacovelli – there was then a period of clinical and instrumental observation to identify the new progression of the disease early to be followed by a new treatment, this time second line. Up to now – concludes Iacovelli – there was insufficient scientific evidence to propose a maintenance drug therapy with the aim of maintaining the result achieved by the first line of chemotherapy, delaying the progression and finally the evolution of the disease “.
New perspectives with immunotherapy
Until now, therefore, there were no treatments for the maintenance of patients who were left without solutions. Avelumab is the first and only immunotherapy to have demonstrated a significant benefit on overall survival in the first-line setting, as demonstrated by the Phase III Javelin Bladder 100 clinical trial, which showed that avelumab therapy at the end of the first line compared to Patient observation alone increased overall survival by 8.8 months, with the patient’s condition maintained or improved due to limited toxicity. “The drug – he declares Sergio Bracarda, director of the Department of Oncology and of the SC of Medical and Translational Oncology of the Santa Maria di Terni Hospital and incoming President of SIUrO (Italian Society of Uro-Oncology) – not only has he proved effective in controlling the disease, and with in survival increased compared to those previously reported, but it is also well tolerated. This latter element is extremely important, in light of the type of patients treated, often elderly and suffering from many other pathologies “.
The first novelty after 30 years
For urothelial tumors, after almost three decades without substantial novelties, avelumab represents a turning point in clinical practice. “Avelumab – explains Bracarda – 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. 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 “. The drug had already received approval for this indication from the FDA in July 2020 and from the EMA in January 2021. Now the reimbursement by Aifa has also arrived. “The prospect of an early death – he declares Edoardo Fiorini, president of the PalinUro Association – has changed my approach to life, I have learned to seize the fleeting moment but I have also chosen to devote myself to volunteering to try to help patients meet their unmet needs. The announcement of this new drug allows us to think again about the future and make plans for our small community. It would be very nice if there were many other moments like this “.
Data from the Javelin Bladder 100 study
Updated data from the Javelin Bladder 100 study were presented at the Asco Genitourinary Cancers Symposium and refer to a median follow-up of 38 months. The data demonstrated a further increase in median overall survival to 23.8 months in patients treated with avelumab plus best supportive care in the first-line maintenance setting, compared to a median overall survival of 15 months in those treated with therapy alone. supportive therapy with a further increase in the median overall survival from approximately 7 initial months to current 8.8 months in cases treated with avelumab. Based on these findings, the frontline maintenance regimen with avelumab was strongly recommended in the guidelines of the National Comprehensive Cancer Network, the European Society for Medical Oncology, the European Association of Urology and the Italian Medical Oncology Association.