The approval by the Italian drug agency Aifa, ad atezolizumab in combination with bevacizumab in adult patients with advanced or unresectable hepatocellular carcinoma (Hcc)not subjected to previous systemic therapy. Roche communicates itnoting that the national regulatory body has also authorized the extension of the indication of atezolizumab allowing its use as monotherapy for the first-line treatment of metastatic non-small cell lung cancer with high PD-L1 protein expression.
The data relating to the IMbrave150 study – explains Roche in a note – showed that atezolizumab provides the longest overall survival (Os) observed in a first-line phase 3 trial in Hcc. Indeed, the study’s primary analysis showed that after a follow-up period of 8.6 months, atezolizumab in combination with bevacizumab reduced the risk of death by 42%. After a median follow-up of 15.6 months, the trial indicated that mixing atezolizumab plus bevacizumab reduced the risk of death by 34%, with a median Os of 19.2 months compared to 13.4 months for sorafenib.
“Approval of the atezolizumab-bevacizumab combination represents a milestone in the field of hepato-oncology – says Antonio Gasbarrini, full professor of internal medicine at the Catholic University of the Sacred Heart, Rome Campus, director of the Department of Medical and Surgical Sciences of the Agostino Gemelli Irccs University Hospital Foundation in Rome – After more than 10 years of immobility, a first-line treatment is finally available capable of prolonging the survival of patients suffering from unresectable hepatocellular carcinoma: delicate patients who are not only suffering from cancer, but also from liver dysfunction “. The specialist speaks of” a big step forward in the management of the patient affected by hepatocarcinoma, which not only broadens the therapeutic horizon, but guides us towards an ever greater personalization of therapy, to the benefit of the patient “.
An analysis conducted for the first time also on the benefits reported by patients in terms of quality of life – continues the note – confirms very positive results. The areas investigated include parameters such as the impact on work, on leisure time, on the ability to walk distances and on symptoms. It appears that patients treated with the atezolizumab-bevacizumab combination report significantly slower deterioration in quality of life and physical function than in the control arm.
“The treatment of hepatocarcinoma has been a great challenge for years and, for the first time, in a randomized phase 3 clinical trial, the combination of atezolizumab and bevacizumab proved extremely statistically significant to previous therapies in terms of activity and efficacy “, remarked Fortunato Ciardiello, Professor of Medical Oncology and Vice Rector of the University of Campania Luigi Vanvitelli, specifying that the therapy” can be administered for the entire duration necessary to control the disease. These are the best data so far. obtained in the history of hepatocarcinoma therapy and are comforting in terms of manageability and tolerability with excellent results also on the quality of life of patients. The interaction between immunotherapy and anti-angiogenic therapy represents the new therapeutic standard for the patient with hepatocarcinoma no longer treatable with locoregional treatments, but which requires t systemic herapy “.
Liver cancer is the sixth most common cancer and in 2020 it represented the third leading cause of cancer death in the world. “Given the particular complexity of the pathology often diagnosed late, and that it often has comorbiditiesit is important that patients with hepatocarcinoma are followed by a multidisciplinary team made up of specialists with different skills – declares Ivan Gardini, president of the EpaC Onlus association – To set up a management system in which gastroenterologists, oncologists, surgeons and radiologists intervene in parallel diagnostic and interventional can represent the functional strategy to guide patients towards structures with the best diagnostic and therapeutic pathways “.
Roche is committed to fighting liver disorders throughout the disease path, from the early stages to advanced pathology, with the ultimate goal of one day stopping chronic liver disease, the company continues in the note. A commitment that has involved not only Roche Pharma since the 90s with drugs for hepatitis and today the development of new therapies such as atezolizumab, but also Roche Diagnostics with immunometric tests aimed at improving the early diagnosis of hepatocarcinoma, and Roche Diabetes Care which for years it has been promoting, through portals aimed at diabetic patients, information on correct lifestyles and nutrition, in order to prevent the development of liver diseases such as cirrhosis and fibrosis, which damage organ functionality and can cause serious consequences, up to the development of liver carcinomas.
As for the extension of use authorized by AIFA for atezolizumab against metastatic non-small cell lung cancer with high PD-L1 expression, the pivotal study IMpower110 demonstrated a statistically and clinically significant improvement in Os, with a decrease 31% risk of death and over 60% of patients alive at one year. Thanks to this further extension of indication, atezolizumab represents today the first and only single-agent immunotherapy against lung cancer, available in 3 dosages, which allow administration every 2, 3 or 4 weeks, thus making it available to doctors and patients greater flexibility in the management of treatment. The use of atezolizumab in this therapeutic setting is an effective and cost-saving alternative to the current standard of care, from the perspective of the national health system. Savings that more translate into resources to be potentially reinvested in the various phases of the diagnostic-therapeutic path.
Roche has an extensive development program for atezolizumab, which includes multiple Phase 3 studies evaluating the drug both as monotherapy and in combination with other drugs. There are ongoing and planned trials in different types of lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.