The results of the studio IND.227 were presented today at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO) during the oral session dedicated to chest tumors. The international phase III study evaluated the use of immunotherapy drug pembrolizumab in combination with platinum chemotherapy and pemetrexed as first-line treatment for patients with inoperable advanced or metastatic pleural mesothelioma.
“The data presented today demonstrates that the use of pembrolizumab in addition to chemotherapy with platinum e pemetrexed prolongs the survival of patients with inoperable advanced or metastatic pleural mesothelioma”, said Dr. Quincy Chumedical oncologist at the Cross Cancer Institute and the Canadian Cancer Trials Group (CCTG), one of the study’s lead investigators for IND.227.
The treatment of pleural mesothelioma
“With the addition pembrolizumab to platinum chemotherapy e pemetrexed resulted in significant improvements in overall survival, progression-free survival, and objective response rate compared to platinum chemotherapy alone and pemetrexed, regardless ofPD-L1 expressionand therefore represents a new therapeutic option for patients with advanced pleural mesothelioma.”
Pembrolizumab is a drug directed against the programmed death receptor-1 (PD-1) which works by increasing the ability of the body’s immune system to help detect and fight cancer cells. Pembrolizumab it is already approved for use in a number of other cancers, such as non-small cell lung cancer, still in combination with pemetrexed e platinum-based chemotherapyas well as for cancers such as melanoma, head and neck cancer, and others.
Treatment with immunotherapy
Doctor Chu conclude: “Unfortunately, in most patients the pleural mesothelioma it is diagnosed at an already advanced stage, when surgery is not an option and survival rates are low. Standard treatments with platinum-based chemotherapy e pemetrexed they have been in use for almost 20 years and more effective treatments are needed; only recently have some studies shown that new drugs such as immunotherapies can improve outcomes.”
Joan Davis Provosta patient who participated in the IND.227 study under the care of Dr Marie Florescu of the Hospital Center of the University of Montreal (CHUM) Of Montrealtells: “I was enrolled in study IND.227. I received chemotherapy and immunotherapy and my cancer disappeared. I haven’t received any treatment since September 2020 and today I’m still in remission, enjoying life and playing golf whenever I can. I was sentenced to death, but this treatment completely changed my fate. I hope all mesothelioma patients can have access to this combination to have a real chance to beat this cancer”.
The immunotherapy drug pembrolizumab
“Only in the last few years have there been changes in the standard of care for patients with pleural mesothelioma. The results of this study are expected to have a tangible and significant impact on patients’ lives, as they show an improvement in both progression-free survival and overall survivaland,” he says Emi Bossiolung cancer survivor and lung cancer patient representative of the CCTG. The study was funded by the Canadian Cancer Society (CCS); Merck supported the study by providing the immunotherapy drug pembrolizumab and additional funding.
“IND.227 is an academic study conducted by cooperative groups, promoted by the Canadian Cancer Trials Group with our partners in Italy (INT-Napoli) and France (IFCT), and defined a new therapeutic option for patients with pleural mesothelioma. International academic collaborations like this represent an important strategy for studying new treatments that will improve the prognosis of our patients, especially in diseases such as pleural mesothelioma”, commented Dr Penelope Bradburydirector of the Lung Disease Site Committee of the CCTG, Oncologist of the Princess Margaret Cancer Center of Toronto and one of the most active researchers in the study.
The IND.227 study
“Exposure to asbestos is the leading risk factor for pleural mesothelioma. Although its use was banned 30 years ago in Italy, the incidence of mesothelioma is still increasing due to the latency between exposure and the disease. Before the recent successes of immunotherapies, chemotherapy was the only treatment available for 20 years, with disappointing results. Participation in this study was an excellent opportunity for Italian patients, as demonstrated by the large participation, in fact almost half of the patients in the study are Italian. The addition of pembrolizumab to chemotherapy in studio IND.227 improved survival, progression-free survival, and objective response rates, with no findings of toxicity that weren’t already expected. Pembrolizumab in combination with platinum chemotherapy and pemetrexed represents a new treatment option for patients with inoperable advanced pleural mesothelioma”, says Dr. Francesco Perronealso principal investigator of the study, Director of the Clinical Trials Unit of the National Cancer Institute of Napoli IRCCS G. Pascale Foundation, President Elect of the Italian Association of Medical Oncology (AIOM file), and coordinator of the Italian cooperative group engaged in the study.
An innovative treatment option for patients of pleural mesothelioma
“While pleural mesothelioma was considered a deadly orphan disease just a few decades ago, significant progress has recently been achieved through clinical research efforts and international collaborations. The results of the IND.227 study represent one of these advances and now offer another valid treatment option for patients suffering from pleural mesothelioma”says Dr. Laurent Greillier, President of the French Thoracic Cooperative Intergroup, IFCT, Director of the Department of Multidisciplinary Oncology and Therapeutic Innovations of the Publique Assistance – Hôpitaux de Marseille of the Aix University of Marseille. “We are proud to support the CCTG and excited that the positive results of this study have the potential to improve patient outcomes”, says Dr. Stuart Edmonds, Executive Vice President of Mission, Research and Advocacy at the Canadian Cancer Society. “With the help of our generous donors, we look forward to funding more international clinical trials like this that benefit so many people living with cancer in our country and around the world”.
The results of the IND.227 study
At the final analysis of the study, pembrolizumab added to chemotherapy significantly improved overall survival, reducing the risk of death by 21% (hazard ratio 0.79 (95% confidence interval 0.64-0.98; p = 0.0324). Survival at 3 years was better for patients treated with pembrolizumab e platinum chemotherapy and pemetrexed compared to those treated with platinum chemotherapy and pemetrexed alone (25% versus 17% of patients alive at 3 years, respectively). Progression-free survival was also significantly better (hazard ratio 0.80, 95% confidence interval 0.65-0.99, p = 0.0372).
Objective response rates were significantly higher (62% for the con pembrolizumab e chemotherapy and 38% for chemotherapy alone (p < 0.0001). Data on quality of life are still being analysed. Severe adverse events (Grade 3 or 4) occurred in 27% of patients treated with pembrolizumab plus platinum chemotherapy and pemetrexed and in 15% of patients treated with pembrolizumab alone. platinum chemotherapy e pemetrexed. These results are in line with what is expected for this type of treatment. About pleural mesothelioma.
Il mesothelioma is a type of cancer that arises from the tissue lining certain parts of the body, and pleural mesothelioma develops in the tissue lining the lungs. It is estimated that more than 30,000 new cases of pleural mesothelioma were diagnosed worldwide in 2020, and that there were more than 26,000 deaths from the disease. Pleural mesothelioma is usually advanced and incurable when diagnosed and is related to asbestos exposure. Because it develops after a long latency period, the worldwide incidence of pleural mesothelioma is expected to continue to increase.