Milan, June 4 (beraking latest news Health) – New hope for patients with metastatic castration-resistant prostate cancer (mCrpc), forms of prostate cancer that do not stop despite the use of hormone treatments aimed at reducing testosterone levels. Novartis will present the results of the phase III Vision study, which evaluated 177Lu-Psma-617 – targeted radioligand therapy – in addition to the best standard of cure (Soc), demonstrating “a significant improvement in overall survival compared to Soc alone in patients with prostate specific membrane antigen (Psma) mCrpc positive”.
“The difference in overall survival between the study arms was statistically significant – reports the Swiss pharmaceutical company – with an estimated 38% reduction in the risk of death in the arm with 177Lu-Psma-617, compared to the arm with only the best. Patients treated with 177Lu-Psma-617 also demonstrated a statistically significant 60% reduction in the risk of radiographic progression, compared to the best standard of care arm alone. In the 177Lu-Psma-617 treatment arm. there was a higher rate of therapy-related adverse events (85.3%), compared to standard of care alone (28.8%). In the 177Lu-Psma-617 plus Soc arm 11.9% of patients discontinued 177Lu-Psma-617 and 8.5% discontinued Soc, while in the Soc-only arm 7.8% of patients discontinued treatment. ”
The launch of two further studies on 177Lu-Psma-617 radioligand therapy in the first lines of metastatic prostate cancer is planned in the first half of 2021, to evaluate the potential clinical utility in the pre-taxane (PsmaFore) setting of mCrpc and in the metastatic hormone-sensitive one (PsmAddition).
“With the Vision study we enter the era of precision medicine in prostate cancer – says Giuseppe Procopio, Head of Genitourinary Medical Oncology of the Irccs Foundation National Cancer Institute (Int) in Milan – For the first time, the selective antitumor action of a radiopharmaceutical, Lutetium, in patients with disease undergoing castration resistance. The anticancer efficacy of Lutetium has induced a significant advantage in progression-free and overall survival in patients selected on the basis of an innovative diagnostic test such as Pet Psma ” .
“In 2020, about 36 thousand new cases of prostate cancer were estimated in Italy – underlines Sergio Bracarda, director of the Oncology Department and of the Complex Structure of Medical and Translational Oncology of the Santa Maria di Terni hospital – The impact of metastatic cancer of the prostate on the daily life of patients who develop symptoms related to the disease can be important, in some cases limiting the possibility of sleeping or walking due to pain. The new targeted therapy with radioligand, in addition to showing very promising clinical efficacy, represents a innovative and non-cross-reactive therapeutic approach with other drugs already available, in a complex disease to be treated. 177Lu-Psma-617 is directed against the Psma antigen, which is overexpressed in most prostate cancer cells. the ability to act only on diseased tissues, saving everything around “.
“Nuclear medicine uses radioactive substances to target cancer cells – highlights Ettore Seregni, director of the complex Nuclear Medicine Foundation Irccs Int Foundation in Milan – The approach to a pathology such as prostate cancer must necessarily be multidisciplinary. The nuclear doctor works in a team. with the oncologist and assesses whether the patient is a candidate for treatment with 177Lu-Psma-617, analyzing the results of the previously performed PET diagnostics. It is foreseeable that this therapy can be performed in many cases even on an outpatient basis, without the need for hospitalization The radiation emitted by the patient, in fact, is limited and the radioactivity disappears in a short time. Therefore, following the appropriate precautions and indications, no risks for caregivers and family members are foreseeable “.
“The Vision study in prostate cancer is the testimony of our commitment in the fight against cancer – declares Giancarlo Benelli, managing director Advanced Accelerator Applications (AAA) Italy, Novartis group – The study has shown important clinical benefits offered by radioligand treatment, an innovative approach to cancer treatment, because it is able to personalize the therapy. Radioligands are part of Novartis’ strategy of reimagining medicine, with the aim of improving and prolonging the life of people affected by cancer “.
Therapy with radioligands – a note recalls – consists in the combined use of a compound (ligand) capable of a precise targeted action and of a radioisotope with therapeutic activity (radioactive particle). After intravenous administration, the radioligand binds to the marker or receptor present on the tumor cell, exerting the therapeutic effect thanks to the radioisotope, which damages target tumor cells by destroying their ability to replicate and / or causing their death. Producing radioligand therapies, AAA’s mission, requires particular know-how, determined by the complexity of the production process that involves a plurality of factors: radioactive isotopes, sterile conditions and the ability to distribute products with a very short duration (a few days). Each dose is produced specifically for each individual patient. The production and distribution system of these products represents a differentiating element for the company.
AAA currently markets a drug in Europe, Canada and the United States, as well as numerous means for precision diagnostics in Europe and one in Canada and the United States. The company has active research and development programs on a pipeline of experimental drugs intended for the treatment of a variety of solid cancers.