593
Assessing the possibilities of studying the therapeutic potential and potential volumes of consumption of an innovative gene antitumor drug that has passed the first phase of clinical trials
Goals and objectives: to identify niches for studying the Russian antitumor drug “AntionkoRAN-M” (INN Stimothimagen copolymerplasmid) within the framework of phase 2 and 3 clinical studies and further use in medical practice.
Materials and methods: during the study, a review of the clinical recommendations of the Ministry of Health of the Russian Federation and NCCN for the management of a number of oncological diseases in the treatment of which the drug “AntionkoRAN-M” could potentially be used was carried out. Further analysis identified groups of patients that differed from each other in the number of available treatment options, as well as the level of strength of recommendations and the reliability of evidence for these options. Further, the description of the selected groups of patients was validated with oncologists from leading federal centers and the characteristics of patients most in dire need of new effective treatment options were noted. Then, according to statistics and epidemiology, the population size in each of the selected groups was predicted by the expected time of the drug entering the market.
Results: it was found that the optimal niches for studying the drug “Antionko- RAN-M” within the framework of a phase 2 clinical trial will be the inoperable stages of the following malignant neoplasms: soft tissue sarcoma for use in the 3+ line and, partially, in the 2nd line; melanoma in combination with immunotherapy (IT) in 2+ lines in patients with unmutated BRAF and KIT status; head and neck tumors (HNT) as neoadjuvant therapy for platinum intolerance; cervical cancer (CC) in relapse at a locally advanced stage. The predicted number of patients in these groups who annually require innovative therapy may total more than 1,300 for orphan diseases: sarcoma and melanoma. There may be more than 5,000 patients in the general hospital and cervical cancer - potential candidates for therapy with the drug “AntionkoRAN-M”.
Скорее всего ваш браузер не поддерживает PDF и Adobe Reader, нажмите здесь, чтобы просмотреть PDF
Bibliography link:
Novikov I.V., Alekseenko I.V., Kondratyeva M.A., Koksharov M.A., Yagudina R.I. Assessing the possibilities of studying the therapeutic potential and potential volumes of consumption of an innovative gene antitumor drug that has passed the first phase of clinical trials . // Pharmacoeconomics: theory and practice. - 2024. - Vol.12, №2. P. 5-12 DOI: https://doi.org/10.30809/phe.2.2024.1
Comments0