Nubeqa (darolutamide) Phase 3 clinical success: Significantly prolong overall survival (OS)!

Bayer yaqinda yangi avlod androgen retseptorlari ingibitorini (ARi) Nubeqa (ARI) ni baholash bo'yicha 3-bosqich ARASENS sinovini e'lon qildi.darolutamid) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has reached its primary endpoint.

This is a randomized, multicenter, double-blind phase 3 trial with a prospective design to evaluate the efficacy and safety of Nubeqa combined with docetaxel and androgen deprivation therapy (ADT) in the treatment of mHSPC patients.

The results showed that compared with the standard care regimen docetaxel + ADT, Nubeqa + docetaxel + ADT significantly prolonged overall survival (OS). In terms of safety, the overall incidence of adverse events reported between the treatment groups was similar.

The detailed results of the study will be announced at an upcoming medical conference. Bayer plans to discuss the data from the ARASENS trial with regulatory agencies around the world and submit Nubeqa's marketing application for mHSPC indications.

darolutamidmolekulyar tuzilish

Dunyo miqyosida prostata saratoni ikkinchi eng keng tarqalgan xavfli o'sma va erkaklar orasida saraton kasalligidan o'limning beshinchi eng keng tarqalgan sababidir. Bu asosan 50 yoshdan oshgan erkaklarga ta'sir qiladi va xavf yoshga qarab ortadi. 2020 yilda butun dunyo bo'ylab taxminan 1,4 million erkak prostata saratoni bilan kasallanadi va taxminan 375 000 kishi vafot etadi. Tashxis qo'yish vaqtida ko'pchilik erkaklarda prostata saratoni lokalizatsiya qilingan, ya'ni ularning saratoni prostata saratoni bilan cheklangan va terapevtik jarrohlik yoki radiatsiya terapiyasi bilan davolash mumkin. Qaytalanish metastazlangan yoki tarqalganda, androgen deprivatsiya terapiyasi (ADT) ushbu gormonga sezgir kasallikni davolash uchun asosiy terapiya hisoblanadi.

Erkaklarning taxminan 5 foizi birinchi tashxisda uzoq metastazlar bilan prostata saratoniga ega. Metastatik gormonga sezgir prostata saratoni (mHSPC) bilan og'rigan erkak bemorlarda ADT, androgen retseptorlari inhibitori (ARi) + ADT, dosetaksel + ADT va boshqalar kabi gormon terapiyasi boshlanadi. Ushbu turdagi davolanishga qaramay, mHSPC bilan og'rigan erkak bemorlarning ko'pchiligi oxir-oqibat kastratsiyaga chidamli prostata saratonini (CRPC) rivojlantiradi, bu cheklangan yashash vaqtiga ega.

Nubeqa was developed by Bayer in cooperation with the Finnish pharmaceutical company Orion and has been approved in many markets around the world, including the United States, the European Union, China, and Japan, for the treatment of male patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa provides an important treatment option for male patients with nmCRPC that can significantly prolong metastasis-free survival (MFS) and overall survival (OS). It has good long-term safety and helps patients continue to receive treatment and achieve treatment Target.

Nubeqa - steroid bo'lmagan androgen retseptorlari (AR) ingibitorlarining yangi avlodi. U retseptorga yuqori yaqinlik bilan bog'langan va kuchli antagonistik faollikni namoyon qiluvchi noyob kimyoviy tuzilishga ega, shu bilan retseptorlar funktsiyasini va prostata saratoni hujayralarining o'sishini inhibe qiladi. O'sish. Boshqa mavjud bo'lgan nmCRPC davolash usullaridan farqli o'laroq, Nubeqa qon-miya to'sig'ini kesib o'tmaydi, shuning uchun potentsial dori vositalarining o'zaro ta'siri va markaziy asab tizimining nojo'ya ta'siri (masalan, tutilishlar, tushishlar va kognitiv buzilishlar) kamroq.

Hozirda Bayer va Orion ham mHSPC ni davolash uchun Nubeqa ni ishlab chiqmoqda. ARASENS sinovidan tashqari, mHSPC davolashda Nubeqa+ADT rejimini baholovchi yana bir 3-bosqich sinovi (ARANOTE) davom etmoqda.