Pivotal clinical trial application for lorlatinib in ROS1-positive advanced non-small cell lung cancer approved in China

On January 4, the Hong Kong-based innovative pharmaceutical company CStone Pharmaceuticals (02616.HK) announced that the clinical trial application (IND) of lorlatinib for ROS1-positive advanced non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration of China. Authority (NMPA) approved. This is the world's first pivotal study of lorlatinib in ROS1-positive NSCLC.

Ma'lum bo'lishicha, tadqiqot ROS1-musbat ilg'or NSCLC bilan og'rigan bemorlarda lorlatinibning antitumor faolligi va xavfsizligini baholashga qaratilgan va kimyoterapiya va aniq terapiya muvaffaqiyatsizlikka uchragan ROS1-musbat ilg'or NSCLC bilan kasallangan bemorlarni ro'yxatga oladi. Tadqiqotning asosiy yakuniy nuqtasi mustaqil tekshirish Qo'mita tomonidan baholangan ob'ektiv javob darajasi (ORR).

Statistik ma'lumotlar shuni ko'rsatadiki, Xitoyda har yili 670 000 dan ortiq NSCLC tashxisi qo'yiladi, ularning taxminan 2% -3% ROS1 genini qayta tashkil etish bilan bog'liq bo'lib, taxminan 20 000 kishini tashkil qiladi. Ularning aksariyati yosh, chekmaydigan yoki engil chekadigan o'pka adenokarsinomalaridir. bemorlarda. Uchinchi avlod ALK/ROS1 tirozin kinaz inhibitori sifatida lorlatinib ROS1-musbat ilg'or kichik hujayrali o'pka saratoni bilan og'rigan bemorlar uchun yangi davolash variantini taqdim etishi mumkin.

In this regard, Dr. Yang Jianxin, Chief Medical Officer of CStone Pharmaceuticals, said that there is currently no effective treatment for ROS1-positive NSCLC patients after they develop drug resistance. "We are delighted that lorlatinib has been approved for pivotal studies in patients with ROS1-positive NSCLC in China. We will accelerate the clinical study of lorlatinib and bring more treatment options to patients as soon as possible."

Ta'kidlash joizki, ushbu tadqiqot CStone va Pfizer o'rtasidagi strategik hamkorlikni yanada chuqurlashtirishdir. 2020-yil sentabr oyida CStone va Pfizer strategik hamkorlikka kirishdi, bu ikki tomon uchun Buyuk Xitoy mintaqasiga ko'proq onkologiya mahsulotlarini joriy etish bo'yicha hamkorlik asoslarini o'z ichiga oladi. 2021 yil iyun oyida CStone va Pfizer birgalikda ikki tomon Buyuk Xitoy hududida lorlatinibni birgalikda ishlab chiqishlari va ROS1-musbat NSCLC bo'yicha tadqiqotlar olib borishlari haqida e'lon qilishdi, bu saraton sohasidagi bemorlarning ko'pchiligiga ko'proq davolash imkoniyatlarini taqdim etadi.

Lolatinibni muhim klinik tadqiqotlar uchun tasdiqlash yaqinda CStone tomonidan olingan yana bir yaxshi xabardir. O'tgan oyning oxirida, potentsial eng yaxshi sinfdagi PD-L1 antikor preparati Zejiemei? (Sugalimumab in'ektsiyasi) NMPA tomonidan marketing uchun ma'qullangan va dunyodagi eng yaxshi potentsial CS5001 (ROR1 ADC) preparatining klinik sinov dasturi klinik tadqiqotlar uchun FDA tomonidan tasdiqlangan. CStone'ning aniq terapiya va immunoterapiyadagi afzalliklari yanada ta'kidlangan.