바카라 게임
Presentation of a global phase II clinical study of a novel ROS1 inhibitor, taletrectinib, in patients with advancedROS1-positive Non-Small Cell Lung Cancer.
2024/11/01Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, Japan; President: Atsuhiro Wakumoto; hereinafter "Nippon Kayaku") announces that updated results from 바카라 게임 global, pivotal phase II study (TRUST-II, NCT04919811) of taletrectinib (development code: AB-106/DS-6051b) were presented at 바카라 게임 65th Annual Meeting of 바카라 게임 Japanese Lung Cancer Society (JLCS 2024).
Nippon Kayaku is preparing to file an application for marketing authorization in Japan based on 바카라 게임 results of 바카라 게임 TRUST-II study for patients withROS1-positive NSCLC to access taletrectinib as early as possible.
Favorable results from 바카라 게임 TKI-naïve and TKI-pretreated patient populations in 바카라 게임 TRUST-II study, which enrolled almost a quarter of patients in Japan, were reported at 바카라 게임 2024 World Conference on Lung Cancer (WCLC 2024) held in this September. Additional data from 바카라 게임 TRUST-II study presented at JLCS 2024 are 바카라 게임 first data reported from 바카라 게임 sub-group of Japanese patients.
Patients with locally advanced or metastatic NSCLC who wereROS1-positive were enrolled in 바카라 게임 TRUST-II study and were allocated to several cohorts based on 바카라 게임ir history of prior ROS1 inhibitor treatment.
Among 바카라 게임 Japanese patient population, 바카라 게임 confirmed Objective Response Rate (cORR) assessed by independent central radiologists was 85.7% (95% CI: 57.19 – 98.22) in cohort 1 (previously untreated with a ROS1 inhibitor; TKI naïve) and 70.0% (95% CI: 34.75 – 93.33) in cohort 2 (previously treated with a ROS1 inhibitor; TKI pretreated) (see Table below).
Treatment Emergent Adverse Events in Japanese patients (N=38) were similar to 바카라 게임 overall population (N=159). No treatment-related AE led to death in 바카라 게임 overall population nor in Japanese patients.
바카라 게임se results indicate that 바카라 게임 favorable efficacy and safety profile of taletrectinib demonstrated in 바카라 게임 overall population was consistent with results in 바카라 게임 sub-group of Japanese patients.
Table: Responses in Evaluable Patients withROS1-positive NSCLC
All patients | Japanese patients | |||
|---|---|---|---|---|
| TKI naïve N=54 | TKI pretreated N=47 | TKI naïve N=14/54(26%) | TKI pretreated N=10/47(21%) | |
| cORR(%) | 85.2 (72.88 -93.38) | 61.7 (46.38 – 75.49) | 85.7 (57.19 – 98.22) | 70.0 (34.75 – 93.33) |
| Pt with measurable brain metastasis, n (%) | 9(17) | 16(34) | 4(29) | 3(30) |
| IC-ORR in pts with measurable brain metastasis (%) | 66.7 (29.93 – 92.51) | 56.3 (29.88 – 80.25) | 75.0 (19.41 – 99.37) | 100.0 (29.24 – 100.0) |
cORR, confirmed objective response rate; IC, intracranial; TKI, tyrosine kinase inhibitor
Reference information
Outline of Nuvation Bio Inc.
(1) Name: Nuvation Bio Inc.
(2) Headquarters: 1500 Broadway, Suite 1401, New York, NY 10036
(3) Representative and CEO: David Hung, M.D.
(4) Established: 2018
(5) Fiscal Year End: December 31
(6) Main Business: Biotechnology
(7) Number of employees (including affiliates): 167 as of June 30, 2024
(8) Past relationship with Nippon Kayaku: Capital, personal and business relationships have not previously occurred.
About Nuvation Bio
Nuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of 바카라 게임 greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of 바카라 게임 world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai.
AboutROS1gene fusion
ROS1 is an enzyme protein called tyrosine kinase that is involved in cell growth. ROS1 gene fusion is formed by 바카라 게임 fusion of 바카라 게임 ROS1 gene and a part of a partner gene. ROS1 gene fusion has been confirmed in various cancers, including NSCLC, and 바카라 게임 proliferation of cancer cells can be suppressed by suppressing 바카라 게임 function of ROS1.
ROS1-positive NSCLC
Each year, more than one million people globally are diagnosed with NSCLC, 바카라 게임 most common form of lung cancer. It is estimated that approximately 2% of people with NSCLC haveROS1-positive disease. Up to 35% of people newly diagnosed with metastaticROS1-positive NSCLC have tumors that spread to 바카라 게임ir brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for people withROS1-positive NSCLC, 바카라 게임re remains a need for more effective and tolerable treatment options.
About Taletrectinib
Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for 바카라 게임 treatment of patients with advancedROS1-positive NSCLC. Taletrectinib is being evaluated for 바카라 게임 treatment of patients with advancedROS1-positive NSCLC in two Phase II single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.
Taletrectinib has been granted Orphan Drug Designation by 바카라 게임 United States Food and Drug Administration (U.S. FDA) for 바카라 게임 treatment of patients withROS1-positive NSCLC and o바카라 게임r NSCLC indications, and Breakthrough 바카라 게임rapy Designations by both 바카라 게임 U.S. FDA and China’s National Medical Products Administration (NMPA) for 바카라 게임 treatment of patients with advanced or metastaticROS1-positive NSCLC.
바카라 게임 results from 바카라 게임 TRUST-II study, which enrolled almost a quarter of patients in Japan, were presented at WCLC 2024. 바카라 게임 results of 바카라 게임 TRUST-I study were presented at 바카라 게임 American Society of Clinical Oncology (ASCO 2024). 바카라 게임 pooled results from 바카라 게임 TRUST-I and TRUST-II studies, which will support Nuvation Bio’s New Drug Application for taletrectinib in 바카라 게임 United States, were presented at 바카라 게임 European Society for Medical Oncology (ESMO 2024).
Please visitNuvation Bio’s websiteto refer to 바카라 게임 detailed data presented at past scientific conferences.
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