Presentation of a global phase II clinical study of a novel ROS1 inhibitor, taletrectinib, in patients with advanced ROS1-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 the global, pivotal phase II study (TRUST-II, NCT04919811) of taletrectinib (development code: AB-106/DS-6051b) were presented at the 65th Annual Meeting of the Japanese Lung Cancer Society (JLCS 2024).
Nippon Kayaku is preparing to file an application for marketing authorization in Japan based on the results of the TRUST-II study for patients with ROS1-positive NSCLC to access taletrectinib as early as possible.
Favorable results from the TKI-naïve and TKI-pretreated patient populations in the TRUST-II study, which enrolled almost a quarter of patients in Japan, were reported at the 2024 World Conference on Lung Cancer (WCLC 2024) held in this September. Additional data from the TRUST-II study presented at JLCS 2024 are the first data reported from the sub-group of Japanese patients.
Patients with locally advanced or metastatic NSCLC who were ROS1-positive were enrolled in the TRUST-II study and were allocated to several cohorts based on their history of prior ROS1 inhibitor treatment.
Among the Japanese patient population, the 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 the overall population (N=159). No treatment-related AE led to death in the overall population nor in Japanese patients.
These results indicate that the favorable efficacy and safety profile of taletrectinib demonstrated in the overall population was consistent with results in the sub-group of Japanese patients.
Table: Responses in Evaluable Patients with ROS1-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 the 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 the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai.
About ROS1 gene fusion
ROS1 is an enzyme protein called tyrosine kinase that is involved in cell growth. ROS1 gene fusion is formed by the fusion of the ROS1 gene and a part of a partner gene. ROS1 gene fusion has been confirmed in various cancers, including NSCLC, and the proliferation of cancer cells can be suppressed by suppressing the function of ROS1.
ROS1-positive NSCLC
Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of people with NSCLC have ROS1-positive disease. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for people with ROS1-positive NSCLC, there 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 the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-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 the United States Food and Drug Administration (U.S. FDA) for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC.
The results from the TRUST-II study, which enrolled almost a quarter of patients in Japan, were presented at WCLC 2024. The results of the TRUST-I study were presented at the American Society of Clinical Oncology (ASCO 2024). The pooled results from the TRUST-I and TRUST-II studies, which will support Nuvation Bio’s New Drug Application for taletrectinib in the United States, were presented at the European Society for Medical Oncology (ESMO 2024).
Please visit Nuvation Bio’s website to refer to the detailed data presented at past scientific conferences.
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