December 20，2024 ，China’s National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) of DOVBLERON ® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated the potential of DOVBLERON® to address unmet needs, particularly in patients with limited therapeutic options after treatment with prior ROS1-targeted therapies.
As of November 29, 2023, 173 Chinese patients (106 TKI naїve; 67 crizotinib-pretreated) received taletrectinib.Among 106 TKI-naїve patients, IRC-assessed cORR was 90.6% (95% CI, 83.33 to 95.38) with four (3.8%) patients achieving CR and 92 (86.8%) achieving PR. The DCR was 95.3% (95% CI, 89.33 to 98.45), and the median TTR was 1.4 months (95% CI, 1.38 to 1.41). With a median follow-up of 22.1 months and 23.5 months, neither median DOR or median PFS were reached; the 24-month DOR and PFS were 78.6% (95% CI, 66.86 to 86.56) and 70.5% (95% CI, 59.17 to 79.16), respectively.
Among 66 crizotinib-pretreated patients, IRC-assessed cORR was 51.5% (95% CI, 38.88 to 64.01) with 34 (51.5%) patients achieving PR . The DCR was 83.3% (95% CI, 72.13 to 91.38), and the median TTR was 1.4 months (95% CI, 1.38 to 1.41). With 8.4 months and 9.7 months of follow-up, the median DOR was 10.6 months (95% CI, 6.31 to not reached [NR]), and the median PFS was 7.6 months (95% CI, 5.52 to 11.96). The 9-month DOR and PFS rates were 69.8% (95% CI, 47.94 to 83.84) and 47.4% (95% CI, 33.50 to 60.02), respectively. Similar results were seen when assessed by investigators .
About DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® 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, the active ingredient in DOVBLERON ®is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II(NCT04919811), a global study.
Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive. Furthermore, brain metastases are a common challenge, affecting up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC, and increasing to as much as 55% of patients whose cancer has progressed following initial treatment. In addition, patients treated with approved ROS1 TKIs often develop resistance mutations to these therapies, representing a major limitation for patients in terms of duration of response. The approval of DOVBLERON® provides a new and effective treatment option for patients who are no longer responding to previously approved therapies.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Press Release (innoventbio.com)
3.https://ascopubs.org/doi/10.1200/JCO.24.00731?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Post time: Dec-27-2024