Congratulations! FAB Supports Approval of ROS1 Inhibitor Taletrectinib for the Treatment of Non-Small Cell Lung Cancer!

On December 20, 2024, the official website of China's National Medical Products Administration (NMPA) announced that the marketing application for taletrectinib adipate capsules, submitted by AnHeart Therapeutics (now a company under Nuvation Bio), had been approved. It is indicated for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior ROS1 tyrosine kinase inhibitor (TKI) therapy.

FAB, as China’s leading medical imaging CRO, provided Independent Review Committee (IRC) services for the Phase II clinical study of this drug.

Source: NMPA

Taletrectinib is an oral, potent, brain-penetrant, next-generation selective ROS1 inhibitor. The product had previously received Breakthrough Therapy Designation from the U.S. FDA for the treatment of ROS1-positive NSCLC, and was included in the Breakthrough Therapy Program by the Center for Drug Evaluation (CDE) of China for adult patients with advanced or metastatic ROS1-positive NSCLC, both those previously treated and those not previously treated with a ROS1 TKI. It is worth mentioning that a second New Drug Application (NDA) for taletrectinib has also been accepted by the CDE and granted priority review, for the first-line treatment of adult patients with ROS1-positive NSCLC. Both NDAs are based on the positive results from the Phase 2 TRUST-I study.

The TRUST-I study is a multicenter, open-label, single-arm, Phase 2 study, primarily consisting of two cohorts: ROS1-TKI naïve and crizotinib-pretreated. A total of 173 patients with advanced ROS1-positive NSCLC receiving taletrectinib monotherapy were analyzed. Results showed that in TKI-naïve patients, the confirmed Objective Response Rate (cORR) assessed by the Independent Review Committee (IRC) was 91%, while in subjects who had failed prior crizotinib treatment, the cORR was 52%. Taletrectinib also continued to demonstrate potent antitumor activity in patients with measurable brain metastases and in those with acquired resistance mutations (including G2032R).

At a median follow-up time of 23.5 months in TKI-naïve patients, the median Duration of Response (DoR) and median Progression-Free Survival (PFS) assessed by the IRC were not reached. At a median follow-up time of 9.7 months in patients who failed prior crizotinib treatment, the median DoR and median PFS assessed by the IRC were 10.6 months and 7.6 months, respectively. The safety profile of taletrectinib was consistent with previous reports, with a low incidence of neurological adverse events.

Source: Innovent Biologics

Since 2019, FAB has established a collaborative partnership with Biotheus. As the service partner, FAB leveraged its deep industry expertise, extensive practical experience, seasoned expert team, efficient project management system, and strong medical support capabilities to ensure the project deliverables were completed on time and with high quality, providing robust support for the successful approval of the product.

A compliant evaluation system was designed according to the specific requirements of the trial protocol, providing excellent technical support for the project. Meanwhile, the self-developed system achieved fully electronic and integrated management throughout the process, significantly improving the efficiency and accuracy of efficacy evaluation, ensuring the integrity of database records and storage, and safeguarding the authenticity and reliability of the clinical study endpoint data.

From project initiation, central image review, to project management and follow-up, FAB maintained efficient communication with all parties. Whether it was medical imaging inquiries from the sponsor or research sites, FAB provided immediate and professional feedback. Faced with the stringent timelines for image review, FAB planned ahead and coordinated expert schedules to ensure each review session proceeded smoothly as planned.

Throughout the years of collaboration, both parties shared a common belief, cooperated seamlessly, and worked together to overcome numerous challenges. During the on-site inspection by the NMPA, the FAB team, with a professional attitude and knowledge, actively and patiently responded to various challenging questions from the inspectors and met all requirements, delivering a perfect performance for the on-site inspection. Biotheus highly commended the work of the FAB team, sending multiple letters of appreciation and expressing a strong desire for continued collaboration.

It is worth noting that this is the 7th project successfully supported by FAB for approval in the field of lung cancer, and also the 30th approved project since its establishment in 2012. Currently, FAB has seen 50 projects submit NDA applications, with 40 projects having passed inspection. Behind these numbers lies the relentless effort, professional competence, and efficient execution of the FAB team, as well as the trust and support of the sponsors.

Looking ahead, FAB will continue to adhere to high quality and professional services, providing scientific, professional, and efficient independent efficacy evaluation services for new drug research and development, ensuring study quality, and assisting sponsors in accelerating the development and approval of high-quality new drugs to benefit more patients.