Lung cancer is the leading cause of cancer incidence and mortality in China, with approximately 3% of advanced non-small cell lung cancer (NSCLC) patients harboring ROS1 gene fusion mutations. Although first-generation ROS1 inhibitors have provided significant survival benefits, challenges such as drug resistance and poor control of brain metastases remain. On January 2, 2025, the National Medical Products Administration (NMPA) announced the approval of AnHeart Therapeutics's Taletrectinib (AB-106) capsules for a new indication: the treatment of ROS1-positive locally advanced or metastatic NSCLC in adult patients who have not received prior ROS1-TKI therapy. This innovative drug, known for its "strong blood-brain barrier penetration and high efficacy against resistance mutations," offers renewed hope for overcoming drug resistance and achieving long-term survival for advanced lung cancer patients.

First Prescription of  Taletrectinib in Beijing

On February 7, 2025, Dr. Wang Shasha from the Department of Thoracic Oncology at Beijing GoBroad Hospital made a significant advancement by issuing  the first in-hospital prescription for Taletrectinib in Beijing. The patient, a 51-year-old male, was diagnosed with stage IV adenocarcinoma of the right lung (ROS1 fusion-positive), which had unfortunately progressed to include brain metastasis, pleural metastasis, and malignant pleural effusion.

After receiving crizotinib as first-line therapy for 13 months, the patient experienced disease progression, including increased pleural lesions and pleural effusion, leading to a progression disease (PD) assessment. Following a thorough evaluation by Director Qin Haifeng from the Department of Thoracic Oncology/Onco-Immunotherapy, the decision was made to initiate second-line therapy with Taletrectinib. This new-generation ROS1 inhibitor was chosen with the expectation that it would enhance the patient's condition and maintain their quality of life compared to traditional chemotherapy. This new treatment option has rekindled hope for the patient, with the anticipation of better therapeutic outcomes and survival benefits.

Taletrectinib: A Breakthrough Solution Against ROS1 Drug Resistance

 Taletrectinib is a new-generation highly selective ROS1/NTRK inhibitor with three significant advantages:

1. Strong Blood-Brain Barrier Penetration: It effectively manages brain metastases, addressing the limitations of first-generation drugs in intracranial efficacy.
2. Broad-Spectrum Resistance Mutation Coverage: It successfully inhibits common resistance mutations such as ROS1 G2032R and L2026M.
3. Durable and Deep Remission: As a first-line therapy, it shows an objective response rate (cORR) of 89%, with a median progression-free survival (PFS) of 46 months.

Indication: For adult patients with ROS1-positive locally advanced or metastatic NSCLC who have experienced progression following ROS1-TKI therapy.

Impressive Clinical Data: Breakthroughs in First-Line and Second-Line Therapy

 Based on data from the pivotal TRUST-I/II clinical trials, Taletrectinib has shown remarkable efficacy:

• First-Line Therapy: cORR of 89%, median duration of response (DOR) of 44 months, and median PFS of 46 months.
• Second-Line Therapy (following resistance to Crizotinib or Entrectinib): cORR of 56%, median DOR of 17 months, and median PFS of 10 months.
• Resistance Mutation Solution: Achieved an ORR of 66.7% in patients with G2032R mutations, effectively tackling the challenge of drug resistance.

The introduction of Taletrectinib signifies a new era of precision treatment for lung cancer at our hospital, characterized by "solvable resistance and controllable brain metastases." By incorporating this medication into our clinical protocols, we are excited to offer more ROS1-positive patients the chance for longer survival and improved quality of life.

 As a pioneer in the research-oriented hospital model, Beijing GoBroad Hospital is committed to innovation in research and development, outcome transformation, and product application. By integrating innovative drugs with personalized treatment plans, we aim to help patients achieve the goal of "coexist with cancer." We will continue to promote the expedited introduction of innovative drugs, enhance clinical application, expand payment options, and strengthen support services, ensuring that innovative therapies truly benefit our patients.