Bayer's Pan-Cancer TRK Inhibitor Selitrectinib Granted IND Approval in China for NTRK Fusion-Positive Tumors

The latest public announcement from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration indicates that Bayer’s investigational new drug application for selitrectinib powder for oral suspension, submitted as a Class 1 chemical drug, has received implicit approval. The product is intended for the treatment of NTRK fusion-positive tumors in adults and pediatric patients. Publicly available information shows that selitrectinib, originally developed by Loxo Oncology under the code name LOXO-195, is a “tumor-agnostic” candidate capable of inhibiting TRK proteins that have developed resistance to existing TRK inhibitors. Bayer acquired exclusive development rights to this product following Eli Lilly and Company’s acquisition of Loxo Oncology.

In tumors with tropomyosin receptor kinase (TRK) fusions, the NTRK gene fuses with unrelated genes, resulting in the production of aberrant TRK proteins. These aberrant TRK or TRK fusion proteins are constitutively activated, thereby triggering persistent signaling cascades. In patients with TRK fusion cancers, these proteins are the primary drivers of tumor growth and metastasis. TRK fusion cancers are not restricted to specific cell or tissue types and can occur anywhere in the body. Tumor types harboring NTRK gene fusions include breast cancer, colorectal cancer, lung cancer, thyroid cancer, and others. Cancer patients need to undergo specific testing based on next-generation sequencing (NGS) or immunohistochemistry (IHC) to confirm the presence of TRK fusion cancers.

Selitrectinib is a next-generation TRK inhibitor developed by Loxo Oncology. Previously, this “broad-spectrum” anticancer drug has demonstrated superior efficacy in treating patients with solid tumors harboring NTRK gene fusions, and it is also capable of treating patients with solid tumors that have developed resistance to the oral TRK inhibitor Vitrakvi.

Based on the results demonstrated in early clinical trials of selitrectinib, the candidate drug achieved an objective response rate (ORR) of 45% in 20 patients with solid tumors who had previously received treatment with a TRK inhibitor and developed resistance. Although this study is still in the early clinical phase, it suggests that selitrectinib may help address the unmet medical needs of patients with solid tumors who have developed resistance to existing TRK inhibitors.

According to the ClinicalTrials.gov website, this product is currently being studied in a two-part Phase 1 and Phase 2 trial involving dose escalation and expansion in pediatric and adult cancer patients.

Congratulations on the approval of Bayer’s selitrectinib for clinical trials in China. We hope that the subsequent clinical development of this product will proceed smoothly, bringing innovative therapies to cancer patients at an early date.

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