Kelun-Biotech Presents Positive Clinical Trial Data at ASCO 2025

Analysis reveals significant industry trends and economic implications

Release Date

2025-05-23

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Kelun-Biotech announced the publication of six abstracts from its clinical studies at the 2025 ASCO Annual Meeting. The abstracts highlight data on three key drug candidates: sac-TMT (TROP2 ADC), tagitanlimab (anti-PD-L1 mAb), and KL590586 (RET inhibitor). Positive results were reported across multiple indications, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Sac-TMT demonstrated significant improvements in objective response rate and progression-free survival compared to docetaxel in a study of previously treated EGFR-mutated NSCLC. The data led to sac-TMT's approval in China for this indication. Further positive results were seen for sac-TMT in TNBC and in combination with tagitanlimab in NSCLC. Tagitanlimab also showed efficacy in combination with chemotherapy for R/M NPC. KL590586 showed promising results in a Phase 1 study for RET-mutant medullary thyroid cancer.

Key Highlights

  • Positive results for sac-TMT (TROP2 ADC) in multiple cancer types, including NSCLC and TNBC.
  • Tagitanlimab (anti-PD-L1 mAb) demonstrated efficacy in combination with chemotherapy for R/M NPC.
  • KL590586 (RET inhibitor) showed promising results in a Phase 1 study for RET-mutant medullary thyroid cancer.
  • Sac-TMT received approval in China for EGFR mutation-positive NSCLC.

Drug used in other indications

Based on the provided context, there is no information available about "sac-TMT" being trialed for any indications, including Non-small cell lung cancer (NSCLC). The context does not contain any reference to a treatment or clinical trial called "sac-TMT."

The context mentions various other treatments for NSCLC including: - MET tyrosine kinase inhibitors (TKIs) like capmatinib, tepotinib, and savolitinib - EGFR tyrosine kinase inhibitors - Combination therapies like avelumab plus axitinib - Docetaxel plus cisplatin and gemzar plus cisplatin regimens - Selpercatinib for RET fusion-positive NSCLC - Larotrectinib for tumors harboring NTRK gene fusions - Targeted therapies (tepotinib, ensartinib, crizotinib, erlotinib) - Immunotherapies (sintilimab, pembrolizumab, nivolumab, ipilimumab) - Radiotherapy approaches

However, since the context does not contain information specifically about "sac-TMT" or its trials, no details can be provided about other indications it might be trialed for or the intervention models used in such trials.

Emerging Mechanism of Action

Emerging Mechanisms of Action for NSCLC Treatment

Immune Checkpoint Inhibitors

Immune checkpoint inhibitors have emerged as promising therapeutic agents in advanced NSCLC. Specifically, PD-1 and PD-1 ligand inhibitors (including nivolumab, MK3475, and MPDL3280) have demonstrated clinical efficacy in patients with advanced/metastatic NSCLC in early clinical trials. Pembrolizumab, a programmed cell death-1 inhibitor, has become an important option in the treatment of metastatic NSCLC. Overall, T-cell checkpoint inhibitors are revolutionizing the management of advanced cancers including NSCLC.

EGFR Tyrosine Kinase Inhibitors (TKIs)

EGFR tyrosine kinase inhibitors remain critical in NSCLC treatment. First-line treatment for EGFR mutation-positive NSCLC includes gefitinib, erlotinib, and afatinib. However, approximately half of the patients with EGFR-mutated NSCLC treated with EGFR-TKIs develop disease progression within 1 year. When disease relapse occurs, investigation for T790M mutation must be made with re-biopsy or liquid biopsy, and osimertinib administered when T790M is diagnosed. Research shows that erlotinib has potent antitumour activity in A549 cells by activating ROS-dependent, JNK-driven cell apoptosis.

MET Inhibition

MET inhibition is an emerging mechanism of action for NSCLC. MET amplification is recognized as an oncogenic driver in lung cancer. Notably, responses to MET TKI have been observed even in patients with low-level amplification. Crizotinib has been used to treat lung adenocarcinoma harboring MET amplification. However, KRAS mutations may act as a resistance mechanism to MET inhibition in MET dependent lung cancer.

Multi-targeted ErbB Family Inhibitors

Multi-targeted ErbB family inhibitors are being developed for NSCLC treatment. Afatinib, dacomitinib, and neratinib inhibit multiple members of the ErbB family and bind their targets irreversibly. These agents have shown clinical activity in NSCLC and other malignancies. Afatinib is approved for EGFR mutation-positive NSCLC and is in development for squamous NSCLC. Dacomitinib is in phase III of clinical development for NSCLC.

Advanced Therapeutic Approaches

Nucleic acid therapies represent promising approaches to modulate the tumor microenvironment to a pro-immunogenic phenotype. Additionally, advanced nanomedicines can be engineered to enable clinical translation of promising cancer immunotherapies.

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