Six Abstracts of Kelun-Biotech's Clinical Studies Published at the 2025 ASCO Annual Meeting

Kelun-Biotech announced positive clinical trial results for its Sac-™T and Tagitanlimab therapies across multiple cancer types. Sac-™T demonstrated statistically significant improvements in objective response rate (ORR) and progression-free survival (PFS) compared to docetaxel in EGFR-mutated non-small-cell lung cancer (NSCLC) and showed promising results in triple-negative breast cancer. Tagitanlimab, in combination with chemotherapy, significantly reduced the risk of progression or death in recurrent or metastatic nasopharyngeal carcinoma (NPC), with an observed overall survival (OS) benefit; additionally, early results for KL590586 in advanced RET-mutant medullary thyroid cancer (MTC) were also presented.

Analysis

Kelun-Biotech (6990.HK) has presented compelling positive clinical trial data for its oncology portfolio, notably for Sac-™T and Tagitanlimab, reinforcing the "strongly positive" sentiment (0.8) and high market impact score (0.7) associated with these developments. For advanced EGFR-mutated non-small-cell lung cancer (NSCLC), Sac-™T significantly outperformed docetaxel in the OptiTROP-Lung03 study, achieving a confirmed objective response rate (ORR) of 45.1% versus 15.6% and a median progression-free survival (PFS) of 6.9 months versus 2.8 months (HR=0.30), with a favorable safety profile including fewer Grade ≥3 TRAEs (56.0% vs 71.7%) and no ILD. In first-line unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC), Sac-™T demonstrated an ORR of 70.7% and a median PFS of 13.4 months in the OptiTROP-Breast05 study. The combination of Sac-™T with tagitanlimab in first-line advanced NSCLC (OptiTROP-Lung01) yielded a 59.3% ORR and 15.0 months median PFS, with superior outcomes in PD-L1 high expressers. Tagitanlimab, combined with chemotherapy, showed a 53% reduction in risk of progression or death (PFS HR=0.47) in a Phase 3 study for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC), with median PFS not reached versus 7.9 months for the control arm, and an observed overall survival benefit (HR=0.62). Preliminary data for KL590586 in advanced RET-mutant medullary thyroid cancer also showed encouraging activity. These collective results highlight the substantial clinical advancements for Kelun-Biotech's core assets and their potential to address unmet medical needs in significant cancer indications, potentially leading to expanded market approvals and adoption.

Key Decisions for Investors

• Given the robust positive clinical data for Sac-™T and Tagitanlimab, these developments significantly de-risk Kelun-Biotech's pipeline and enhance its growth prospects in the oncology market, suggesting a positive outlook.
• Investors might consider the strong efficacy and safety profiles presented as supportive of potential expanded approvals and market adoption for Sac-™T in NSCLC and TNBC, and for Tagitanlimab in NPC.
• Key upcoming catalysts to monitor include final data readouts, regulatory submissions, approvals, and the company's commercialization strategy for these drug candidates, which will be crucial for future value realization.
• Further due diligence on Kelun-Biotech's valuation is warranted, especially in light of the InvestingPro suggestion of potential undervaluation against its enhanced clinical pipeline and recent positive data.