The British Medical Journal Publishes Study Results on Sacituzumab Tirumotecan for Previously Treated EGFR-Mutant Advanced NSCLC

Kelun-Biotech announced positive results from its OptiTROP-Lung03 study, demonstrating that sac-™T monotherapy achieved statistically significant and clinically meaningful improvements in objective response rate (45% vs 16%), progression-free survival (6.9 months vs 2.8 months), and overall survival compared to docetaxel in patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-TKI and platinum-based chemotherapy. The study also showed a manageable safety profile for sac-™T, with fewer Grade ≥ 3 treatment-related adverse events compared to docetaxel (56% vs 71.7%). These results support the ongoing development of sac-™T in NSCLC across various treatment settings and combination regimens, with five company-led registrational clinical studies currently underway.

Analysis

The OptiTROP-Lung03 study results for Kelun-Biotech's (6990.HK) sac-™T monotherapy represent a significant clinical advancement for patients with locally advanced or metastatic EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) who have progressed after EGFR-TKI and platinum-based chemotherapy. Sac-™T demonstrated statistically significant and clinically meaningful superiority over docetaxel, with a confirmed objective response rate (ORR) of 45% (95% CI, 35-56) versus 16% (95% CI, 7-30) and a median progression-free survival (PFS) of 6.9 months (95% CI, 5.4-8.2) compared to 2.8 months (95% CI, 1.6-4.1) (Hazard Ratio [HR]=0.30, 95% CI, 0.20-0.46, one-sided p<0.0001), as assessed by Blinded Independent Review Committee (BIRC). Importantly, even with a 36.4% crossover rate from the docetaxel arm to sac-™T, an improvement in overall survival (OS) was observed (HR=0.49, 95% CI, 0.27-0.88, one-sided p=0.007), and a pre-specified rank-preserving structural failure time (RPSFT) model adjusted for crossover showed a median OS of 9.3 months for docetaxel versus not reached for sac-™T (HR=0.36, 95% CI, 0.20-0.66). Furthermore, sac-™T exhibited a more manageable safety profile, with Grade ≥ 3 treatment-related adverse events (TRAEs) occurring in 56.0% of patients, compared to 71.7% in the docetaxel group. These strong efficacy and safety data, reflected in a "strongly positive" general sentiment score of 0.8 and a specific ticker sentiment of 0.9 for 6990.HK, underscore the potential of sac-™T, a novel TROP2 ADC with proprietary intellectual property. The company's extensive development plan, including five ongoing company-led registrational studies for sac-™T in various NSCLC settings, signals a strategic focus to maximize this asset's potential, further supported by the InvestingPro insight suggesting potential undervaluation of 6990.HK.

Key Decisions for Investors

• Re-assess Kelun-Biotech's (6990.HK) valuation upwards, considering the strong sac-™T Phase 3 data significantly de-risks this core asset and enhances its market potential in a key NSCLC segment.
• Monitor upcoming catalysts from the five ongoing registrational studies for sac-™T, as further positive readouts could substantially broaden its application and commercial value for Kelun-Biotech.
• Focus investment thesis on Kelun-Biotech (6990.HK) due to its direct exposure and high positive sentiment (0.9), as the impact on parent Kelun Pharmaceutical (002422.SZ) appears limited based on neutral sentiment.