#USA #Chicago #Kelun-Biotech #TROP2 ADC #Sac-TMT

Kelun-Biotech Unveils Key Studies at 2025 ASCO Annual Meeting

The American Society of Clinical Oncology (ASCO) Annual Meeting 2025 is set to take place in Chicago, Illinois, from May 30 to June 3. Among the participants, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HK Stock No: 6990) has generated significant attention with the presentation of six pivotal clinical studies. These studies highlight the promising results of their innovative treatments, including the TROP2 antibody-drug conjugate, sac-TMT, along with other compounds like anti-PD-L1 mAb tagitanlimab and the RET inhibitor KL590586 (A400/EP0031).

Discoveries Highlighted at the Meeting

1. Advanced EGFR-Mutant NSCLC Treatment with Sac-TMT

Kelun-Biotech's OptiTROP-Lung03 study, which focuses on previously treated advanced non-small-cell lung cancer (NSCLC) associated with epidermal growth factor receptor (EGFR) mutations, showed impressive outcomes. In this randomized study involving 137 patients, sac-TMT demonstrated a significantly higher objective response rate (ORR) of 45.1% compared to 15.6% for docetaxel. The progression-free survival (PFS) was also notable, with 6.9 months reached for the sac-TMT group compared to just 2.8 months in the comparator group, affirming the drug's potential in this challenging patient population.

The success of sac-TMT not only leads to improved outcomes for patients but also resulted in its approval for treating EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC in China, marking a historic milestone as the first TROP2 ADC approved for lung cancer globally.

2. Sac-TMT in Triple-Negative Breast Cancer (TNBC)

Another significant presentation at ASCO was from the Phase 2 OptiTROP-Breast05 study, showcasing sac-TMT as a first-line treatment for unresectable locally advanced or metastatic TNBC. With 41 patients enrolled, the study observed an ORR of 70.7% and a disease control rate (DCR) of 92.7%. These outcomes highlight sac-TMT's potential to transform TNBC treatment paradigms, offering substantial hope for patients who have few alternatives.

3. Combination Therapies and Novel Results

Kelun also explored the effects of sac-TMT in combination with tagitanlimab in a Phase 2 study for advanced NSCLC without actionable genomic alterations, achieving an ORR of 59.3% and median PFS of 15.0 months after follow-ups. These findings hint at a synergistic effect between the two agents that could enhance patient outcomes.

In another notable study, they evaluated tagitanlimab against a placebo combined with gemcitabine and cisplatin for recurrent or metastatic nasopharyngeal carcinoma (NPC). The results indicated a significant benefit with tagitanlimab, which led to a 53% reduction in the risk of disease progression or death, showcasing its promising role in this aggressive cancer type.

4. Insights into KL590586 (A400/EP0031)

Kelun-Biotech is also focusing on KL590586, a next-generation selective RET inhibitor currently in pivotal clinical studies for NSCLC and medullary thyroid cancer (MTC). Positive data from the Phase 1 trial were presented, showcasing a 63.0% confirmed ORR in RET-mutant MTC patients, highlighting the agent's potential in targeted cancer therapies.

Looking Ahead

As Kelun-Biotech moves forward with these breakthrough studies, it reflects its commitment to pushing the boundaries of innovative cancer therapies. The results being showcased at the ASCO Annual Meeting reinforce the company’s position as a key player in the biopharmaceutical landscape. With the exciting potential of sac-TMT and other agents, Kelun is poised to make significant contributions to oncology treatment protocols in the near future.

For further updates and detailed information on these studies, stay tuned for the presentations at ASCO 2025.