Recently, Kelun Biotech announced that its TROP2-targeted ADC drug sac-TMT (sac-TMT, R&D code SKB264/MK-2870) was approved by the NMPA for a third indication for the treatment of adult patients with EGFR-positive non-squamous non-small cell lung cancer (NSCLC) that progressed after EGFR-TKI treatment.

Lung cancer is the number one malignant tumor in my country. Its pathological classification mainly includes non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most common pathological type, accounting for approximately 80%-85% of all lung cancer patients.

EGFR mutations are the most common tumor-driving gene mutations in lung cancer. First-line treatment is primarily with third-generation EGFR-TKI targeted therapy, but patients inevitably develop drug resistance after receiving this type of therapy. Treatment options for EGFR-TKI resistance are very limited, and platinum-based doublet chemotherapy is currently the primary standard of care. However, these treatment options are suboptimal, particularly in extending overall patient survival. This creates a significant unmet clinical need, and new drugs are urgently needed to improve patient survival.

Lukangsatuzumab is a novel TROP2 ADC developed by Kelun Biotech. It utilizes a novel linker to conjugate KL610023, a belotecan-derived topoisomerase I inhibitor, as a payload, achieving a drug-to-antibody ratio (DAR) of 7.4. KL610023 not only induces DNA damage in tumor cells but also possesses cell membrane permeability, enabling a bystander effect, killing neighboring tumor cells.

Its Phase III clinical study (OptiTROP-Lung04) showed that in the pre-set OS interim analysis, compared with the current standard treatment regimen (platinum-containing doublet chemotherapy), monotherapy with ruconazole achieved statistically significant and clinically significant improvements in progression-free survival (PFS) and OS, effectively prolonging patients' survival.

This is the first and only ADC in the world to date that has shown significant overall survival (OS) benefit compared to platinum-based doublet chemotherapy and has been approved for the treatment of advanced NSCLC that has progressed after TKI treatment alone (2L).

It is worth mentioning that the study has been selected as the latest breakthrough abstract (LBA) of the 2025 European Society for Medical Oncology (ESMO) Congress and will be released in the form of an oral report at the Presidential Symposium (report number: LBA5).

In addition, Rukansatuzumab has previously been approved for the treatment of two indications: unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) that has received at least two previous systemic therapies, and locally advanced or metastatic non-squamous NSCLC that is EGFR mutation-positive and has progressed after EGFR-TKI and platinum-containing chemotherapy.

As Kelun Biotech's core product, in addition to these three approved indications, the company is also conducting multiple clinical studies on the use of Lukang Satuzumab in the treatment of various solid tumors.

In China, Kelun Biotech has conducted nine registrational clinical studies. Among them, the Phase III registrational clinical study of rukangsatuzumab combined with osimertinib as the first-line treatment for locally advanced or metastatic non-squamous NSCLC with EGFR mutations has completed enrollment of all patients in China. The new marketing application for rukangsatuzumab for the treatment of unresectable, locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC, which has previously received endocrine therapy and other systemic therapies in the advanced or metastatic stage, has been accepted by the CDE and has been included in the priority review and approval process.

In the international market, Kelun Biotech exclusively licensed sac-TMT rights outside of Greater China to Merck in May 2022. Currently, Merck has initiated 14 ongoing global Phase 3 clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anticancer drugs for various types of cancer.

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