Kelun-Biotech's TROP2-ADC sac-TMT Secures Second NDA for EGFR-Mutant NSCLC

Overview

Kelun-Biotech new drug application (NDA) for sacituzumab tirumotecan (sac-TMT), formerly known as SKB264/MK-2870, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

About Lung Cancer

• Lung cancer is primarily divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the most common, accounting for approximately 80%-85% of all lung cancer cases. 
• In China, the molecular profile of NSCLC patients often includes EGFR mutations, which occur in about 40%-50% of lung adenocarcinoma cases. 
• Current guidelines recommend EGFR-TKIs as the first-line treatment for stage IV EGFR-mutant NSCLC.

About OptiTROP-Lung03 study

• The OptiTROP-Lung03 study is a multi-centre, randomized clinical trial that evaluated sac-TMT as a monotherapy (5mg/kg every two weeks) administered intravenously, against docetaxel, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
• These patients had previously failed treatment with EGFR-tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. 
• The study demonstrated that sac-TMT significantly improved both the objective response rate (ORR) and progression-free survival (PFS) compared to docetaxel.

This acceptance follows positive results from the pivotal OptiTROP-Lung03 study, as announced by Sichuan Kelun-Biotech Biopharmaceutical.

Challenges in Treatment After EGFR-TKI Resistance

• However, when resistance to EGFR-TKIs develops, platinum-based chemotherapy is typically used, though it is not very effective for patients who have failed both EGFR-TKIs and platinum-based treatments. 
• Docetaxel, the standard single-agent chemotherapy in such cases, has low efficacy, with ORR ranging from 3.2% to 10.8%, a median PFS of about 2 months, and a median overall survival (OS) of 6-8 months.

NDA for sac-TMT

Kelun-Biotech has submitted the NDA for sac-TMT to treat patients with locally advanced or metastatic EGFR-mutant NSCLC who have not responded to EGFR-TKI and platinum-based chemotherapy. This marks the second NDA for sac-TMT accepted by the NMPA. 

The application is set to be included in the CDE’s priority review and approval process, as announced on 14 August 2024. Previously, an NDA for sac-TMT was accepted for patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who had undergone at least two prior systemic therapies.

Company’s Commitment to Innovation

The acceptance of the second NDA for sac-TMT, highlighting the company’s commitment to innovation in drug development. Kelun-Biotech aims to address unmet medical needs through the development of new drugs with unique advantages and global potential, striving for excellence in the field of oncology.

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