SKB BIO-B (06990) announced that its Trophoblast Cell Surface Antigen 2 (TROP2)-targeting Antibody-Drug Conjugate (ADC), Sac-TMT (also known as SKB264/MK-2870) (Jiatailai®), in combination with Merck's anti-Programmed Cell Death Protein 1 (PD-1) monoclonal antibody, Pembrolizumab (Keytruda®), has been granted a Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have a Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) of ≥1% and who are negative for Epidermal Growth Factor Receptor (EGFR) gene mutations and Anaplastic Lymphoma Kinase (ALK).
The Breakthrough Therapy Designation is primarily granted to drug candidates that provide an effective treatment option for conditions with no current effective therapies, or that demonstrate significant clinical advantages over existing treatments.
For drugs included in the Breakthrough Therapy program, under qualifying circumstances, applications for conditional approval and priority review can be submitted when filing for marketing authorization.
Previously, the company disclosed results from the Phase 3 OptiTROP-Lung05 clinical trial evaluating Sac-TMT combined with Pembrolizumab as a first-line treatment for PD-L1 positive NSCLC. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in Progression-Free Survival (PFS), and a trend towards benefit was observed in Overall Survival (OS).
The OptiTROP-Lung05 study is the first Phase 3 clinical trial of an immunotherapy combined with an ADC to meet its primary endpoint in the first-line treatment of NSCLC.
Receiving this Breakthrough Therapy Designation for the first-line treatment of PD-L1 positive NSCLC is expected to facilitate and accelerate the review and potential market approval process for Sac-TMT in this specific indication.