Regulatory & Policy

China grants breakthrough status to CSPC’s EGFR ADC in AGA-negative NSCLC

Edited by Robert McTiernan··2 min read
China grants breakthrough status to CSPC’s EGFR ADC in AGA-negative NSCLC

CSPC Pharmaceutical Group Ltd (HKEX: 01093) announced that China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to SYS6010, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC), for recurrent or metastatic actionable genomic alteration (AGA)-negative non-squamous non-small cell lung cancer (NSCLC) that has progressed on prior immunotherapy and platinum-based chemotherapy.

The designation covers a patient population that accounts for approximately 40% of all NSCLC cases in China, according to CSPC. Following first-line failure, this group has limited options beyond single-agent chemotherapy, which the company said delivers suboptimal response rates and modest survival benefits.

SYS6010 is composed of a humanised anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker. The construct binds EGFR on tumour cell surfaces and releases its cytotoxic payload upon internalisation. CSPC reported that in AGA-negative non-squamous NSCLC, SYS6010 produced a progression-free survival (PFS) more than twice that of standard treatment and demonstrated a durable objective response, though specific response rate figures and patient numbers were not disclosed in the announcement.

A randomized, open-label, multicentre Phase III trial comparing SYS6010 monotherapy against investigator-selected chemotherapy in AGA-negative locally advanced or metastatic non-squamous NSCLC that has failed standard treatment is currently underway.

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The NMPA's Breakthrough Therapy Designation is intended to accelerate development and review of drugs that show substantial improvement over existing therapies for serious conditions. This is now the fourth such designation CSPC has received for SYS6010 in China. Previous designations covered EGFR mutation-positive NSCLC after failure of EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy; unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after first-line platinum-based chemotherapy and immune checkpoint inhibitors; and recurrent or metastatic head and neck squamous cell carcinoma after immunotherapy and platinum-based chemotherapy.

The AGA-negative NSCLC setting is also being targeted by Daiichi Sankyo and AstraZeneca's TROP2-directed ADC datopotamab deruxtecan (Datroway). The Phase III TROPION-Lung17 study is comparing the drug with docetaxel in previously treated, TROP2 NMR-positive non-squamous NSCLC without actionable genomic alterations following platinum-based chemotherapy and anti-PD-(L)1 therapy.

The Phase III trial in this indication is enrolling.

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