Merck Submits Clinical Trial Application in China for HER3-Targeted ADC MK-1022 (Patritumab Deruxtecan)
MSD
Pharmaceutical R&D and Manufacturer
July 24,CDE official shows that MSD has submittedInjectable MK-1022The clinical trial application has been accepted.
MK-1022 (Daiichi Sankyo's development code HER3-DXd,Patritumab deruxtecan) is a potential first-in-class HER3-targeted ADC designed using Daiichi Sankyo's technology. It consists of a fully humanized anti-HER3 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor payload (a derivative of exatecan, DXd) via a cleavable tetrapeptide linker.
On December 22, 2023, Daiichi Sankyo and MSD jointly announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for Patritumab deruxtecan. This drug aims to provide a new treatment option for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have undergone at least two different systemic therapies but whose disease remains uncontrolled.
The final approval date for the drug has been set for June 26, 2024. Notably, this priority review is based on the "Breakthrough Therapy" designation granted by the FDA in December 2021. Despite a temporary delay in the approval process of Patritumab deruxtecan on June 26, 2023, due to issues with the production partner, the drug's efficacy and safety have been fully validated according to existing clinical data.
BLA Based on HERTHENA-Lung01 Study Results: HER3-DXd Demonstrates Durable and Clinically Meaningful Efficacy in 225 Patients with EGFR-Mutated Locally Advanced or Metastatic NSCLC Who Experienced Disease Progression After Prior Treatment with EGFR TKI and Platinum-Based Chemotherapy, with an Objective Response Rate (ORR) of 29.8% (95% CI: 23.9–36.2), Including 1 Complete Response (CR) and 66 Partial Responses (PR). Additionally, the Median Duration of Response (DOR) was 6.4 Months (95% CI: 4.9–7.8), and the Median Progression-Free Survival (PFS) was 5.5 Months (95% CI: 5.1–5.9).
Antitumor Activity
(A) PFS and (B) DOR Kaplan-Meier Plots
In terms of safety, the proportion of patients discontinuing treatment due to treatment-emergent adverse events (TEAEs) was low (7.1%). The incidence rate of TEAEs graded 3 or higher was 64.9%.
At the same time,Patritumab DeruxtecanStill in progressEfficacy Study of Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Treatment (NCT05338970) and HER3-DXd in patients with locally advanced or metastatic solid tumors (gastric cancer and melanoma,NCT06172478）。
Source:
1. CDE Official Website
2. MSD Official Website
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