China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study of SHR-A1811, a HER2-targeted antibody drug conjugate (ADC), combined with SHR-1316 or pyrotinib for advanced non-small cell lung cancer (NSCLC) with HER2 mutations.
Drug Profile
- SHR-A1811: A HER2-targeted ADC that binds to tumor surface antigens and releases small-molecule toxins via endocytosis. The drug is under investigation in multiple clinical trials (Phase I-III) for HER2-expressing or mutated advanced solid tumors, including breast, gastric, colorectal cancers, and NSCLC.
- Pyrotinib: An in-house developed EGFR/HER2 inhibitor. Conditionally approved in China in August 2018, it received full approval in July 2020 for HER2-positive advanced or metastatic breast cancer in combination with capecitabine. Included in the National Reimbursement Drug List (NRDL) in 2019, it also received conditional approval in June 2023 for neoadjuvant therapy in early or locally advanced HER2-positive breast cancer combined with trastuzumab and docetaxel.
- SHR-1316: A PD-L1 monoclonal antibody (mAb) under clinical study for multiple solid tumors. Awaiting regulatory approval in China for first-line extensive-stage small cell lung cancer in combination with chemotherapy.
Study Details
The Phase Ib/II study will assess the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 combined with SHR-1316 or pyrotinib in patients with advanced NSCLC and HER2 mutations.-Fineline Info & Tech
