HQ Team
September 30, 2024: Shanghai Henlius Biotech, Inc., and US-based Organon & Co. announced their end-stage trial for investigational breast cancer had met its main goal of an absence of cancer in treated patients.
The study aimed to compare the efficacy and safety of Perjeta, or pertuzumab, biosimilar HLX11 as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen.
Neoadjuvant therapy is given as a first step to shrink a tumour and includes chemotherapy, radiation therapy and hormone therapy.
Eligible patients in a recent clinical trial were randomly assigned to receive one of two treatments —HLX11, a biosimilar to the drug Perjeta (pertuzumab), or the original Perjeta itself.
Total pathological complete response
Both treatments were given alongside other medications, trastuzumab and docetaxel, every three weeks for four cycles. The study aimed to evaluate how effective and safe HLX11 is compared to the original drug in treating certain types of breast cancer.
“The primary endpoint of this study was met,” according to a statement from Organon. “The primary endpoint of this study was the total pathological complete response (tpCR) rate assessed by an Independent Review Committee.”
The pathological complete response (pCR) rate is the percentage of patients who have a complete absence of cancer in the breast and lymph nodes after treatment. A pathologist examines tissue samples from a biopsy or surgery to determine if there is a pCR.
The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response rate, objective response rate, event-free survival, disease-free survival, safety, pharmacokinetics, and immunogenicity.
Licence and supply agreement
Henlius has a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon.
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.
Tumours that are not classified as HER2-positive are classified as HER2-negative. HR-positive and HER2-negative are the most common breast cancer subtypes, accounting for approximately 70% of all breast cancers.
