Overview –
Breast cancer and [vic-]trastuzumab duocarmazine (SYD985) and
In a recent press release by Byondis, the pharmaceutical company expressed excitement and optimism about the clinical results of their new drug, [vic-]trastuzumab duocarmazine (SYD985).
This antibody-drug conjugate (ADC) aims to help patients with HER2-positive breast cancer, where the tumor is unresectable (e.g., locally advanced, metastases).
The purpose of the clinical trial is to compare the effectiveness of [vic-]trastuzumab duocarmazine with a physician’s choice of chemotherapy. In other words, a set of patients in the study received [vic-]trastuzumab duocarmazine, whereas another group took a combination of chemotherapy drugs recommended by an oncologist.
What is [Vic-]trastuzumab duocarmazine?
[Vic-]trastuzumab duocarmazine is a drug that targets cancer cells. It contains a monoclonal antibody –trastuzumab – and valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole, a cleavable linker-drug.
The monoclonal antibody component of the drug binds to cancer cells that express the HER2 protein on their surface. Once the agent locks with the receptor, it gets internalized into the cell.
The final step revolves around damaging the DNA and inducing cell death, which effectively targets breast cancer cells.
FDA approval of trastuzumab duocarmazine
In January 2018, [Vic-]trastuzumab duocarmazine was granted a fast-track designation by the Food and Drug Administration (FDA) to treat patients with HER2-positive metastatic breast cancer.
The approval was encouraged by the results of the second part of the phase 1 trial, which showed:
- Objective response rate (ORR) of 33%
- Median progression-free survival (PFS) of 9.4 months
Objective response rate: the tumor objective response rate (ORR) is the assessment of the total amount of tumor (cells/mass) after receiving treatment.
Progression-free survival (PFS) – this parameter is defined as the time during or after receiving cancer treatment when the patient lives with the disease, but it does not get worse.
The details of the study which is called the “TULIP trial”
In the clinical trial, 436 patients with breast cancer participated.
The criteria for enrollment included:
Age – participants had to be above 18 years old
Treatment progress – progressed during or after at least 2 HER2-targeting treatment regimens for locally advanced or metastatic disease
The patients were then randomized to receive [Vic-]trastuzumab duocarmazine or a physician’s choice of chemotherapy. Note that the treatment with either drug persisted until toxicity reached intolerable levels
To analyze the results objectively, researchers assessed for the following clinical parameters:
- Overall survival (OS)
- Objective response rate (ORR)
- Quality of life
- Safety of the drug
Hopefully, the detailed results of the TULIP trial will reveal more information about the superiority of trastuzumab duocarmazine over a physician’s choice of chemotherapy.
According to reports, Byondis plans to submit its biologics license application before the end of 2021.
Takeaway message for breast cancer patients
The initial results released by this study give both patients and physicians hope about the clinical advances that can be provided by [Vic-]trastuzumab duocarmazine in the treatment of HER2-positive metastatic breast cancer.
We hope that this article managed to simplify this complex topic into understandable bits.
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