Trodelvy for triple-negative breast cancer reduces the risk of death by 57%!

New drug – Trodelvy for triple-negative breast cancer reduces the risk of death by 57%! Triple-negative breast cancer is one of many types of breast cancer, and it is the most dangerous one.

Recently, the US FDA announced the full approval of the TROP-2 antibody conjugate drug Trodelvy (Sacituzumab Govitecan-hziy) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) adult patients. These patients had previously received 2 or more systemic treatments, at least one of which was used for metastatic disease.

This is the first antibody conjugate approved by the FDA for the treatment of relapsed or refractory mTNBC, and it is also the world’s first approved antibody conjugate targeting Trop-2.

In a phase 3 clinical trial, Trodelvy reduced the risk of disease progression or death by 57% compared with chemotherapy.

▌The most dangerous breast cancer: triple negative breast cancer

According to the global cancer burden data in 2020, there are 2.3 million new cases of female breast cancer, making it the most common type of cancer in the world for the first time. Among newly diagnosed cancer patients, 1 in 8 is a breast cancer patient.

Triple-negative breast cancer accounts for about 20% of all breast cancers. It is highly invasive and belongs to the most difficult type of breast cancer to treat. This type of breast cancer is more common in premenopausal young women, and is also known as “the killer of beauty.”

Triple-negative breast cancer is named because it is negative for estrogen, progesterone receptor or human epidermal growth factor receptor 2 (HER2). This means that specific drugs that target these receptors are usually ineffective in such patients.

Moreover, triple-negative breast cancer progresses rapidly, the prognosis is extremely poor, and the 5-year survival rate is less than 15%. The clinical treatment mainly relies on chemotherapy, and the treatment options are very limited.

For TNBC patients who have previously received other therapies, there is currently no approved standard treatment plan, and there is a large unmet need for treatment.

▌Antibody conjugate drug: Trodelvy

Human trophoblast cell surface antigen 2 (Trop-2) is a cell surface protein that is expressed in a variety of solid tumors, including breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, etc. It plays a role in tumor growth. Key role.

Trop-2 is overexpressed in more than 90% of triple-negative breast cancer cells, and the high expression of Trop-2 may increase the risk of tumor recurrence and poor prognosis.

Trodelvy is an antibody conjugate drug formed by linking the targeting TROP-2 antibody with the active metabolite SN-38 of the chemotherapeutic drug irinotecan. TROP-2 antibody drugs can target cancer cells and bind to Trop-2 to deliver the chemotherapeutic drug SN-38 to the inside of the cancer cells, thereby killing the cancer cells.

In April last year, based on the objective response rate and response duration of the Phase 1/2 study, the FDA announced an accelerated approval for the listing of Trodelvy. The full approval this time expands the scope of use of the drug and will benefit more triple-negative breast cancer patients.

Currently, the drug is used as a monotherapy or in combination with other drugs, and has been clinically tested in various solid tumors including metastatic urothelial cancer, breast cancer, and lung cancer.

It is worth mentioning that Good Doctors learned from the website of the Center for Drug Evaluation (CDE) of the State Drug Administration that the drug has also been approved for clinical trials in China, which is worth looking forward to for domestic triple-negative breast cancer patients.

▌Significantly improve PFS and OS, the gospel of triple-negative breast cancer

This full approval is based on the positive results of an open, actively controlled, randomized Phase 3 ASCENT clinical trial.

The study included 500 patients with relapsed/refractory metastatic triple-negative breast cancer who had received 2 or more systemic therapies (including taxane) and were randomly assigned to receive Trodelvy or standard chemotherapy.

The primary endpoint is the progression-free survival (PFS) of patients with no brain metastases compared to baseline, and the secondary endpoint is the PFS and overall survival (OS) of all patients, regardless of whether they have brain metastases.

The results show that:

Compared with chemotherapy, Trodelvy reduced the risk of disease progression or death by 57%, and the median PFS was extended from 1.7 months to 4.8 months (HR=0.43), with statistically and clinically significant differences;

In addition, compared to chemotherapy, Trodelvy extended the median overall survival (OS) from 6.9 months to 11.8 months (HR=0.51), meaning that the risk of death in the treatment group was reduced by 49%.

Among the 482 patients whose efficacy can be evaluated, Trodelvy is safe and consistent with the previously approved FDA label.

The full approval of Trodelvy is a breakthrough in the treatment of triple-negative breast cancer patients with poor prognosis and is expected to change the standard of treatment for such patients.

In recent years, the treatment of triple-negative breast cancer has made great progress.

Immunotherapy: In March 2019, the FDA approved the immunotherapy drug atelizumab combined with Abraxane (albumin paclitaxel) for the first-line treatment of PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer.

(source:internet, reference only)

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