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Another anticancer drug approved! There is hope for the most difficult-to-treat breast cancer patients

Time：2023-02-01 22:36:20 source：psychiatricethics.com author：Relax Read：993次

Another anticancer drug approved! There is hope for the most difficult-to-treat breast cancer patients

Today (June 10, 2022), the official website of the China National Medical Products Administration (NMPA) announced the latest announcement that the marketing application of goxatuzumab for injection has been approved. According to previously published information, the approved indication is for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two systemic therapies (at least one of which is for metastatic disease). . Goxatuzumab is the world's first approved TROP-2-targeting antibody-drug conjugate (ADC), and in the treatment of triple-negative breast cancer patients, it significantly improves progression-free survival compared with standard therapy period and overall survival. (Screenshot source: NMPA official website)

Where is goxatuzumab sacred?

Antibody-drug conjugate (ADC) is a new class of targeted drugs consisting of monoclonal antibodies (mAbs), cytotoxic drugs and linkers between them. The tropism selectively delivers cytotoxic molecules to tumor cells, exerting anti-cancer effects while avoiding the effects on healthy cells. Simply put, the advantage of ADC is better anti-tumor effect and fewer adverse reactions. Sacituzumab govitecan is an ADC consisting of an antibody targeting TROP-2 and a topoisomerase 1 inhibitor. TROP-2, the full name of human trophoblast cell-surface antigen 2, is a protein that is overexpressed in many epithelial cancers, and high expression is associated with poor cancer survival and recurrence. Goxatuzumab binds to the TROP-2 protein to deliver the active metabolite (SN-38) of the chemotherapeutic drug irinotecan to the interior of cancer cells. With such a powerful combination, the anti-cancer effect has an amazing effect of "1+1>2". SN-38 is a cancer drug that blocks an enzyme called topoisomerase I, which is involved in DNA synthesis in replicating cells, and by blocking this enzyme, it prevents cancer cells from multiplying and ultimately dying. In addition, the drug exclusively has a hydrolyzable linker that can be attached to the payload, and this unique design ensures its potent activity in TROP-2 expressing cells and the adjacent microenvironment, further enhancing the anticancer effect.

Why is it an anticancer weapon for triple negative breast cancer?

Triple-negative breast cancer (TNBC) is one of the most refractory types of breast cancer. Triple negative is when estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) are all negative, which makes endocrine therapy or HER2-targeted therapy (eg, trastuzumab, pertuzumab) etc.) are basically ineffective. But what is more gratifying is that most TNBCs express TROP-2, so there is hope for the treatment of TROP-2 as a target. Based on this, goxatuzumab received accelerated FDA approval for the first time in April 2020 for the treatment of patients with metastatic TNBC, becoming the first TROP-2-targeted ADC approved for marketing. In April 2021, the FDA also expanded a previously approved indication for goxatuzumab for the treatment of locally advanced or metastatic TNBC. To date, goxatuzumab has been approved for second-line treatment of metastatic TNBC in many countries around the world.

How effective is goxatuzumab?

Let's talk about foreign countries first. According to the data that goxatuzumab was fully approved by the FDA, in a global phase 3 clinical trial called ASCENT, compared with chemotherapy, goxatuzumab killed patients. The risk was reduced by 49%, and the median overall survival (OS) was 11.8 months in the treatment group and 6.9 months in the chemotherapy group. Goxatuzumab also reduced the risk of disease progression or death by 57%. In China, a single-arm, multi-center Phase 2b registration study recruited 80 TNBC patients in China, and the results were consistent with the results shown in the global Phase 3 ASCENT study, and showed similar efficacy in the Chinese population. In conclusion, both foreign and domestic studies have concluded that triple-negative breast cancer patients can prolong their survival and improve their quality of life after treatment with goxatuzumab.

What are the adverse effects of goxatuzumab?

Of course, the drug also has certain adverse reactions. According to studies, the most common adverse reactions (incidence>25%) in patients receiving goxatuzumab are nausea, neutropenia, diarrhea, fatigue, Hair loss, anemia, vomiting, constipation, rash, loss of appetite, and abdominal pain. In particular, severe diarrhea, including neutropenic colitis, requires extra attention. For patients with diarrhea, loperamide should be initiated immediately after an infectious cause has been ruled out, and supportive measures (rehydration, electrolyte replacement) should be instituted as clinically indicated. For grade 3 or 4 diarrhea that is not controlled by antidiarrheals, the dose of the drug should be reduced immediately. The recommended dose of goxatuzumab is 10 mg/kg weekly on days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Please strictly follow the doctor's advice.

Goxatuzumab has more possibilities in the future

In fact, TROP-2 is expressed in many epithelial cancers , such as urothelial cancer, etc., so in addition to breast cancer, goxatuzumab may also be approved for the targeted therapy of urothelial cancer and other malignant tumors in the future. The FDA approved it in April 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer who have been previously treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. In addition, a number of clinical studies are also underway, such as for the treatment of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer.

References: [1] State Drug Administration. On June 10, 2022, the drug approval document is pending information release. https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/ 20220610083017154.html[2]Bardia A , Hurvitz S A , Tolaney S M , et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer[J]. The New England journal of medicine, 384(16):1529-1541.[3] FDA. FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer. [OL] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-sacituzumab-govitecan -triple-negative-breast-cancer.[4] Wu Hailan, Liu Jun, Liu Fenghua, et al. Analysis of the global development trend of antibody conjugated drugs [J] . International Journal of Biologicals, 2021, 44(1) : 38-43. DOI: 10.3760/cma.j.cn311962-20200902-00086. Medical Editor: Su Bangjie Medical Review: Li Xingxing Content Operation: Duffy Content Producer: Xiaohe Medical Dictionary

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