June 7, 2022, State Drug Administration of China (NMPA)Formal approval of Goxatuzumab targeting Trop-2 (trade name Tuodawei®) listed for treatment acceptance 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), are Domestic triple-negative breast cancer patients bring new hope.
This approval also makes goxatuzumab span>The first domestic marketed Trop-2 targeted therapy.
1Excellent resultsBreak the treatment dilemma of triple-negative breast cancerBreast cancer has become the most common malignant tumor in the world, and triple-negative breast cancer is the breast cancer One of the most refractory subtypes of cancer is not only easy to metastasize and easy to relapse, but also has not made much progress in treatment for a long time. In recent years, although there are new treatments such as PARP inhibitors and immunotherapy for triple-negative breast cancer, they still have great limitations. In particular, PARP inhibitors require patients to carry BRCA mutations, and immunotherapy also requires patients to have a CPS score of ≥10. The scope of application is relatively narrow, and only about 30% and 38% of patients can be used.[1,2], far from meeting the treatment needs of triple-negative breast cancer. The birth of goxatuzumab has brought a new hope to triple-negative breast cancer patients. Different from PARP inhibitors and immunotherapy with a narrow range of applications,Trop-2 targeted by goxatuzumab has a medium-to-high expression rate of about 90% in triple-negative breast cancer [3], Can cover the vast majority of triple-negative breast cancer patients. 
and because of the very high expression rate of Trop-2 in triple negative breast cancer , in patients with triple-negative breast cancer, Trop-2 expression testing is not required before the application of goxatuzumab. This not only saves patients a test fee, but also saves time waiting for test results, allowing them to receive treatment as soon as possible. In the phase III clinical trial ASCENT, 468 patients with refractory or recurrent triple-negative breast cancer who were not screened for Trop-2 expression were assigned to receive either goxatuzumab or chemotherapy. The objective response rate of the goxatuzumab group was 35%, the median progression-free survival was 5.6 months, and the median overall survival was 12.1 months, which were 7 times that of the chemotherapy group, respectively. , 3 times more and nearly 2 times [4]. Compared with chemotherapy, goxatuzumab reduced the risk of disease progression or death by 61% and reduced the risk of death by 52%. Goxatuzumab was also approved by the FDA in April last year for marketing in the United States. Goxatuzumab also achieved an objective response rate of 38.8% in the EVER-132-001 trial in Asian patients in China[5], similar to foreign data, further supports its domestic listing. 
median progression-free survival with goxatuzumab more than 3 times longer than chemotherapy 2The future can be expected to enter more tumorsGoxatuzumab mAb targets Trop-2 molecules, in factNot unique to triple-negative breast cancer, but also widely distributed in many other tumors. The medium and high expression rate of Trop-2 in urothelial carcinoma and cervical carcinoma can also reach about 90%, and many carcinomas such as lung cancer, endometrial cancer, prostate cancer, etc. The species also has a high expression rate of Trop-2[3]. This also makes goxatuzumab expected to be used in more cancer types. In patients with metastatic urothelial carcinoma who progressed after platinum-based chemotherapy and PD-1 therapy, goxatuzumab monotherapy achieved an objective response rate of 27.7% and an objective response rate of 7.2 median duration of response in months[6]. Goxatuzumab is currently FDA-approved for patients with locally advanced or metastatic urothelial carcinoma who have received platinum-based chemotherapy and PD-1 therapy. In addition, in patients with metastatic endometrial cancer and non-small cell lung cancer, goxatuzumab also achieved objective response rates of 22.2% and 19%, respectively [7,8]. In glioma, prostate cancer and other cancers, and some basket trials including multiple cancers are also underway. We expect this drug to conquer more cancers and benefit more cancer patients.
References:
[1]. Greenup R, Buchanan A , Lorizio W, et al. Prevalence of BRCA mutations among women with triple-negative breast cancer (TNBC) in a genetic counseling cohort[J]. Annals of surgical oncology, 2013, 20(10): 3254-3258.
[2]. Cortes J, Cescon D W, Rugo H S, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE- 355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial[J]. The Lancet, 2020, 396(10265): 1817-1828.
[3]. Zaman S, Jadid H, Denson A C, et al. Targeting Trop-2 in solid tumors: future prospects[J]. OncoTargets and therapy, 2019, 12: 1781.
[4]. Bardia A, Hurvitz S A, Tolaney S M, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer[J]. New England Journal of Medicine, 2021, 384(16): 1529-1541.
[5]. https://www.everestmedicines.com/News_detail.aspx?nid=431
[6]. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer
[7]. Santin A, Komiya T, Goldenberg D M, et al. Sacituzumab govitecan (SG) in patients (pts) with previously treated metastatic endometrial cancer (mEC): results from a phase I/II study[J]. 2020 .
[8]. Heist R S, Guarino M J, Masters G, et al. Therapy of advanced non–small-cell lung cancer with an SN-38-anti-trop-2 drug conjugate, sacituzumab govitecan[J]. Journal of Clinical Oncology, 2017, 35(24): 2790-2797.
