▎ WuXi AppTec content team editor
Cancer is the leading cause of impaired health and longevity in Chinese. According to the latest data released by the National Cancer Center of China, there were about 4.064 million new cases of cancer in China in 2016, resulting in 2.4135 million deaths. That's equivalent to 464 new cancers and 276 deaths every hour.
In the process of fighting cancer, drug treatment is one of the main ways. With the advancement of medicine and science and technology, new anti-cancer drugs continue to emerge, providing people with powerful weapons to fight cancer.
In Q1 2022, several anti-cancer drugs were approved for marketing by China's State Drug Administration (NMPA), providing new options for people to fight different types of cancer. In today's content, we will take you to see what these new anti-cancer drugs are.
Yttrium [90Y] microsphere injection
Screenshot source: NMPA official website
Yttrium [90Y] microsphere injection is a targeted endurance product for liver malignancies that can be used in patients with non-resectable colorectal cancer liver metastases that have failed standard therapy.
According to the "Guidelines for the Diagnosis and Comprehensive Treatment of Liver Metastases in Colorectal Cancer in China (2020)", liver metastasis is an important cause of death in colorectal cancer patients in China, about 30%-50% of colorectal cancer patients will develop liver metastasis, 80%-90% of liver metastases cannot be initially radically resected, and the 5-year survival rate of patients with unresectable liver metastases is less than 10%.
According to public information, the characteristics of the product are that the radioactive resin microspheres enter the tumor area through interventional therapy, and the high-energy β rays carry out internal radiation therapy on the tumor, which has a good local control ability.
The results of overseas post-marketing clinical studies show that after the treatment of this product, the patient's liver metastasis lesion can be effectively controlled, and the technical resection rate of non-inoperable patients can be improved, so that patients can regain the opportunity for surgery.
Duvelixe capsules
Screenshot source: NMPA official website
Duvalixe capsules (formerly known as Doencibu capsules) are a dual inhibitor of PI3K-δ and PI3K-γ for the treatment of relapsed or refractory follicular lymphoma (FL) that has undergone at least two previous systemic treatments.
PI3K signaling may lead to proliferation of malignant B cells and plays an important role in the formation and maintenance of the tumor microenvironment. Pi3K-δ and PI3K-γ two protein kinases have been shown to contribute to the growth and survival of malignant B cells and T cells.
Publicly available information shows that Copiktra's inhibition of PI3K-δ can lead to apoptosis of malignant tumor cells, while inhibition of PI3K-γ reduces the differentiation and metastasis of support cells in the tumor microenvironment.
At the 2021 American Society of Clinical Oncology (ASCO), the results of the Phase 2 clinical study on efficacy and safety of duvelese in patients with relapsed/refractory follicular lymphoma in China were published, showing:
The Objective Response Rate (ORR) reported by the Independent Review Committee (IRC) was 83%, including 6 full responses (CR) and 13 partial responses (PR);
The ORR reported by the researchers was 78%, of which 18 cases reached PR;
21 (91%) of the 23 patients experienced treatment-related adverse events (TRAEs) of any level, of which 12 (52%) ≥ grade 3;
The most common TRAEs are neutropenia, elevated alanine aminotransferases, elevated aspartate aminotransferases, and so on.
Remosilumab injection
Screenshot source: NMPA official website
Ramucirumab injection is a fully human IgG1 monoclonal antibody that specifically binds to VEGFR-2 (vascular endothelial growth factor receptor 2) to achieve anti-tumor effect by inhibiting the production of blood vessels in tumor tissue.
The indications for the approval of remosizizumab injection are: combined with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal-conjugate adenocarcinoma in which the disease progresses during or after chemotherapy-containing chemotherapy.
According to public information, remosilliumab has been approved for marketing in many countries and regions around the world (including Hong Kong, China, Taiwan), and is the world's first targeted drug approved for the second-line treatment of advanced gastric cancer.
In a Phase 3 trial called RAINBOW-Asia, a total of 440 participants from East Asia (China, Malaysia, the Philippines and Thailand) were patients with advanced gastric or gastroesophageal-conjunctive adenocarcinoma that progressed after first-line chemotherapy, the vast majority of whom were in China. The results of this test showed:
Compared with the placebo group, ramoxizizumab plus paclitaxel significantly prolonged median progression-free survival (PFS, 4.14 versus 3.15 months).
Patients were well tolerated overall, consistent with known safety features of ramoxizumab, and no new safety signals were found.
Slulizumab injection
Screenshot source: NMPA official website
Slullizumab Injection (trade name: Hans)) is an innovative anti-PD-1 monoclonal antibody that is expected to be widely used in the treatment of solid tumors with monotherapy or other products with immunotherapy. The drug was approved for the following indications: non-resectable or metastatic highly microsatellite unstable (MSI-H) solid tumors that have failed standard treatment.
"Microsatellites" are a class of short tandem repeats of DNA sequences in genes, and insertion or deletion of DNA during DNA replication causes a change in the length of microsatellite sequences, known as microsatellite instability. Numerous studies have shown that microsatellite instability is closely related to the occurrence of tumors. According to statistics, more than 300,000 new highly microsatellite unstable tumor patients occur in China every year.
In the classification of microsatellite instability, 2 or more site changes are called microsatellites that are highly unstable and are common in endometrial cancer, colorectal cancer, stomach cancer, etc., and these patients usually have a high response rate to immune checkpoint inhibitors.
The approval of Slulizumab Injection is based on a single-arm, multicenter, critical Phase 2 clinical study. As of January 9, 2021, a total of 108 patients were enrolled in this study, of which 68 patients with high microsatellite instability confirmed by the central laboratory or research center were included in the main efficacy analysis population, and 42 were included in the special attention to the efficacy analysis population.
Among the main efficacy analyses, the objective response rate (ORR) assessed by the Independent Imaging Evaluation Board (IRRC) according to the RECIST v1.1 criteria was 38.2% (2 complete responses and 24 partial responses), and in the population with special attention to efficacy analysis, the ORR assessed by the IRRC was 31.0% (1 complete response, 12 partial responses).
In terms of secondary efficacy endpoints, the median progression-free survival (PFS), overall survival (OS), and sustained response (DoR) of the main efficacy-analyzed populations were not yet met, with 61.9% of the 12-month PFS rate assessed by the IRRC, 81.2% of the 12-month OS rate, and 95.7% of the 12-month DoR rate of the IRRC assessment. Among the people with special attention to efficacy analysis, the median PFS assessed by irrc was 4.2 months, and the median DoR and OS were not yet reached.
Bougatinib tablets
Screenshot source: NMPA official website
Brigatinib (trade name: Aberry) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase.
Non-small cell lung cancer is the most common type of lung cancer. Studies have shown that about 3%-5% of non-small cell lung cancers present positive for ALK. In these tumors, the patient's ALK gene tends to fuse with other genes to produce the ALK fusion protein, a mutation that causes the tumor to grow.
Publicly available information shows that bugtinib tablets can target and inhibit the ALK fusion protein in a targeted manner, thereby inhibiting tumor growth. Moreover, the efficacy of bugatinib tablets in prolonging progression-free survival, controlling brain metastasis, and improving quality of life has been clinically verified.
According to the results of the International Multicenter Phase 3 clinical study ALTA-1L:
For patients treated with bougatinib tablets, the median progression-free survival (PFS) assessed by the Independent Review Committee was 24 months, compared with 11.1 months in the control group;
The median progression-free survival assessed by the investigators was 30.8 months vs 9.2 months (control group), and the risk of disease progression or death was reduced by 57% compared with the control group.
For patients with brain metastases at baseline, the objective response rate (ORR) was 78% in the bugotinib tablets treatment group and 26% in the control group;
For patients with intracranial lesion remission, there was a sustained response time of 27.9 months in the buguetinib tablets treatment group and 9.2 months in the control group;
In patients with baseline with brain metastases, the median progression-free survival (PFS) assessed by the Independent Review Committee was 24 months, compared with 5.6 months in the control group;
The adverse reactions of buguetinib tablets are mostly mild, and they are safe to tolerate with long-term use.
Image credit: 123RF
We expect that with the progress of science, more anti-cancer drugs will emerge, providing patients with new treatment options, providing more weapons for human beings to defeat cancer, prolonging survival and improving quality of life.
Resources
[1] Rongshou Zheng, et al.,(2022). Cancer incidence and mortality in China, 2016. Journal of the National Cancer Center, DOI: https://doi.org/10.1016/j.jncc.2022.02.002.
[2] On February 9, 2022, the drug approval certificate was released. Retrieved Apr 28 ,2022,from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20220209100101132.html
[3] On March 18, 2022, the drug approval certificate was released to be collected. Retrieved Apr 28 ,2022,from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20220318112431186.html
[4] On March 24, 2022, the drug approval certificate was released for collection. Retrieved Apr 28 ,2022,from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20220324160221168.html
[5] Yuanda Pharma's global innovative radiopharmaceutical SIR-Spheres yttrium[90Y] microsphere injection was approved for marketing by the State Food and Drug Administration. Retrieved Apr 28 ,2022,from http://www.grandpharma.cn/News/7/3677.aspx
[6] Efficacy and safety of duvelisib, a phosphoinositide 3 kinase (PI3K) δ and γ inhibitor, in Chinese patients (pts) with relapsed/refractory follicular lymphoma (R/R FL): A single-arm, open-label, multicenter, phase Ⅱ clinical trial. Retrieved Apr 28 ,2022,from https://meetinglibrary.asco.org/record/199952/abstract
[7] China's advanced gastric cancer treatment adds new evidence! Eli Lilly Ramucirumab's latest Asia PHASE III clinical RAINBOW-Asia study data released. Retrieved Apr 28 ,2022,from https://mp.weixin.qq.com/s/ZttbSVcJhViV08C6Nm6TjA
[8] 2021 CSCO | Henlius's innovative PD-1 inhibitor Slullizumab "Pan-Cancer Species" in the Treatment of MSI-H/dMMR Solid Tumor Phase II Clinical Data Were Published. Retrieved Apr 28 ,2022,from https://www.henlius.com/NewsDetails-3210-26.html
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