On November 25, 2022 Hengrui Pharmaceuticals reported that Carrelizumab + Famitinib Malate Was Included in the Public Announcement of the Proposed Breakthrough Treatment (Press release, Hengrui Pharmaceuticals, NOV 25, 2020, View Source [SID1234633521]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Cervical cancer is one of the common malignant tumors in women. Its incidence ranks first among female reproductive system tumors in my country, and its mortality ranks seventh among malignant tumors. According to the epidemiological survey results of cervical cancer reported in my country in 2014 reported in 2018, it is estimated that the number of new cervical cancer cases nationwide is 102,000, with an incidence rate of 15.30 per 100,000; the number of deaths is about 30,400, and deaths The rate is 4.57 per 100,000.
Early cervical cancer can be treated by means of surgery, radiotherapy and chemotherapy, but under comprehensive treatment, about 15-20% of patients still relapse; in addition, 70% of locally advanced cervical cancer will relapse after concurrent radiotherapy and chemotherapy ; For metastatic (FIGO stage IVB) or recurrent cervical cancer, systemic chemotherapy is the main treatment, and the 5-year survival rate is poor, with only about 17% reported in the literature.
The current recommended first-line treatment for patients with recurrent and metastatic cervical cancer is a combination of platinum (cisplatin or carboplatin) combined with paclitaxel. For patients with contraindications to taxanes, cisplatin combined with topotecan can be considered. The objective response rate of the first-line combination chemotherapy is about 30%, the median PFS is about 6 months, and the median OS is about 12 months. For recurrent or metastatic cervical cancer that has failed first-line treatment, there is currently no standard treatment plan. The guidelines recommended options include bevacizumab single-agent, albumin paclitaxel, docetaxel, pemetrexed, gemcitabine, and vinorelbine However, the remission rate of these drugs in the treatment of recurrent and metastatic cervical cancer is less than 15%, the median PFS is about 3 months, and the median OS is about 7 months. It can be seen that for recurrent and metastatic cervical cancer, treatment options are limited, and those who have failed first-line systemic treatment face the dilemma of no drugs to choose from, and it is urgent to develop effective treatment drugs.
Carrelizumab is a humanized PD-1 monoclonal antibody independently developed by Hengrui Medicine with intellectual property rights. It can bind to human PD-1 receptors and block the PD-1/PD-L1 pathway to restore the body Anti-tumor immunity, which forms the basis of cancer immunotherapy. Since its listing in May 2019, four indications have been approved for Hodgkin’s lymphoma, advanced hepatocellular carcinoma, advanced esophageal squamous cell carcinoma and non-squamous non-small cell lung cancer. In April 2019, the first-line phase III clinical study of carrelizumab for injection combined with apatinib for the treatment of advanced hepatocellular carcinoma has been conducted in the United States, Russia, Belgium, Germany, France, Spain, Italy, Poland, South Korea and China, etc. 123 centers in 14 countries and regions were launched simultaneously.
Famitinib Malate Capsules is a small molecule multi-target tyrosine kinase inhibitor independently developed by Hengrui Pharmaceuticals. It is effective against multiple receptor tyrosine kinases such as c-Kit, KDR, PDGFR, VEGFR3, Flt1, Ret, Flt3, c-Src, FGFR2, FGFR3 and PDGFRα have good inhibitory activity. Currently, clinical studies at different stages for multiple indications such as advanced solid tumors, nasopharyngeal carcinoma, non-small cell lung cancer, gastrointestinal stromal tumors, neuroendocrine tumors, renal clear cell carcinoma, and colorectal cancer are being carried out.
Preliminary research data shows that carrelizumab combined with famitinib malate has shown outstanding efficacy and controllable safety for patients with recurrent and metastatic cervical cancer who have failed first-line treatment.
Hengrui Medicine submitted an application for a breakthrough treatment drug for carrelizumab combined with famitinib malate for the treatment of recurrent and metastatic cervical cancer on October 21, 2020, and was approved by the National Medical Products Administration on November 23. The review center included the list of proposed breakthrough treatments for publicity. This is a major milestone for Hengrui Pharmaceuticals to develop carrelizumab combined with famitinib malate treatment plan, which means that the combination drug is expected to be approved quickly and bring new treatment options to patients as soon as possible. At the same time, Hengrui Medicine is carrying out clinical research on the combination of carrelizumab and famitinib malate in various fields such as metastatic non-squamous non-small cell lung cancer and advanced renal cell carcinoma.