Hengrui Pharmaceutical two new drugs are intended to be included in the breakthrough treatment varieties of two drugs combined to treat cervical cancer

China's State Drug Administration Drug Review Center (CDE) website recently announced that Hengrui Pharmaceutical two new drugs are intended to be included in the breakthrough treatment varieties, respectively, PD-1 inhibitor injection karili pearl monoanti, and multi-target tyrosine kinase inhibitor nectic acid fatini capsules, the proposed adaptation for these two new drugs after a line-level treatment failure of the recurrence of metastatic cervical cancer.
screenshot source: CDE official website Karelli pearl single anti (Alrito) is Hengrui Pharmaceutical's independent research and development of PD-1 single anti, in May 2019 was officially approved for listing in China, has been approved 4 adaptations, covering classic Hodgkin lymphoma, hepatocellular cancer, non-scale non-small cell lung cancer, esophageal squamous cancer.
addition, the first- and second-line treatment for nasopharyngeal cancer has been submitted in China and is included in the priority review.
malic acid famini capsule is a new class 1 drug independently developed by Hengrui Pharmaceuticals, which is a multi-target tyrosine kinase inhibitor with anti-proliferation and anti-angiogenesic double anti-tumor effect.
currently, the product is in a number of adaptations on different stages of clinical research, such as nasopharyngeal cancer, non-small cell lung cancer, neuroendocrine tumors, colorectal cancer and so on.
the CDE is intended to be included in the breakthrough treatment is Karelli pearl monoanti and famini combined for relapsed metastatic cervical cancer adaptation applications.
anti-angiogenesic drugs can regulate the immune microenvironment, in theory, immuno-checkpoint inhibitors combined with anti-angiogenesic treatment of cancer can produce synergistic effects, improve the effectiveness of immunotherapy.
in previous studies, Hengrui Pharmaceuticals has confirmed that Carelliju monoantigeno-combined famini has a synergetic anti-tumor effect.
screenshot Source: CDE's official website: The latest clinical data on cervical cancer from this year's annual meeting of the European Society of Oncology (ESMO).
study was entitled Ovarian/fallopian tube/primary peritoneal cancer and advanced cervical cancer in the combined carelli pearl single anti-treatment of ovarian/fallopian tubes and advanced cervical cancer: open labeling, multi-center, phase 2 studies.
meeting, the researchers reported preliminary results from the late cervical cancer (CC) queue and the relapsed platinum-resistant epithelitis/fallopian tube/peritometrial cancer (OC) queue.
in this study, the patients included in the advanced cervical cancer were histologically confirmed patients who had relapsed or continued to progress after at least one line of chemotherapy.
subjects were given a 3-week injection with kariliju single anti-200 mg intravenous injection, plus a daily oral dose of 20 mg of nectic acid famini capsules.
objective mitigation rate (ORR) assessed on the basis of the RECIST v1.1 standard.
screenshot Source: ESMO website results show that from April 4, 2019 to March 20, 2020, a total of 19 patients with advanced cervical cancer were admitted to the group.
follow-up time was 10.0 months.
of the 15 patients who received at least one post-baseline efficacy assessment received confirmed partial remission (PR) and 2 were unproven.
ORR was 46.7% (7/15) and the disease control rate (DCR) was 80.0% (12/15).
6 out of 7 patients who responded were still responding and did not achieve a medium response time (mDoR).
In terms of safety, the most common treatment-related adverse events (TRAEs) were hypertension (33.3%), neutral granulocyte reduction (23.5%), thyroid reduction (9.8%), hand-foot syndrome (7.8%) and hyperglyceride triglycerides (7.8%).
no patient has been terminated due to TRAE.
conclusions show that the injection of carelli-pearl monoantigeno-combined appleic acid famini capsules for the treatment of relapsed platinum-resistant advanced cervical cancer shows encouraging activity and safety, and it is worth further studying this new potential treatment.
cervical cancer is a major threat to women's health worldwide and is one of the leading causes of cancer deaths, with more than 310,000 women dying each year.
, patients with advanced cervical cancer who progress after first-line chemotherapy have few treatment options.
immune checkpoint inhibitors showed anti-tumor efficacy in this case, although the response rate was not high.
data show that current treatments for recurrence and/or metastatic cervical cancer are usually less than 15 per cent with a medium total survival of 6.0 to 9.4 months.
The relapsed metastatic cervical cancer, which has failed treatment at or above the first-line level, is to be included in the list of CDE breakthrough treatment varieties, meaning that patients with advanced cervical cancer are expected to accelerate the development of a new treatment program, and hope to achieve higher clinical benefits.
References: 1. Drug Review Center of the State Drug Administration of China. Retrieved Nov 23,2020, From s2 s 840P - Famitinib malate plus camrelizumab for recurrent platinum-resistantovarian/fallopian tube/primary peritoneal cancer and advanced cervical cancer: An open-label, multicenter phase II study, Retrieved Sep 17, 2020 from Henri Pharmaceutical Press Release and Public Source: Supplied