Gelonghui, April 2 | Cinda Biotech (01801.HK) announced that China's National Drug Administration (“NMPA”) has officially accepted a new drug marketing application (“NDA”) for the combination therapy of cindilizumab and furoquintinib and has granted priority review qualifications to treat patients with advanced mismatch repair (“pMMR”) or endometrial cancer patients with advanced mismatch repair (“non-MSI-H”) after previous systemic anti-tumor treatment and are unsuitable for radical surgical treatment or radical radiotherapy (“non-MSI-H”) endometrial cancer patients.
The FRUSICA-1 study data supports this NDA. FRUSICA-1 is a multi-center, open-label endometrial cancer registration cohort for phase II clinical trials aimed at evaluating endometrial cancer patients with recurrent disease, disease progression, or intolerable toxicity after treatment with cindilizumab plus fruquintinib in platinum-containing dual-agent chemotherapy. The primary endpoint of the study was the objective response rate (ORR) as assessed by the Independent Review Committee (IRC), and secondary endpoints included disease control rate (DCR), time to remission (DOR), progression-free survival (PFS), overall survival (OS), and pharmacokinetics (PK) assessment. The data from the FRUSICA-1 study will be presented at an upcoming academic conference. Additional details of the study can be found on clinicaltrials.gov and search registration number NCT03903705.
Endometrial cancer is a type of cancer that starts in the uterus. Globally, an estimated 417,000 new cases of endometrial cancer were added in 2020, causing approximately 97,000 deaths. i In China, an estimated 82,000 new cases of endometrial cancer were added in 2020, causing about 17,000 deaths. ii Although early-stage endometrial cancer can be surgically removed, there is still a huge unmet need in the field of recurrent and/or metastatic endometrial cancer, with poor treatment outcomes and limited treatment options for patients.
As a cornerstone therapy in the field of immuno-oncology, dabershu (cindilizumab injection) is expected to improve the prognosis of endometrial cancer patients in China when used in combination with anti-angiogenic drugs. The company is excited that this NDA has been accepted and prioritized for review, which increases the potential to bring new treatment options to patients with endometrial cancer, while also strengthening the leading position of dabershu (cindilizumab injection) in China.