Innovent Biologics Inc and HUTCHMED (China) have recently announced the acceptance of new drug application (NDA) for fruquintinib (Elunate) in combination with sintilimab (Tyvyt) for the treatment of advanced endometrial cancer with pMMR or non-MSI-H tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation with priority review status by the China National Medical Products Administration (NMPA). Following approval, the combination is expected to face intense competition within the endometrial cancer market in China, says GlobalData, a leading data and analytics company.

The NDA is supported by data from the multi-center, open-label Phase Ib/II, FRUSICA-1 (NCT03903705) study investigating Innovent’s sintilimab in combination with Hutchison MediPharma’s fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.

Innovent Biologics entered into a global collaboration agreement with Hutchison MediPharma in November 2018 to evaluate the safety and tolerability of sintilimab in combination with fruquintinib in patients with advanced solid tumors.

The current marketed drug space for endometrial cancer in China is dominated by cisplatin (first line) and lenvatinib mesylate (second line).

Nelluri Geetha, Pharma Analyst at GlobalData, comments: “Platinum-based systemic chemotherapy is the standard first-line treatment for endometrial cancer in China. However, patients who progress following first-line therapy have limited treatment options, and the prognosis remains poor. Therefore, other treatment options have been widely sought.”

According to GlobalData’s Pharmaceutical Intelligence Center, the number of five-year diagnosed prevalent cases of endometrial cancer in China is expected to increase at an annual growth rate (AGR) of 2.96% from 282,815 in 2023 to 333,349 in 2030.

Geetha concludes: “Chia Tai Tianqing Pharmaceutical Group had filed a NDA for benmelstobart in combination with anlotinib hydrochloride (catequentinib hydrochloride) in January 2024 as the first anti-PD-L1 monoclonal antibody and small molecule anti-angiogenic drug combination therapy for endometrial cancer in China. This makes ‘sintilimab with fruquintinib’ the second drug combination filed in China in this category. Following the approval of both drug combinations, competition is expected to increase multi-fold in the endometrial cancer market in China.”