On January 4, 2024, Simcere Zaiming Pharmaceutical Co. Ltd. (“Simcere Zaiming”), an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd. (HKEX: 2096, “Simcere”), announced that Phase 3 clinical trial of Suvemcitug for injection combined with chemotherapy (the “Experimental Group”) versus placebo combined with chemotherapy (the “Placebo Group”) in patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer (the SCORES Study) has met the primary endpoints.
The results include the final analysis of the progression-free survival (the “PFS”) as the primary endpoint, the first analysis of the overall survival (the “OS”) as the key secondary endpoint, and the safety analysis.
The results showed that:
(1) The SCORES Study has met the primary endpoint of PFS assessed by the Blinded Independent Review Committee (BIRC) according to the RECIST 1.1 criteria. Compared with the Placebo Group, the improvement of PFS in the Experimental Group is both statistically and clinically significant, and Suvemcitug has shown consistent PFS benefits among all pre-defined sub-groups. The PFS benefit of the Experimental Group evaluated by the researchers is consistent with those evaluated by BIRC;
(2) The OS data are immature, but there is a trend of OS benefit in the Experimental Group; and
(3) The safety is manageable and no new safety signals were identified.
The SCORES study (NCT04908787) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial that enrolled 421 patients at 55 sites nationwide, with Cancer Hospital at the Chinese Academy of Medical Sciences being the leading site. The first patient enrollment (FPI) in the SCORES study was reached on June 11, 2021, and the last patient enrollment (LPI) was completed on June 27, 2023.
"The platinum-resistant ovarian cancer has a high mortality rate and limited treatment options. Suvemcitug is an anti-angiogenic antibody with the same target as bevacizumab. ” Leading PI of the SCORES Study Professor Lingying Wu from Cancer Hospital, Chinese Academy of Medical Sciences, said: “The data analysis of this study shows that the combination of Suvemcitug and chemotherapy has prolonged progression-free survival. The SCORES Study is the first double-blind Phase 3 clinical trial in the whole population of platinum-resistant ovarian cancer in China that has reached a positive primary endpoint. The successful development of this drug will bring new treatment options and hope to patients with relapsed and refractory ovarian cancer.”
“Suvemcitug is potentially the first anti-VEGF monoclonal antibody in China indicated for patients with platinum-resistant ovarian cancer. Its clinical application is not limited by previous VEGF treatment and it can be combined with various chemotherapies regardless of chemotherapy type to benefit a wide range of platinum-resistant ovarian cancer patients. ”said Dr. Renhong Tang, Chairman of Simcere Zaiming, “We will actively advance the data analysis and submit new drug marketing authorization applications in China, to realize the clinical value of this product as soon as possible. "
About Suvemcitug
Suvemcitug is a new-generation recombinant humanized anti-VEGF rabbit monoclonal antibody co-developed by Simcere and Apexigen, Inc., (“Apexigen”). Simcere Zaiming currently holds the exclusive rights to develop and commercialize this product in greater China. Pre-clinical studies have shown that Suvemcitug has higher affinity and anti-tumor efficacy than Bevacizumab at the same dose in multiple tumor models. Phase 1b clinical studies of Suvemcitug conducted in China for the treatment of ovarian cancer preliminary demonstrated its favorable safety profile and efficacy signals. An open-label, multi-cohort, and multi-center Phase 2 clinical trial commenced simultaneously by Simcere evaluates the efficacy and safety of Envafolimab (PD-L1) in combination with Suvemcitug with or without chemotherapy in patients with advanced solid tumors, and the results of hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer cohort published in 2023 ESMO conference showed that Envafolimab in combination with Suvemcitug has good anti-tumor activity and manageable safety profile in solid tumors.
About Apexigen
Apexigen is a clinical-stage biopharmaceutical company focused on discovering and developing innovative antibody therapeutics for oncology. On August 23, 2023, Apexigen was acquired by Pyxis Oncology, Inc., (NASDAQ: PYXS, Pyxis). Pyxis is a clinical-stage company focused on defeating difficult-to-treat cancers and is efficiently building next-generation therapeutics that hold the potential for mono and combination therapies.
About Simcere Zaiming
Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere is committed to developing disruptive therapies that have the potential to address unmet clinical needs for cancer patients around the world. Simcere Zaiming has built an innovative R&D pipeline, with differentiated clinical assets. Several products of Simcere Zaiming are commercially available in China, which include COSELA®, Endostar®, and Envafolimab. Simcere Zaiming strives to bring potentially breakthrough treatment options to cancer patients worldwide through in-house R&D, manufacturing, and commercialization, as well as collaborations with global partners of innovative cancer therapeutics.
Media contact: pr@zaiming.com