HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) is delighted to share the exciting news that the combination of fruquintinib and sintilimab has been granted Breakthrough Therapy Designation from the Center for Drug Evaluation at China’s National Medical Products Administration.
The combination therapy is to be used for treatment of patients with advanced endometrial cancer (EMC) with pMMR1 tumors that have failed at least one line of platinum-based therapy. Significantly, a study targeting potential registration of this combination in patients with previously treated advanced EMC in China has already completed enrollment.
This open-label, multi-center clinical study aims to evaluate the efficacy and safety of fruquintinib in combination with sintilimab for the treatment of advanced epithelial-mesenchymal transition (EMC) patients who have seen disease recurrence, progression, or Grade 3 or higher adverse events with earlier platinum-based chemotherapy.
A total of 142 participants are enrolled in the trial, with primary outcome measure of independent review committee-assessed objective response rate and other secondary endpoints such as disease control rate, progression-free survival, overall survival, and pharmacokinetic assessments. For more detailed information, please visit clinicaltrials.gov and search for the identifier NCT03903705.
This trial has the potential to yield promising results that could see it submitted to the NMPA in the first half of 2024 in the hopes of securing regulatory approval for this potential treatment option. If successful, this could be a significant breakthrough for those in need.
About Breakthrough Therapy Designation in China
The U.S. Food & Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD) program is enabling life-saving new treatments for life-threatening diseases and serious conditions to become available to patients in need, faster!
Those who submit a New Drug Application (NDA) for a drug candidate that has been awarded BTD may get conditional approval and accelerated review in order to provide faster relief from otherwise untreatable conditions. This innovative and groundbreaking program is a clear demonstration of the continued commitment from the FDA to provide patients with the medical solutions they require.
About EMC
Uterine cancer, a formidable foe, was diagnosed in an estimated 417,000 people globally and caused 97,000 deaths worldwide in 2020. In China, an estimated 82,000 were diagnosed, leading to 17,000 deaths.
Early-stage cases of EMC can be surgically resected, however recurrent and/or metastatic cases continue to be a challenge. Despite great advancements in the fight against cancer, these types of uterine cancer still present an area of high unmet need, with poor outcomes and limited treatment options.4,5,6
About Fruquintinib
Fruquintinib is an innovative oral inhibitor of VEGFR -1, -2 and -3, providing a new avenue to tackle tumor angiogenesis. This groundbreaking medicine has been designed to ensure a high level of selectivity and potency, providing a greater level of safety and consistent efficacy.
Already, clinical trials have demonstrated the promising good tolerability of Fruquintinib, and researchers are now exploring the possibilities of combining it with other treatments to maximize its benefit in cancer care.
In September 2018, ELUNATE®, the medicine produced by Fruquintinib, was officially launched in China by the NMPA after approval. Since January 2020, it has also been included in the National Reimbursement Drug List, enabling patients with metastatic colorectal cancer, previously treated with fluoropyrimidine, oxaliplatin and irinotecan (including those who have received anti-VEGF and/or anti-EGFR therapy) to access it. ELUNATE® is now making a big difference for those in need of its help.
Fruquintinib may hold promise for a variety of investigational uses, but the safety and efficacy of its use in these contexts have yet to be determined and remain unconfirmed. Despite this uncertainty, the potential for it to be approved and made commercially available in countries across the globe is a tantalizing prospect that could bring hope to many.
The FDA has accepted and granted priority review for the rolling submission of a New Drug Application (NDA) in May 2023, setting a Prescription Drug User Fee Act (PDUFA) date of November 30, 2023.
The submission to the European Medicines Agency (EMA) has been successfully validated in June 2023, with an application to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) being completed in due course.
These submissions are supplemented by the results of the Phase III FRESCO-2 trial, a multi-regional trial conducted around the world investigating fruquintinib in combination with best supportive care (BSC) for previously treated metastatic colorectal cancer (CRC).
Compelling data from FRESCO-2 demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS). So far, fruquintinib has been well tolerated with minimal side effects (NCT04322539).
In April 2023, the NMPA accepted an NDA for the combination of fruquintinib and paclitaxel to treat second-line advanced gastric or gastroesophageal junction adenocarcinoma. The supporting data for the acceptance came from the Phase III FRUTIGA trial conducted in China, which had dual-primary endpoints – PFS and OS.
The results of the trial showed a statistically and clinically meaningful level of PFS and an overall improvement of median OS, although the endpoint was not statistically significant. Secondary endpoints such as ORR, DCR and duration of response (DoR) also recorded statistically significant improvements. Furthermore, the safety profile of the treatment was similar to those previously reported in the NCT03223376 study.
HUTCHMED is transforming the healthcare landscape with the development of fruquintinib in China for the treatment of multiple solid tumor cancers. By partnering with Eli Lilly & Company, HUTCHMED is providing a potentially life-saving therapy for those in need.
What’s more, Takeda Pharmaceutical Company Limited has licensed fruquintinib for use outside of China, proving its efficacy and safety. With an emphasis on quality and success, HUTCHMED is striving to revolutionize cancer care.
About Sintilimab
Innovent Biologics, Inc. and Eli Lilly and Company’s groundbreaking immunotherapy, TYVYT® (sintilimab injection), stirs up hope for cancer patients. A powerful PD-1 immunoglobulin G4 monoclonal antibody, sintilimab binds to PD-1 molecules, blocks the PD-1/PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells, effectively destroying cancer cells.
So far, TYVYT® has completed more than 10 health registrational and pivotal clinical trials to evaluate its safety, success and efficacy in a variety of cancers. With its powerful potential against the devastating disease, TYVYT® is paving the way for a brave new future in cancer treatment.
In China, sintilimab has made its mark with an impressive seven approved indications and even being included in the National Reimbursement Drug List for six of them – a testament to its effectiveness and efficacy.
About HUTCHMED
Hutchmed (Nasdaq/AIM: HCM; HKEX:13) is an ambitious biopharmaceutical company on a mission to help make a meaningful difference in the lives of those affected by cancer and immunological diseases.
The company is working toward the global development and commercialization of tailored therapies and immunotherapies, and have over 5,000 people working in and around its oncology/immunology division.
With its first three oncology treatments, Hutchmed has made huge strides in bringing its drug candidates from lab to life, now marketed and available to people in China.