HUTCHMED Initiates Phase II/III Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma in Collaboration with Hengrui
HUTCHMED has commenced a Phase II/III trial exploring the efficacy of a combination therapy involving surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). The trial began on May 8, 2024, and aims to enroll 500 patients after an initial safety run-in stage, with the primary endpoint being overall survival (OS). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and safety. PDAC is a particularly aggressive cancer with a five-year survival rate of less than 10%, and existing treatments have not shown significant improvement in patient outcomes.
- Initiation of a Phase II/III trial for a combination therapy, potentially leading to new treatment options.
- Partnership with Hengrui Pharma, leveraging their PD-1 antibody camrelizumab.
- Focus on improving overall survival (OS) and other significant endpoints such as objective response rate (ORR) and progression-free survival (PFS).
- Multicenter, randomized, and active-controlled design enhances the robustness of trial results.
- Emerging data indicate promising efficacy compared to existing chemotherapy-based treatments.
- Pancreatic ductal adenocarcinoma (PDAC) remains highly aggressive, with a five-year survival rate of less than 10%.
- Existing treatments like chemotherapy, surgery, and radiation have not shown significant effectiveness in improving survival rates.
- The high mortality rate associated with PDAC, causing approximately 467,000 deaths globally in 2022, indicates the challenging nature of the disease.
Insights
The initiation of a Phase II/III trial combining surufatinib and camrelizumab for pancreatic ductal adenocarcinoma (PDAC) treatment is notable in oncology. PDAC is notoriously aggressive with a dismal five-year survival rate of less than
Pancreatic cancer has seen minimal advancements in treatment; thus, this trial could be a game-changer if successful. The primary endpoint, overall survival, underscores the study's focus on significantly extending patient life expectancy. Secondary endpoints like progression-free survival and quality of life will provide a holistic view of the treatment's benefits.
However, it's important to temper enthusiasm with caution. Clinical trials are fraught with uncertainties and previous successes in early-stage studies do not guarantee Phase III triumph. Investors should watch for interim results and note that positive early signals do not ensure regulatory approval or commercial success.
From a financial perspective, the initiation of this trial presents both potential opportunities and risks for HUTCHMED. Successfully demonstrating the efficacy and safety of this drug combination could significantly enhance the company's market position and revenue streams. Additionally, partnering with Hengrui Pharma, a prominent player in the pharmaceutical industry, adds credibility and shared resource benefits to this endeavor.
Investors should be aware that clinical trials require substantial investment and the Phase II/III stage's enrollment of up to 500 patients will be capital intensive. The partnership with Hengrui Pharma may mitigate some financial strains through shared costs. Monitoring HUTCHMED's financial health, burn rate and funding strategy will be important during this period.
A successful trial could lead to a new revenue stream from a novel treatment in a high-need area, potentially driving stock appreciation. Conversely, negative trial results could adversely impact stock value and investor confidence. The trial's long timeframe also means that financial impacts will unfold over several years.
— Almost half a million people diagnosed each year across the globe —
— Collaboration based on synergistic potential of inhibiting angiogenesis and tumor-associated macrophages with HUTCHMED’s surufatinib and anti-PD-1 activity with Hengrui’s camrelizumab, promoting the immune response against tumor cells —
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the initiation of a Phase II/III trial to evaluate the efficacy of a combination of the HUTCHMED drug candidate surufatinib, the Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui Pharma”) PD-1 antibody camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (“PDAC”) in China. PDAC is an exocrine tumor and the most common form of pancreatic cancer. The first patient received the first dose on May 8, 2024.
PDAC is a highly aggressive form of cancer, representing over
The trial is a multicenter, randomized, open-label, active-controlled, Phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as a treatment for adults with metastatic pancreatic cancer who have not been previously treated with a systemic anti-tumor therapy. After an initial safety run-in stage, the Phase II/III stage of the study may enroll a further 500 patients, with a primary endpoint of overall survival (OS). Other endpoints include objective response rate (ORR), progression free survival (PFS), disease control rate (DCR), safety, quality of life, duration of response and time to response. Additional details may be found at clinicaltrials.gov, using identifier NCT06361888.
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “Emerging data including those from an investigator-initiated study presented at the ASCO Gastrointestinal Cancers Symposium, demonstrated that combinations of surufatinib, camrelizumab and chemotherapy have promising efficacy in comparison with existing chemotherapy-based treatments in metastatic PDAC.3 We hope that this partnership will enable us to bring new, potentially life-changing treatment options to patients.”
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®, and was first included in the China National Reimbursement Drug List (NRDL) in January 2022 for the treatment of non-pancreatic and pancreatic neuroendocrine tumors (NETs).
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Currently, more than 10 clinical trials are underway worldwide in a broad range of tumors and treatment settings.
Camrelizumab, under the brand name AiRuiKa®, is currently approved for nine indications in China, including hepatocellular carcinoma (“HCC”) (second-line and first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. All indications have been included in China’s national medical insurance catalog, making it the leading domestic PD-1 product in terms of approved indications and tumor types covered. The U.S. Food and Drug Administration (“FDA”) granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021, and accepted a New Drug Application (NDA) for camrelizumab and rivoceranib as a first-line therapy for unresectable HCC, with FDA Prescription Drug User Fee Act (PDUFA) dates in May 2024.
About Hengrui Pharma
Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked 24th among top 1,000 global pharmaceutical companies in 2021. Hengrui Pharma has been on the Pharma Exec’s annual listing of the top 50 global pharmaceutical companies for the fifth consecutive year.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world. Its first three medicines are marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of patients with PDAC and the further development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support an NDA submission of surufatinib for the treatment of patients with PDAC or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety profile of surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib and the timing of these events. In addition, as certain studies rely on the use of other drug products such as camrelizumab as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
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REFERENCES
| 1 | The Global Cancer Observatory, World Fact Sheets. Accessed April 9, 2024. | |
| 2 | Sarantis P et al. Pancreatic ductal adenocarcinoma: Treatment hurdles, tumor microenvironment and immunotherapy. World J Gastrointest Oncol. 2020;12(2):173-181. DOI:10.4251/wjgo.v12.i2.173 | |
| 3 | Jia R et al. Updated results of a phase 1b/2 study of surufatinib plus camrelizumab, nab-paclitaxel and S-1 (NASCA) as first-line therapy for metastatic pancreatic adenocarcinoma (mPDAC). JCO 42, 671-671(2024). DOI:10.1200/JCO.2024.42.3_suppl.671 |
FAQ
What is the focus of HUTCHMED's new clinical trial initiated in May 2024?
When did HUTCHMED start the Phase II/III trial for metastatic PDAC?
What are the primary and secondary endpoints of HUTCHMED's Phase II/III trial?
What is the significance of the combination therapy being tested in HUTCHMED's trial?
How many patients does HUTCHMED plan to enroll in the Phase II/III trial?
