HUTCHMED Highlights Phase III FRESCO-2 MRCT Data Summary of

— Fruquintinib remedy diminished the danger of loss of life by 34% in metastatic colorectal most cancers (0.66 HR) —

— Increased illness management with threat of illness development or loss of life diminished by 68% (0.32 HR) —

— Results to be introduced in a late-breaking, proffered paper presentation at ESMO —

— Conference name and webcast to be held on Monday, September 12 at 2:00 pm Paris time to debate the total trial outcomes and the unmet medical want in colorectal most cancers —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 07, 2022 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) right this moment publicizes abstract outcomes of the 691-patient, multi-regional scientific trial (“MRCT”) of fruquintinib. These outcomes have been shared in an summary of the upcoming presentation on the European Society for Medical Oncology Congress 2022 (“ESMO22”) on September 12, 2022. ESMO22 might be held on the Paris Expo Porte de Versailles.

Dr Arvind Dasari, Associate Professor, Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, will current the FRESCO-2 outcomes at ESMO22. Dr Dasari commented, “These results are exciting and encouraging for patients and healthcare providers alike since they address a huge unmet need in refractory metastatic colorectal cancer. Fruquintinib provides a possible new treatment option with a meaningful survival benefit and manageable toxicity profile. These results also offer opportunities for further development of fruquintinib in other settings and combinations.”

The MRCT FRESCO-2 research demonstrated that remedy with fruquintinib resulted in a statistically important and clinically significant enhance within the major general survival (“OS”) endpoint and key secondary progression-free survival (“PFS”) endpoint in comparison with remedy with placebo. Specifically, the median OS was 7.4 months for the 461 sufferers handled with fruquintinib in comparison with 4.8 months for the 230 sufferers within the placebo group (hazard ratio [“HR”] 0.66; 95% confidence interval [“CI”] 0.55–0.80; p<0.001). Median PFS was 3.7 months for sufferers handled with fruquintinib in comparison with 1.8 months for sufferers within the placebo group (HR 0.32; 95% CI 0.27–0.39; p<0.001). The illness management charge (“DCR”) was 55.5% within the fruquintinib group in comparison with 16.1% for sufferers within the placebo group. Median period of follow-up was roughly 11 months for sufferers in each teams.

The security profile of fruquintinib in FRESCO-2 was per beforehand reported fruquintinib research. Grade 3 or above hostile occasions occurred in 62.7% of sufferers who acquired fruquintinib, in comparison with 50.4% of sufferers who acquired placebo. Grade 3 or above hostile occasions that occurred in additional than 5% of sufferers who acquired fruquintinib had been hypertension (13.6% vs 0.9% within the placebo group), asthenia (7.7% vs 3.9% within the placebo group) and hand-foot syndrome (6.4% vs 0% within the placebo group).

Further particulars of the FRESCO-2 presentation at ESMO22 are as follows:

Investor audio webcast and convention name is scheduled on Monday, September 12 at 2:00 pm Paris Time (1:00 pm London time, 8:00 am New York time, and eight:00 pm Hong Kong time).

Participating on the webcast might be members of the HUTCHMED administration group, Dr Dasari and different co-Principal Investigators from the research:

• Dr Cathy Eng, David H. Johnson Endowed Chair in Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research Program, on the Vanderbilt-Ingram Cancer Center;
• Dr Josep Tabernero, Head of the Medical Oncology Department of Vall d’Hebron University Hospital, Barcelona, Spain; Director of Clinical Research at Vall d’Hebron Institute of Oncology; Head of the Gastrointestinal and Endocrine Tumors Group; Past President, the European Society for Medical Oncology;
• Dr James Yao, Professor, Ellen F. Knisely Distinguished Chair in Colon Cancer Research, Department of GI Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX; and
• Dr Takayuki Yoshino, Professor, Director Department of Gastrointestinal Medical Oncology, National Cancer Hospital East, Chiba, Japan.

Details of the convention name dial-in and the webcast hyperlink might be offered on the corporate web site at www.hutch-med.com/occasion/. A replay may even be obtainable on the web site shortly after the occasion.

About FRESCO-2

The FRESCO-2 research is a MRCT performed within the U.S., Europe, Japan and Australia that investigated fruquintinib plus finest supportive care (“BSC”) vs placebo plus BSC in sufferers with superior, refractory metastatic colorectal most cancers (“CRC”). As beforehand disclosed, the 691-patient research met its major endpoint of OS in sufferers with metastatic CRC who had progressed on commonplace chemotherapy and related biologic brokers and who had progressed on, or had been illiberal to, TAS-102 and/or regorafenib. In addition to OS, a statistically important enchancment in progression-free survival PFS, a key secondary endpoint, was noticed. The security profile of fruquintinib in FRESCO-2 was per beforehand reported research. Additional particulars of the research could also be discovered at clinicaltrials.gov, utilizing identifier NCT04322539.

About CRC

CRC is a most cancers that begins in both the colon or rectum. CRC is the third commonest most cancers worldwide, estimated to have induced greater than 915,000 deaths in 2020.¹ In the U.S., an estimated 151,000 individuals could have been identified with CRC and 53,000 individuals could have died from CRC in 2022.² In Europe, CRC is the second commonest most cancers, with an estimated 507,000 new circumstances and 240,000 deaths in 2020.¹ In Japan, CRC is the most typical most cancers, with an estimated 147,000 new circumstances and 59,000 deaths in 2020.¹

About Fruquintinib

Fruquintinib is a extremely selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal position in blocking tumor angiogenesis. Fruquintinib was designed to enhance kinase selectivity to attenuate off-target toxicities, enhance tolerability and supply extra constant goal protection. The usually good tolerability in sufferers to this point, together with fruquintinib’s low potential for drug-drug interplay based mostly on preclinical evaluation, means that it could even be extremely appropriate for combos with different anti-cancer therapies.

About FRESCO and Fruquintinib Approval in China

Metastatic CRC in China: Fruquintinib was permitted for advertising and marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 underneath the model title ELUNATE^®. It has been included within the China National Reimbursement Drug List (NRDL) since January 2020. ELUNATE^® is indicated for the remedy of sufferers with metastatic CRC who’ve been beforehand handled with fluoropyrimidine, oxaliplatin and irinotecan, together with those that have beforehand acquired anti-VEGF remedy and/or anti-EGFR remedy (RAS wild kind).

Results of the FRESCO research³, a Phase III pivotal registration trial of fruquintinib in 416 sufferers with metastatic CRC in China, had been printed in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819). The research demonstrated that fruquintinib offered a statistically important and clinically significant profit in third-line metastatic CRC sufferers in China. Median OS was 9.3 months for sufferers handled with fruquintinib, as in comparison with 6.6 months for sufferers within the placebo group (HR 0.65; 95% CI 0.51–0.83; p<0.001). Median PFS was 3.7 months for sufferers handled with fruquintinib, as in comparison with 1.8 months for sufferers within the placebo group (HR 0.26; 95% CI 0.21–0.34; p<0.001). DCR was 62.2% vs. 12.3% for placebo. In phrases of security, outcomes confirmed that fruquintinib had a manageable security profile. The most incessantly reported fruquintinib-related grade 3 and above hostile occasions included hypertension (21.2%) and hand-foot pores and skin response (10.8%).

About Fruquintinib Development Beyond CRC Monotherapy

The security and efficacy of fruquintinib for the next investigational makes use of haven’t been established and there’s no assure that it’ll obtain well being authority approval or grow to be commercially obtainable in any nation for the makes use of being investigated:

Gastric Cancer (“GC”) in China: The FRUTIGA research is a randomized, double-blind, Phase III trial evaluating the efficacy and security of fruquintinib mixed with paclitaxel for the remedy of sufferers with superior gastric or esophagogastric junction (GEJ) adenocarcinoma who didn’t reply to first-line commonplace chemotherapy. Approximately 700 sufferers have acquired both fruquintinib mixed with paclitaxel or placebo mixed with paclitaxel. The co-primary efficacy endpoints are OS and PFS (NCT03223376).

Immunotherapy combos: HUTCHMED has entered into collaboration agreements to guage the security, tolerability and efficacy of fruquintinib together with PD-1 monoclonal antibodies, together with with tislelizumab (developed by BeiGene, Ltd) and sintilimab (developed by Innovent Biologics, Inc.).

• Metastatic breast, endometrial, and CRC within the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II research within the U.S. to research if the addition of fruquintinib can probably induce exercise to immune checkpoint inhibitor remedy in superior, refractory triple unfavorable breast most cancers (“TNBC”), endometrial most cancers, and CRC (NCT04577963). Safety and preliminary efficacy of fruquintinib as a single agent had been demonstrated in superior stable tumors, together with TNBC, in a Phase I research performed in China (NCT01645215) and a Phase I/Ib research is ongoing within the U.S. (NCT03251378).
• Gastric, colorectal and non-small cell lung cancers (“NSCLC”) in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II research to evaluate the security and efficacy of fruquintinib together with tislelizumab in sufferers with superior or metastatic, unresectable GC, CRC or NSCLC (NCT04716634).
• Endometrial most cancers and different stable tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II research to evaluate the security and efficacy of fruquintinib together with sintilimab in sufferers with superior cervical most cancers, endometrial most cancers, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Preliminary outcomes of sure cohorts had been introduced on the 2021 American Society of Clinical Oncology Annual Meeting (ASCO) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO). Following encouraging information within the superior endometrial most cancers cohort, it has been expanded right into a single-arm registrational Phase II research of over 130 sufferers (NCT03903705).

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an progressive, commercial-stage, biopharmaceutical firm. It is dedicated to the invention and world growth and commercialization of focused therapies and immunotherapies for the remedy of most cancers and immunological illnesses. It has greater than 4,900 personnel throughout all its corporations, on the middle of which is a group of about 1,800 in oncology/​immunology. Since inception it has superior 13 most cancers drug candidates from in-house discovery into scientific research all over the world, with its first three oncology medicine now permitted and marketed in China. For extra data, please go to: www.hutch-med.com or observe us on LinkedIn.

Forward-Looking Statements

This press launch incorporates forward-looking statements inside the which means of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements mirror HUTCHMED’s present expectations relating to future occasions, together with its expectations relating to the therapeutic potential of fruquintinib for the remedy of sufferers with superior CRC and the additional scientific growth of fruquintinib on this and different indications. Forward-looking statements contain dangers and uncertainties. Such dangers and uncertainties embrace, amongst different issues, assumptions relating to the timing and consequence of scientific research and the sufficiency of scientific information to assist NDA approval of fruquintinib for the remedy of sufferers with superior CRC or different indications within the U.S., Europe, Japan, Australia or different jurisdictions, its potential to realize approvals from regulatory authorities on an expedited foundation or in any respect, the security profile of fruquintinib, HUTCHMED’s skill to fund, implement and full its additional scientific growth and commercialization plans for fruquintinib, the timing of these occasions, and the influence of the COVID-19 pandemic on basic financial, regulatory and political situations. In addition, as sure research depend on the use of different drug merchandise akin to paclitaxel, tislelizumab and sintilimab as mixture therapeutics with fruquintinib, such dangers and uncertainties embrace assumptions relating to the security, efficacy, provide and continued regulatory approval of these therapeutics. Existing and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date hereof. For additional dialogue of these and different dangers, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to replace or revise the data contained on this press launch, whether or not because of this of new data, future occasions or circumstances or in any other case.

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