Innovent and HUTCHMED Release Phase 1b preliminary Results of TYVYT (Sintilimab Injection) plus Fruquintinib as a Third Line Treatment for Advanced Colorectal Cancer at ASCO Annual Meeting 2021

SAN FRANCISCO and SUZHOU, China, June 6, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced with HUTCHMED (Nasdaq/AIM: HCM) that the results of the Phase 1b study in advanced colorectal cancer (CRC) patients were released today in an poster discussion at the 2021 American Association for Clinical Oncology (ASCO) Annual Meeting.

This is a Phase 1b dose escalation and dose expansion study to evaluate the tolerability, safety and preliminary efficacy of sintilimab plus fruquintinib, and to determine the recommended phase 2 dose (RP2D). 44 CRC patients that had failed at least 2 previous lines of therapy containing fluoropyrimidine, oxaliplatin or irinotecan were enrolled. They received either 5mg-intermittent or 3mg-continous dosage (n=22, each). The objective response rate (ORR) was 22.7% (10/44, 95% CI: 11.5-37.8%) with 27.3% (6/22, 95% CI: 10.7-50.2%) in the 5mg-intermittent group and 18.2% (4/22, 95% CI: 5.2-40.3%) in the 3mg-continuous group. With a median follow-up time of 11.3 (range: 9.8-11.7) months, the Kaplan-Meier estimated median progression free survival (PFS) was 5.6 (95% CI:4.3-7.5) months among all 44 patients, with 6.9 (95% CI:5.4-8.3) months for the 5mg-intermittent group and 4.2 (95% CI:2.9-9.5) months for the 3mg-continuous group. The safety for this combination therapy was controllable.

Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, said, "The preliminary results were very encouraging, which have given us a very promising efficacy signal that TYVYT^® (sintilimab injection) in combination with ELUNATE^® (fruquintinib) could be used as a third-line treatment for advanced CRC with microsatellite stability. These results would warrant further investigation in a larger population. This study also underscores our commitment to provide innovative treatment options to patients with cancer."

Dr. Weiguo Su, Chief Scientific Officer of HUTCHMED, said, "Fruquintinib's clean profile led us to evaluate this sintilimab combination in many different tumor types, with this favorable safety profile further highlighted by the combination's RP2Ds similarity to their monotherapy RP2D. This CRC data at RP2D is promising, showing median PFS at nearly double what was demonstrated under monotherapy. We are exploring next steps in bringing this novel therapy to cancer patients."

About Colorectal Cancer

Colorectal cancer is one of the most common malignancies in the world with relatively high morbidity and mortality. With the improvement of living conditions, the incidence of CRC in China has been increasing in recent years. Surgery is the major treatment for early stage CRC, but a large proportion of patients who have received surgery would develop relapse or distant metastasis, and die from disease progression. More than 95% of advanced CRCs are microsatellite stable, with very limited efficacy of immunotherapy and large unmet clinical needs.

About TYVYT^® (Sintilimab Injection)

TYVYT^® (sintilimab injection) is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, TYVYT^® (sintilimab Injection) has been approved for two indications, including:

• The treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy
• In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
• In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer

Additionally, Innovent currently has regulatory submissions under review in China for TYVYT^® (sintilimab Injection):

• In combination with BYVASDA® (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
• The second-line treatment of squamous non-small cell lung cancer

In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

TYVYT^® (sintilimab Injection) was included in China's National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year..

About ELUNATE^® (fruquintinib)

Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs –1, –2 and –3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib's low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing by the NMPA in September 2018 and is marketed under the brand name ELUNATE^® in China.  ELUNATE^® is for the treatment of patients with metastatic CRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). 

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By leveraging this platform, the company has built a robust pipeline of 24 valuable assets in major therapeutic areas, with 4 products officially approved for marketing in China - TYVYT^® (sintilimab injection), BYVASDA^® (bevacizumab biosimilar injection), SULINNO^® (adalimumab biosimilar injection) and HALPRYZA^® (rituximab biosimilar injection), one Biologics License Application (BLA) submission for sintilimab accepted by the U.S. FDA, six assets in Phase 3 or pivotal clinical trials, and 14 more molecules in clinical trials. TYVYT^® (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives.  For more information, please visit: www.innoventbio.com.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

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SOURCE Innovent Biologics, Inc.

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