Innovent Updates Phase 1b Data of IBI939 (Anti-TIGIT Monoclonal Antibody) Combined with Sintilimab in Previously Untreated PD-L1-selected NSCLC at the 2023 ASCO Annual Meeting

ROCKVILLE,Md. and SUZHOU,China,June 4,2023 -- Innovent Biologics,Inc. ("Innovent") (HKEX: 01801),a world-class biopharmaceutical company that develops,manufactures and commercializes high-quality medicines for the treatment of oncology,autoimmune,metabolic,ophthalmology and other major diseases,updated the Phase 1b efficacy and safety results of IBI939 (anti-TIGIT antibody) combined with sintilimab (anti-PD-1 antibody) in previously untreated PD-L1-selected NSCLC without sensitizing mutations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Efficacy and safety of IBI939 in combination with sintilimab in patients with previously untreated locally advanced unresectable or metastatic PD-L1-selected NSCLC: updated results in a Phase 1b study

Abstract#: e14578

IBI939 is an IgG4κ recombinant fully human anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) monoclonal antibody developed by Innovent Biologics.

This Phase 1b study aimed to evaluate safety,tolerability,and efficacy of combination therapy of IBI939 with sintilimab in patients with previously untreated,locally advanced unresectable or metastatic PD-L1 TPS≥50% NSCLC without sensitizing mutations(ClinicalTrials.gov,NCT04672369). As of January 1st,2023,42 pts were randomized (2:1) to receive IBI939 plus sintilimab (experimental arm,n=28) or sintilimab monotherapy (control arm,n=14). The study results were as follows:

With median progression free survival (PFS) follow-up of 12.2 months in the experimental arm and 11.3 months in the control arm,respectively,median PFS per investigator was 13.2 months (95%CI: 6.7-16.5) and 6.4 months (95%CI: 1.4-NA),and the hazard ratio (HR) between two arms was 0.62;

96.4% patients in the experimental arm and 71.4% patients in the control arm experienced treatment-related adverse event (TRAE). Each arm occurred one treatment-emergent adverse event (TEAE) leading to end of treatment. No TEAE leading to death occurred in the experimental arm.

Results from this updated analysis after longer follow-up demonstrated that IBI939 plus sintilimab combination therapy had continued efficacy and manageable safety profile in previously untreated PD-L1 TPS≥50%NSCLC without sensitizing mutations.

Professor Ying Cheng,Jilin Cancer Hospital,stated: "In recent years,we are exploring novel treatment strategies to further improve survival benefit in first-line PD-L1 TPS ≥50% NSCLC patients. We are pleased to see that anti-PD-(L)1 antibody plus anti-TIGIT antibody in this patient population has indicated preliminary efficacy in several early phase studies[1],[2]. With promising efficacy confirmed in first analysis[3],IBI939 plus sintilimab continues to show clinical benefits with longer follow-up. We are looking forward to the clinical benefit of this combination immunotherapy in clinical trial with larger sample size."

Dr. Hui Zhou,Senior Vice President of Innovent,stated: "We are pleased to present updated Phase 1b clinical results of IBI939 at the 2023 ASCO Meeting. IBI939,in combination with sintilimab,demonstrated promising and sustained efficacy and manageable safety profile. We are encouraged by the potential clinical benefit of IBI939 may provide,and will continue to advance the clinical development with the aim to develop and commercialize high-quality biopharmaceuticals that are affordable to ordinary people."

About IBI939

IBI939 is an IgG4κ recombinant human anti-TIGIT monoclonal antibody developed by Innovent Biologics. Targeting TIGIT on T cells and NK cell membranes in the tumor microenvironment,IBI939 can prevent the binding of CD155 overexpressed on the cancer cell membrane to TIGIT,thereby restoring the activation of cytotoxic T cells and NK cells,and exerting tumor killing effects1. Besides,TIGIT and PD-1 are both immunosuppressive checkpoint receptors. Dual blockage of TIGIT and PD-1 can synergistically promote immune cells to kill tumors and enhance anti-tumor immune response2.

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 disease,metabolic disorder and other major diseases. 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. Leveraging the platform,the company has built a robust pipeline of 35 valuable assets in the fields of cancer,metabolic disorder,autoimmune disease and other major therapeutic areas,with 8 approved products on the market. These include: TYVYT® (sintilimab injection),BYVASDA® (bevacizumab injection),SULINNO® (adalimumab injection),HALPRYZA® (rituximab injection),Pemazyre® (pemigatinib oral inhibitor),olverembatinib(BCR ABL TKI),Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review,6 assets are in Phase III or pivotal clinical trials,and 18 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization,including many global experts. The company has also entered into strategic collaborations with Eli Lilly,Roche,Sanofi,Adimab,Incyte,MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry,improve drug availability and enhance the quality of the patients' lives.

Disclaimer:Innovent does not recommend any off-label usage.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection),SULINNO®,and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection,Innovent)

BYVASDA® (bevacizumab biosimilar injection,Innovent)

HALPRYZA® (rituximab biosimilar injection,Innovent)

SULINNO® (adalimumab biosimilar injection,Innovent)

Pemazyre® (pemigatinib oral inhibitor,Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China,Hong Kong,Macau and Taiwan.

CYRAMZA® (ramucirumab,Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (selpercatinib,Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Forward-Looking Statements

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Reference

[1] Cho BC,Abreu DR,Hussein M,et al. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised,double-blind,phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792.

[2] https://www.gilead.com//news-and-press/press-room/press-releases/2022/12/anti-tigit-domvanalimab-containing-study-arms-improve-progression-free-survival-compared-to-anti-pd1-alone-in-phase-2-non-small-cell-lung-cancer-study.

[3] Cheng Y,Liu B,Wu L,et al. 77P A study to evaluate the safety,tolerability and efficacy of IBI939 in combination with sintilimab in patients with previously untreated locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC). Immuno-Oncology and Technology. 2022;16.