Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial

Exploring the efficacy of PD-1 inhibitor combination therapy strategies for adjuvant therapy in a population that has not achieved major pathological regression after neoadjuvant immunotherapy for non-small cell lung cancer: a multicenter, phase II clinical study

Start Date30 Sep 2024

Sponsor / Collaborator

Shanghai Pulmonary Hospital

NCT06580574

/ RecruitingPhase 2IIT

Sintilimab With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability

This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability

Start Date13 Aug 2024

Sponsor / Collaborator

Peking University

NCT05890742

/ RecruitingPhase 3

A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

Start Date25 May 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Ipilimumab biosimilar (Innovent Biologics)

100 Translational Medicine associated with Ipilimumab biosimilar (Innovent Biologics)

100 Patents (Medical) associated with Ipilimumab biosimilar (Innovent Biologics)

Literatures (Medical) associated with Ipilimumab biosimilar (Innovent Biologics)

01 May 2025·Med

IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial

Article

Author: Tang, Yaling ; Zhang, Guonan ; Huang, Yi ; Ma, Xinyan ; Li, Huayi ; Zhao, Weidong ; Qian, Jianhua ; Xu, Qin ; Zhang, Jieqing ; Zheng, Hong ; Wang, Danbo ; Gao, Qinglei ; Zhou, Hui ; Tang, Ying ; Peng, Zikun ; Qiu, Hui ; Ji, Jianghai ; Liu, Jihong ; Yin, Kang ; Cai, Chujun ; An, Ruifang ; Shen, Yiyang ; Wang, Li ; Zhang, Hongfei ; Wang, Shuyan ; Xie, Han ; Wang, Xia ; Li, Guiling ; Chang, Baoping ; Yuan, Jianlin ; Ma, Cailing ; Sun, Li ; He, Aiqin ; Zhu, Lijing ; Jiao, Xiaofei ; Xu, Yu ; Wang, Ya ; Zhu, Jianqing ; Lou, Ge ; Wang, Jing ; Xia, Bairong ; Ma, Ding ; Duan, Wei ; Lu, Liqin ; Li, Li ; Wang, Ke ; Zhu, Hong ; Cheng, Yan ; Yu, Guohua ; Huang, Jianli ; Huang, Bowen ; Zhang, Youzhong ; Chen, Youguo

BACKGROUND:

It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC).

METHODS:

In this randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov: NCT04590599), patients with recurrent/metastatic CC (R/M CC) who experienced disease progression after or during platinum-based chemotherapy were enrolled from 37 centers across China and randomly assigned (1:1), stratified by PD-L1 expression and prior treatment lines, to receive either IBI310 plus sintilimab or placebo plus sintilimab intravenously every 3 weeks for 12 weeks, followed by sintilimab alone. The primary endpoint was the objective response rate (ORR). Pivotal secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

FINDINGS:

205 patients were randomized to receive IBI310-sintilimab (n = 103) or placebo-sintilimab (n = 102). The ORR difference between the IBI310-sintilimab arm (32.3%, 95% confidence interval [CI]: 23.3%-42.5%) and the placebo-sintilimab arm (23.5%, 95% CI: 15.5%-33.1%) was not significant (p = 0.17). IBI310-sintilimab and placebo-sintilimab exhibited median PFS values of 3.6 (95% CI: 2.7-6.3) and 4.2 months (95% CI: 2.8-6.2), respectively (hazard ratio [HR] = 0.91, 95% CI: 0.65-1.27; p = 0.58). The median OSs were 13.9 months (95% CI: 11.5-25.6) in the IBI310-sintilimab arm and 17.2 months (95% CI: 13.7-25.9) in the placebo-sintilimab arm (HR = 1.12, 95% CI: 0.79-1.58; p = 0.54). Adding IBI310 to sintilimab increased the incidence of grade ≥3 treatment-related adverse events (55% versus 19%).

CONCLUSIONS:

Compared to single-agent PD-1/PD-L1 blockade, dual blockade of CTLA-4 and PD-1/PD-L1 did not significantly improve clinical outcomes in R/M CC.

FUNDING:

This work was funded by Innovent Biologics (Suzhou).

01 Jul 2024·The Innovation

IBI310 (anti-CTLA-4 antibody) monotherapy or in combination with sintilimab in advanced melanoma or urothelial carcinoma

Article

Author: Yang, Yue ; Shen, Yuping ; Li, Juan ; Si, Lu ; Wei, Xiaoting ; Guo, Jun ; Tang, Bixia ; Chi, Zhihong ; Zheng, Shirui ; Zhou, Li ; Mao, Lili ; Li, Siming ; Guo, Qun ; Lian, Bin ; Cui, Chuanliang ; Yan, Xieqiao ; Wang, Xuan

IBI310 is a recombinant fully human IgG1 antibody against cytotoxic T lymphocyte antigen 4. This study was conducted to evaluate IBI310 monotherapy or combination therapy with sintilimab in the patients with advanced melanoma or urothelial carcinoma (UC). Patients in phase 1a received IBI310 at 0.3/1/2/3 mg/kg intravenously (IV) every 3 weeks (Q3W) following the accelerated titration and 3 + 3 escalation design. Patients in phase 1b received IBI310 (1/2/3 mg/kg IV, Q3W) plus sintilimab (200 mg IV, Q3W) for four cycles, followed by sintilimab maintenance therapy. The phase 1b expansion of IBI310 plus sintilimab was performed in patients with advanced melanoma or UC. Overall, 53 patients were enrolled, including 10 patients with melanoma in phase 1a, 34 with melanoma, and 9 with UC in phase 1b. Overall, 94.3% of patients (50/53) experienced at least one treatment-related adverse event (TRAE) with most being grade 1-2; 26.4% of patients (14/53) experienced grade 3 or higher TRAEs. In phase 1a, the disease control rate (DCR) was 50.0% (95% confidence interval [CI], 18.7%-81.3%). In phase 1b, the objective response rate (ORR) and DCR were 17.6% (95% CI, 6.8%-34.5%) and 44.1% (95% CI, 27.2%-62.1%), respectively, for melanoma, and were 22.2% (95% CI, 2.8%-60.0%) and 66.7% (95% CI, 29.9%-92.5%), respectively, for UC. IBI310 monotherapy or combination therapy with sintilimab was well tolerated with favorable antitumor activity across patients with advanced melanoma and UC.

01 Feb 2024·Cancer medicine

A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non‐small‐cell lung cancer who have progressed after anti‐PD‐1/L1 therapy

Article

Author: Yao, Jun ; Long, Jianlin ; Zhao, Jun ; Chen, Ye ; Cui, Jiuwei ; Meng, Rui ; Liu, Ziling ; Zhao, Yuguang ; Li, Li ; Zang, Aimin ; Guo, Qun ; Mao, Yong ; Chen, Xiao ; Luo, Yang ; Wu, Di

Abstract:

Background:

The development of immune checkpoint inhibitors has made a significant breakthrough in the treatment of non‐small‐cell lung cancer (NSCLC). However, there remains a huge unmet clinical need for patients with acquired resistance after initial treatment response.

Methods:

This study evaluated the combination of IBI310 (an anti‐cytotoxic T lymphocyte‐associated antigen‐4 [CTLA‐4] antibody) and sintilimab (an anti‐programmed death 1 [PD‐1]) antibody) in NSCLC patients who have previously been treated with anti‐PD‐1/ligand (L)1 and acquired resistance. The patients were randomly assigned to receive either a lower dose of IBI310 (1 mg/kg Q3W, cohort A) or a higher dose of IBI310 (3 mg/kg Q3W, cohort B) in combination with sintilimab (200 mg Q3W). The primary endpoints of the study were objective response rate (ORR) assessed by RECISTv1.1 and safety, while secondary endpoints included disease control rate (DCR), progression‐free survival (PFS), and overall survival (OS).

Results:

As of November 2, 2023, the study had enrolled 30 patients, with 15 patients in each cohort. The ORR was 13.3% (2/15, 95% confidence interval [CI], 1.7–40.5) in cohort B. DCR were 46.7% (95% CI, 21.3–73.4) and 66.7% (95% CI, 38.4–88.2) in cohorts A and B, respectively. In cohorts A and B of this trial, the median follow‐up times were 4.2 and 5.6 months, respectively. Median PFS was 1.45 (95% CI, 1.35–2.73) versus 2.73 (95% CI, 1.41–4.90) months for cohort A versus B; the median OS was 7.03 (95% CI, 3.09–not calculable [NC]) months in cohort A and 8.90 (95% CI, 5.13–NC) months in cohort B. Of the 30 patients, 86.7% in both cohorts experienced treatment‐related adverse events (TRAEs) with Grade ≥3 TRAEs occurring in 40% and 53.3% of patients in cohorts A and B, respectively.

Conclusion:

IBI310 3 mg/kg Q3W plus sintilimab was effective in a small number of previously treated anti‐PD‐1/L1‐resistant NSCLC patients.

News (Medical) associated with Ipilimumab biosimilar (Innovent Biologics)

23 Feb 2025

·www.prnewswire.com

NMPA Accepts NDA and Grants Priority Review Designation to Innovent's Ipilimumab Injection, China's First Domestic CTLA-4 Inhibitor, in Combination with Sintilimab as Neoadjuvant Treatment for Colon Cancer

SAN FRANCISCO and SUZHOU, China, Feb. 23, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and granted Priority Review designation[1] in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. This is China's first NDA for a domestic CTLA-4 inhibitor and another milestone strengthening sintilimab's leadership position in cancer immunotherapy. Immune checkpoint blockade (ICB) therapy targeting PD-1 and CTLA-4 has transformed oncology treatment, ipilimumab with sintilimab as a neoadjuvant treatment could increase R0 resection rate, achieve pathological complete response, and relieve the majority of patients from adjuvant chemotherapy burdens. This novel treatment is also expected to reduce recurrence rate and improve long-term prognosis, anticipated to benefit MSI-H/dMMR colon cancer patients upon NDA approval. The NDA acceptance and Priority Review designation are based on results from a randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742) which evaluated the safety and efficacy of ipilimumab combined with sintilimab as neoadjuvant therapy and as compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) showed that the NeoShot trial has met its primary endpoint. Detailed results will be presented at future academic conferences or published in academic journals. Previously, the results of a randomized controlled Phase 1b trial evaluating ipilimumab in combination with sintilimab as neoadjuvant treatment for MSI-H/dMMR colon cancer were presented orally at the 2024 American Society of Clinical Oncology (ASCO) Annual Meetingi. Based on promising Phase 1b results, the CDE has granted Breakthrough Therapy Designation (BTD) for ipilimumab. As of February 4, 2024, 101 patients were enrolled and randomized to receive ipilimumab plus sintilimab (n=52) or sintilimab alone (n=49). In the per-protocol population, the pCR rate in the ipilimumab-plus-sintilimab arm was significantly higher than in the sintilimab-alone arm（80.0% vs 47.7%, p=0.0007）. All patients in both treatment arms had R0 resection. With median follow-up of 5.65 months, no patient had disease recurrence. At postoperative pathological evaluation, 3.9% of patients with ipilimumab plus sintilimab and 15.9% of patients with sintilimab alone were stage N+. The majority of patients could be relieved from adjuvant treatment according to clinical guidelines. Ipilimumab -plus-sintilimab increased neither safety risk compared to sintilimab alone nor risk for subsequent surgery delay or cancellation. The Principal Investigator of the NeoShot study, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated: "At present, R0 resection for certain locally advanced colon cancer patients remains a significant challenge, along with risks of extensive trauma and poor prognosis. The results of the FOxTROT study suggested that neoadjuvant chemotherapy is not effective in MSI-H/dMMR colon cancer, and the pCR rate is only around 5%ii. The NeoShot trial is the first randomized, controlled, Phase 3 clinical trial to show promising efficacy of dual checkpoint inhibition as neoadjuvant therapy in MSI-H/dMMR colon cancer. Results from the phase 1b study suggest that ipilimumab with sintilimab as short-term neoadjuvant treatment could increase R0 resection rate, achieve pathological complete response, and relieve patients from adjuvant chemotherapy burdens. This novel treatment is also expected to lower recurrence rate and improve long-term prognosis i.As this dual immunotherapy regimen has the potential to change clinical practice, we look forward to the NDA approval of this novel drug to benefit more MSI-H/dMMR colon cancer patients soon. " Dr. Hui Zhou, Senior Vice President of Innovent, stated: "There is a huge unmet clinical need for neoadjuvant therapy of resectable MSI-H/dMMR colon cancer in China. Interim analysis showed that the NeoShot trial has met its primary endpoint. With Innovent's highly efficient and high-quality clinical development, ipilimumab has become China's first domestic CTLA-4 inhibitor to submit an NDA. We will actively cooperate with regulatory authorities to accelerate approval, and provide a new treatment option for patients with resectable MSI-H/dMMR colon cancer in China." About Ipilimumab Ipilimumab (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent. Ipilimumab can specifically bind cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4 mediated T cell inhibition, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. iii The NDA for ipilimumab in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer is under the NMPA review and has been granted Priority Review designation. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. 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.iv In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Furthermore, sintilimab's eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was conditional approved by the NMPA in December 2024. And the NDA for sintilimab in combination with ipilimumab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer is under the NMPA review and has been granted Priority Review designation. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 14 products in the market. It has 4 new drug applications under regulatory review, 2 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Reference: SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Breakthrough TherapyASCOImmunotherapy

25 Nov 2024

·www.prnewswire.com

Innovent to Present Clinical Data of Multiple Novel Molecules at ESMO Asia 2024

SAN FRANCISCO and SUZHOU, China, Nov. 24, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that nearly 10 accepted clinical data of its novel oncology molecules, including an oral presentation of updated Phase 1 result of its novel TOPO1i CLDN18.2 ADC (IBI343) in previously-treated pancreatic cancer, will be released at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2024 from Dec 06-08, 2024, in Singapore. Details on the abstracts are listed below: Mini Oral Abstract Title: Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients with advanced pancreatic ductal adenocarcinoma (PDAC): updated results from a Phase 1 study Abstract No: 132MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 09:50-09:55 Presenter: Jian Zhang, Fudan University Shanghai Cancer Center, CN Abstract Title: mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody in Locally Advanced MSS CRC (BASKETⅡ): A Prospective, Single-Arm, Open-Label, Phase 2 Study Abstract No: 74MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 10:20-10:25 Presenter: Jun Huang, The Sixth Affiliated Hospital, Sun Yat-sen University, CN Posters Abstract Title: Anlotinib plus Sintilimab as First-line Treatment for Patients with Advanced Colorectal Cancer (APICAL-CRC): an Open-Label, Single-arm, Phase 2 study Abstract No: 75P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhan Wang, Shanghai Changzheng Hospital, The Second Affiliated Hospital of Naval Medical University, CN Abstract Title: A single-arm, multicenter, Phase 2 study of hepatic arterial infusion chemotherapy (HAIC) combined with donafenib and sintilimab as first-line treatment for unresectable intrahepatic cholangiocarcinoma (CHANCE 2203) Abstract No: 137P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Gaojun Teng, Zhongda Hospital, Southeast University, CN Abstract Title: FOLFOX-HAIC combined with sintilimab and bevacizumab for advanced hepatocellular carcinoma: a single-arm, Phase 2 study Abstract No: 207P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Bin Liang/ Zizhuo Wang, Union Hospital Tongji Medical College Huazhong University of Science and Technology, CN Abstract Title: Updated results from Phase 2 study of HAIC plus sintilimab and bevacizumab biosimilar in patients with advanced hepatocellular carcinoma (HCC) Abstract No: 214P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Haibin Zhang, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital of Naval Medical University, CN Abstract Title: Anlotinib Combined with Sintilimab Versus Chemotherapy Combined with Immunotherapy in Perioperative NSCLC: A Phase 2 Study Abstract No: 599P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Tianqing Chu, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, CN Trial in Progress abstracts (TiP) Abstract Title: A randomized, controlled, multicenter Phase 3 study of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) as neoadjuvant treatment for resectable microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colon cancer: Trial in Progress Abstract No.: 119TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Ruihua Xu, Sun Yat-sen University Cancer Center, CN Abstract Title: Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy with Cryoablation in the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Abstract No.: 722TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhiqiang Gao, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, CN Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present and share a robust set of clinical data at EAMO Asia 2024. Notably, we are highlighting the breakthrough potential for our TOPO1i CLDN18.2 ADC (IBI343) in pancreatic cancer, a global difficult-to-treat cancer. Consistent with the preliminary signal observed in small patient size, the data in dose expansion stage demonstrated encouraging efficacy and good safety, which reinforced our confidence in advancing its development. Given unique design of Fc-silent antibody, combined with stable linker and potent extecan payload, IBI343 pioneered in the exploration of CLDN18.2 ADC agents for PDAC treatment. As one of the few biopharmaceutical companies with both advanced technology platforms and a robust pipeline in "IO+ADC" areas, Innovent remains dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Clinical ResultADCImmunotherapy

24 Oct 2024

·synapse.patsnap.com

AstraZeneca Submits Application for "Dual Immunotherapy Combination" in China

On October 18, 2024, according to the CDE website, AstraZeneca submitted a market application for the injectable drug Tremelimumab. This drug has already been approved overseas for use in combination with a PD-L1 antibody for the first-line treatment of hepatocellular carcinoma and non-small cell lung cancer. In this submission, the company also filed for the approval of Durvalumab, suggesting that the two drugs could be used in combination as a first-line treatment for tumors. About TremelimumabTremelimumab is a first-generation CTLA-4 antibody that was initially developed by Pfizer, entering Phase III clinical trials even before the first approved CTLA-4 antibody, Ipilimumab. In 2008, Pfizer abandoned Tremelimumab after interim analyses showed no difference in overall survival (OS), eventually transferring the product to MedImmune in 2011 (MedImmune was acquired by AstraZeneca in 2007). Subsequent attempts to use Tremelimumab as monotherapy were unsuccessful, making its combination with a PD-1 antibody the last hope for its market approval. In the fall of 2019, AstraZeneca disclosed details of the POSEIDON trial. In this trial, Imfinzi (Durvalumab) combined with platinum-based chemotherapy, or a combination of Imfinzi, Tremelimumab, and chemotherapy, was compared to chemotherapy alone for first-line treatment of Stage IV metastatic NSCLC. Tremelimumab significantly improved progression-free survival (PFS), although the interim analysis of the POSEIDON trial did not indicate sufficient advantages at that time. However, in May 2021, final high-level positive results showed that the combination of Imfinzi, Tremelimumab, and chemotherapy offered statistically and clinically significant OS benefits over chemotherapy alone. Each combination demonstrated acceptable safety profiles with no new safety signals detected. Statistics show that the combination of Tremelimumab and Durvalumab has been approved for hepatocellular carcinoma and non-small cell lung cancer. Beyond these indications, the company is also exploring their use in locally advanced hepatocellular carcinoma (EMERALD-3 study), small cell lung cancer (ADRIATIC study), bladder cancer (VOLGA and NILE studies), and other indications. In September 2024, the company released significant 5-year OS data from the HIMALAYA study. The HIMALAYA study is a randomized, open-label, multi-center, global Phase III trial with a primary endpoint of OS in the intent-to-treat population comparing the STRIDE regimen to Sorafenib. The results showed an unprecedented 5-year OS rate of 19.6% for the STRIDE regimen group, double that of the Sorafenib group, reinforcing its status in first-line treatment for liver cancer. Furthermore, ADRIATIC is the first global Phase III immunotherapy trial targeting LS-SCLC, which reached both PFS and OS primary endpoints this April. The study aimed to evaluate the efficacy of Durvalumab ± Tremelimumab versus placebo in 730 LS-SCLC patients who had not progressed after cCRT. This clinical study was conducted across 164 research centers in 19 countries in North America, South America, Europe, and Asia. About CTLA-4 AntibodiesCTLA-4, also known as CD152, is a transmembrane protein found on the surface of T cells and is encoded by the CTLA-4 gene, located at chromosome 2q33. It is primarily expressed on the surface of activated T lymphocytes. CTLA-4 shares significant similarities with CD28, a co-stimulatory receptor molecule on T cells, in terms of gene structure, chromosomal positioning, sequence homology, and gene expression. CTLA-4 can bind to co-stimulatory molecules (B7) on the surface of antigen-presenting cells (APCs). CTLA-4 exists as a homodimer composed of an extracellular domain, a transmembrane region, and a cytoplasmic region. It is mainly expressed on activated CD4+ and CD8+ T cells and also found on the surface of Treg cells. The CTLA-4 expressed on Tregs plays a crucial role in their function, accumulating within tumor tissues to suppress anti-tumor immunity. By blocking CTLA-4, the function of tumor-infiltrating Tregs is mitigated, thereby enhancing immune responses within the tumor. Consequently, CTLA-4 is considered an immunosuppressive molecule that hinders anti-tumor immunity, making it a focal point in current tumor-targeted immunotherapy. According to incomplete statistics, there are about a hundred CTLA-4 therapies under investigation globally, with seven products already approved. Building on the considerable success of combination therapies, companies like Hengrui, Akeso, Innovent, and Henlius in China are actively exploring related combination treatment strategies. Selection of Drugs for Liver CancerAs a country with a high prevalence of liver cancer, China accounts for nearly half of the world's new and fatal cases each year. Currently, both domestic and international clinical studies have been extensively conducted on first-line immunotherapy for advanced hepatocellular carcinoma (HCC). Notably, the "Double A" regimen, the "T+A" regimen, and the "Double D" regimen have all received approval from the National Medical Products Administration (NMPA) for marketing and have been included as a Level I recommendation (Category 1A evidence) in the "CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer." In addition to combination therapies involving targeted and immune approaches, the NMPA has also approved toripalimab as a monotherapy for the first-line treatment of patients with advanced HCC. Furthermore, the HIMALAYA study yielded positive results for the combination of tremelimumab and durvalumab, although this dual immunotherapy regimen has not yet been approved domestically. Currently, several studies focusing on immunotherapy combined with local treatments are underway, promising to offer more therapeutic options for liver cancer patients in the near future. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

100 Deals associated with Ipilimumab biosimilar (Innovent Biologics)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Mismatch repair-deficient Colonic Cancer	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2025
Mismatch repair-deficient Colonic Cancer	NDA/BLA	China	Innovent Biomedical Technology (Hangzhou) Co., Ltd.	22 Feb 2025
Advanced Hepatocellular Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Feb 2021
Acral Lentiginous Malignant Melanoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	17 Apr 2020
Melanoma	Phase 3	China	Suzhou Xinda Biotechnology Co., Ltd.	17 Apr 2020
Advanced biliary tract cancer	Phase 2	China	Suzhou Xinda Biotechnology Co., Ltd.	16 Feb 2023
Nasopharyngeal Carcinoma	Phase 2	China	Suzhou Xinda Biotechnology Co., Ltd.	07 Jul 2021
Advanced Cervical Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	23 Nov 2020
Microsatellite instability-high colorectal cancer	Phase 2	China	Innovent Biologics, Inc.	07 Aug 2020
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	13 Dec 2019

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05890742 (PRNewswire) Manual	Phase 1	Microsatellite instability-high colorectal cancer Deficient DNA Mismatch Repair (dMMR) \| MSI-High	101	IBI310 + sintilimab	smfxgxiptr(dpfwuphwkq) = htvyzgconp txabeepcfz (kfwtsnlzxb ) View more	Positive	02 Jun 2024
				sintilimab	smfxgxiptr(dpfwuphwkq) = ylofljelbt txabeepcfz (kfwtsnlzxb ) View more
NCT05890742 (ASCO2024) Manual	Phase 1	Microsatellite instability-high colorectal cancer First line \| Neoadjuvant microsatellite instability-high \| mismatch repair-deficient	101	IBI310 1 sintilimabsintilimab 200 mg Q3W	ypoqmlbdhm(xxrzouhhvv) = hqeqrpnzxp yzpwvwdhpt (vxflpkrorz, 66.3 - 90.0) View more	Positive	24 May 2024
				Sintilimab 200 mg Q3W	ypoqmlbdhm(xxrzouhhvv) = herdfilumb yzpwvwdhpt (vxflpkrorz, 32.5 - 63.3) View more
NCT04202601 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Epstein-Barr virus associated gastric carcinoma First line \| Second line EBV Positive	49	Sintilimab 3mg/kg plus IBI310 1mg/kg	hrkpkkhbfv(hcdefwtwjn) = ymmgnhhegn nzcglbwtbp (pxbetgvbfk ) View more	Positive	23 Oct 2023
				Sintilimab 3mg/kg plus IBI310 1mg/kg (treatment-naïve)	ejpqdyjsvw(zqdzykfgfq) = alaenzqwol imucdhuupx (feqpnrmdut, 40.6 - 79.8) View more
NCT04401813 (ASCO_GI2022) Manual	Phase 1	Advanced Hepatocellular Carcinoma	29	sintilimab+IBI310	utkhpmpiug(exypyikeit) = wqtjmozvop hsybtrfchd (jywmmptftl ) View more	Positive	19 Jan 2022
NCT03545971 (ESMO 12021 \| ESMO 22021) Manual	Phase 1	Locally Advanced Melanoma	44	IBI310	qmehuyktem(msfovbgegk) = part A: only one treatment-related AE (TRAE) of grade 3 (gamma glutamyltransferase increased); part B: ≥grade 3 TRAE occurred in 20.6% of 34 pts fkwaphlsjz (vtghgjuucg ) View more	Positive	16 Sep 2021
				IBI310+sintilimab

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