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

Start Date31 Oct 2024

Sponsor / Collaborator

Shanghai Pulmonary Hospital

NCT06620822

/ Not yet recruitingPhase 2IIT

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

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 Oct 2025·CANCER CELL

Neoadjuvant treatment of IBI310 plus sintilimab in locally advanced MSI-H/dMMR colon cancer: A randomized phase 1b study

Article

Author: Qiu, Meng ; Wan, Xiangbin ; Li, Leping ; Luo, Jia ; Li, Liren ; Wang, Yaxu ; Xu, Jianmin ; Zhao, Peng ; Jiang, Wu ; Wang, Guihua ; Fu, Zan ; Liu, Haiyi ; Mo, Xianwei ; Xu, Rui-Hua ; Yuan, Xianglin ; Chen, Gong ; Guo, Qun ; Zhou, Hui ; Zhong, Haijun ; Du, Xiaobo ; Tang, Jianqiang ; Wu, Xiaojun ; Ma, Jinfeng ; Wang, Quan ; Li, Yongqiang ; Sun, Yanlai ; Song, Zhangfa ; Wang, Feng ; Deng, Yanhong ; Hu, Yingbin ; Ding, Peirong ; Zhang, Rongxin ; Jiang, Weiqin ; Kang, Liang ; Liu, Heli ; Lu, Xiaoxiao ; Huang, Xiwen ; Lin, Junzhong ; Wang, Nanya ; Ge, Jie ; Liu, Linlin ; Zhou, Yanbing ; You, Jun ; Yuan, Weitang ; Li, Taiyuan

Although neoadjuvant immunotherapy showed promising efficacy in locally advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) colon cancer, whether dual immune checkpoint inhibition provides additional benefit over anti-PD-1 monotherapy remains unclear. This randomized phase 1b trial (NCT05890742) evaluated a neoadjuvant regimen of IBI310 (anti-cytotoxic T lymphocyte-associated antigen 4 [CTLA-4]) plus sintilimab (n = 52) versus sintilimab monotherapy (n = 49). Surgery was performed in 51 and 45 patients, respectively. The primary endpoint, pathological complete response (pCR) rate, was significantly higher in the combination compared to the monotherapy arm within the modified intent-to-treat (mITT) population (78.4% versus 46.7%, p = 0.0015), with consistent results in the intent-to-treat (ITT) population (76.9% versus 42.9%). Safety in both arms was comparable and manageable without new safety signals. After a median follow-up of 21.4 months, no disease recurrences occurred. One death occurred in each arm due to postoperative complication and adverse events. These findings demonstrate the added benefit of neoadjuvant IBI310 plus sintilimab over sintilimab monotherapy for locally advanced MSI-H/dMMR colon cancer.

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 ; Yin, Kang ; Liu, Jihong ; Cai, Chujun ; An, Ruifang ; Wang, Li ; Shen, Yiyang ; Zhang, Hongfei ; Wang, Shuyan ; Wang, Xia ; Xie, Han ; 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 ; Wang, Ke ; Li, Li ; Cheng, Yan ; Zhu, Hong ; Yu, Guohua ; Huang, Jianli ; Zhang, Youzhong ; Chen, Youguo ; Huang, Bowen

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.

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

25 Dec 2025

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China's First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent's TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval

TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. The TABOSUN® and TYVYT® combination therapy significantly improved pathological complete response (pCR) rates and enabled most patients to avoid the burden of postoperative adjuvant chemotherapy. This therapy is the first and only dual-IO regimen approved globally for neoadjuvant treatment of colon cancer[i], filling a critical gap in neoadjuvant treatment of colon cancer and benefiting more patients with MSI-H/dMMR colon cancer. SAN FRANCISCO and SUZHOU, China, Dec. 25, 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 TABOSUN® (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by China's National Medical Products Administration (NMPA), in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. TABOSUN® (ipilimumab N01 injection) is the world's first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer. Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination demonstrated a substantial improvement in pathological complete response, offering the potential to benefit a broader population of patients with MSI-H/dMMR colon cancer. Resectable MSI-H/dMMR colon cancer urgently requires effective neoadjuvant therapies to improve prognosis MSI-H/dMMR colon cancer accounts for around 15% of all resectable colon cancer cases[ii]. Due to its unique biological characteristics, this class of tumor shows limited sensitivity to chemotherapy and generally responds poorly[iii]. In recent years, immune checkpoint inhibitors have demonstrated significant efficacy in advanced MSI-H/dMMR colon cancer, but a gap remains in the neoadjuvant setting. For locally advanced MSI-H/dMMR colon cancer, the current standard of care is direct surgery followed by adjuvant chemotherapy. Under this regimen, approximately 10%-30% of patients experience disease recurrence or metastasis after surgery, while chemotherapy-related toxicities may negatively affect quality of life[iv]. Thus in the neoadjuvant setting, there remains an urgent need for more effective therapies to improve outcomes for patients with locally advanced MSI-H/dMMR colon cancer. The world ' s first dual-IO neoadjuvant therapy: TABOSUN ® (ipilimumab N01 injection) combined with TYVYT ® (sintilimab injection) markedly enhances pathological complete response rates Immune checkpoint blockade (ICB) therapy targeting PD-1 and CTLA-4 has transformed cancer treatment. The combination of DABOSUN® (ipilimumab N01 injection) and TYVYT® (sintilimab injection) as neoadjuvant therapy can significantly improve pathological complete response(pCR) rates and allow the majority of patients to avoid adjuvant chemotherapy. Previously, results from a randomized, controlled Phase 1b trial evaluating ipilimumab N01 plus sintilimab as neoadjuvant treatment for MSI-H/dMMR colon cancer were published in the top-tier journal Cancer Cell[i]. As of June 17, 2025, 101 patients were enrolled and randomized to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49). In the per-protocol population, the pCR rate in the ipilimumab N01-plus-sintilimab arm was significantly higher than in the sintilimab-alone arm (80.0% vs 47.7%, p=0.0007). With median follow-up of 21.4 months, no patient experienced disease recurrence. Approval is based on results from the randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742), which evaluated the safety and efficacy of ipilimumab N01 combined with sintilimab as neoadjuvant therapy compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pCR rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) confirmed that the NeoShot trial met its primary endpoint. As of November 28, 2024, among the first 50 patients in the treatment arm, 41 achieved pathological complete response after neoadjuvant treatment, yielding a pCR rate of 82%. Neoadjuvant treatment with ipilimumab N01 combined with sintilimab did not significantly increase safety risks compared with direct surgery. Detailed results will be presented at future academic conferences or published in academic journals. The Principal Investigator of the NeoShot study, Academician of the Chinese Academy of Engineering, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated: "Achieving R0 resection remains challenging for certain patients with locally advanced colon cancer, who also face substantial surgical trauma and poor prognosis. Results from the FOxTROT study indicated that neoadjuvant chemotherapy provides limited benefit in MSI-H/dMMR colon cancer, with a pCR rate of only around 5%[v]. 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. Interim analysis suggests that ipilimumab N01 with sintilimab as short-term neoadjuvant treatment can lead to pathological complete response in 82% of treated patients. In addition, NeoShot Ph1b and Ph3 interim results both show the R0 resection under this regimen could reach 100% and spare patients from adjuvant chemotherapy. In NeoShot-1b, the dual-immunotherapy neoadjuvant regimen combining ipilimumab N01 and sintilimab significantly improved the pCR rate, which serves as a surrogate endpoint for long-term prognosis. Based on the existing data, this regimen shows promising potential to reduce recurrence risk and improve long-term survival outcomes. We look forward to observing continued reductions in recurrence with longer-term follow-up. The approval of this dual-immunotherapy regimen is expected to change clinical practice, fill a critical gap in neoadjuvant treatment of colon cancer and benefit more patients with MSI-H/dMMR colon cancer." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "There remains a substantial unmet clinical need for neoadjuvant therapies for stage IIB-III resectable MSI-H/dMMR colon cancer in China. Interim analysis has shown that the NeoShot trial met its primary endpoint. Through Innovent's efficient and high-quality clinical development, ipilimumab N01 has become China's first domestically developed innovative CTLA-4 inhibitor approved by the NMPA, offering a new treatment option for patients in China with stage IIB-III resectable MSI-H/dMMR colon cancer." About Ipilimumab N01 Ipilimumab N01 (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent. Ipilimumab N01 specifically binds cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4-mediated inhibition of T cell activity, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. [vi] The NDA for ipilimumab N01 in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer has recently been approved by the NMPA. 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.[vii] In China, sintilimab has been approved and included in the updated NRDL for eight 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; and 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. The NDA for sintilimab's ninth indication, in combination with ipilimumab N01 as neoadjuvant treatment for stage IIB-III resectable MSI-H/dMMR colon cancer is recently approved by the NMPA. The NDA for sintilimab's tenth indication, in combination with fruquintinib for the treatment of locally advanced or metastatic renal cell carcinoma who previously failed systematic treatment, has been accepted by the Center for Drug Evaluation (CDE) of NMPA. 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; and 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 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, 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. 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 21% more press release views with Request a Demo

Clinical ResultImmunotherapyPhase 3Drug ApprovalPhase 2

23 Feb 2025

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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

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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

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Indication	Country/Location	Organization	Date
Mismatch repair-deficient Colonic Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Dec 2025

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
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
Epstein-Barr virus associated gastric carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	13 Dec 2019
Signet Ring Cell Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	13 Dec 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05890742 (NeoShot-III, PRNewswire) Manual	Phase 3	Mismatch repair-deficient Colonic Cancer Neoadjuvant MSI-High \| Deficient DNA Mismatch Repair (dMMR)	50	伊匹木单抗N01 + 信迪利单抗	hevowtwxhj(jyigmypnrx) = osvbxavlck gplvmgrids (qbiycrjwaq )	Positive	25 Dec 2025
NCT05890742 (NeoShot-1b, Pubmed) Manual	Phase 1	Mismatch repair-deficient Colonic Cancer Neoadjuvant Deficient DNA Mismatch Repair (dMMR) \| MSI-High	101	IBI310 + sintilimab	dvyugjgdeo(trdessfxdf) = unacoiusnc pgvbrgiogv (ermcwdtfgp ) View more	Positive	01 Oct 2025
				sintilimab	dvyugjgdeo(trdessfxdf) = xcegmqggjk pgvbrgiogv (ermcwdtfgp ) View more
NCT04590599 (Pubmed \| Med)	Phase 2	Uterine Cervical Cancer	-	IBI310 plus sintilimab	jipzpbfgwh(acobolktxb) = 55% versus 19% vovibfqxga (kbwctzjwtt ) View more	-	01 May 2025
				Placebo plus sintilimab
NCT05890742 (PRNewswire) Manual	Phase 1	Microsatellite instability-high colorectal cancer Deficient DNA Mismatch Repair (dMMR) \| MSI-High	101	IBI310 + sintilimab	qpiekuidcd(aloukkbtdi) = zkwtrzcvus upsyjuerko (vizrdawbke ) View more	Positive	02 Jun 2024
				sintilimab	qpiekuidcd(aloukkbtdi) = wncnnpgfst upsyjuerko (vizrdawbke ) View more
NCT05890742 (ASCO2024) Manual	Phase 1	Microsatellite instability-high colorectal cancer First line \| Neoadjuvant microsatellite instability-high \| mismatch repair-deficient	101	IBI310 1mg/kg + sintilimab 200 mg Q3W	zthfmbkqfx(veguljynms) = sksjgobzgb tobpaylcsd (wwpxhxobdf, 66.3 - 90.0) View more	Positive	24 May 2024
				Sintilimab 200 mg Q3W	zthfmbkqfx(veguljynms) = neylzjzfnk tobpaylcsd (wwpxhxobdf, 32.5 - 63.3) View more
NCT05118334 (phase Ib study, Pubmed \| Cancer Med)	Phase 1	metastatic non-small cell lung cancer anti‐PD‐1 \| L1	30	IBI310 1 mg/kg	fqcvxvpiwm(nryamcwthz) = idtlpzsxil pkntycquyr (ruhezkcgae, 21.3 - 73.4) View more	Positive	01 Feb 2024
				IBI310 3 mg/kg	cizdemhxel(krzmuytkno) = ygrswlqppo uhydurcyyt (cbgiqckjbz, 1.7 - 40.5) 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	aqfjgrcuxz(rcmjwbnygx) = pibsfdhpah bmojkstxlw (nkpojngmzy ) View more	Positive	23 Oct 2023
				Sintilimab 3mg/kg plus IBI310 1mg/kg (treatment-naïve)	lzfisunyjv(hqbwmicrdb) = kosduwguos pcyccvgnlj (isavwnjcep, 40.6 - 79.8) View more
NCT04401813 (ASCO_GI2022) Manual	Phase 1	Advanced Hepatocellular Carcinoma	29	sintilimab+IBI310	ctnrscoeuz(igsqjhvkqk) = jyngipmgoz qndxpgdibo (ckpcduetwj ) View more	Positive	19 Jan 2022
NCT03545971 (ESMO 12021 \| ESMO 22021) Manual	Phase 1	Locally Advanced Melanoma	44	IBI310	efjofwxydm(cydpagjwtf) = 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 mvaaxkeani (hiykvpbbza ) View more	Positive	16 Sep 2021
				IBI310+sintilimab

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