IBI-310 (ipilimumab biosimilar) / Innovent Biologics - LARVOL DELTA

Bringing immunotherapy to clinical practice in dMMR/MSI-high colon cancer. (PubMed, Cancer Cell) - "showed that dual anti-CTLA-4/PD-1 IBI310/sintilimab for 6 weeks improved pathological complete response over sintilimab in patients with cT4/N+ tumors. This combination represents a referral regimen for neoadjuvant or organ-preserving strategies."

dMMR • Journal • MSI-H • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Neoadjuvant treatment of IBI310 plus sintilimab in locally advanced MSI-H/dMMR colon cancer: A randomized phase 1b study. (PubMed, Cancer Cell) - P3 | "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."

dMMR • Journal • MSI-H • P1 data • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CTLA4 • MSI

Updated results from a multicenter, single-arm phase II study of surufatinib plus sintilimab and IBI310 in patients with high-grade advanced-neuroendocrine neoplasm (HG-NEN). (ASCO 2025) - P2 | "Ipilimumab (anti-CTLA-4 antibody) plus nivolumab (anti-PD-1 antibody) is recommended by the NCCN guidelines for extrapulmonary and non-pancreatic neuroendocrine carcinomas (NEC) that progress after chemotherapy. Surufatinib combined with sintilimab and IBI310 demonstrated promising efficacy and manageable safety in HG-NEN, with greater benefit observed in earlier treatment lines. This regimen may offer a new therapeutic option for patients with HG-NEN."

Clinical • Metastases • P2 data • Cardiovascular • Endocrine Cancer • Hematological Disorders • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Pancreatitis • Solid Tumor • Thrombocytopenia • CSF1R • FGFR1

A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers (clinicaltrials.gov) - P1 | N=148 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion

PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Shanghai Zhongshan Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Sep 2025

Enrollment closed • Trial completion date • Biliary Cancer • Cholangiocarcinoma • Hepatology • Oncology • Solid Tumor • CTLA4

Sintilimab Combined with IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Peking University | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • PD-L1

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 (PRNewswire) - "Innovent Biologics...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 in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer....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."

China filing • Evidence highlight • Priority review • Colon Cancer • Microsatellite Instability • MSI

IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial. (PubMed, Med) - P2 | "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."

Clinical • IO biomarker • Journal • Cervical Cancer • Oncology • Solid Tumor

A randomized, controlled, multicenter phase III 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 (ESMO Asia 2024) - P3 | "Use of adjuvant chemotherapy with oxaliplatin plus capecitabine is at the investigator's discretion according to postoperative pathological evaluation and clinical guidelines. The primary endpoints are pCR rate of the experimental group and event-free survival. The secondary endpoints are R0 resection rate, overall survival, safety, pharmacokinetics and immunogenicity."

Clinical • Mismatch repair • P3 data • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • PD-1

Innovent to Present Clinical Data of Multiple Novel Molecules at ESMO Asia 2024 (PRNewswire) - "Innovent Biologics...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."

Clinical data • Cholangiocarcinoma • Colorectal Cancer • Hepatocellular Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Pancreatic Cancer

IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Terminated; After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi

Combination therapy • Metastases • Mismatch repair • Trial termination • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=97 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Jun 2024 | Trial primary completion date: Apr 2023 ➔ Jun 2024

Metastases • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Peking University

New P2 trial • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor

Abs #3505 @asco #asco24 of IBI310 (CTLA-4) +/- Sintilimab (PD-1) in neoadjuvant stage IIB/III colon cancer pts primary endpoint: pCR pCR = 80% vs 47.7% (in favor of combo) all pts had Ro resection #cancer #cancerresearch #colorectalcancer @OncoAlert @FightCRC

IBI310 (anti-CTLA-4 antibody) monotherapy or in combination with sintilimab in advanced melanoma or urothelial carcinoma. (PubMed, Innovation (Camb)) - "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."

Combination therapy • Journal • Metastases • Monotherapy • Melanoma • Oncology • Solid Tumor • Urothelial Cancer

Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. (ASCO 2024) - P3 | "Neoadjuvant IBI310 plus sintilimab significantly improved pCR rate than sintilimab alone in MSI-H/dMMR CRC. The safety profiles were comparable and manageable in both treatment arms."

Clinical • Mismatch repair • P1 data • Cardiovascular • Colorectal Cancer • Endocrine Disorders • Gastrointestinal Cancer • Gastrointestinal Disorder • Microsatellite Instability • Oncology • Solid Tumor • MSI

Innovent Delivers Oral Presentation of Clinical Data of A Randomized Controlled Phase 1b Study Evaluating IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab as Neoadjuvant Treatment of Colon Cancer at 2024 ASCO Annual Meeting (PRNewswire) - P1b/3 | N=360 | NCT05890742 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that the clinical data of a randomized controlled Phase 1b study evaluating IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab as neoadjuvant treatment of colon cancer was orally presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting....As of February 4, 2024, 101 pts were enrolled and randomized to receive IBI310 plus sintilimab (n=52) or sintilimab alone (n=49). For per-protocol set, the pathologic complete response (pCR) rates in IBI310 plus sintilimab arm were significantly improved than sintilimab alone arm（80.0% vs 47.7%, p=0.0007). Treatment related adverse events (TRAEs) leading to surgery delay occurred in 2 pts (3.8%) in IBI310 plus sintilimab arm and 0 pt in sintilimab alone arm."

P1 data • Colon Cancer

Initial efficacy of surufatinib plus sintilimab and IBI310 for patients with high-grade advanced-neuroendocrine neoplasm: A multicenter, single arm phase 2 study (AACR 2024) - "Ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) has been recommended for extrapulmonary and non-pancreatic NEC if the disease progresses following chemotherapy by the NCCN guidelines for neuroendocrine tumors. Surufatinib combined with Sintilimab and IBI310 showed a potential antitumor activity and a tolerable safety profile, providing an additional treatment option for pts with high-grade NEN."

Clinical • Metastases • P2 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • FGFR1

Innovent Announces 2023 Annual Results and Business Updates (PRNewswire) - "Encouraging progress in the next wave innovation of 'IO+ADC': TYVYT (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors; IBI310 (CTLA-4): plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer; IBI343 (CLDN18.2 ADC): preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications....IBI363 (PD-1/IL-2): preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S."

Licensing / partnership • New P3 trial • Trial status • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Innovent Dosed First Participant in Phase 3 Clinical Study (Neoshot) of IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab for MSI-H/dMMR Colon Cancer Neoadjuvant Therapy (PRNewswire) - "Innovent Biologics...announces that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR colon cancer (stage cT4 or cN+) neoadjuvant therapy. Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer."

Trial status • Colon Cancer • Microsatellite Instability

A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Phase classification: P1b ➔ P3 | N=100 ➔ 360

Combination therapy • Enrollment change • Mismatch repair • Phase classification • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

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. (PubMed, Cancer Med) - "IBI310 3 mg/kg Q3W plus sintilimab was effective in a small number of previously treated anti-PD-1/L1-resistant NSCLC patients."

Journal • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4

A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy (clinicaltrials.gov) - P2 | N=205 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Nov 2023 | Trial primary completion date: Feb 2024 ➔ Nov 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor

A phase II study of sintilimab plus IBI310 for Epstein-Barr virus (EBV)-associated gastric cancer (ESMO 2023) - P1/2 | "With a median follow-up of 21.1 months, the median PFS and OS were 5.4 months (95% CI, 1.3-8.4) and 12.8 months (95% CI, 4.1-NR), respectively. Conclusions Sintilimab in combination with IBI310 were well tolerated, and shown promising anti-tumor efficacy both in first-line and ≥ 2 line locally advanced or metastatic EBV-associated gastric cancer."

P2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase II study of SHR-1316 plus IBI310 in patients with advanced intrahepatic cholangiocarcinoma after failure of first-line therapy (ESMO 2023) - P2 | "Conclusions The treatment of SHR-1316 combined with IBI310 was tolerable and showed promising antitumor activity in iCCA refractory to standard therapy. Further studies are required to identify predictive/prognostic biomarkers to improve selection of pts most likely to benefit from this treatment strategy."

Clinical • IO biomarker • Metastases • P2 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor