IBI-363 / Innovent Biologics, Takeda, Fortvita Biologics - LARVOL DELTA

IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC): Update of a phase 1b study (ESMO 2026) - No abstract available

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

IBI363 (TAK-928) plus XELOX as the first line (1L) treatment for advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) (ESMO 2026) - No abstract available

Clinical • Metastases • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

IBI363 (TAK-928) plus bevacizumab (Bev) vs docetaxel (DTX) in patients (pts) with locally advanced or metastatic immunotherapy (IO)-resistant lung adenocarcinoma (LUAC) without actionable genomic alterations: a randomized phase Ib study (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients (pts) with immunotherapy-treated, advanced acral and mucosal melanoma. (ASCO 2025) - P1, P2 | "IBI363 showed encouraging efficacy in pts with IO-treated advanced acral and mucosal melanoma. The safety profile was acceptable and manageable. Further global clinical development of IBI363 in melanoma is ongoing."

Clinical • Metastases • Anemia • Hematological Disorders • Infectious Disease • Melanoma • Mucosal Melanoma • Musculoskeletal Pain • Oncology • Septic Shock • Solid Tumor • IL2 • PD-1

Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026 (Businesswire) - "Late-breaking data from the Phase 3 G-HOPE-001 study (NCT06238843) of arcotatug tavatecan being conducted in Japan and China in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) will be presented during the ESMO proffered paper session on October 23, 13:30-15:00 CEST (Abstract LBA77)....Additionally, new findings for TAK-928 plus bevacizumab in immunotherapy-resistant non-small cell lung cancer (NSCLC) and TAK-928 plus chemotherapy in first-line NSCLC will be featured in two presentations."

Late-breaking abstract • P1 data • P3 data • Non Small Cell Lung Cancer

First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC). (ASCO 2025) - P1 | "IBI363 was well tolerated with encouraging and durable efficacy observed in pts with advanced NSCLC who progressed to PD-(L)1, especially in the squamous subtype."

Clinical • Metastases • Anemia • Lung Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • IL2 • PD-1

A multicenter, randomized, controlled, open-label, phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma. (ASCO 2025) - "Here, we present the trial in progress of a phase 2 study evaluating efficacy and safety of IBI363 monotherapy versus pembrolizumab in mucosal and acral melanoma. No interim analysis is planned. A total of 118 PFS events among 180 pts is estimated to demonstrate the superior efficacy of IBI363 compared to the control, with a power of 90% (α=0.025, one-sided)."

Clinical • P2 data • Melanoma • Oncology • Solid Tumor • PD-1

Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer. (ASCO 2025) - P1 | "IBI363 monotherapy demonstrated prolonged overall survival in pts with advanced CRC compared to historic data of standard of care. IBI363 plus beva showed even more encouraging efficacy with acceptable safety and warrants further development."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • Colorectal Cancer • Endocrine Disorders • Microsatellite Instability • Musculoskeletal Pain • Oncology • Solid Tumor • KRAS • MSI • NRAS

Session III: ADC/iADC: TAK-928 (IBI-363): A First-in-class PD-1/IL-2 α-bias Bispecific Fusion Protein (SITC 2026) - No abstract available

ADC • Bispecific • Oncology • IL2 • PD-1

CIBI363A102: Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=504 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting | N=260 ➔ 504 | Trial completion date: Dec 2024 ➔ Jun 2027 | Trial primary completion date: Mar 2024 ➔ Dec 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Innovent Announces First Patient Dosed in Pivotal Registrational Study of IBI363/TAK-928 (PD-1/IL-2α-biased Bispecific Fusion Protein) in Combination with Bevacizumab in Late-Line Advanced Colorectal Cancer in China (PRNewswire) - "This trial (NCT07722494) is a multicenter, randomized, open-label, Phase 3 clinical study designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator's choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are planned to be enrolled."

Trial status • Colorectal Cancer

A Study of IBI363 in Subjects With Advanced Melanoma (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Jul 2026 ➔ Oct 2028 | Trial primary completion date: Jun 2025 ➔ Oct 2028

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer (clinicaltrials.gov) - P3 | N=550 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Colorectal Cancer • Oncology • Solid Tumor

First-in-class PD-1/IL-2α-bias bispecific antibody IBI363 (TAK-928) in patients (pts) with advanced immunotherapy-resistant non–small cell lung cancer (NSCLC): Updated results from a phase I study. (ASCO 2026) - P1 | "IBI363 was well tolerated with a manageable safety profile consistent with earlier reports, and continued to show strong and durable efficacy in pts with heavily pretreated NSCLC."

Bispecific • Clinical • Metastases • P1 data • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL2 • PD-1

IBI363 (TAK-928) plus chemotherapy as first-line (1L) treatment for advanced non–small cell lung cancer (NSCLC). (ASCO 2026) - P1 | "Here, we report a phase 1 study evaluating IBI363 plus platinum-based doublet-chemotherapy (PDC, pemetrexed/paclitaxel plus platinum) in 1L NSCLC. IBI363 plus PDC was well tolerated and showed encouraging efficacy in advanced NSCLC. Safety, efficacy, and PK data supported 3-1.5 mg/kg as the recommended dose."

Clinical • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-1 • ROS1

Randomized phase 3 study (MarsLight-11) evaluating IBI363 (TAK-928) versus docetaxel in patients (pts) with squamous non-small cell lung cancer (sqNSCLC) after prior chemotherapy (chemo) and immunotherapy (IO). (ASCO 2026) - P3 | "After chemo and IO failure, docetaxel±ramucirumab remains the standard of care for advanced sqNSCLC, but offers only short-lived disease control (median progression-free survival [PFS] of approximately 3–4 months), and high rates of severe toxicities. One interim analysis (IA1) and one final analysis are planned for OS. The study plans to enroll approximately 600 pts globally, including sites in China, the United States, Canada, the European Union, the United Kingdom, Japan and South Korea."

Clinical • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL2

2026 ASCO | Innovent Presents Long-Term Follow-up Results from the PoC Study of IBI363 (TAK-928) (PD-1/IL-2α-bias bispecific fusion protein), Showing Robust Survival Benefits in Advanced Immunotherapy-Resistant Non-Small Cell Lung Cancer (PRNewswire) - "In the 3 mg/kg Q3W dose group, the median PFS reached 10.1 (95%CI 6.0, 14.0) months, and the median OS achieved 18.2 (95%CI 10.7, NE; maturity 48.4%) months, with a 24-month OS rate of 47.8% (95%CI 28.7, 64.7)....Among the 58 patients with EGFR wild-type adenoNSCLC, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 25 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg dose group, the median PFS reached 4.2 (95%CI 3.0, 7.0) months, and the median OS achieved 15.2 months (95%CI 9.6, NE; maturity 56.0%), with a 24-month OS rate of 42.7% (95%CI 23.1, 61.0)....The median OS for smokers across all dose groups (N=31) reached 23.4 (95%CI 11.3, NE, maturity 48.4%) months."

P1 data • Non Small Cell Lung Cancer

2026 ASCO Abstract Highlights | Innovent Announces Preliminary PoC data of IBI363 (PD-1/IL-2α-bias bispecific fusion protein) in Combination with Chemotherapy as First-line Treatment for Advanced NSCLC, Showing Encouraging Efficacy Signals and Favorable Safety (PRNewswire) - "In the dose optimization stage, the 3→1.5 mg/kg dose group (n=22) showed ORR of 86.4% and confirmed ORR (cORR) of 81.8% (95% CI: 59.7-94.8) and DCR of 100%. The efficacy was consistent in the squamous (ORR 85.7%, n=14) and non-squamous (ORR 87.5%, n=8) subgroups. Additionally, durable efficacy signals were observed in the 3→1.5 mg/kg groups with ongoing follow-up. For the 1.5mg/kg (N = 19) and 3 mg/kg cohorts (N = 21), ORR was 57.9% (cORR: 42.1%) and 66.7% (cORR: 57.1%), respectively."

P1 data • Non Small Cell Lung Cancer

Innovent Announces IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) Received Third NMPA Breakthrough Therapy Designation for MSS/pMMR Metastatic Colorectal Cancer (PRNewswire) - "A Phase III clinical trial is about to initiate in China for this indication in the near term."

Breakthrough therapy • New P3 trial • pMMR • Colorectal Cancer

IBI363 Monotherapy Following Low-Dose Whole Abdominal Radiotherapy in Recurrent Ovarian Cancer: A Single-Center, Single-Arm, Phase Ib Clinical Study (ChiCTR) - P1 | N=10 | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

Monotherapy • New P1 trial • Oncology • Ovarian Cancer • Solid Tumor

Innovent Biologics…announces that clinical data for its first-in-class IBI363 (PD-1/IL-2α-biased bispecific fusion protein) as well as TYVYT (sintilimab injection) will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire)

Clinical data • Colorectal Cancer • Epithelioid Sarcoma • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Laryngeal Cancer • Non Small Cell Lung Cancer • Pleural Mesothelioma

Novel PD-1xVEGFxIL-2 trispecific immune modulator with superior safety and greater efficacy (AACR 2026) - "In an exploratory toxicity study, the attenuated IL-2 mutein supported a higher maximum tolerated dose for the trispecific than IBI363 in cynomolgus monkeys, which matched the optimal therapeutic doses for PD-1 and PD-1xVEGF antibodies...In summary, WuXi Biologics has developed a novel PD-1xVEGFxIL-2 trispecific molecule. This potent next-generation immune modulator shows great potential for further clinical investigation."

Clinical • Trispecific • Oncology • IL2

Programmed Cell Death Protein 1-Interleukin-2 Bispecific Agents for Cancer Therapy. (PubMed, BioDrugs) - "This review summarizes their latest progress, including the synergistic mechanism of PD-1/PD-L1 and IL-2 signaling, molecular designs (e.g., βγ-biased IL-2v and Innovent's α-biased IBI363), and 'cis delivery' for targeted activation...Challenges remain, such as unclear mechanisms, drug resistance, and long-term safety. Future advancements rely on optimized molecular design, combination therapies, and predictive biomarkers, driving PD1-IL2 bispecific drugs toward more precise and effective tumor immunotherapy for broader patient populations."

IO biomarker • Journal • Review • Oncology • IL2 • PD-1

Preclinical data of IAR037, a novel CD40/PD-L1 bispecific antibody for the treatment of advanced solid tumors resistant to immune checkpoint inhibitors (AACR 2025) - "It strongly synergized with IBI363, a clinical-stage PD-1/IL-2v bispecific fusion protein, and demonstrated superior tumor regression in highly PD-1-resistant tumor model. IAR037 could specifically activate immune responses in the tumor microenvironment and tumor-draining lymph node while minimizing systemic side effects, showing unique advantages over other CD40-targeting anti-tumor therapies. In summary, IAR037 presents a novel therapeutic approach for ICI-resistant advanced solid tumors and the IND enabling study of IAR037 is ongoing."

Bispecific • Checkpoint inhibition • IO biomarker • Late-breaking abstract • Metastases • Preclinical • Oncology • Solid Tumor • CD40