IBI-363 / Innovent Biologics, Takeda - LARVOL DELTA

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

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

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

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

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

A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting | N=84 ➔ 40 | Trial primary completion date: Jun 2026 ➔ Jan 2026

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

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=43 | Recruiting | Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University

New P1/2 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=48 | Not yet recruiting | Sponsor: Ruijin Hospital

New P1/2 trial • Oncology • Pancreatic Cancer • Solid Tumor

MarsLight-11: IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Fortvita Biologics (USA)Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Zhejiang Cancer Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) (clinicaltrials.gov) - P1/2 | N=600 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

IO biomarker • New P1/2 trial • Oncology • Solid Tumor

A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Innovent Biologics Announces Closing of Global Strategic Partnership with Takeda for Next-Generation IO and ADC Therapies (PRNewswire) - "Takeda will pay Innovent an upfront payment of US$1.2 billion, including a US$100 million equity investment in Innovent through new share issuance at premium, i.e., HK$112.56 per share. Furthermore, Innovent is eligible for development and sales milestone payments for IBI363, IBI343, and IBI3001 (if option exercised) totaling up to approximately $10.2 billion, for a total deal value of up to $11.4 billion. Innovent is also eligible to receive potential royalty payments for each molecule outside Greater China, except with respect to IBI363 in the U.S...."

Licensing / partnership • Solid Tumor

IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MarsLight-11: IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Fortvita Biologics (USA)Inc.

New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

IBI363 (PD-1/IL-2α-bias): Global Joint Development and Commercialization Collaboration (PRNewswire) - "According to the agreement, Innovent and Takeda will co-develop IBI363 globally, sharing development costs 40/60 (Innovent/Takeda). In the U.S., Innovent and Takeda will co-commercialize IBI363, sharing the U.S. profit or loss 40/60. Takeda will lead the co-development and co-commercialization efforts under joint governance and aligned development plan. In addition, Innovent will grant Takeda commercialization rights outside Greater China and the U.S. Takeda will have global manufacturing rights to supply IBI363 outside of Greater China..."

Licensing / partnership • Colorectal Cancer • Non Small Cell Lung Cancer

Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer (PRNewswire) - "The upcoming study will be the first global Phase 3 trial of IBI363....This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting....Innovent has also received IND approval from China's National Medical Products Administration (NMPA) for this program."

IND • New P3 trial • Non Small Cell Lung Cancer

IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Platinum resistant • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Breakthrough efficacy of IBI363 monotherapy has been achieved in patients with "immune-cold" melanoma, with notable durable response and prolonged survival benefit (Yahoo Finance) - P1 | N=260 | NCT05460767 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "In patients with at least one post-baseline tumor assessment (n=30), the confirmed objective response rate (cORR) was 23.3%, including 25.0% for mucosal type and 20.0% for acral type. The disease control rate (DCR) reached 76.7%, with 85.0% in mucosal type and 60.0% in acral type. In patients treated with 1 mg/kg Q2W with confirmed responses (n=7), a durable response was observed with a median duration of response (DoR) of 14.0 months and events of 42.9%. In patients treated with 1 mg/kg Q2W (n = 31) had a median progression-free survival (PFS) of 5.7 (2.7, 6.8) months, which was significantly longer than data from previous studies (PFS less than 3 months[1] ). The median follow-up time was 14.7 months, the median overall survival (OS) was 14.8 (9.9, NC) months, and the median OS of patients with mucosal subtype was 19.3 (9.9, NC) months. The overall 12-month OS rate was 61.5%."

P1 data • Mucosal Melanoma

2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from the Phase 1 PoC Clinical Study in Advanced Non-small Cell Lung Cancer (PRNewswire) - P1a/1b | N=260 | NCT05460767 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "As of the data cutoff date, April 7, 2025, a total of 136 patients with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W)....In the 1/1.5 mg/kg dose group, promising ORR/DCR/PFS/OS were observed. Median OS achieved 15.3 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 1/1.5 mg/kg dose group, the 3 mg/kg Q3W dose group observed more prominent confirmed ORR (36.7%), DCR (90.0%), PFS (median PFS 9.3 months) and OS trends (median OS not reached, 12-month OS rate 70.9%)....Among the patients with PD-L1 TPS<1%, IBI363 demonstrated outstanding efficacy signals: in the 1/1.5 mg/kg group (N=10), the confirmed ORR was 30.0% and the DCR was 90.0%, while that of the 3 mg/kg group (N=13) were 46.2% and 92.3%, suggesting the potential advantage of IBI363 in the population with low expression of PD-L1."

P1 data • Non Small Cell Lung Cancer

ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α -bias Bispecific Antibody Fusion Protein) from Phase 1 and 2 Clinical Studies on Immunotherapy-treated Advanced Malignant Melanoma (Innovent Biologics Press Release) - P1 | N=260 | NCT05460767 | Sponsor: Innovent Biologics | P2 | N=150 | NCT06081920 | Sponsor: Innovent Biologics | "The data presented at this ASCO meeting are from two multi-center Phase 1 and 2 clinical studies...designed to evaluate the efficacy and safety of IBI363 monotherapy in the treatment of advanced melanoma....In patients with at least one post-baseline tumor assessment (n=30), the confirmed objective response rate (cORR) was 23.3%, including 25.0% for mucosal type and 20.0% for acral type. The disease control rate (DCR) reached 76.7%, with 85.0% in mucosal type and 60.0% in acral type....In patients treated with 1 mg/kg Q2W (n = 31) had a median progression-free survival (PFS) of 5.7 (2.7, 6.8) months, which was significantly longer than data from previous studies (PFS less than 3 months[1] ). The median follow-up time was 14.7 months, the median overall survival (OS) was 14.8 (9.9, NC) months, and the median OS of patients with mucosal subtype was 19.3 (9.9, NC) months."

P1 data • P2 data • Melanoma

A pivotal Phase 2 registrational study of IBI363 in the treatment of advanced acral and mucosal malignant melanoma has been initiated (Yahoo Finance) - "Innovent Biologics announced a trial in progress (TiP) . It is a randomized, open-label, multi-center Phase 2 study evaluating the efficacy and safety of IBI363 monotherapy compared to pembrolizumab (Keytruda) in patients with unresectable, locally advanced or metastatic mucosal and acral melanoma who have not received prior systemic treatment. As the first pivotal registration trial of IBI363, this study is designed to directly compare IBI363 monotherapy with pembrolizumab in this patient population. A total of 180 patients are planned to be enrolled and randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC)."

Trial status • Mucosal Melanoma