Yidafan (ivonescimab) / Akesobio, Summit Therapeutics - LARVOL DELTA

Ivonescimab Versus Pembrolizumab for PD-L1-Positive NSCLC: A Subgroup Analysis of HARMONi-2 by Tumor PD-L1 Expression Level (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Biomarker • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Phase II trial of ivonescimab in patients with advanced clear cell renal cell carcinoma previously treated with immune checkpoint blockade: IVORY Trial (NCT06940518) (KCRS 2025) - P2 | "In treatment-naïve non-small cell lung cancer, ivonescimab has recently shown superior clinical activity over pembrolizumab (HARMONi-2 Xiong et al. Potential clinical activity signals and translational insights obtained will (1) shape the understanding of approaches to revert ICI-resistance and (2) open venues for further clinical testing of this agent in mccRCC. NCT: NCT0694051."

Checkpoint block • Checkpoint inhibition • Clinical • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Cedars-Sinai Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1 (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: M.D. Anderson Cancer Center | N=48 ➔ 0 | Trial completion date: Jun 2031 ➔ Jul 2025 | Initiation date: Dec 2025 ➔ Jul 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jun 2029 ➔ Jul 2025

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Trial withdrawal • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma

Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Neoadjuvant Immunogenic Radiotherapy Followed by Ivonescimab (PD-1/VEGF-A Bispecific Antibody) And Chemotherapy In Stage II-III Non-small Cell Lung Cancer: A Single-arm, Multicenter, Open-label, Phase II Clinical Study (ESMO 2025) - No abstract available

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Ivonescimab Combined with HAIC as First-Line Therapy for uHCC: Updated Interim Analysis of a Prospective, Single-Arm Phase II Study (ESMO 2025) - No abstract available

Clinical • P2 data • Hepatocellular Cancer • Oncology

Ivonescimab (PD-1/VEGF Bispecific Antibody) Plus Radiofrequency Ablation for Multiple Advanced Tumors After PD-1 Therapy Failure (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Sheng Zhang

New P2 trial

SENIOR-HN: Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: University of Michigan Rogel Cancer Center

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Akeso Announces Completion of First Dosing in Phase III Clinical Trial of Ivonescimab (PD-1/VEGF) Combination Therapy for Immunotherapy-Resistant NSCLC (PRNewswire) - "Akeso...announced that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed following PD-1/L1 inhibitors and platinum-based chemotherapy....The ongoing AK112-305/HARMONi-8A Phase III study targeting IO-resistant NSCLC is expected to offer a novel and highly effective treatment option for patients with IO-resistant NSCLC, in line Akesos ' 'Immuno-2.0' strategy."

Trial status • Non Small Cell Lung Cancer

Ivonescimab for the Treatment of Thymic Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • Thymic Carcinoma • Thymus Cancer

I-MAC: A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Glenn J. Hanna | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial primary completion date • Adenoid Cystic Carcinoma • Non-Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer

Efficacy and Safety of AK112 Combined Chemotherapy as Neoadjuvant Treatment for Signet Ring Cell-containing G/GEJ Adenocarcinoma (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

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

Efficacy and Safety of Ivonescimab Plus Chemotherapy for Recurrent/Metastatic Thymic Carcinoma: A Phase II Study (iThyme) (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • P2 data • Oncology • Solid Tumor • Thymic Carcinoma • Thymus Cancer

Bispecific Antibodies in Solid Tumors: Advances and Challenges. (PubMed, Int J Mol Sci) - "There are currently five BsAbs approved by the FDA in the United States for solid tumors-amivantamab, tarlatamab, tebentafusp, zanidatamab and zenocutuzumab-and two BsAbs approved in China-cadonilimab and ivonescimab. Currently, several BsAbs are under clinical development for solid tumors, but are mostly in early phase I and II trials. This review provides an overview of the basic mechanism of action of BsAbs, current FDA-approved BsAbs, and current BsAbs under clinical development, their challenges in clinical use, the management of toxicities, and future directions."

Journal • Review • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial (clinicaltrials.gov) - P2 | N=208 | Recruiting | Sponsor: Ming-Yuan Chen

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer (PRNewswire) - "Akeso...is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC)....The sNDA for ivonescimab's new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy."

China filing • Lung Non-Small Cell Squamous Cancer

Ivonescimab Plus Platinum-Doublet Chemotherapy as First-Line Therapy for Locally Advanced/Metastatic SMARCA4-Deficient NSCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • SMARCA4

NEOINSPIRE: A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC (clinicaltrials.gov) - P2 | N=164 | Not yet recruiting | Sponsor: Yang Fan, MD

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

Multi-Omic Profiling Identifies Key Factors Associated With Response to Ivonescimab (AK112) in Non-Small Cell Cancer (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Non Small Cell Lung Cancer • Oncology

Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer (PRNewswire) - "Akeso...is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company. The trial is investigating ivonescimab in combination with chemotherapy, with or without ligufalimab (CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer."

Trial status • Pancreatic Cancer

A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Akeso

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

AstraZeneca eyes licensing lung cancer drug (The Manila Times) - "ASTRAZENECA is in talks with Summit Therapeutics to license an experimental lung-cancer drug under a deal worth as much as $15 billion, Bloomberg News reported on Thursday, citing people familiar with the matter. Shares of Summit Therapeutics surged 9.7 percent to $25.81 in morning trade....A deal could include an upfront payment of several billion dollars to Summit, besides milestone payments later on, Bloomberg News said. The talks could still fall apart or Summit could opt for a different partner for licensing, according to the report. The negotiations involve ivonescimab, a drug Summit secured rights for through a separate deal worth up to $5 billion with China-based Akeso in December 2022....Earlier data last year had shown some lung cancer patients having better survival rates on the drug than those on Merck’s blockbuster Keytruda."

Licensing / partnership • Non Small Cell Lung Cancer

Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Massachusetts General Hospital

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