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

Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China. (PubMed, Lancet) - P3 | "Ivonescimab significantly improved PFS compared with pembrolizumab in previously untreated patients with advanced PD-L1 positive non-small cell lung cancer. Therefore, ivonescimab might represent another treatment option in the first-line setting for PD-L1-positive advanced non-small cell lung cancer."

Clinical • IO biomarker • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ALK • EGFR • PD-L1

RC148 (ABBV-1480, PD-1/VEGF Bispecific Antibody) Plus Chemotherapy in First-Line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (IASLC-WCLC 2026) - P1 | "Previous data showed encouraging anti-tumor activity with a manageable safety profile for RC148 monotherapy and combined with docetaxel in patients with NSCLC (ESMO IO Congress, 2025)...Patients with squamous NSCLC (sq-NSCLC) were randomized 1:1 to receive RC148 (10 or 20 mg/kg) plus carboplatin/paclitaxel (Cohort 1), followed by maintenance treatment; patients with non-squamous NSCLC (nsq-NSCLC) were randomized 1:1 to receive RC148 (10 or 20 mg/kg) plus carboplatin/pemetrexed (Cohort 2), also with maintenance...In Cohort 1, RC148 10 mg/kg achieved an ORR of 90.0% (95% CI: 73.5-97.9), with PD-L1-negative (TPS <1%) ORR of 93.3%—exceeding AK112's 71.2% in HARMONi-6...The 10 mg/kg dose, with superior outcomes across histology and high activity irrespective of PD-L1 status, is the recommended phase 3 dose in first-line NSCLC. Pivotal phase 3 studies have been initiated or planned both in China and globally."

Bispecific • Clinical • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Ivonescimab-Chemo vs Placebo-Chemo in EGFR-TKI-Resistant, EGFR-Mutated NSCLC (HARMONi): Updated Overall Survival Analysis (IASLC-WCLC 2026) - "Eligible patients were randomly assigned (1:1) to receive ivonescimab (20 mg/kg) or placebo plus pemetrexed and carboplatin every 3 weeks for 4 cycles, followed by maintenance therapy. Conclusions : This updated OS analysis conducted with extended follow-up in the Western cohort showed a sustained OS benefit with ivonescimab-chemotherapy in the ITT population. The OS improvements were durable and consistent across geographic regions, with no new safety signals."

Clinical • IO biomarker • Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • PD-1

Overall Survival Analysis From HARMONi-2: Ivonescimab vs Pembrolizumab as First-Line Treatment for PD-L1-Positive NSCLC (IASLC-WCLC 2026) - P3 | "No new safety signals were identified with ivonescimab relative to the established pembrolizumab safety profile. These findings support ivonescimab as a chemotherapy-free first-line treatment with the potential to redefine the standard of care and serve as a cornerstone of treatment in this patient population."

Clinical • Late-breaking abstract • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • PD-1 • PD-L1

Ivonescimab plus chemotherapy versus durvalumab plus chemotheray as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, phase 3 trial (HARMONi-GI1) (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in previously untreated advanced squamous non–small cell lung cancer: Overall survival results of the phase 3 HARMONi-6 trial. (ASCO 2026) - P3 | " Patients with previously untreated stage III-IV sq-NSCLC were randomly assigned (1:1) to receive ivonescimab 20 mg/kg every 3 weeks (Q3W) or tislelizumab 200 mg Q3W, each in combination with paclitaxel (175 mg/m²) and carboplatin (AUC 5) for 4 cycles, followed by maintenance ivonescimab or tislelizumab monotherapy. Ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared with tislelizumab plus chemotherapy in previously untreated patients with advanced sq-NSCLC. Notably, ivonescimab plus chemotherapy is the first regimen to show clinical superiority over an active PD-1 inhibitor control arm in the first-line setting. The dual-targeted approach of ivonescimab delivers improved survival outcomes with a favorable risk-benefit profile, establishing a compelling new standard of care in the management of advanced sq-NSCLC."

Clinical • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (HARMONi-6) (ESMO 2025) - P3 | "Background Ivonescimab significantly improved PFS over pembrolizumab as first-line therapy for advanced NSCLC in PD-L1 TPS ≥1%...Methods Eligible patients with untreated stage IIIB-IV squamous NSCLC were randomized (1:1) to ivonescimab 20 mg/kg Q3W or tislelizumab 200 mg Q3W, plus paclitaxel (175 mg/m2) and carboplatin (AUC 5) for 4 cycles, followed by ivonescimab or tislelizumab monotherapy as maintenance treatment...Safety analyses revealed treatment-related SAE in 32.3% vs. 30.2%, and grade≥3 hemorrhagic events occurred in 1.9% vs. 0.8%, for ivonescimab and tislelizumab groups, respectively. Conclusions This phase III trial result suggests first-line ivonescimab-chemotherapy may be a new standard of care for advanced/metastatic squamous NSCLC."

Clinical • IO biomarker • IO biomarker • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in China. (PubMed, Lancet) - P3 | "Ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with tislelizumab plus chemotherapy in previously untreated patients with advanced squamous NSCLC. This regimen could provide a novel treatment option as first-line treatment in this patient group."

Journal • P3 data • P3 data: top line • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial. (PubMed, Lancet) - P3 | "In patients with untreated advanced squamous NSCLC, ivonescimab plus chemotherapy showed significantly improved progression-free survival compared with tislelizumab plus chemotherapy, regardless of PD-L1 status, as well as a manageable safety profile. This regimen could be used as a novel first-line treatment in this patient group."

Journal • 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

A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103) (clinicaltrials.gov) - P1/2 | N=184 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Pan tumor • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Recent Advances and Future Challenges of Bispecific Antibodies in Lung Cancer. (PubMed, Crit Rev Oncol Hematol) - "Randomized trials have established meaningful benefits for selected agents, exemplified by amivantamab-based therapy in EGFR-mutated NSCLC, ivonescimab-based therapy across several NSCLC settings, and DLL3-directed T-cell engagement with tarlatamab in previously treated SCLC. Future development should move beyond empirical target combinations toward biomarker-guided patient selection, globally representative randomized validation, rational treatment sequencing, and molecular designs that increase tumor selectivity while preserving efficacy. Clinical value varies substantially among constructs and must be established in each disease setting."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Ivonescimab plus chemotherapy as first-line treatment for advanced thymic carcinoma: preliminary results of a phase II trial with biomarker analyses. (PubMed, J Immunother Cancer) - "Tumorous CXCL1 expression showed an exploratory positive correlation with the CD4+/CD8+ ratio (R=0.84, nominal p=0.035, n=6).First-line ivonescimab plus paclitaxel-carboplatin showed promising preliminary antitumor activity and manageable safety in advanced thymic carcinoma. The peripheral blood CD4+/CD8+ ratio showed an exploratory association with depth of response and warrants prospective evaluation in the complete cohort and independent validation.Trial registration numberChiCTR2400094398."

Biomarker • IO biomarker • Journal • P2 data • Tumor mutational burden • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Thymic Carcinoma • Thymus Cancer • CD4 • CD8 • CXCL1 • PD-1 • TMB

Phase II Prospective Single-Arm Study of Ivonescimab plus Re-irradiation in Patients with Recurrent High-Grade Glioma: Efficacy and Safety Assessment (ChiCTR) - P2 | N=21 | Recruiting | Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospital

New P2 trial • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor

A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2029 ➔ Dec 2029 | Initiation date: Feb 2026 ➔ Jul 2026 | Trial primary completion date: Oct 2028 ➔ Dec 2028

Checkpoint inhibition • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial. (PubMed, J Hepatol) - P=N/A, P1/2 | "Ivonescimab plus chemotherapy showed potential anti-tumor activity and tolerable safety as first-line treatment of aBTC patients. Exploratory analyses suggest that MAP2K7 may serve as a candidate biomarker of resistance and a potential therapeutic target for optimizing ivonescimab-based therapy of aBTC patients."

IO biomarker • Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Hematological Disorders • Oncology • Solid Tumor • MAP2K7

A retrospective controlled study of chemotherapy combined with bevacizumab versus chemotherapy combined with ivonescimab in the treatment of EGFR-TKI-resistant advanced NSCLC (ChiCTR) - P=N/A | N=40 | Completed | Sponsor: Peking University Shenzhen Hospital; Peking University Shenzhen Hospital

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

A Phase 2 Study of Ivonescimab (PD1/VEGF bispecific antibody) For the Treatment of Endometrial Cancer (EC) (ESMO 2026) - No abstract available

Bispecific • P2 data • Endometrial Cancer • Oncology • Solid Tumor • PD-1

An Intact Tumor Microenvironment in Patient-Derived NSCLC Organoids Facilitates Subtype-Specific Drug Profiling (IASLC-WCLC 2026) - "Drug sensitivity assays were performed in different groups: control, standard chemotherapy, chemotherapy combined with pembrolizumab, and chemotherapy combined with AK112. Incorporation of the novel bispecific antibody AK112 demonstrated improved antitumor efficacy and microenvironment remodeling in patient-derived organoids. This platform provides a practical and translational tool for studying lung cancer biology and guiding personalized therapeutic strategies."

Biomarker • Clinical • Tumor microenvironment • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Brief report: Ivonescimab combined with etoposide plus carboplatin as first-line treatment for extensive-stage small-cell lung cancer: results of a phase Ib clinical trial. (PubMed, J Thorac Oncol) - "Ivonescimab in combination with etoposide and carboplatin was well-tolerated and showed promising antitumor activity in ES-SCLC."

Journal • P1 data • Hematological Disorders • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Testing the Addition of Ivonescimab Combined With Standard Chemotherapy Compared to the Usual Chemotherapy and Immunotherapy Treatment for Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2/3 | N=336 | Not yet recruiting | Sponsor: ECOG-ACRIN Cancer Research Group

New P2/3 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Akeso…announced that a pre-specified interim analysis of overall survival (OS) in the HARMONi-2 (AK112-303) trial, as assessed by the Independent Data Monitoring Committee (IDMC), met the key secondary endpoint of OS (PRNewswire) - "The results demonstrated that ivonescimab showed statistically significant and clinically meaningful improvement over pembrolizumab. HARMONi-2 is a randomized, double-blind, multicenter, registrational Phase III trial evaluating ivonescimab, Akeso's first-in-class PD-1/VEGF bispecific antibody, versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (TPS ≥1%). Detailed data from the interim OS analysis will be presented at an upcoming international medical conference and published in a peer-reviewed journal."

DSMB • P3 data • Non Small Cell Lung Cancer

Ivonescimab Combined with Radiotherapy for PD-L1-Positive Locally Advanced Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Phase II Clinical Trial (ChiCTR) - P2 | N=34 | Not yet recruiting | Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospital

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

Ivonescimab in combination with chemotherapy in advanced or metastatic gastric cancer (GC) or esophagogastric junction cancer (EGJC): The UCGI 52 - GRACIE trial. (PubMed, Dig Liver Dis) - P2 | "GRACIE will provide crucial information about Ivonescimab plus chemotherapy regimens efficacy either as a first- or second-line treatment in molecularly defined advanced/metastatic gastric and esophageal adenocarcinomas to inform future phase III trials."

IO biomarker • Journal • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Ivonescimab as Later-Line Therapy for NSCLC Patients With CNS Metastases: A Multicenter Retrospective Study (IASLC-WCLC 2026) - "Conclusions : This multicenter retrospective study shows that ivonescimab provides moderate intracranial disease control and a manageable safety profile in heavily pretreated later-line NSCLC patients with brain metastases. Limited by its retrospective design and small sample size, these findings offer preliminary real-world reference for this refractory population and require further validation in large-scale prospective clinical trials."

IO biomarker • Retrospective data • CNS Disorders • Hypertension • Ischemic stroke • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • PD-1

Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC (clinicaltrials.gov) - P2 | N=47 | Not yet recruiting | Sponsor: Shaodong Hong

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