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

The anti-tumor activity of BB-202, a novel anti-PD-1/anti-VEGF bispecific antibody (AACR 2026) - "In PD-1/PD-L1 blockade assays, BB-202 showed potency similar to pembrolizumab and substantially greater than AK112 and LM-299. BB-202 also blocked VEGFA activity with potency comparable to bevacizumab (Avastin), AK112, and LM-299...BB-202 is a potent, stable, and well-tolerated anti-PD-1/anti-VEGF bispecific antibody. Its superior in vitro potency and robust in vivo efficacy, together with a favorable developability profile, position BB-202 as a promising best-in-class therapeutic candidate among PD-1/VEGF-targeting bispecific antibodies."

Bispecific • Oncology

Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study) (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital

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

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 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

AK104-223: A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • HER2 Negative Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Ivonescimab vs Placebo Plus Chemo, Phase 3 in Patients with EGFR+ NSCLC Progressed with 3rd gen EGFR-TKI Treatment: HARMONi (IASLC-WCLC 2025) - "Methods : Patients were randomized 1:1 to receive ivonescimab (20 mg/kg) or placebo plus pemetrexed (500 mg/m 2 ) and carboplatin (AUC 5) every 3 weeks for 4 cycles, followed by maintenance pemetrexed plus ivonescimab or pemetrexed plus placebo every 3 weeks with stratification for presence of brain metastases (BM) by region. Ivonescimab plus chemotherapy had a clinically meaningful, statistically significant PFS benefit in patients with EGFR+ NSCLC post-3rd generation EGFR-TKI therapy while maintaining a manageable and favorable safety profile. Efficacy was seen in patients with and without BM and across regions and strengthened by a meaningful, positive OS trend."

Clinical • IO biomarker • P3 data • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Renal Disease • Solid Tumor • PD-1

Safety and Efficacy of Yiwoxidan Anti (AK112) Monotherapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Are Intolerant to TKI Treatment: a Prospective, Single Arm, Phase II Clinical Study (clinicaltrials.gov) - P2 | N=60 | Enrolling by invitation | Sponsor: Sun Yat-sen University

Monotherapy • New P2 trial • Clear Cell Carcinoma • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

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

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

TGI-17b: A potential first-in-class PD-1/VEGF/IL-2α-bias trispecific antibody and the potential next generation cornerstone for pan-cancer therapy (AACR 2026) - "In functional assays, TGI-17b blocked PD-1/PD-L1 interaction with a slightly higher EC50, and blocked VEGF/VEGFR1 and VEGF/VEGFR2 interactions with significantly lower EC50 values compared to AK112, a PD-1/VEGF bispecific antibody (PD-1/PD-L1 blockade EC50: 0.70 µg/mL for TGI-17b vs. 0.32 µg/mL for AK112; VEGF/VEGFR1 blockade EC50: 0.37 µg/mL vs. 3.53 µg/mL; VEGF/VEGFR2 blockade EC50: 1.29 µg/mL vs. 7.71 µg/mL). These results indicate that TGI-17b, a potential first-in-class PD-1/VEGF/IL-2α-bias trispecific antibody, possesses compelling anti-tumor efficacy and a favorable safety profile in preclinical models. This robust evidence supports its further clinical development as a promising therapeutic candidate for pan-cancer applications."

Pan tumor • Trispecific • Oncology • Solid Tumor • FLT1 • PD-1

IvoLoC Trial: A phase II trial evaluating the efficacy of ivonescimab in metastatic endocrine refractory HR-positive HER2-negative or triple negative invasive lobular carcinoma (ILC) (AACR 2026) - "Abstract is embargoed at this time."

Clinical • Metastases • P2 data • Oncology • HER-2

ALX006, a PD-1/VEGF bispecific antibody with best-in-class potential demonstrates superior antitumor activity and favorable PK in preclinical models (AACR 2026) - "ALX006, a PD-1/VEGF bispecific antibody with best-in-class potential, demonstrates superior antitumor activity and favorable PK in preclinical models, supporting its potential as a therapeutic candidate for immuno-oncology applications."

Bispecific • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG • IL2 • PD-1

Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial. (PubMed, JAMA) - P3 | "Participants received ivonescimab (n = 161) or placebo (n = 161) plus pemetrexed and carboplatin once every 3 weeks for 4 cycles, followed by maintenance therapy of ivonescimab plus pemetrexed or placebo plus pemetrexed. Ivonescimab plus chemotherapy significantly improved progression-free survival with tolerable safety profile in TKI-treated non-small cell lung cancer. ClinicalTrials.gov Identifier: NCT05184712."

Clinical • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Final overall survival analysis of HARMONi-A study comparing ivonescimab plus chemotherapy to chemotherapy alone in patients with EGFR+ NSCLC progressed on EGFR-TKI treatment (SITC 2025) - P3 | "Here, we report the overall survival (OS) results in the final and only formal OS analysis of this study.Methods Patients (pts) were randomized 1:1 to receive ivonescimab (20 mg/kg) or placebo plus pemetrexed (500 mg/m2) and carboplatin (AUC 5) every 3 weeks for 4 cycles, with presence of brain metastases (BM) and prior exposure to 3rd generation EGFR-TKI as two stratification factors. The safety of the combination therapy remained favorable, with no new safety signals identified.Conclusions Ivonescimab plus chemotherapy demonstrated a clinically meaningful and statistically significant OS benefit in pts with EGFR+ NSCLC post EGFR-TKI therapy in this randomized Phase 3 HARMONi-A study. This study results establish ivonescimab plus chemotherapy as a new standard of care for EGFR+ NSCLC patients who progressed on EGFR-TKI treatments.Trial Registration This study has been registered on ClinicalTrial.gov under the registration number NCT05184712."

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

A phase II clinical study of neoadjuvant immunogenic radiotherapy followed by ivonescimab (PD-1/VEGF-A bispecific antibody) and chemotherapy in stage II-III non-small cell lung cancer (ELCC 2026) - P2 | "19 pts underwent thoracoscopic surgery. Grade ≥3 TRAEs occurred in 28.5% of pts, predominantly hematological toxicity."

Bispecific • Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

Health-related quality of life with ivonescimab versus pembrolizumab for PD-L1 positive, non-small cell lung cancer (HARMONi-2): A randomised, double-blind, phase III study in China (ELCC 2026) - "For EQ-5D-5L, the mean health status score slightly increased, and the mean utility value remained stable in both groups. Table: 107P Mean change from baseline in QLQ-C30 functional and QLQ-L13 symptom scores Ivonescimab Pembrolizumab Change from baseline, mean (SD) Change from baseline, mean (SD) QLQ-C30 GHS/QoL W12 6.3 (17.6) 3.4 (17.4) W30 5.2 (16.0) 4.4 (17.8) Physical functioning W12 1.3 (11.6) 2.8 (13.8) W30 3.4 (11.4) 5.2 (12.6) QLQ-LC13 Cough W12 −9.1 (23.9) −10.0 (22.5) W30 −12.9 (26.8) −17.2 (23.2) Dyspnea W12 −3.8 (13.6) −3.7 (17.6) W30 −6.5 (17.8) −6.3 (17.8) Conclusions Treatment with ivonescimab was associated with improvement in QoL relative to baseline as measured across multiple platforms; this improvement was comparable to that observed in the control arm."

Clinical • HEOR • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Health-related quality of life in patients previously treated with an EGFR-TKI from HARMONi: A phase III trial of ivonescimab vs placebo plus chemotherapy (ELCC 2026) - P3 | "Here we assess health-related quality of life (HRQoL) in pts from HARMONi.Methods Pts were randomized 1:1 to IVO 20 mg/kg or PBO + CT [pemetrexed (PTX) + carboplatin] every 3 weeks (Q3W) for 4 cycles followed by IVO 20 mg/kg or PBO + PTX Q3W. Median TTD in functioning and symptom scores were similar between arms. TTD in GHS/QoL was also comparable in both arms, with a longer TTD for IVO + CT than PBO + CT, median 7.0 mos vs 6.5 mos (HR 0.90, 95% CI 0.73-1.12).Conclusions IVO + CT significantly improved PFS vs PBO + CT and maintained QoL, supporting its role as a new treatment option for EGFR-TKI–refractory advanced or metastatic NSCLC."

Clinical • HEOR • IO biomarker • P3 data • Lung Cancer • Non Small Cell Lung Cancer • PD-1

Intracranial (IC) efficacy of ivonescimab (ivo) plus chemotherapy (chemo) in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant, EGFR-mutated non-small cell lung cancer (NSCLC) in the HARMONi study (ELCC 2026) - P3 | "Grade ≥3 bleeding occurred in <1% of pts with ivo + chemo, and rates of discontinuation (n=16 [7.3%] vs n=11 [5.0%]) and death (n=4 [1.8%] vs n=5 [2.3%]) were comparable with ivo + chemo vs chemo.Methods Pts were randomly assigned (1:1) with stratification by presence/absence of brain metastases (mets) and geographic region to ivo (20 mg/kg) or placebo with pemetrexed and carboplatin every 3 weeks for 4 cycles, followed by maintenance therapy. Median IC PFS was longer in the ivo + chemo vs placebo + chemo arm in patients with brain mets (10.1 vs 6.5 mo; HR, 0.53 [95% CI, 0.33-0.84], P=0.0068) and in pts without brain mets (15.7 vs 11.6 mo; HR, 0.72 [95% CI, 0.55-0.94], P=0.0172), respectively. Cumulative incidence probability (95% CI) for IC progression was significantly lower with ivo + chemo vs placebo + chemo at both 6 and 12 mo for pts with brain mets (6 mo: 0.06 [0.02-0.15] vs 0.30 [0.19-0.43]; 12 mo: 0.10 [0.04-0.21] vs 0.36 [0.22-0.49]; P=0.0007) and pts..."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=87 | Recruiting | Sponsor: Akeso | Trial completion date: Dec 2024 ➔ Jun 2027 | Trial primary completion date: Jun 2024 ➔ Dec 2026

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

GORTEC 2024-01: Phase 3 study comparing ivonescimab alone or ivonescimab with ligufalimab versus pembrolizumab for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (clinicaltrialsregister.eu) - P2/3 | N=310 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete Cou

New P2/3 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Ivonescimab in metastatic clear cell renal cell carcinoma (mccRCC) after immune checkpoint inhibitor therapy: The phase II IVORY trial. (ASCO-GU 2026) - P2 | "In non-small cell lung cancer, ivonescimab has recently shown superiority over pembrolizumab (HARMONi-2). Tissue, blood, and stool correlatives will be collected at baseline, during therapy and at the end of treatment to identify changes in specific immune-cell and gut microbiome subsets and elucidate the dynamic evolution of tumor and immune-cell compartments as well as their spatial relationships following ivonescimab. NCT06940518."

Checkpoint inhibition • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

HARMONi-2: AK112 in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=398 | Active, not recruiting | Sponsor: Akeso | Trial completion date: Dec 2025 ➔ Dec 2026

IO biomarker • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A phase II trial of ivonescimab for previously treated thymic carcinoma UCLA L-11 (AACR 2026) - "Abstract is embargoed at this time."

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

Mechanism-driven cell-based assays to screen & characterize bi-specific antibodies (AACR 2026) - "BsAb-based therapies have demonstrated significant preclinical and clinical potential, as evidenced by the regulatory approval of molecules like blinatumomab (CD19/CD3), amivantamab (EGFR/Her3), ivonescimab (PD-1/VEGF-A), and others.Eurofins DiscoverX® provides a robust portfolio of cell-based assays for oncology targets and offers three primary assay formats to characterize BsAbs: (1) Cytotoxicity assays: To assess functional activity of BsAbs in trans, specifically for characterizing T-cell engagers (BiTEs) and similar molecules, (2) Dimerization assays: To record hetero dimerization of target receptors in cis, and (3) Pathway signaling assays: To evaluate the functional activity of each individual BsAb target armThis presentation highlights case studies illustrating the use of these cell-based assays to monitor key BsAb MOAs targeting critical tumor antigens, including CD19, PD-1, and VEGF-A. Applications will demonstrate the evaluation of BsAb-mediated tumor..."

Bispecific • Oncology • EGFR • ERBB3 • PD-1