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

Ivonescimab for EGFR-mutant lung adenosquamous carcinoma after multiline therapy: A case report. (PubMed, Front Oncol) - "Despite initial responses to first-line firmonertinib-based combination therapy, progression-free survival (PFS) 13 months, the patient developed sequential resistance to subsequent regimens, including liver/brain metastases and treatment-related toxicities. After fourth-line therapy failure and severe intolerance to albumin-bound paclitaxel and bevacizumab, two cycles of ivonescimab-a first-in-class programmed cell death protein receptor-1 (PD-1)/vascular endothelial growth factor-A (VEGF-A) bispecific antibody-induced significant regression of pulmonary target lesions (PR), sustained over six cycles with minimal toxicity...While the rapid PR and favorable safety profile are promising, longer follow-up is required to assess durability and survival benefits. These findings underscore the need for further investigation of bispecific antibodies in precision oncology paradigms for multi-refractory EGFR-driven NSCLC."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-1 • PD-L1 • TP53

Invited Discussant – Asian perspectives on 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 Asia 2025) - No abstract available

Clinical • 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 Asia 2025) - No abstract available

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

Phase II trial of neoadjuvant short-course radiotherapy followed by ivonescimab with or without chemotherapy in locally advanced rectal cancer (TRIUNITE-03). (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT06718543 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025 (PRNewswire) - "As of July 15, 2025, a total of 36 patients with TNBC were enrolled....The key results are: The objective response rate (ORR) for the overall population was 80.0%, the disease control rate (DCR) was 100.0%, and the median duration of response (mDOR) was 12.2 months; the median progression-free survival (mPFS) was 15.2 months, with a 12-month PFS rate of 56.3%. In the CPS≥10 subgroup, the ORR was 83.3%, the DCR was 100%, the mDOR was 12.2 months; the mPFS was 15.9 months, with a 12-month PFS rate of 66.7%. In the CPS<10 subgroup, the ORR was 79.3%, the DCR was 100%, the mDOR was 9.9 months; the mPFS was 13.04 months, with a 12-month PFS rate of 54.3%. In the CPS≥1 subgroup, the ORR was 72.2%, the DCR was 100%, the mDOR was 12.2 months; the mPFS was 15.9 months, with a 12-month PFS rate of 63.8%."

P2 data • Triple Negative Breast Cancer

Significant Improvement in Quality of Life Reported in Updated HARMONi-6 Data for Ivonescimab at ESMO Asia (PRNewswire) - "Quality of life (QoL) assessments from the HARMONi-6 study show that, compared with PD-1 inhibitor plus chemotherapy, ivonescimab plus chemotherapy not only significantly prolongs progression-free survival (PFS) but also helps patients maintain better overall health status....The ivonescimab-based regimen met the primary PFS endpoint versus the tislelizumab-based regimen, delivering a decisive, strongly positive outcome with both statistical significance and clear clinical benefit. PFS was substantially prolonged with ivonescimab plus chemotherapy compared with tislelizumab plus chemotherapy."

P3 data • Lung Non-Small Cell Squamous Cancer

Ivonescimab: All 1L and 2L NSCLC Indications Now Covered by NRDL (PRNewswire) - "Akeso's first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has successfully secured the inclusion of its new first-line indication for PD-L1-positive non-small cell lung cancer (NSCLC) in the NRDL. In a Phase III head-to-head clinical trial, ivonescimab demonstrated compelling results, reducing the risk of disease progression or death by 49% compared to pembrolizumab."

Reimbursement • Non Small Cell Lung Cancer

ILLUMINE: Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN (clinicaltrials.gov) - P3 | N=780 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

New P3 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

JMT108-001: First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=400 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Phase classification: P1 ➔ P1/2 | N=270 ➔ 400

Enrollment change • First-in-human • Phase classification • Oncology • Solid Tumor

A Phase II Trial of Ivonescimab in Combination with Carboplatin and Docetaxel in Patients with Early Stage Triple Negative Breast Cancer (TNBC) (SABCS 2025) - P2 | "Background: Immune checkpoint inhibitor pembrolizumab in combination with chemotherapy has shown promising pathological complete response rate (pCR) in early stage TNBC and currently FDA approved for stage II-III TNBC...Ivonescimab showed promising progression free survival (PFS) in combination with paclitaxel or nab-paclitaxel as first line therapy, including PD-L1 negative TNBC...The trial is projected to start patient enrollment in July 2025. Clinical trial information: NCT07017673"

Clinical • Combination therapy • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Efficacy and safe of Ivonescimab Combined with Cadonilimab and Chemotherapy in Extensive-Stage Small Cell Lung Cancer:a multicentre, open-label, phase II trial. [WITHDRAWN] (ESMO Asia 2025) - No abstract available

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

A Cost-Effectiveness Analysis of Ivonescimab Plus Chemotherapy versus Chemotherapy in Advanced Non–Small Cell Lung Cancer with EGFR Mutation [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Cost effectiveness • HEOR • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Evaluation of the safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC): Updated findings from the open-label, phase II study (ESMO-IO 2025) - "Pts received ivonescimab at 20 mg/kg Q2W and paclitaxel at 90 mg/m2 or nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th day of each four-week treatment cycle. Conclusions Ivonescimab in combination with chemotherapy showed promising anti-tumor activity across all PD-L1 subgroups and was associated with a favorable safety profile. A phase III study of ivonescimab combined with chemotherapy as 1L treatment for TNBC is ongoing.Clinical trial identification NCTO5227664.Legal entity responsible for the study Akeso Biopharma Inc."

Clinical • Combination therapy • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

GRACIE: Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=88 | Recruiting | Sponsor: UNICANCER | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor

Unlocking new horizons in oncology: ivonescimab's dual-target approach to anti-VEGF/PD-1(L1) therapy. (PubMed, Front Immunol) - "PD-1(L1)/VEGF BsAbs like ivonescimab represent a novel therapeutic strategy with potential for improved efficacy and mitigated toxicity compared to combination therapies. Ongoing trials will define broader applications."

IO biomarker • Journal • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Ivonescimab: “PFS HR 0.46 (95% C: 0.34, 0.62), p< 0.001 (primary endpoint)”; Non-small cell lung cancer (Akeso Biopharma) - SITC 2025: “OS HR 0.74 (95% CI : 0.58, 0.95), p=0.019 (key secondary endpoint)”

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

A Study of Ivonescimab in First-Line ES-SCLC (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Akeso

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

HARMONi-3: Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients (clinicaltrials.gov) - P3 | N=1600 | Recruiting | Sponsor: Summit Therapeutics | N=1080 ➔ 1600 | Trial completion date: Dec 2028 ➔ Dec 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2028

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Neoadjuvant Ivonescimab（AK112） Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=49 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Neoadjuvant Ivonescimab Plus Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Women's Hospital School Of Medicine Zhejiang University

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: Peking University Cancer Hospital & Institute

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

A Randomized Phase II Study Evaluating Upfront SRT to All Brain Metastases Followed by Ivonescimab Plus Chemotherapy Versus Upfront Ivonescimab Plus Chemotherapy in Patients With Asymptomatic Active Brain Metastases From NSCLC (clinicaltrials.gov) - P2 | N=158 | Not yet recruiting | Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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

Synthetic signaling platform uncovers and rewires cellular responses to PD-1 perturbation. (PubMed, bioRxiv) - "In addition, Sphyder biosensors revealed previously unrecognized mechanisms of the PD-1/VEGF bispecific antibody Ivonescimab, showing that it induces VEGF-dependent clustering, phosphorylation, and degradation of PD-1. These findings may underlie its promising clinical activity relative to conventional PD-1 blockade. Together, our study establishes a broadly applicable strategy for sensing and reprogramming cell signaling, while also providing mechanistic insights into a new class of immune checkpoint inhibitors of major clinical interest."

Journal • Oncology • PD-1

SEVILLA: Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: UNICANCER | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor