Kaitanni (cadonilimab) / Akesobio - LARVOL DELTA

Case Report: Successful Surgical Resection of PVTT Vp4 Hepatocellular Carcinoma Following Hepatic Arterial Infusion Chemotherapy Combined with Cadonilimab Plus Donafenib. (PubMed, Pharmgenomics Pers Med) - "Following multidisciplinary team evaluation, the patient received conversion therapy consisting of hepatic artery infusion chemotherapy (HAIC) using oxaliplatin, fluorouracil, and leucovorin, in combination with cadonilimab and donafenib...This regimen may substantially improve oncological outcomes and enable curative resection. This case provides compelling evidence to support further clinical investigation of this multimodal therapeutic combination."

Journal • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Thrombosis • AFP

Cadonilimab plus chemotherapy demonstrates clinically meaningful activity in treatment-refractory STK11-mutant advanced NSCLC: results from an open-label, single-arm phase II study (ESMO Asia 2025) - P2 | "Cadonilimab (AK104), a bispecific antibody targeting PD-1 and CTLA-4, enhances antitumor immunity through dual checkpoint inhibition. This phase II study evaluated first-line cadonilimab plus chemotherapy in advanced/metastatic STK11-mutant NSCLC. Eligible patients with stage IV STK11-mutant NSCLC received cadonilimab (10 mg/kg, D1) plus pemetrexed (500 mg/m2) and carboplatin (AUC=5) for 4 cycles, followed by Cadonilimab+pemetrexed maintenance for non-squamous histology; or Cadonilimab (10 mg/kg, D1) plus nab-paclitaxel (100 mg/m2) and carboplatin (AUC=5) for 4 cycles, followed by Cadonilimab+nab-paclitaxel maintenance for squamous histology... First-line cadonilimab plus chemotherapy demonstrated encouraging antitumor activity and manageable safety in advanced STK11-mutant NSCLC, with PFS nearly doubling historical expectations for this treatment-resistant subgroup. Updated survival data with longer follow-up will be presented at the Congress."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • STK11

Cadonilimab plus lenvatinib (LEN) and hepatic arterial infusion chemotherapy (HAIC)-FOLFOX as conversion therapy in unresectable hepatocellular carcinoma (uHCC) (CCGLC-011): Interim results from a phase II trial (ESMO Asia 2025) - P2 | "Pts received HAIC-FOLFOX (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-FU bolus 400 mg/m2 and infusion 2400 mg/m2, Q3W), cadonilimab (10 mg/kg IV, Q3W) and LEN (12 or 8 mg, QD)... Cadonilimab plus LEN and HAIC-FOLFOX showed robust antitumor activity and acceptable safety, enabling curative-intent conversion in initially uHCC pts."

IO biomarker • P2 data • Tumor mutational burden • Hepatocellular Cancer • Oncology • Solid Tumor • CTLA4 • PD-1 • TMB

Cadonilimab (cado) plus oxaliplatin and tegafur-gimeracil-oteracil potassium (SOX) in resectable gastric and gastroesophageal junction (G/GEJ) adenocarcinoma: A phase II study (Compassion-25) (ESMO Asia 2025) - P2, P3 | "Cado plus SOX effectively reduced tumor burden and had a manageable safety profile in pts with resectable G/GEJ adenocarcinoma. A phase III study of Cado plus SOX as perioperative treatment for these pts is ongoing (NCT07023315)."

IO biomarker • P2 data • Gastroesophageal Junction Adenocarcinoma • Oncology • PD-L1

Akeso, Inc…announced FDA approval to initiate COMPASSION-37/AK104-311 trial, a global multicenter Phase III trial in gastric cancer evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody. T (PRNewswire) - "The study will compare cadonilimab plus chemotherapy against chemotherapy with or without nivolumab as first-line treatment for HER2-negative, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma."

IND • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Cadonilimab combined with FOLFIRINOX and bevacizumab as first-line treatment for microsatellite stable/proficient mismatch repair metastatic colorectal cancer: Updated survival analysis and safety outcomes from a multicenter, single-arm, phase 2 study (SYLT-026). (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT05839470 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • Mismatch repair • P2 data • pMMR • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Cadonilimab plus chemotherapy versus PD-1 inhibitor plus chemotherapy as first-line (1L) treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS <5: A propensity-matched, retrospective cohort study. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Retrospective data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

Immune checkpoint therapy in locally advanced, persistent, recurrent, and metastatic cervical cancer: A systematic review and Bayesian network meta-analysis. (PubMed, Int J Gynaecol Obstet) - "Pembrolizumab ranked highest in OS and PFS among patients with locally advanced or advanced cervical cancer. These findings support its preferential use over other ICIs. However, direct head-to-head trials are needed to validate these results and inform optimal ICI selection."

Journal • Retrospective data • Review • Cervical Cancer • Oncology • Solid Tumor

Efficacy and safety of first-line treatments in HER2-negative advanced gastric and gastroesophageal junction cancer (GC/GEJC): A systematic review and Bayesian network meta-analysis (ESMO-IO 2025) - "Among these regimens, cadonilimab +chemo and SHR-1701 +chemo achieved similar OS improvement, ranking first (HR 0.66; 95% Crl 0.54, 0.81) and second (HR 0.66; 95% Crl 0.53, 0.81) respectively, followed by zolbetuximab + chemo (HR 0.76; 95% Crl 0.65, 0.89), sintilimab + chemo (HR 0.77; 95% Crl 0.63, 0.94) and other regimens...Similar results were observed in patients with PD-L1 CPS ≥ 5. Regarding grade ≥3 TRAEs, compared with chemo alone, sugemalimab + chemo (OR 1.145; 95% Crl 0.804, 1.627), SHR-1701 + chemo (OR 1.165; 95% Crl 0.863, 1.557), and tislelizumab + chemo (OR 1.174; 95% Crl 0.919, 1.51)showed better safety profile than other regimens.Conclusions Considering the balance between efficacy and safety, SHR - 1701 + chemo might be considered the preferred first-line treatment for patients with HER2-negative advanced GC/GEJC, particularly those with PD-L1 CPS ≥1 or CPS ≥5.Legal entity responsible for the study The authors."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Akeso, Inc…announced that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO Asia Congress. (Yahoo Finance) - "Among all evaluable patients, the overall pCR rate was 28.6%. Notably, in patients receiving the cadonilimab Q3W dosing regimen, the pCR rate reached 50.0%....The overall MPR rate (defined as ≤10% residual viable tumor cells) across all evaluable patients was 71.4%. For the cadonilimab Q3W regimen, the MPR rate was as high as 85.7%....Among all evaluable patients, 85.7% achieved downstaging of the primary tumor (ypT), and 75.0% achieved nodal downstaging (ypN)."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Cadonilimab: All 1L Gastric Cancer, 1L Cervical Cancer, and 2L/3L Cervical Cancer Indications Now Covered by NRDL (PRNewswire) - "Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, has successfully negotiated the inclusion of its new first-line gastric cancer and first-line cervical cancer indications into the NRDL."

Reimbursement • Cervical Cancer • Gastric Cancer

Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC) (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Akeso

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

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=67 | Completed | Sponsor: Akesobio Australia Pty Ltd | Active, not recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

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 study of cadonilimab combined with anlotinib in advanced NSCLC patients after systemic therapy failure and resistance to Anti–PD-(L)1 antibody treatment (ESMO-IO 2025) - "The most common TRAEs were skin and mucosal reactions.Conclusions This preliminary analysis suggests that cadonilimab in combination with anlotinib demonstrates promising antitumor activity and a manageable safety profile in patients with advanced NSCLC who progressed after systemic therapy and developed resistance to prior anti-PD-(L)1 antibody treatment. Enrollment is ongoing, and longer follow-up is required to accurately assess the ORR and PFS.Legal entity responsible for the study M. Hou."

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

Low and Intermediate Grade Glioma Umbrella Study of Molecular Guided TherapieS (LUMOS2) study (WFNOS 2025) - P2 | "LUMOS2 currently has four active arms each with n=19 participants: paxalisib (PIK3CA-MTOR inhibitor) for participants with PIK3CA pathway alterations, or randomization to one of three target-agnostic options: AK104 (PD-1/CTLA-4 bispecific antibody), selinexor (selective inhibitor of nuclear export), or niraparib plus AK104 (PARP inhibitor plus AK104). Feasibility of molecular guided therapy in recurrent grade 2-3 glioma based on comprehensive genomic profiling is established with trial recruitment to date."

IO biomarker • Brain Cancer • Oncology • Solid Tumor • CTLA4 • MTAP • PD-1 • PIK3CA

COMPASSION-16: A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=445 | Active, not recruiting | Sponsor: Akeso | Trial primary completion date: Apr 2025 ➔ Dec 2025

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

Low and Intermediate Grade Glioma Umbrella Study of Molecular Guided TherapieS (LUMOS2) study (SNO 2025) - P2 | "LUMOS2 currently has four active arms each with n=19 participants: paxalisib (PIK3CA-MTOR inhibitor) for participants with PIK3CA pathway alterations, or randomization to one of three target-agnostic options: AK104 (PD-1/CTLA-4 bispecific antibody), selinexor (selective inhibitor of nuclear export), or niraparib plus AK104 (PARP inhibitor plus AK104). Feasibility of molecular guided therapy in recurrent grade 2-3 glioma based on comprehensive genomic profiling is established with trial recruitment to date."

IO biomarker • Brain Cancer • Glioma • Solid Tumor • CTLA4 • MTAP • PD-1 • PIK3CA

Kirsten rat sarcoma G12C inhibitor treatment for a patient with relapsed metastatic lung adenocarcinoma: A case report. (PubMed, World J Clin Cases) - "After multiple-line treatment including chemotherapy, targeted therapy, and immunotherapy, disease control was achieved in a case of advanced pulmonary adenocarcinoma carrying the KRAS G12C mutation by mutation-specific inhibitor therapy, and the adverse reactions to the therapy were tolerable."

IO biomarker • Journal • Preclinical • Cough • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Sarcoma • Solid Tumor • KRAS

COMPASSIOn-15: A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma (clinicaltrials.gov) - P3 | N=610 | Completed | Sponsor: Akeso | Active, not recruiting ➔ Completed | Trial primary completion date: Apr 2025 ➔ Dec 2024

Trial completion • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Stereotactic body radiation therapy combined with cadonilimab and lenvatinib in the treatment of hepatocellular carcinoma with Vp3 or Vp4 portal vein tumor thrombus: a prospective, multicenter, single-arm, phase II clinical trial. (PubMed, Front Immunol) - P1/2 | "Early AFP or PIVKA-II response at 6 weeks may serve as a prognostic biomarker. ClinicalTrials.gov, identifier NCT06040177."

Journal • P2 data • Cardiovascular • Fatigue • Hematological Disorders • Hepatocellular Cancer • Hepatology • Hypertension • Oncology • Solid Tumor • Thrombocytopenia • Thrombosis

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

Dual immune checkpoint inhibitor cardonilumab induces immune myocarditis in a patient with cancer-related myocardial metastasis: A case report. (PubMed, Oncol Lett) - "Following treatment with low-dose diuretics and intravenous methylprednisolone (adjusted dose), and management of anemia, the patient recovered well and was discharged on hospital day 21...Special consideration should be given to risk factors, such as cardiac metastasis and impaired lung function, which could predispose patients to irAEs associated with immunotherapy, and more particularly with myocarditis. Based on the current experience, the present study offers practical recommendations for the prevention of cadonilimab-induced myocarditis to improve patient outcomes."

Checkpoint inhibition • Journal • Cardiovascular • Cervical Cancer • Congestive Heart Failure • Cough • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Immunology • Infectious Disease • Lung Cancer • Oncology • Pancreatic Cancer • Pneumonia • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma

Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Complete response of advanced HER2-amplified lung adenocarcinoma to cadonilimab combined with disitamab vedotin: a case report. (PubMed, Front Oncol) - "Thus, this combination therapy may offer a promising, effective, and well-tolerated treatment alternative for similar patients. Further clinical trials are warranted to validate these findings and potentially establish a new standard of care for this subset of lung cancer patients."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • PD-1 • PD-L1