Kaitanni (cadonilimab) / Akesobio - LARVOL DELTA

A phase Ib/II study of second-line cadonilimab, anlotinib and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer (ELCC 2026) - P1/2 | "Background This study (AK104-IIT-018, NCT05816499) aimed to evaluate the safety and efficacy of cadonilimab (a PD-1/CTLA-4 bispecific antibody), anlotinib, and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer (NSCLC) without sensitizing EGFR/ALK/ROS1 mutations.Methods It was a prospective, open-label, single-arm, multi-center, phase Ib/II trial comprising a dose exploration and an expansion phase. The objective response rate (ORR) was 26.2%, and the disease control rate (DCR) was 90.5%.The duration of response (DoR) was 5.36 months, and the overall survival has not mature. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 14.0%.Conclusions Cadonilimab in combination with anlotinib and docetaxel showed promising efficacy and well-tolerated safety in advanced NSCLC patients who had failed prior CPI, as a potential strategy to overcome resistance to anti-PD-(L)1 therapy."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CTLA4 • EGFR • ROS1

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

Efficacy of disitamab vedotin, AK104, and bevacizumab in HER2-positive recurrent ovarian clear cell cancer: Phase II DAB-OCCC trial (ESMO 2025) - P2 | "(%) Taxene 15 (100%) PARPi 4 (27%) Bevacizumab 11 (73%) Immune Therapy 1 (7%) Conclusions The combination of DV, AK104, and bevacizumab demonstrated clinically meaningful antitumor activity and a manageable safety profile in HER2-positive, PRR OCCC. This phase 2 trial met its pre-specified efficacy threshold in the first stage."

Clinical • IO biomarker • P2 data • Oncology • Ovarian Cancer • Ovarian Clear Cell Cancer • HER-2 • PD-L1

A phase II, multicenter, open-label study (COMPASSION-26) of cadonilimab, a PD-1/CTLA-4 bispecific antibody,combined with chemotherapy (chemo) as first-line therapy for advanced pancreatic ductal adenocarcinoma (PDAC) (AACR 2026) - "Abstract is embargoed at this time."

Bispecific • Clinical • Metastases • P2 data • Oncology • Pancreatic Ductal Adenocarcinoma • CTLA4

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: Sun Yat-sen University | Active, not recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Cadonilimab (Cado) plus chemotherapy (chemo) versus chemotherapy as first-line (1L) treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Final results of the phase III COMPASSION-15 trial (ESMO 2025) - P3 | "Pts were randomized 1:1 to receive Cado (10mg/kg Q3W) or placebo plus chemo (XELOX Q3W)...These authors contributed equally: Lin Shen, Yanqiao Zhang, Ziyu Li, Xiaotian Zhang. Lin Shen and Jiafu Ji are the corresponding authors."

Clinical • IO biomarker • Metastases • P3 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • CTLA4 • HER-2 • PD-1 • PD-L1

Comparison of drug regimens for recurrent or metastatic cervical cancer: a systematic review and network meta-analysis. (PubMed, Front Immunol) - "Specifically, the regimen of pembrolizumab plus chemotherapy and bevacizumab showed the greatest potential for OS benefit (Frequentist HR: 0.45, 95%CI: 0.30-0.67 vs. cisplatin plus paclitaxel), ranking first by SUCRA (87%)...This study provides comprehensive indirect comparison evidence for clinicians in selecting R/MCC treatment strategies. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251180897, identifier CRD42024604107."

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

Dual PD-1 and CTLA-4 targeting in endometrial carcinoma: integrating efficacy, toxicity, and biomarkers into clinical practice. (PubMed, Front Immunol) - "In dMMR EC, the conventional ipilimumab-nivolumab combination yields higher objective response rates (ORR ≈ 63%) than PD-1 monotherapy (ORR ≈ 48%) but is associated with a substantially increased incidence of grade ≥ 3 immune-related adverse events (≈ 23% vs. ≈ 12%)...In contrast, for patients with mismatch repair-proficient (pMMR) tumors, the evidence firmly supports alternative regimens, such as lenvatinib plus pembrolizumab, over dual PD-1/CTLA-4 blockade. Navigating the evolving landscape of immunotherapy in EC requires a nuanced, patient-centric approach. The integration of novel bispecific antibodies may soon simplify the balance between efficacy and toxicity, but until then, treatment selection remains a deliberate process, underscoring the gynecologic oncologist's pivotal role in personalizing care."

Biomarker • IO biomarker • Journal • Review • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor • CTLA4

Cadonilimab plus platinum-based chemotherapy ± bevacizumab for persistent, recurrent, or metastatic cervical cancer: Subgroup analyses of COMPASSION-16. (ASCO 2025) - P3 | "Treatment effects on PFS and OS were evaluated in subgroups including age (<65 or ≥65 years), bevacizumab use (yes or no), prior concurrent chemoradiotherapy (CCRT; yes or no), metastatic disease at baseline (yes or no), PD-L1 CPS (<1, ≥1, or ≥10), and platinum use (cisplatin or carboplatin)... Subgroup analyses of COMPASSION-16 showed that the addition of cadonilimab to chemotherapy ± bevacizumab improved PFS and OS across subgroups defined by age, bevacizumab use, prior CCRT, metastatic disease, PD-L1 CPS, and platinum use, consistent with results for the overall population. Cadonilimab plus standard treatment is a potential treatment option for patients with R/M CC."

Metastases • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Updated exploratory biomarker analysis of cadonilimab plus regorafenib as second-line or later therapy in advanced hepatocellular carcinoma: Identification of Bola3 as a potential predictive biomarker (AACR 2026) - P1 | "Integrated exploratory analyses nominate BOLA3 as a candidate outcome-associated biomarker and support a model in which responders exhibit a mitochondria-low, inflamed-high phenotype. These findings provide early, complementary evidence that BOLA3-related features may inform patient stratification, with further validation underway. Research Sponsor: The Joint Funds of the Natural Science Foundation of Tianjin (No.25JCLZJC00120)."

Biomarker • Clinical • IO biomarker • Metastases • Hepatocellular Cancer • Oncology • Solid Tumor • CD8 • PD-L1

Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer (clinicaltrials.gov) - P2 | N=32 | Active, not recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Endometrial Adenocarcinoma • Endometrial Cancer • Oncology • Solid Tumor

Cadonilimab plus lenvatinib in advanced renal cell carcinoma: Interim analysis of a prospective, multi-cohort phase II study. (ASCO-GU 2026) - "The Cadonilimab plus Lenvatinib combination regimen demonstrates encouraging antitumor activity and a manageable safety profile in patients with advanced RCC, with promising short-term DCR. These findings support continued patient enrollment and longer-term follow-up to further evaluate survival benefits. Tumor treatment efficacy summary."

Clinical • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urethral Cancer • CTLA4

Efficacy and Safety of Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Combined with Chemotherapy or Radiotherapy with or without Bevacizumab in Recurrent or Metastatic Cervical Cancer- a Retrospective, Real-world Stud (SGO 2026) - No abstract available

Bispecific • Metastases • Real-world • Real-world evidence • Retrospective data • Cervical Cancer • Oncology • Solid Tumor • CTLA4

Cadonilimab plus neoadjuvant chemotherapy for locally advanced cervical cancer: a real-world study (SGO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Cervical Cancer • Oncology • Solid Tumor

Efficacy and safety of cadonilimab combined with chemotherapy as the first-line treatment for recurrent/advanced endometrial carcinoma: a multi-center, single-arm phase II clinical trial (SGO 2026) - No abstract available

Clinical • Metastases • P2 data • Endometrial Cancer • Oncology • Solid Tumor

Cadonilimab plus chemotherapy for patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma in China and the United States: a cost-effectiveness analysis. (PubMed, Ther Adv Med Oncol) - "Its economic advantage is most pronounced in patients with high PD-L1 expression and at lower drug prices. These findings provide quantitative evidence supporting reimbursement negotiations and future pricing strategies for cadonilimab in global markets."

HEOR • IO biomarker • Journal • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Cadonilimab plus chemotherapy with or without bevacizumab as first-line treatment for advanced cervical cancer: subgroup analyses from the COMPASSION-16 phase 3 trial. (PubMed, Nat Commun) - "Moreover, the addition of cadonilimab is also associated with prolonged overall survival. This subgroup analysis confirms that improvements in progression-free and overall survival are consistent with the primary results of the COMPASSION-16 study across diverse patient profiles."

Journal • P3 data • Cervical Cancer • Oncology • Solid Tumor

AK112-208: AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=233 | Active, not recruiting | Sponsor: Akeso | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2025 ➔ Jun 2026

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

Cadonilimab plus chemotherapy vs. PD-1 inhibitor plus chemotherapy as first-line treatment for advanced gastric or gastroesophageal junction cancer with PD-L1 combined positive score <5: a propensity-matched, retrospective cohort study. (PubMed, J Gastrointest Oncol) - "Cadonilimab (AK104) is a first-in-class bispecific antibody targeting programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)...Immune-related AEs occurred in 8 patients (30.8%) in the cadonilimab group and 6 patients (23.1%) in the PD-1 inhibitor group. Compared to PD-1 inhibitor plus chemotherapy, cadonilimab plus chemotherapy significantly improved PFS and OS with a manageable safety profile in the first-line treatment of advanced G/GEJ cancer with PD-L1 CPS <5 in a real-world setting."

Journal • Retrospective data • Gastric Cancer • Oncology • Solid Tumor • CTLA4 • PD-L1

Case Report: A successfully managed case of SMARCA4-deficient undifferentiated gastric carcinoma. (PubMed, Front Oncol) - "The regimen included ifosfamide, liposomal doxorubicin hydrochloride, cadonilimab, and anlotinib capsules...Here we present a successfully treated case of this tumor type originating in the stomach. This case may serve as a reference for future management of such tumors."

Journal • Gastric Cancer • Oncology • Solid Tumor • SMARCA4

A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

Efficacy and safety of cadonilimab combined with chemotherapy for gastric or gastroesophageal junction adenocarcinoma: a single-arm meta-analysis. (PubMed, Front Immunol) - "Further large-scale, high-quality randomized controlled trials are needed to validate these findings and define the optimal treatment strategy. https://www.crd.york.ac.uk/PROSPERO, identifier CRD420251089855."

Journal • Retrospective data • Review • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • CTLA4

AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=110 | Active, not recruiting | Sponsor: Akeso | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Pancreatic Cancer • Solid Tumor

Cadonilimab plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma: a step forward for bispecific immunotherapy? (PubMed, Chin Clin Oncol) - No abstract available

Journal • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Interim analysis of vorolanib combined with cadonilimab in previously untreated patients with advanced renal cell carcinoma. (ASCO-GU 2026) - P1/2 | "Vorolanib has demonstrated OS benefit and safety as monotherapy or combined with everolimus in later-line settings... The combination of vorolanib and cadonilimab represents a 1L treatment option for aRCC, demonstrating a high ORR and favorable tolerability. Further large-scale studies are warranted to validate OS, PFS, and long-term safety. PD-L1+ CTCs show potential as predictive biomarkers for treatment efficacy."

Clinical • IO biomarker • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CTLA4