RegulationFast Track (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Sequence Code 616719055

Source: *****

Sequence Code 616719118

Source: *****

229

Clinical Trials associated with Cadonilimab

NCT06913218

/ Not yet recruitingPhase 1

An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma

To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC

Start Date22 Jul 2025

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

[+1]

NCT07023315

/ Not yet recruitingPhase 3

A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.

Start Date01 Jul 2025

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT06984718

/ Not yet recruitingPhase 2

A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination With Lenvatinib Versus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have progressed on the first line treatment of atezolizumab and bevacizumab.

Start Date25 Jun 2025

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

100 Clinical Results associated with Cadonilimab

100 Translational Medicine associated with Cadonilimab

100 Patents (Medical) associated with Cadonilimab

264

Literatures (Medical) associated with Cadonilimab

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Cost-effectiveness analysis of a first-line treatment with cadonilimab plus platinum-based chemotherapy with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer in China: COMPASSION-16 trial

Article

Author: Wang, Chunping ; Wang, Jinglin ; Zhang, Qilin ; Ding, Yiling ; Shu, Yamin

Background:

The addition of cadonilimab to first-line platinum-based chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. However, the economic value of using this novel therapy for this indication is currently unknown. The aim of this study is to evaluate the cost-effectiveness of the addition of cadonilimab to first-line standard chemotherapy for patients with persistent, recurrent, or metastatic cervical cancer from the perspective of Chinese healthcare system.

Methods:

A partitioned survival model was constructed to compare the cost-effectiveness of cadonilimab versus placebo in patients enrolled in the COMPASSION-16 trial. Cost, life-year, quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), and incremental net monetary benefit (INMB) were calculated for 2 treatment strategies. Sensitivity, scenario, and subgroup analyses, and value of information analysis (EVPI) were performed.

Results:

Cadonilimab provided an additional 1.18 QALYs and $89,528.64 compared with placebo, which resulted in an ICER of $75,944.56/QALY. At the willingness-to-pay threshold of $38,042.49/QALY, INHB was estimated to be -1.17 QALYs, while INMB amounted to -$44,681.55 and EVPI was calculated as $71.40/person. Sensitivity analyses revealed that the model was most sensitive to hazard ratio (HR) for OS and PFS, and the probability of cadonilimab being cost-effective was 0.70%. To achieve cost-effectiveness, the price of cadonilimab must be reduced by approximately 50%. Subgroup analysis found that all subgroups unfavored cadonilimab by varying the HR for OS and PFS. Scenario analyses showed using life-year as effectiveness, altering time horizon and selection of survival analysis did not reverse results.

Conclusions:

Although the use of cadonilimab resulted in clinical benefit, it was not deemed cost-effective as a first-line therapy for persistent, recurrent, or metastatic cervical cancer in China. Lowering the price of cadonilimab may enhance its cost-effectiveness.

01 May 2025·BMJ Open

Efficacy and safety of cadonilimab combined with chemotherapy as the first-line treatment for primary advanced or recurrent endometrial cancer: a prospective single-arm open-label phase II clinical trial

Article

Author: Chen, Xiaoxiang ; Liu, Tongyu ; Lin, Yingtao ; Lin, Jie ; Chen, Jian ; Jiang, Yu ; Sun, Yang ; Zou, Jianping ; Li, Yuzhi ; Tu, Chunhua ; Zhuo, Yanhong ; Liu, Bin ; Yang, Linlin ; Chen, Lijun

Introduction:

Recently, immunotherapy has significantly transformed the treatment landscape of endometrial cancer (EC). Results from KEYNOTE-158, RUBY and AtTEnd showed programmed cell death 1 (PD-1) or programmed cell death-ligand 1 inhibitors with promising efficacy in primary advanced or recurrent EC. However, few studies focused on the role of dual immune checkpoints in primary advanced or recurrent EC. Cadonilimab is an immune checkpoint inhibitor targeting the PD-1 and T-lymphocyte antigen-4, which is expected to show substantial clinical efficacy in EC. Combining cadonilimab with standard chemotherapy may have synergistic effects, making this combination a promising first-line treatment for primary advanced or recurrent EC. Furthermore, incorporating molecular classification for guidance on the use of cadonilimab may hold valuable clinical benefits.

Methods and analysis:

In this multicentre, open-label, phase II study, patients with histologically confirmed EC were eligible. Forty-five patients will be recruited. Seventeen patients will be enrolled in stage I, and at least seven cases of complete response (CR) and partial response (PR) should be observed before entering stage II. All patients will receive cadonilimab at a dosage of 10 mg/kg along with carboplatin (area under the curve (AUC)=4–5) plus paclitaxel (175 mg/m2) every 3 weeks (Q3W) for 6–8 cycles. Subsequently, patients with CR, PR or stable disease will receive maintenance of cadonilimab at 10 mg/kg Q3W for 24 months or until progressive disease or adverse events are reported. The objective response rate is the primary endpoint. The secondary endpoints include the disease control rate, duration of response, progression-free survival, overall survival and safety. Additionally, exploratory endpoints involve biomarkers that may predict the efficacy of cadonilimab and chemotherapy, as well as their relationship with molecular classifications. The interim analysis will be conducted after 17 patients have been enrolled.

Ethics and dissemination:

The study protocol meets the approval of the ethical committee of Fujian Cancer Hospital (K2023-173-04) and all other participating hospitals. Study findings will be disseminated in peer-reviewed publications.

Trial registration number:

NCT06066216.

18 Apr 2025·ANGLE ORTHODONTIST

Effects of chemotherapeutic vs regular toothpastes on dental plaque and gingival inflammation in orthodontic patients with fixed appliances: a systematic review and meta-analysis

Article

Author: Liu, Yinli ; Jonkman, Ronald Edwin Gaston ; Slot, Dagmar Else ; Valkenburg, Cees

ABSTRACT:

Objectives:

To analyze, appraise, and synthesize papers in which authors have compared the effects of chemotherapeutic toothpaste (CTP) and regular toothpaste (RTP) on plaque scores (PSs), gingival scores (GSs), and bleeding scores (BSs) in orthodontic patients wearing fixed appliances (FAs).

Materials and Methods:

PubMed-MEDLINE, Cochrane-CENTRAL, and Embase databases were searched with predefined search terms until April 2024 for controlled or randomized controlled clinical trials aligning with the aim. In the eligible papers, risk of bias was evaluated, data of interest were extracted, and a descriptive analysis was performed. If possible, meta-analyses and subanalyses on specific factors were conducted. The quality of evidence and strength of the recommendation were rated.

Results:

In our search and selection, we obtained five papers describing eight comparisons. Potential risk of bias was assessed as some concerns to high, and heterogeneity was considered substantial. Descriptive analysis revealed no significant difference in PS and BS, with an improvement in GS favoring CTP. Meta-analyses of the end scores showed CTP significantly reduced PS (standardized mean difference [SMD] = −0.26; 95% confidence interval [CI] = −0.52, −0.01; P = .04). However, no significant effects were observed on GS and BS. These findings were supported by the subanalyses on CTP with chlorhexidine (CHX; PS: mean difference [MD] = −5.12; 95% CI = −10.08, −0.15; P = .04). The quality of evidence was graded as very low, and strength of the recommendation was judged as very weak.

Conclusions:

For orthodontic patients with FAs, very weak certainty exists in recommending CTP (eg, with CHX) over RTP for use with toothbrushing. CTP may have a very small effect on PS and a small effect on GS.

News (Medical) associated with Cadonilimab

16 Jun 2025

·www.prnewswire.com

Subgroup Analysis of Cadonilimab as First-Line Therapy for Advanced Cervical Cancer Reported in an Oral Presentation at ASCO 2025

HONG KONG, June 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") presented the subgroup analysis data from the Phase III COMPASSION-16 trial, evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, in the first-line treatment of advanced, recurrent, or metastatic cervical cancer. The data was featured as an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The subgroup analysis demonstrated that cadonilimab treatment significantly improved progression-free survival (PFS) and overall survival (OS) across different patient subgroups, including: levels of PD-L1 expression, prior treatment with concurrent chemoradiotherapy (CCRT), bevacizumab use, and age of the patients (≥65, <65). These results further demonstrate the clinical value and the global women's health impact of cadonilimab in advancing thetreatment standart for advanced cervical cancer. The results of the COMPASSION-16 study were previously published in The Lancet and presented at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting. The Lancet publication and the IGCS presentation disclosed that cadonilimab, in combination with platinum-based chemotherapy (with or without bevacizumab), significantly extended survival in both PD-L1-positive and PD-L1-negative patient populations (mOS HR 0.64, P=0.0011), and reduced the risk of disease progression and death (mPFS HR 0.62, P<0.0001). At the 2025 ASCO annual meeting, the study's principal investigator, Professor Xiaohua Wu from the Fudan University Shanghai Cancer Center, presented the subgroup analysis findings from the COMPASSION-16 study, with data cut-off as of April 30, 2024. Key Findings: Significant Reduction in Mortality Risk Across All Patient Subgroups, Regardless of PD-L1 Expression: In the CPS<1 group, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.65), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.77). In the CPS≥1 group, mPFS was 14.7 months in the cadonilimab arm vs. 8.3 months in the control arm (HR=0.62), and mOS was not reached in the cadonilimab arm vs. 22.7 months in the control arm (HR=0.69). In the CPS≥10 group, mPFS was 17.1 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.54), and mOS was not reached in the cadonimab arm vs. 29 months in the control arm (HR=0.68). Clinical Benefit in PFS and OS Regardless of Prior CCRT Treatment: In patients previously treated with CCRT, mPFS was 16.1 months in the cadonilimab arm vs. 7.9 months in the control arm (HR=0.55), and mOS was not reached in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.54). Clinical Benefit in PFS and OS Regardless of Bevacizumab Use: In real-world settings, approximately 40% of patients are considered unsuitable for bevacizumab due to underlying conditions or bleeding/perforation risks. Cadonilimab demonstrated clinically meaningful improvements in both PFS and OS, whether or not bevacizumab was included in the treatment. In the bevacizumab-naive groups, mPFS was 11.7 months in the cadonilimab arm vs. 6.7 months in the control arm (HR=0.44), and mOS was 28.2 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.5). Improvement in PFS and OS Across Age Subgroups, with Greater Efficacy in Patients ≥65 Years: In patients < 65 years, mPFS was 13.5 months in the cadonilimab arm vs. 9.5 months in the control arm (HR=0.68), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.69). In patients ≥ 65 years, mPFS was 12 months in the cadonilimab arm vs. 7.4 months in the control arm(HR=0.39), and mOS was 26.6 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.49). Cadonilimab Combined with Platinum Agents (Cisplatin/Carboplatin) Improves PFS and OS: In the cisplatin arm, mPFS was 14.7 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.49), and mOS was not reached in the cadonilimab arm vs. 23.9 months in the control arm (HR=0.43). In the carboplatin arm, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.72), and mOS was 27.8 months in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.82). In June 2022, cadonilimab was granted approval by the China National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer in patients who had previously failed platinum-based chemotherapy. This indication has since been included in the national reimbursement list. In September 2024, the use of cadonilimab in first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma was approved by the NMPA. The use of cadonilimab in first-line treatment for advanced, recurrent, or metastatic cervical cancer was approved by the NMPA in May 2025. In addition, cadonilimab is currently being evaluated in nearly 30 registrational/Phase III and Phase II clinical trials across a number of high-incidence cancers. Preliminary results show that cadonilimab demonstrates clinical benefit for patient populationsin both the positive and the negative PD-L1 expression groups, marking a significant advancement over existing immunotherapies. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 9926.HK, "Akeso") contains "forward-looking statements" . These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalASCOPhase 2

05 Jun 2025

·www.prnewswire.com

Akeso's PD-1/CTLA-4 Bispecific Antibody Cadonilimab Approved for First-Line Treatment of Cervical Cancer in All-Comer Populations--Third Approved Indication for Cadonilimab

HONG KONG, June 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab. The NMPA approval marks the third approved indication for cadonilimab. With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy. The approval for cadonilimab's use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer. Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were presented as a Late-Breaking Abstract (LBA) at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and were subsequently published in The Lancet and later reported again in Nature Reviews Clinical Oncology. Cervical cancer remains one of the most prevalent and deadly cancers among women, with a 5-year survival rate of approximately 17.0% for patients in the advanced stages. In 2022, China reported 150,700 new cervical cancer cases, resulting in the second-largest burden of cervical cancer worldwide. Professor Wu Xiaohua, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center, stated, "COMPASSION-16 is the first Phase III study focused on first-line cervical cancer patients in China, with internationally recognized data. We've seen cadonilimab's breakthrough efficacy in both recurrent and metastatic cervical cancer, showing high effectiveness, low toxicity, and strong anti-tumor activity regardless of PD-L1 expression. This first-line combination therapy sets a new standard in cancer treatment and is expected to accelerate the clinical adoption of cadonilimab, benefiting more patients." Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, commented, "Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. For patients who respond to PD-1/L1 monotherapy, cadonilimab offers superior therapeutic outcomes over PD-1/PD-L1 therapies. For patients with low PD-L1 expression or those who are resistant to PD-1 monotherapy, cadonilimab provides significant clinical benefits over current treatment options. Cadonilimab takes advantage of the synergistic anti-tumor effect of two immune checkpoint targets, PD-1 and CTLA-4, while producing a meaningfully lower immune side effects than the combination of PD-1 and CTLA-4 antibody therapies. This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and in patient quality of life. This achievement reflects Akeso's robust innovation capabilities and commitment to cancer patient outcomes, and it also aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide. " Currently, cadonilimab is included in 16 authoritative clinical treatment guidelines and consensus documents across multiple oncology indications, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Beyond the three approved indications, cadonilimab is also currently in over 30 Phase II and III clinical trials for other cancer types, which includes different stages of disease progression as well as different cancer sub-types. These include clinical studies on gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 9926.HK, "Akeso") contains "forward-looking statements" . These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultImmunotherapyPhase 2

05 Jun 2025

·www.pharmaceutical-technology.com

Akeso gains NMPA approval for cadonilimab to treat cervical cancer

Cadonilimab is approved for recurrent or metastatic cervical cancer. Credit: JOURNEY STUDIO7/Shutterstock. China’s National Medical Products Administration (NMPA) has approved Akeso’s PD-1/CTLA-4 bispecific antibody, cadonilimab, to treat persistent, recurrent or metastatic cervical cancer. This third indication approval allows its use in combination with platinum-based chemotherapy and potentially bevacizumab. The therapy is also approved for treating advanced gastric cancer and relapsed or metastatic cervical cancer after platinum-based chemotherapy failure. The NMPA approval is based on the results from the Phase III COMPASSION-16 study. Patients treated with cadonilimab in this trial exhibited efficacy benefits, particularly those whose tumours tested negative for PD-L1 expression, when compared to the control group. The study achieved both overall survival (OS) and progression-free survival (PFS) endpoints. Further insights from COMPASSION-16 revealed that irrespective of PD-L1 status or bevacizumab use, patient subgroups experienced enhanced outcomes with cadonilimab therapy. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The inclusion of this new agent in 16 clinical guidelines features its growing importance across oncology fields such as gastric and gynaecological cancers. Akeso founder, chairwoman, president and CEO Xia Yu commented: “Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. “This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and patient quality of life. “This achievement reflects Akeso’s robust innovation capabilities and commitment to cancer patient outcomes, and aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide.” More than 30 ongoing Phase II and III trials are evaluating cadonilimab’s potential against other malignancies, including lung and pancreatic cancers. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

Clinical ResultPhase 3Drug ApprovalImmunotherapy

100 Deals associated with Cadonilimab

External Link

KEGG	Wiki	ATC	Drug Bank
D12190	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced gastric carcinoma	China	Akeso Pharmaceuticals, Inc.	26 Sep 2024
Advanced Gastroesophageal Junction Adenocarcinoma	China	Akeso Pharmaceuticals, Inc.	26 Sep 2024
Metastatic Cervical Carcinoma	China	Akeso Pharmaceuticals, Inc.	28 Jun 2022
Recurrent Cervical Cancer	China	Akeso Pharmaceuticals, Inc.	28 Jun 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	NDA/BLA	China	Akeso Biopharma Co., Ltd.	05 Jan 2024
Non-small cell lung cancer stage III	Phase 3	China	Akeso Biopharma Co., Ltd.	12 Nov 2024
metastatic non-small cell lung cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	14 Nov 2023
Squamous non-small cell lung cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	14 Nov 2023
Nasopharyngeal Carcinoma	Phase 3	China	Akeso Pharmaceuticals, Inc.	01 Aug 2023
Hepatocellular Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	14 Dec 2022
Locally Advanced Cervical Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	08 Jun 2022
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	17 Sep 2021
Locally Advanced Unresectable Gastric Adenocarcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	17 Sep 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	China	Akeso Biopharma Co., Ltd.	27 Aug 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ELCC2025	Not Applicable	progressive non-small cell lung cancer	70	Cadonilimab alone	irnacrtlfl(iqtxmynezg) = tkonunljxe qulqkyofed (nkfxjknbab ) View more	Positive	26 Mar 2025
NCT05235516 (AK104-305 \| COMPASSION-18, Company_Website) Manual	Phase 3	Locally Advanced Cervical Carcinoma	-	AK104 + CCRT	mjoezeefgn(azzavelijo) = wvwteypjax lzqigaqfjo (xswssqpmgt ) View more	Positive	21 Mar 2025
				AK104 + CCRT (PD-L1 CPS≥1)	shenunfutt(imbgvbgmiu) = oiekpmkvek kwhkvujhxn (yehbdhpysw )
NCT05792735 (NeoCaCRT, ASCO_GI2025) Manual	Phase 2	Locally Advanced Rectal Carcinoma Neoadjuvant Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	27	SCRT + Cadonilimab + mFOLFOX6	atmvrtwrja(bhvuldbopn) = igmugminrn jxtnnkoxcl (ufkhyteaaw, 19.4 - 57.6) View more	Positive	23 Jan 2025
NCT05522894 (AK104-IIT-014, ASCO_GI2025) Manual	Phase 2	Advanced Esophageal Squamous Cell Carcinoma Maintenance \| First line	43	Cadonilimab + Paclitaxel + Cisplatin	khqyngfmvz(kxwsesazoo) = psqwjnugii pobuoaoljy (azekaulelm, 66.1 - 91.1) View more	Positive	23 Jan 2025
				Cadonilimab + Paclitaxel + Cisplatin (PD-L1 CPS≥10)	khqyngfmvz(kxwsesazoo) = olqsujfohb pobuoaoljy (azekaulelm, 77.1 - 100.0) View more
NCT05008783 (Pubmed) Manual	Phase 3	HER2 negative Gastric Cancer \| HER2 negative Gastroesophageal Junction Adenocarcinoma First line HER2 Negative	610	Cadonilimab + Chemotherapy	wzvkkplqjb(byqziasybg) = ifmdcvudgb rrxnpjzxlm (cavibdhsrn ) Met View more	Positive	22 Jan 2025
				Placebo + Chemotherapy	wzvkkplqjb(byqziasybg) = jfptvlhtgu rrxnpjzxlm (cavibdhsrn ) Met View more
ESMO_IO2024 \| NEWS Manual	Not Applicable	Metastatic Gastroesophageal Junction Adenocarcinoma \| Metastatic gastric adenocarcinoma First line	31	Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX)	sglvqhmqce(hqprwtwqua) = zoktnxgyhu fgvongmsgp (frqsvvmnjv ) View more	Positive	12 Dec 2024
				Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX) (PD-L1 CPS＜1)	sglvqhmqce(hqprwtwqua) = fppzusvelt fgvongmsgp (frqsvvmnjv ) View more
NCT05430906 (AK104-IIT-003, ESMO_IO2024) Manual	Phase 2	Ovarian Cancer Neoadjuvant	28	Cadonilimab + Platinum-Taxane Chemotherapy	pigbenumqe(ampnikwzii) = hylkiivmfn flmpmibkwm (loplmoxpvv ) View more	Positive	12 Dec 2024
ESMO_IO2024 Manual	Phase 2	Advanced gastric carcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma First line	19	Cadonilimab+SOX (HER2-negative)	gpspapwhir(kzccqgsrbv) = miytmopnfo zmwoatbfvt (jhoeggbkou ) View more	Positive	12 Dec 2024
				Cadonilimab+Trastuzumab+SOX (HER2-positive)	gpspapwhir(kzccqgsrbv) = unbqpjgmjb zmwoatbfvt (jhoeggbkou ) View more
ESMO_IO2024 Manual	Not Applicable	metastatic non-small cell lung cancer Second line \| Last line \| Third line	21	Cadonilimab (AK104) + Single-agent Chemotherapy	ddyhbfodvi(rxezgklebl) = ptxnmmmqvs dmlyqtkrdi (mqhhpwziyr ) View more	Positive	12 Dec 2024
NCT05815290 (ESMO_IO2024) Manual	Phase 2	Microsatellite instability-high colorectal cancer Neoadjuvant MSI-High \| Deficient DNA Mismatch Repair (dMMR)	34	Cadonilimab (AK104) 10mg/kg	jjaaoakhdv(cyodyrbqil) = ticeolmgyy tfgkgfllri (gchlaxwmnk ) View more	Positive	12 Dec 2024

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