This phase II trial studies how well ivonescimab works prior to surgery in treating patients with high-risk clear cell kidney (renal cell) cancer that has not spread to other parts of the body (localized). Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab may also stop or slow the cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving ivonescimab before standard surgery may make the tumor smaller.

Start Date08 Jun 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07234877

/ Not yet recruitingPhase 2IIT

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

This is a randomized, two-arm, comparative Phase II clinical trial designed to evaluate the difference in intracranial progression-free survival (iPFS) between two treatment strategies, assessed locally.
Approximately 158 patients will be randomized in a 1:1 ratio. Will be included patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment available and active asymptomatic brain metastasis (newly diagnosed or progressive).
The primary objective is to compare iPFS between the two arms.

Start Date01 Apr 2026

Sponsor / Collaborator

European Organisation for Research & Treatment of Cancer

[+1]

NCT07158489

/ Not yet recruitingPhase 2IIT

Protocol SAKK 18/ 25 Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC Progressing on Immune Checkpoint Inhibitors: A Multicenter, Single-arm, Open-label Phase II Trial (ORIGIN2)

This Phase II clinical trial (investigates the efficacy of combining gemcitabine, a chemotherapy agent, with ivonescimab, a bispecific PD-1/VEGF antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following chemoimmunotherapy (CIT). Lung cancer remains the leading cause of cancer-related death globally, and treatment options after CIT failure are limited. Gemcitabine has demonstrated immunostimulatory properties, including enhanced T-cell infiltration and reduced immunosuppressive cell populations, which may synergize with immune checkpoint inhibitors. Ivonescimab targets both PD-1 and VEGF pathways, potentially enhancing antitumor immune responses and inhibiting tumor angiogenesis. The trial aims to evaluate the objective response rate (ORR) according to RECIST v1.1 criteria. The combination therapy is expected to offer a novel and effective treatment strategy for patients with relapsed NSCLC, addressing a significant unmet medical need.

Start Date01 Mar 2026

Sponsor / Collaborator-

100 Clinical Results associated with Ivonescimab

100 Translational Medicine associated with Ivonescimab

100 Patents (Medical) associated with Ivonescimab

Literatures (Medical) associated with Ivonescimab

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

01 Nov 2025·LANCET

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

Article

Author: Pu, Xingxiang ; Du, Yingying ; Li, Baiyong ; He, Ming ; Li, Xingya ; Lu, Dongmei ; Wang, Pingli ; Ying, Shenpeng ; Fan, Yun ; Zhou, Ming ; Liu, Ying ; Yang, Runxiang ; Shi, Qin ; Yang, Hongzhong ; Shi, Jian ; Han, Zhengxiang ; Sun, Longhua ; Zhao, Yanqiu ; Chu, Qian ; Pan, Pinhua ; Li, Wenting ; Ma, Xuelei ; Zhang, Zhihong ; Xia, Michelle ; Lu, Shun ; Tang, Kejing ; Maxwell Wang, Zhongmin ; Wang, Zhiwu ; Wu, Hongcheng ; Guo, Shuliang ; Zhou, Jianya ; Zhang, Junqiang ; Cao, Chao ; Wang, Hongbiao ; Fang, Jian ; Ai, Xiaohong ; Xu, Haipeng ; He, Yong ; Hu, Mingxiu ; Yang, Hui ; Ji, Yinghua ; Jiang, Zhou ; Chen, Zhiwei ; Yang, Fang ; Liu, Xuewen ; Li, Jie ; Sun, Hongmei ; Wu, Lin ; Ma, Xuezhen ; Zhang, Zhiye ; Luo, Hui ; Li, Dairong ; Meng, Xiangjiao ; Li, Juan ; Zhang, Zhongmin ; Li, Zhengguo ; Chen, Hualin

BACKGROUND:

Squamous non-small-cell lung cancer (NSCLC) is associated with worse clinical outcomes than non-squamous NSCLC, but treatment options are scarce. We aimed to evaluate the efficacy and safety of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as a first-line therapy for patients with advanced squamous NSCLC.

METHODS:

We conducted a randomised, double-blind, phase 3 trial at 50 sites across China (HARMONi-6). Patients aged 18-75 years with previously untreated, pathologically confirmed, unresectable stage IIIB, IIIC, or stage IV squamous NSCLC and an Eastern Cooperative Oncology Group performance status score of 0 or 1 were eligible for inclusion. Patients were randomly assigned (1:1) to receive intravenous ivonescimab (20 mg/kg) or tislelizumab (200 mg), plus intravenous paclitaxel (175 mg/m²) and carboplatin (area under the curve 5 mg/mL per min) once every 3 weeks for four cycles, followed by ivonescimab (20 mg/kg) or tislelizumab (200 mg) monotherapy as maintenance treatment for up to 24 months. Randomisation was stratified by disease stage (IIIB or IIIC vs IV) and PD-L1 tumour proportion score (≥1% vs <1%). The primary endpoint was progression-free survival assessed by the independent radiographic review committee as per Response Evaluation Criteria in Solid Tumours guidelines (version 1.1) in all randomly assigned patients. Safety, defined as adverse events and serious adverse events related to treatment, as well as adverse events related to immunity or VEGF blockade, were analysed in all randomly assigned patients who received at least one dose of the assigned study treatment. This study is registered at ClinicalTrial.gov (NCT05840016), has completed enrolment, and is ongoing for treatment and follow-up.

FINDINGS:

From Aug 17, 2023, to Jan 21, 2025, 761 patients were screened for eligibility, among whom 532 (70%) patients were enrolled and randomly assigned to receive ivonescimab plus chemotherapy (266 [50%] patients) or tislelizumab plus chemotherapy (266 [50%] patients). As of Feb 28, 2025, median follow-up time was 10·3 months (95% CI 9·5-11·0). Median progression-free survival was 11·1 months (95% CI 9·9-not evaluable) in the ivonescimab group and 6·9 months (5·8-8·6) in the tislelizumab group (hazard ratio 0·60 [95% CI 0·46-0·78]; one-sided p<0·0001). The progression-free survival benefit with ivonescimab plus chemotherapy was consistent regardless of PD-L1 status. 170 (64%) patients in the ivonescimab group and 144 (54%) patients in the tislelizumab group had grade 3 or higher treatment-related adverse events, with grade 3 or higher immune-related adverse events occurring in 24 (9%) patients in the ivonescimab group and in 27 (10%) patients in the tislelizumab group. Grade 3 or higher treatment-related haemorrhage occurred in five (2%) patients in the ivonescimab group and in two (1%) patients in the tislelizumab group.

INTERPRETATION:

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.

FUNDING:

Akeso Biopharma.

01 Sep 2025·BMJ Open

Neoadjuvant stereotactic body radiotherapy combined with chemotherapy and Ivonescimab for Chinese luminal-type breast cancer patients: study protocol for a single-arm, open-label, phase II trial

Article

Author: Han, Guang ; Shao, Jun ; Ruan, Hanguang ; Pi, Guoliang ; Ke, Zirui ; Bi, Jianping ; Huang, Yujie ; Yuan, Zilong ; Zhang, Caixun ; Li, Ying

Introduction:

Immunotherapy combined with chemotherapy has shown potential in improving the pathological complete response (pCR) rate in luminal-type breast cancer. This study explores whether the addition of stereotactic body radiotherapy (SBRT) and the bispecific antibody AK112 (Ivonescimab) further enhances treatment efficacy.

Methods and analysis:

This is a single-centre, prospective, phase II trial using Simon’s two-stage design to evaluate the efficacy and safety of neoadjuvant SBRT combined with Ivonescimab and chemotherapy. A total of 50 patients will be enrolled. The primary endpoint is pCR. Secondary endpoints include objective response rate, disease control rate, Residual Cancer Burden Index, 12-month event-free survival, safety and quality of life. Exploratory endpoints include six-point minimal residual disease (MRD) assessment. Data will be analysed using the Kaplan-Meier method and one-sided exact binomial test (alpha=0.05).

Ethics and dissemination:

This study has been approved by the ethics committee of Hubei Cancer Hospital (Approval No.: LCKY2024011). Results will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number:

NCT06402435.

307

News (Medical) associated with Ivonescimab

11 Dec 2025

·www.prnewswire.com

Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025

HONG KONG, Dec. 10, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the presentation of a Phase II clinical study that included a longer-term efficacy data evaluating ivonescimab (a PD-1/VEGF bispecific antibody) combined with chemotherapy as a first-line treatment for locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) at the 2025 European Society for Medical Oncology Immuno-Oncology Congress (ESMO IO) in London, UK. Based on positive efficacy and safety profile, the ivonescimab combination therapy for first-line TNBC was previously included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Currently, the multicenter, randomized, double-blind Phase III clinical trial (HARMONi-BC1/AK112-308) for this indication is currently ongoing. Preliminary results from this study were previously announced at the European Society for Medical Oncology (ESMO) Congress 2024 and the 2024 San Antonio Breast Cancer Symposium (SABCS). With the follow-up period now extended to 22.1 months, the study further validates the efficacy and safety profile of the ivonescimab regimen in first-line TNBC treatment. As of July 15, 2025, a total of 36 patients with TNBC were enrolled. The median age was 55 years, 83.3% of patients had a PD-L1 combined positive score (CPS) <10, and 55.6% had received prior taxane-based neo/adjuvant therapy. As of the data cutoff, 35 patients had undergone at least one post-baseline tumor assessment and were included in the efficacy analysis set. The results showed that the ivonescimab combined with chemotherapy regimen demonstrated efficient tumor relief, disease control, and survival benefits in all PD-L1 subgroups of TNBC patients receiving first-line treatment. 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%. Overall survival (OS) data is not yet mature. Ivonescimab combined with chemotherapy as first-line treatment for TNBC demonstrated a good safety profile. No treatment-related adverse events (TRAEs) led to discontinuation or death in this study, and the most common TRAEs were mostly grade 1-2. 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. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 3Phase 2Breakthrough Therapy

09 Dec 2025

·endpoints.news

BioNTech, Bristol Myers unwrap Phase 2 data for PD-L1xVEGF-A bispecific in breast cancer

BioNTech and Bristol Myers Squibb on Tuesday shared positive mid-stage breast cancer results for their PD-L1xVEGF-A bispecific antibody, which they claim has the potential to be a treatment backbone across many different cancers. Combined with nab-paclitaxel chemotherapy, pumitamig achieved a 62% confirmed overall response rate in a cohort of patients with triple-negative breast cancer (TNBC). The Phase 2 data from 39 patients with first- or second-line locally advanced or metastatic disease will be presented on Wednesday at the San Antonio Breast Cancer Symposium. The ORR increased to about 72% when factoring in responses that have yet to be confirmed, BioNTech and Bristol Myers said. Also, the drug seemed to be effective regardless of patients’ PD-L1 status, producing the same unconfirmed ORR of 71% in those with a combined positive score (CPS) of 10 or more and in those with a CPS under 10. CPS is a measure of PD-L1 expression. The standard of care for patients with locally advanced or metastatic TNBC and a CPS score of 10 or more is Merck’s Keytruda plus chemotherapy, BioNTech’s chief medical officer Özlem Türeci told Endpoints News in an interview ahead of the confab. That Keytruda-chemo combo achieved an ORR of about 53% in patients in the KEYNOTE-355 trial, representing a significant improvement over chemotherapy alone. But the Keytruda regimen didn’t significantly improve response rates in patients with a CPS score under 10, so the standard of care for that group is still chemotherapy alone, Türeci said. The Phase 2 data also show the pumitamig regimen achieved a disease control rate of about 92%. Almost 60% of patients were still alive without disease worsening at nine months. BioNTech and BMS have already started a Phase 3 study of pumitamig in patients with previously untreated locally advanced or metastatic TNBC who aren’t eligible for current PD-L1 treatments because they have PD-L1-negative disease. The vision is to target this setting initially because it represents an “unserved medical need.” And now, there are plans to look at higher segments of PD-L1 expression in TNBC as a strategy, Türeci said. BioNTech originally licensed pumitamig from Chinese biotech Biotheus in 2023, before acquiring the company outright for $800 million in cash in 2024. Bristol Myers then paid BioNTech $1.5 billion upfront in June to co-develop and co-commercialize pumitamig. BioNTech and BMS previously reported positive mid-stage pumitamig data in small-cell lung cancer . Before their deal, BioNTech also shared results for the drug in a rare type of cancer called mesothelioma . Elsewhere, Summit Therapeutics and partner Akeso are developing a PD-1xVEGF bispecific called ivonescimab. Pfizer is advancing its own candidate called PF-08634404. Editor’s Note: The article was updated to correct the timing of the presentation at SABCS.

Clinical ResultAcquisitionPhase 3Phase 2License out/in

09 Dec 2025

·firstwordpharma.com

SABCS25: BioNTech, BMS flex upbeat interim mid-stage data for PD-L1/VEGF-A in TNBC

BioNTech and partner Bristol Myers Squibb on Tuesday unveiled promising interim findings from a mid-stage study evaluating their investigational PD-L1xVEGF-A blocking bispecific antibody pumitamig (BNT327/BMS986545) in combination with chemotherapy to treat patients with locally advanced or metastatic triple-negative breast cancer (TNBC), irrespective of PD-L1 expression levels.After touting encouraging response data from an earlier Phase Ib/II trial in a treatment-naïve population at the San Antonio Breast Cancer Symposium (SABCS) last year, the partners — at this year’s meeting — reported further encouraging antitumour activity and a manageable safety profile for pumitamig across both first- and second-line treatment settings, laying the groundwork for the Phase III ROSETTA BREAST-01 trial.The Phase II study assessed two pumitamig regimens with chemotherapy: Cohort 1 received 15 or 20 mg/kg every two weeks with nab-paclitaxel, and Cohort 2 received a flat 20 mg/kg dose with either paclitaxel, gemcitabine plus carboplatin, or eribulin across three arms.Notable responsesThe interim analysis as of the October 1 cut-off included 74 patients with first- or second-line locally advanced/metastatic TNBC. Results showed that among 39 efficacy-evaluable patients in Cohort 1, the confirmed objective response rate (cORR) was 61.5%, whilst the unconfirmed ORR (uORR) was 71.8% and disease control rate was 92.3%. Additionally, responses proved consistent across PD-L1 expression levels, with an uORR of 70.6% observed in both combined positive score (CPS) ≥10 and CPS <10 subgroups.“The encouraging results are especially meaningful in patients with PD-L1 low or negative tumours…representing the potential of pumitamig…across PD-L1 expression levels, including patients who historically have had fewer effective treatments,” remarked Anne Kerber, head of development for haematology, oncology, cell therapy at BMS.The companies also noted higher pumitamig doses correlated with better responses, reaching 80.0% uORR at 20 mg/kg versus 63.2% at 15 mg/kg. In terms of lines of treatment, the uORRs were 76.5% and 68.2% in first- and second-line settings, respectively. Furthermore, the 9-month progression-free survival (PFS) rate was 59.3%, while median PFS, duration of response and overall survival were yet to mature at the time.Safety-wise, pumitamig’s profile was manageable, with Grade ≥3 treatment-related adverse events reported in 42.5% and 38.2% of patients in Cohorts 1 and 2, respectively, and no treatment-related deaths.Extensive development footprintBesides TNBC, the bispecific is being investigated in lung cancer indications as part of the pivotal ROSETTA clinical programme. Two mid-stage studies in extensive-stage small-cell lung cancer read out favourably this year — first in a Chinese population and second in a global one. Meanwhile, the asset is also being explored in non–small-cell lung cancer and mesothelioma (for more, see Spotlight On: Combos key to BioNTech’s PD-L1/VEGF bispecific strategy). “The activity we see in TNBC…further supports the pan-tumour potential of pumitamig, which we are advancing…in a broad development programme that also includes novel/novel combination regimens,” remarked Özlem Türeci, BioNTech’s chief medical officer.Interest in PD-(L)1/VEGF bispecifics started gaining traction last year when Akeso Biopharma and Summit Therapeutics indicated that ivonescimab could potentially unseat Merck & Co.’s Keytruda (pembrolizumab) in lung cancer. Merck soon responded, securing rights to LM-299 from LaNova Medicines in a $588-million upfront deal.

Clinical ResultPhase 2Cell TherapyPhase 3Immunotherapy

100 Deals associated with Ivonescimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	China	Akeso-Sino Pharma Co., Ltd.	22 Apr 2025
EGFR positive Non-squamous non-small cell lung cancer	China	Akeso-Sino Pharma Co., Ltd.	21 May 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Akeso Pharmaceuticals, Inc.	25 Jul 2025
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Akeso-Sino Pharma Co., Ltd.	25 Jul 2025
Squamous Cell Carcinoma of Head and Neck	Phase 3	-	Akeso Biopharma Co., Ltd.	01 Jan 2026
Non-Small Cell Lung Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	30 Jun 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	-	Akeso Biopharma Co., Ltd.	01 Jun 2025
Small Cell Lung Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	29 May 2025
Small cell lung cancer limited stage	Phase 3	China	Akeso Biopharma Co., Ltd.	29 May 2025
Metastatic Pancreatic Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	14 May 2025
Adenocarcinoma of large intestine	Phase 3	China	Akeso Biopharma Co., Ltd.	09 May 2025
Metastatic Colorectal Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	09 May 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05227664 (ESMO_IO2025 \| PRNewswire) Manual	Phase 2	Triple Negative Breast Cancer PD-L1	36	Ivonescimab + paclitaxel or nab-paclitaxel	wvbddiykiz(kebklzajsr) = iorznbbbzb imbfejjrgs (rsfrqpfljo ) View more	Positive	10 Dec 2025
				Ivonescimab + paclitaxel or nab-paclitaxel (PD-L1 CPS≥10)	wvbddiykiz(kebklzajsr) = nqgatmfnau imbfejjrgs (rsfrqpfljo ) View more
SITC2025	Not Applicable	Brain Stem Glioma H3K27M+	1	Ivonescimab 10 mg/kg	wiwkfdkkor(vhaxvvoftx) = No Grade 3 or higher adverse events were observed during the treatment period, based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. wvrdimgrrq (dmdvpwrkoj )	Positive	05 Nov 2025
NCT05840016 (HARMONi-6, ESMO2025) Manual	Phase 3	Squamous non-small cell lung cancer First line	532	Ivonescimab 20 mg/kg Q3W + paclitaxel (175 mg/m2) +carboplatin (AUC 5)	bngrapfidt(ghshtapqrt) = cafblckvoa soukxabwyc (tcqqmijibv ) View more	Positive	17 Oct 2025
				Tislelizumab 200 mg Q3W + paclitaxel (175 mg/m2) + carboplatin (AUC 5)	bngrapfidt(ghshtapqrt) = bujzfskbfe soukxabwyc (tcqqmijibv ) View more
NCT06375486 (ESMO2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line	33	Ivonescimab 20 mg/kg	nmbuvoeaay(yjufqypubs) = qkpyrurzum hxcyqkrrcm (slvsqyukxf ) View more	Positive	17 Oct 2025
				Ivonescimab 20 mg/kg (BCLC C subgroup)	nmbuvoeaay(yjufqypubs) = turerxosvq hxcyqkrrcm (slvsqyukxf ) View more
NCT06396065 (HARMONi, WCLC2025 \| NEWS) Manual	Phase 3	EGFR positive non-small cell lung cancer EGFR Positive	438	Ivonescimab + pemetrexed + carboplatin	mqvrxufyyk(qfpftbvsmk) = xjzncffnhj krhxgxwqce (wqyyovartq, 5.7 - 7.1) Met View more	Positive	09 Sep 2025
				Placebo + pemetrexed + carboplatin	mqvrxufyyk(qfpftbvsmk) = qvpjxiuikt krhxgxwqce (wqyyovartq, 4.1 - 5.5) Met View more
NCT05184712 (HARMONi-A, NEWS) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	-	ivonescimab + chemotherapy	vswejakxnl(fldpwcjqdj) = the Phase III HARMONi-A trial met its OS goal, showing that ivonescimab. omqmrpqhoz (qrxzixsude ) Met	Positive	26 Aug 2025
				placebo + chemotherapy
NCT06396065 (HARMONi, NEWS 1 \| NEWS 2) Manual	Phase 3	Non-squamous non-small cell lung cancer \| EGFR positive Neoplasms Second line EGFR Mutation	-	ivonescimab +化疗	yqoswoodgn(zyydyvagiz): 0.52 (95.0% CI, 0.41 - 0.66), P-Value = <0.00001 View more	Positive	30 May 2025
				化疗
NCT06375486 (ASCO2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line HBV infection \| portal vein tumor thrombosis \| extrahepatic spread	27	Ivonescimab + HAIC	dypuzzdigy(bnsoodxmjj) = utrhfdnfln fiaococjwg (gcohilksbs ) View more	Positive	30 May 2025
NCT05899608 (HARMONi-3, ASCO2025)	Phase 3	metastatic non-small cell lung cancer First line \| Maintenance	1,080	Ivonescimab plus chemotherapy	pyqbczhhfe(ywnxkbwpnu) = ihuxyyemym aurrseczas (krbmgwafdk ) View more	Positive	30 May 2025
				Pembrolizumab plus chemotherapy	pyqbczhhfe(ywnxkbwpnu) = rxxqdfbomp aurrseczas (krbmgwafdk ) View more
NCT05840016 (AK112-306 \| HARMONi-6, Company_Website) Manual	Phase 3	Squamous non-small cell lung cancer First line	532	ivonescimab + chemotherapy	fjmwinwsfb(kdreolobml) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). iahzagjprs (xntczlnmtf ) Met View more	Superior	22 Apr 2025
				tislelizumab + chemotherapy

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