STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1

To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy.

Start Date03 Dec 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT06940518

/ Not yet recruitingPhase 2IIT

Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma

To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ccRCC.

Start Date09 Oct 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06959550

/ Not yet recruitingPhase 2IIT

Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer

The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.

Start Date01 Oct 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

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 ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; 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 Jun 2025·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Bispecific Antibodies in Non–Small Cell Lung Cancer: From Targeted Innovation to Real-World Integration

Review

Author: Johnson, Melissa ; Naqash, Abdul Rafeh ; Mitchell, Carley ; Pannu, Sagal ; Carlisle, Jennifer W. ; Aijaz, Ayesha ; Wolner, Zachary ; Hsu, Melinda

Bispecific antibodies have ushered in a transformative era in treating non–small cell lung cancer (NSCLC), enabling dual-pathway targeting with promising clinical outcomes in previously refractory disease subsets. Recent US Food and Drug Administration approvals—including amivantamab, an epidermal growth factor receptor (EGFR)/mesenchymal-epithelial transition factor–targeting monoclonal antibody for EGFR exon 20 insertions and frontline EGFR-mutant (Exon 19 and 21) NSCLC, and zenocutuzumab for tumors harboring neuregulin 1 fusions—highlight their expanding therapeutic footprint. However, a new spectrum of on-target toxicities and implementation challenges are essential considerations as part of this innovation. This review dissects the evolving clinical data for bispecific antibodies in NSCLC, focusing on amivantamab, and provides a practical framework for managing dermatologic, infusion-related, and class-specific adverse events. We explore quality-of-life outcomes, financial toxicity, and the role of subcutaneous formulations in improving patient adherence and treatment experience. Furthermore, we highlight an emerging PD-1/vascular endothelial growth factor-A bispecific antibody (ivonescimab) and its potential to reshape frontline therapy paradigms in NSCLC. By integrating clinical trial evidence with real-world considerations, this review aims to equip oncologists with the tools to optimize the use of bispecific antibodies in NSCLC and guide future therapeutic integration.

04 May 2025·EXPERT OPINION ON BIOLOGICAL THERAPY

Ivonescimab in non-small cell lung cancer: harmonizing immunotherapy and anti-angiogenesis

Review

Author: Liu, Xinyu ; Zhang, Yan ; Ren, Shengxiang

INTRODUCTION:

Immunotherapy combined with anti-angiogenesis has become a useful strategy in cancer treatment. Ivonescimab, the first-approved bispecific antibody targeting both immune checkpoint inhibition and anti-angiogenesis, represents a breakthrough over the conventional dual-drug combination approach. The emerging clinical evidence demonstrates promising efficacy and manageable safety profile of ivonescimab in the treatment of non-small cell lung cancer (NSCLC), suggesting its potential role as a cornerstone in the next generation of cancer immunotherapy.

AREAS COVERED:

This review presents the pharmacological characteristics of ivonescimab, revisits relevant clinical trials and key data, and provides an in-depth analysis. Additionally, the potential of ivonescimab in NSCLC treatment is discussed, along with its clinical prospects.

EXPERT OPINION:

The available clinical data demonstrate that simultaneously targeting both immune checkpoint inhibition and angiogenesis pathways through a single bispecific antibody represents a significant therapeutic advancement in NSCLC treatment. Ivonescimab's innovative dual-targeting mechanism, supported by promising efficacy data from the HARMONi trials and its manageable safety profile, appears to be fundamental to its potential to challenge current standards of care. As the first approved bispecific antibody with this unique mechanism of action, ivonescimab may not only transform current treatment paradigms but also pioneer a new direction in cancer immunotherapy.

209

News (Medical) associated with Ivonescimab

30 Jun 2025

·pipelinereview.com

Revolution Medicines and Summit Therapeutics Enter Into Clinical Collaboration to Evaluate Combinations of Three RAS(ON) Inhibitors With Ivonescimab in RAS Mutant Tumors

REDWOOD CITY, CA & MIAMI, FL, USA I June 30, 2025 I Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers and Summit Therapeutics Inc. (Nasdaq: SMMT), a biopharmaceutical oncology company focused on patient-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs, today announced the companies have entered into a clinical collaboration in multiple solid tumor settings to evaluate the safety and efficacy of each of Revolution Medicines’ clinical-stage RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805) and G12C-selective inhibitor elironrasib (RMC-6291), in combination with Summit Therapeutics’ ivonescimab, a PD-1 / VEGF bispecific antibody. “We’ve disclosed promising initial evidence that each of daraxonrasib and elironrasib can deliver additive antitumor activity safely when combined with a PD-1 antibody in first-line treatment of patients with RAS mutant non-small cell lung cancer,” said Mark A. Goldsmith, M.D., Ph.D., Chairman and Chief Executive Officer of Revolution Medicines. “Combinations with novel PD-1 bispecific inhibitors could unlock further therapeutic potential. We are eager to evaluate combinations of investigational drugs from our RAS(ON) inhibitor portfolio with ivonescimab, an advanced PD-1 / VEGF bispecific inhibitor with a differentiated profile, in a range of common RAS mutant cancers.” The clinical collaboration aims to evaluate these combinations across three priority tumor types including RAS mutant non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC). Under the terms of the agreement, Summit Therapeutics will supply ivonescimab for clinical research and Revolution Medicines will be the study sponsor. Each company will retain commercial rights to their respective compounds, and the agreement is mutually non-exclusive. “We’re thrilled to partner with Revolution Medicines to evaluate in a clinical setting how our highly promising ivonescimab combined with their compelling RAS(ON) inhibitors could potentially improve outcomes for patients with lung and gastrointestinal cancers,” said Robert W. Duggan, Chairman and Co-Chief Executive Officer and Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. “As we continue to rapidly advance the clinical development of ivonescimab across non-small cell lung cancer and other solid tumors, we believe that it is critically important to combine ivonescimab with some of the most promising medicines and drug candidates as we seek to provide innovative therapy options to patients facing high unmet needs.” About Revolution Medicines, Inc. Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn . About Summit Therapeutics Inc. Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and its shares are listed on the Nasdaq Global Market (symbol “SMMT”). It is headquartered in Miami, Florida, and has additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX . About Ivonescimab Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to enroll patients in the United States for HARMONi-7. HARMONi is a Phase III clinical trial which is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Top-line results were announced in May 2025, which included a statistically significant and clinically meaningful benefit in progression-free survival and a positive trend in overall survival, the trial’s two primary endpoints. Consistent results were noted between the single region HARMONi-A study and the multiregional HARMONi study. HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. Approximately 85% of patients received a 3 rd generation EGFR-TKI prior to randomization in the study. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024, and its label was expanded in China in April 2025. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (“FDA”) for the HARMONi clinical trial setting. SOURCE: Summit Therapeutics

Phase 3License out/inImmunotherapyFast Track

25 Jun 2025

·www.biospace.com

TIGIT Turmoil: How Pharma Burned Billions on Failed Immuno-Oncology Projects

Created with Canva Dreamlab † Leading companies spent $1.4 billion upfront on licensing deals and embarked on vast R&D programs. Clinical setbacks mean many companies are unlikely to ever recoup their investments. TIGIT was once the hottest target in immuno-oncology. Just a few years later, the pipeline has thinned significantly as a who’s who of drugmakers have retreated from the mechanism in response to lackluster clinical data. Some R&D programs are ongoing, but the rapid retreat means the industry has already burnt billions of dollars on deals and development for failed candidates. Bristol Myers Squibb , Gilead, GSK and Novartis paid $1.4 billion upfront between them to join Merck and Roche in the TIGIT race. The figure excludes the $175 million Gilead paid to enter into a multi-asset deal that gave it the right to license candidates including Arcus Biosciences’ domvanalimab, but includes the $275 million the big biotech handed over when it took up its option on the anti-TIGIT antibody. The deals collectively included more than $5 billion in milestones. However, the overwhelming majority of them were unpaid when BMS, GSK and Novartis dropped their TIGIT programs. Gilead is still developing its asset and could owe Arcus up to $500 million in milestones tied to approvals in the U.S. Even without the regulatory milestones, Gilead has bet more on TIGIT than some of its peers. The outlay includes $740 million in equity investments in Arcus. Gilead paid an average of $27.58 per share across the three purchases. Arcus currently trades below $10. The fate of domvanalimab will go a long way in determining what return, if any, Gilead gets on its investment in Arcus. TIGIT Development Costs TIGIT development costs are embedded in the vast R&D budgets of the biopharma companies advancing the candidates. Roche’s broad tiragolumab development program accounted for some of the almost $15 billion the Swiss drugmaker spent on R&D last year, but publicly available figures lack details of the company’s spending on TIGIT. Similarly opaque accounts obscure TIGIT spending at other companies. Programs partnered with smaller biotechs shed some light on TIGIT development costs. GSK and iTeos Therapeutics agreed to spend $900 million on the global development plan for their TIGIT drug. The asset’s failure in Phase II means GSK and iTeos likely only spent a fraction of that amount, but the figure provides a ballpark estimate of what companies with large late-phase programs may have invested. Roche has tested tiragolumab in 10 Phase III studies with a collective enrollment target of almost 4,600 patients. Merck’s Phase III vibostolimab program spanned five studies with a collective enrollment target of more than 4,600 patients. Gilead, Arcus and AstraZeneca, which is partnered on a domvanalimab trial, have sponsored three Phase III studies that are enrolling almost 3,000 patients among them. If GSK and iTeos’ spending plan is indicative of R&D costs at other companies, Gilead, Merck and Roche may have spent billions of dollars between them taking their TIGIT assets through mid- and late-phase trials. Gilead’s relationship with Arcus provides another datapoint. Arcus received between $161 million and $165 million from its collaboration partners as reimbursement for R&D costs in 2022, 2023 and 2024. Mechanisms other than TIGIT will account for some of the spending. Equally, the figures do not capture spending on Gilead-led activities, which Arcus said increased in 2024. ITeos’ accounts provide another glimpse at the cost of TIGIT development. As of the end of March, the biotech had raised more than $1.1 billion across public and private financing rounds and its deal with GSK. ITeos, which is closing down over its TIGIT flop, had $624 million in cash and investments. The difference between the amount iTeos had raised and the amount it was holding was more than $500 million. A History of Failed Oncology Bets Spending on TIGIT adds to the mountain of money that drug developers have plowed into an alphabet soup of targets that at one time were seen as the next big thing in cancer immunotherapy. IL-2 attracted interest in 2018 and 2019, when BMS paid Nektar Therapeutics $1.85 billion to co-develop a molecule and Sanofi acquired Synthorx for $2.5 billion. Both programs ended in failure. Other companies placed bets on CD47. Gilead acquired Forty Seven for $4.9 billion in 2020 and Pfizer snapped up Trillium Therapeutics for $2.3 billion the following year. Pfizer continues to list maplirpacept, a CD47 candidate acquired in the Trillium takeover, in its pipeline, but Gilead’s travails have dampened expectations. Gilead gave up on Forty Seven’s magrolimab last year after a series of setbacks. TIM-3, 4-1BB, ICOS, OX40 and CD73 are among the other targets that have attracted heavy investment, including triple-digit upfront licensing fees, over the years. Active clinical development is continuing in some areas but the targets are yet to live up to the early excitement, such as the report that 4-1BB drug candidates were driving “pretty phenomenal responses” in cancer patients. Work on LAG-3 delivered an approved drug, BMS’ Opdualag, but sales have been fairly modest by the standards of leading immuno-oncology products. Opdualag, a fixed-dose combination of PD-1 and LAG-3 blockers, generated sales of $928 million last year. BMS is on course to reach the blockbuster threshold this year, with sales in the first quarter coming in at $252 million. As excitement about TIGIT and the other targets has faded, PD-1/L1xVEGF-A bispecifics have emerged as the industry’s next big hope. With China’s Akeso validating the mechanism, albeit without allaying concerns about overall survival and efficacy in global trials , leading biopharma companies have moved swiftly to secure riders in immuno-oncology’s new hottest race. In the nine months since Akeso’s ivonescimab beat Keytruda, BioNTech, BMS, Merck and Pfizer have paid more than $4 billion upfront among them for rights to PD-1/L1xVEGF-A bispecifics. The outlay will rise by at least $2 billion as BMS makes noncontingent payments and could top $20 billion if the deals hit their milestones. The fallout from failure would make the TIGIT turmoil look like a tempest in a teapot.

AcquisitionPhase 3ImmunotherapyLicense out/inPhase 2

10 Jun 2025

·www.fiercebiotech.com

Pfizer CEO talks Chinese due diligence, ADC synergies to justify $6B bet on ‘fabulous’ bispecific

Pfizer’s due diligence process involved people from Bourla down and boots on the ground in China.\n Pfizer CEO Albert Bourla has pulled back the curtain on his $1.25 billion bet on a PD-1xVEGF bispecific, revealing that his team went through individual scans and interviewed investigators to gain reassurance about the quality of the Chinese data.The question of whether promising data generated at Chinese sites will hold up in global trials has hung over the PD-1/L1xVEGF sector since Summit Therapeutics and Akeso’s ivonescimab beat Merck & Co.’s blockbuster oncology drug Keytruda in a head-to-head study last year. Despite the doubts, companies have bet billions on assets in recent months.Pfizer joined the race last month by paying 3SBio $1.25 billion upfront for ex-China rights to SSGJ-707. Speaking at a Goldman Sachs event Monday, Bourla said (PDF) 3SBio’s data looked “very good” but “of course they were data in China.”The Chinese origins of the data meant Pfizer wanted to get to know 3SBio and be “very careful” with due diligence, Bourla said. Pfizer’s due diligence process involved people from Bourla down and boots on the ground in China. “We sent teams [to] China. They spent weeks. They went to the sites. They viewed the scans one after the other. They interviewed the physicians that [ran] the study,” Bourla said. “We didn\'t do due diligence in a data room. We sent people on-site. We feel very comfortable. I met the CEO. They are credible guys.”Asked by an analyst about the size of the deal, Bourla said Pfizer will only pay the full $6 billion “if the whole thing is very successful and sells a lot.” The comment suggests some payments are tied to sizable sales milestones but, even at the current level, the deal is a significant outlay on a single investigational asset.Pfizer sees SSGJ-707 as a strategic asset because of its potential to displace PD-1/L1 checkpoint inhibitors and combine with its portfolio of antibody-drug conjugates (ADCs). The portfolio, the core of which came to Pfizer in the Seagen takeover, features ADCs that use vedotin as a payload. The vedotin-based Pacdev and Keytruda work well together. Pfizer is betting SSGJ-707 will also pair nicely with its vedotin ADCs.“Vedotin has been proven that, because it creates immunogenic cell death, it has synergistic effects with PD-1s,” Bourla said. “For us to have the new, let\'s say, standard of immunotherapy as part of our portfolio is very strategically important given that we have all the ADCs.” The potential for SSGJ-707 to enhance ADCs led Pfizer to pick up the asset despite the company having bigger gaps in other parts of its portfolio. Bourla said the bar for Pfizer striking a deal in oncology “is much higher” than in other therapeutic areas “because we have plenty of assets.”Pfizer is looking at obesity assets, Bourla said. The company axed an asset in April after seeing a potential drug-induced liver injury, sparking speculation that it would buy itself back into the race. Pfizer sees “a lot of risk with pricing” in obesity, Bourla said, and is considering lower prices in its calculations of asset value. With Bourla saying premiums are “very, very high,” Pfizer is staying on the sidelines for now.“We are not going to overpay. And, right now, there are a lot of crazy demands,” Bourla said.

ADCImmunotherapy

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 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.	28 May 2025
Metastatic Pancreatic Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	14 May 2025
Non-Small Cell Lung Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	13 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.	11 Mar 2025
PD-L1 negative Triple Negative Breast Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	07 Feb 2025
Triple Negative Breast Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	01 Jan 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	China	Akeso Biopharma Co., Ltd.	31 Oct 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05899608 (HARMONi-3, ASCO2025)	Phase 3	metastatic non-small cell lung cancer First line \| Maintenance	1,080	Ivonescimab plus chemotherapy	lgsftbabtn(qqdjgedvcg) = xnxtyepgky qddqajsxcv (iwloeizwin ) View more	Positive	30 May 2025
				Pembrolizumab plus chemotherapy	lgsftbabtn(qqdjgedvcg) = sdirrkgbgr qddqajsxcv (iwloeizwin ) View more
NCT06375486 (ASCO2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line HBV infection \| portal vein tumor thrombosis \| extrahepatic spread	27	Ivonescimab + HAIC	mpkmpqvtio(ehvqhgdwht) = gxrvraxzsb ltfwdvlonl (fwsyaxjgcc ) View more	Positive	30 May 2025
NCT05840016 (AK112-306 \| HARMONi-6, Company_Website) Manual	Phase 3	Squamous non-small cell lung cancer First line	532	ivonescimab + chemotherapy	szgvbxiypd(gisyzagcat) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). zbxdsguarg (nmvntkumcc ) Met View more	Superior	22 Apr 2025
				tislelizumab + chemotherapy
NEWS Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	-	伊沃西单抗 20 mg/kg (队列1)	pcxbnixsbp(czxwropfzu) = oxypovyhfy tmfmkhhymv (qxabkahwyn ) View more	Positive	20 Jan 2025
				伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗 (队列2)	pcxbnixsbp(czxwropfzu) = exfyqvdznd tmfmkhhymv (qxabkahwyn ) View more
NCT05184712 (HARMONi-A, ESMO_IO2024 \| NEWS) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	322	Ivonescimab (Ivo) + Pemetrexed/Carboplatin	tpfmukcsfv(jblxkzgzjv) = xyxmcjbcrg srmfheilct (svpyxpduso ) View more	Positive	12 Dec 2024
				Placebo + Pemetrexed/Carboplatin	tpfmukcsfv(jblxkzgzjv) = mwkwxjdete srmfheilct (svpyxpduso ) View more
NCT05227664 (SABCS2024) Manual	Phase 2	Triple Negative Breast Cancer First line	30	Ivonescimab + Paclitaxel/Nab-paclitaxel	saspmftylr(gpnxaruqyc) = qriddszoxi grwtmfkawa (vpgemizjks ) View more	Positive	26 Nov 2024
				Ivonescimab + Paclitaxel/Nab-paclitaxel (PD-L1 CPS ≥10)	saspmftylr(gpnxaruqyc) = kiotimcruj grwtmfkawa (vpgemizjks ) View more
NCT05227664 (ESMO2024) Manual	Phase 2	Triple Negative Breast Cancer First line HER2 Negative \| ER Negative \| PR Negative	30	Ivonescimab 20Paclitaxel + Pnab-paclitaxelg/m2	sjyfqzxsap(xvivdglbww) = iboynceghn arbqfeffxx (fdfvmmdeqt ) View more	Positive	16 Sep 2024
				Ivonescimab 20Paclitaxel + Nnab-paclitaxel100 mg/m2	sjyfqzxsap(xvivdglbww) = dnoqeoieai arbqfeffxx (fdfvmmdeqt ) View more
NCT05382442 (ESMO2024) Manual	Phase 2	Metastatic Colorectal Carcinoma First line KRAS \| BRAF \| MSS	40	FOLFOXIRI + Ivonescimab	ycuadsuzht(aledbkgiqg) = kzoznhlxvx qtnuyhkuzv (euugncatch ) View more	Positive	14 Sep 2024
				FOLFOXIRI + Ivonescimab + Ligufalimab	ycuadsuzht(aledbkgiqg) = arwbisclhs qtnuyhkuzv (euugncatch ) View more
NCT05229497 (ESMO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Positive	30	Ivonescimab monotherapy	phzicryeyf(npvqbxyeri) = qxxaoxfrkh pyvvryuojb (ribmotbmmh ) View more	Positive	14 Sep 2024
				Ivonescimab plus ligufalimab	phzicryeyf(npvqbxyeri) = jvseanksin pyvvryuojb (ribmotbmmh ) View more
NCT05499390 (HARMONi-2 \| AK112-303, WCLC2024 \| NEWS 1 \| NEWS 2 \| Pubmed \| Company_Website) Manual	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 Positive	398	Ivonescimab 20 mg/kg	ucpwaxtore(dtudueibax) = kgcdlzgqba cwepyqbjgo (xigjpsqogm ) View more	Positive	08 Sep 2024
				Pembrolizumab 200 mg	ucpwaxtore(dtudueibax) = efbqtbdxkr cwepyqbjgo (xigjpsqogm ) View more

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis