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-

NCT07070466

/ Not yet recruitingPhase 2IIT

A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas

This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.

Start Date12 Dec 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT07057791

/ Not yet recruitingPhase 2IIT

Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ≥ 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg/kg) or ivonescimab 20 mg/kg in combination with carboplatin and etoposide.
Ivonescimab is a type of drug called a bispecific antibody. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time.
Ivonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow.
Participants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal.
The purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.

Start Date01 Dec 2025

Sponsor / Collaborator

Summit Therapeutics, Inc.

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 ; Kaplon, Hélène ; Crescioli, Silvia ; 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 Oct 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: Shao, Jun ; Han, Guang ; Ruan, Hanguang ; Pi, Guoliang ; Ke, Zirui ; Bi, Jianping ; Huang, Yujie ; Yuan, Zilong ; Li, Ying ; Zhang, Caixun

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.

284

News (Medical) associated with Ivonescimab

03 Nov 2025

·www.prnewswire.com

Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer

HONG KONG, Nov. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China's National Medical Products Administration (NMPA). The Phase III multicenter, randomized, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for ivonescimab. The previous three designations include: Ivonescimab combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China's National Reimbursement Drug List. First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China. Ivonescimab combined with docetaxel for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing. Receiving four Breakthrough Therapy Designations affirms ivonescimab's substantial clinical benefit across multiple major cancer types and reinforces Akeso's commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicenter studies. These large pivotal studies, backed by repeated regulatory recognition, position ivonescimab to deliver transformative, life-saving outcomes for patients worldwide. 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 依达方 ® (PD-1/VEGF Bispecific, Ivonescimab) Ivonescimab is a first-in-class, PD-1/VEGF bispecific immuno-oncology agent developed by Akeso. In May 2024, it received approval from the China National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) after EGFR-TKI therapy. This approval made ivonescimab the world's first bispecific antibody based on a synergistic "immunotherapy plus anti-angiogenesis" mechanism. In November 2024, ivonescimab was also included in China's National Reimbursement Drug List (NRDL). Additionally, ivonescimab has been approved as a first-line treatment for advanced NSCLC with positive PD-L1 expression. In the Phase III HARMONi-2 study, ivonescimab demonstrated superior efficacy compared to pembrolizumab, resulting in significantly improved clinical outcomes. In 2025, the final overall survival (OS) analysis from the HARMONi-A study showed that ivonescimab met the OS endpoint, providing clinically meaningful and statistically significant OS benefits. As the first final OS analysis in a Phase III trial of ivonescimab, these results reaffirm the agent's groundbreaking value in both progression-free survival (PFS) and overall survival for patients. Moreover, a head-to-head Phase III trial comparing ivonescimab plus chemotherapy to tislelizumab plus chemotherapy in first-line treatment for squamous NSCLC also yielded promising results. These findings position ivonescimab as a substantial clinical breakthrough whether in comparison to PD-1 monotherapy in immuno-oncology, the current standard of care (SOC) of PD-1 inhibitors combined with chemotherapy, or VEGF-targeted therapies in the anti-angiogenesis field. This underscores ivonescimab's significant potential in cancer treatment. As ivonescimab continues to demonstrate substantial clinical value and the potential to redefine treatment standards, its presence in key immuno-oncology indications is expanding rapidly. In lung cancer, the most prevalent cancer globally, ivonescimab is currently involved in 8 registrational/Phase III clinical studies, including: First-line NSCLC (squamous and non-squamous, compared to pembrolizumab + chemotherapy, international multicenter) First-line squamous NSCLC (compared to tislelizumab + chemotherapy) NSCLC after EGFR-TKI progression (HARMONi-A and HARMONi) First-line PD-L1-positive NSCLC (compared to pembrolizumab) First-line PD-L1-highly expressed NSCLC (compared to pembrolizumab) IO-resistant NSCLC Consolidation therapy for limited-stage small cell lung cancer post-concurrent chemoradiotherapy In other major tumor types, ivonescimab is rapidly advancing first-line indications with ongoing Phase III trials in: First-line biliary tract cancer (compared to durvalumab + chemotherapy) First-line PD-L1–positive head and neck squamous cell carcinoma in combination with ligufalimab (CD47) (compared to pembrolizumab) In the challenging area of cold tumors, ivonescimab has received its fourth Breakthrough Therapy Designation for first-line triple-negative breast cancer. Additionally, Phase III studies are underway for first-line MSS/pMMR colorectal cancer (which accounts for 95% of CRC cases) and first-line pancreatic cancer. Further Phase III studies are also being prepared. With nearly 20 Phase II studies across more than 10 additional indications, ivonescimab has established a robust data foundation to support the rapid global expansion of Phase III trials. 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, 24 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

Phase 3Drug ApprovalBreakthrough TherapyClinical ResultPhase 2

30 Oct 2025

·www.prnewswire.com

Clinical Late-Breaking Abstracts Announced for the Society for Immunotherapy of Cancer's 40th Anniversary Annual Meeting

MILWAUKEE, Oct. 30, 2025 /PRNewswire/ -- The Society for Immunotherapy of Cancer (SITC) received an incredible number of abstract submissions in 2025, more than 1,300, including many clinical based Late-breaking Abstracts. SITC is proud to announce the titles and authors for the clinical Late-breaking Abstracts (LBA) . The abstracts will be presented at SITC's upcoming 40th Anniversary Annual Meeting & Pre-Conference Programs taking place Nov. 5–9, 2025, in National Harbor, MD and virtually. Continue Reading SITC 2025 Logo "We are excited to incorporate these clinical abstracts into an already impressive lineup of abstracts that will be presented at SITC. The Late-breaking Abstracts this year will only focus on late-breaking data from interventional clinical trials in humans and will further enhance the cutting-edge science offered at the 40th Anniversary Annual Meeting," said SITC Vice President Sandra Demaria MD. "SITC is committed to accelerating the approval of 100 novel agents by 2034, and providing a platform to showcase the latest clinical advancements at our Annual Meeting is an important component of this goal." The Late-breaking Abstracts with oral presentations at the 40th Anniversary Annual Meeting are: (1316) Initial monotherapy clinical activity of invikafusp alfa, a first-in-class TCR β-chain-targeted bifunctional antibody, in tissue-agnostic, TMB-H patients from STARt-001, a Phase 1/2 trial Aurélien Marabelle, MD, PhD – Gustave Roussy & Paris Saclay University Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1342) First-in-human dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and initial efficacy of mRNA-LNP MT-302 in vivo CAR therapy in solid tumors Rasha Cosman, BSc (Med), MBBS, FRACP – St. Vincent's Hospital Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1348) Final overall survival analysis of HARMONi-A study comparing ivonescimab plus chemotherapy to chemotherapy alone in patients with EGFR+ NSCLC progressed on EGFR-TKI treatment Li Zhang, MD – Sun Yat-Sen University Cancer Center Session 104: Clinical Oral Abstract Session – Friday, Nov. 7, 2025 – 11:30 a.m. ET (1305) Coformulation of favezelimab and pembrolizumab as neoadjuvant therapy for resectable cutaneous squamous cell carcinoma (cSCC): results from cohort A of the phase 2 KeyForm-010 study Matteo Carlino, MBBS, PhD, BMedSC, FRACP – The University of Sydney Session 106a: Considerations for Incorporating Biomarkers in Perioperative/Neoadjuvant Therapy – Friday, Nov. 7, 2025 – 1:45 p.m. ET (1346) Molecular and immunologic correlates of response in a phase II study of neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma Kenneth Tsai, MD, PhD – Moffitt Cancer Center Session 106a: Considerations for Incorporating Biomarkers in Perioperative/Neoadjuvant Therapy – Friday, Nov. 7, 2025 – 1:45 p.m. ET (1327) Biomarker and updated clinical data for RP1 plus nivolumab in anti-PD-1-failed melanoma from the IGNYTE trial demonstrate reversal of mechanisms of resistance to immune checkpoint blockade Trisha Wise-Draper, MD, PhD– University of Cincinnati Cancer Center Session 107d: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics – Friday, Nov. 7, 2025 – 3:55 p.m. ET (1328) SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): results from a phase 2 study Lin Wu, PhD –Hunan Cancer Hospital Session 107d: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics – Friday, Nov. 7, 2025 – 3:55 p.m. ET (1310) A phase 1/IIa study of ILKN421H, a LNP mRNA encoding an IL2Rβγ selective IL-2v, as monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors Haining Huang, PhD- ILeukon Therapeutics Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1325) SCOPE, an open label phase 2 parallel multi cohort clinical trial evaluating an off-the-shelf DNA plasmid vaccine in first line advanced melanoma combined with check point blockade - interim read-out Nermeen Varawalla, MD, PhD, MBA – Scancell Ltd Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1336) Final ph1b/2 results for Nous-209 monotherapy in Lynch syndrome carriers: Annual revaccination boosts T cell immunity informing future cancer interception strategies Anna Morena D'Alise, PhD – Nouscom SRL Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1340) Lead-in therapy targeting PD1 and/or LAG3 distinguishes differential impacts upon the immune response in first-line treatment of metastatic melanoma Lilit Karapetyan, MD – Moffitt Cancer Center Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET (1345) Initial phase 1a/1b results of STK-012, an α/β IL-2 receptor biased partial agonist, with pembrolizumab, pemetrexed, and carboplatin in 1L PD-L1 negative non-squamous NSCLC Adam Schoenfeld, MD – Memorial Sloan-Kettering Cancer Center Session 206: Clinical Oral Abstract Session – Saturday, Nov. 8, 2025 – 1:45 p.m. ET The full Regular and Young Investigator Award abstracts will be available on Nov. 4 at 9 a.m. ET and LBA – Clinical Only abstracts will be made available on Nov. 7 at 9 a.m. ET. Both types of abstracts will be published in the Journal for ImmunoTherapy of Cancer (JITC) Clinical Late-breaking Abstract Sessions with oral abstract presentations will take place on Friday, Nov. 7 from 11:30 a.m.–12:15 p.m. CT and Saturday, Nov. 8 from 1:45–3 p.m. ET in the Gaylord National Resort and Convention Center - Ballroom Level - Potomac Ballroom. In addition, Late-breaking Abstract posters will be presented in the Exhibit and Poster Hall and the virtual ePoster Hall beginning Friday, Nov. 7 at 10 a.m. ET. To learn more about the Late-breaking Abstracts, visit the 40th Annual Meeting & Pre-Conference Programs website. To register for the 40th Anniversary Annual Meeting and Pre-Conference Programs, click here. About SITC The Society for Immunotherapy of Cancer (SITC) is the world's leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Established in 1984, SITC, a 501(c)(3) not-for-profit organization, serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Through educational programs that foster scientific exchange and collaboration, SITC aims to one day make the word cure a reality for cancer patients everywhere. To learn more, visit and follow us on X, LinkedIn, Facebook and YouTube. SOURCE Society for Immunotherapy of Cancer (SITC) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultImmunotherapyVaccine

30 Oct 2025

·www.prnewswire.com

First Dual-Positive Immunotherapy with PFS and OS Benefit in EGFR+ NSCLC After EGFR-TKI Progression: Ivonescimab Final OS Analysis from HARMONi-A to Be Presented at SITC 2025

HONG KONG, Oct. 30, 2025 /PRNewswire/ -- Akeso (9926.HK) is excited to announce that the significant results from the final overall survival analysis of the Phase III HARMONi-A study, which evaluates the first-in-class bispecific antibody ivonescimab (PD-1/VEGF bispecific antibody) combined with chemotherapy for EGFR-mutated, non-squamous non-small cell lung cancer (NSCLC) patients after EGFR-TKI progression, have been selected as a Late-Breaking Abstract at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (2025 SITC). Title: Final Overall Survival Analysis of HARMONi-A Study Comparing Ivonescimab Plus Chemotherapy to Chemotherapy Alone in Patients With EGFR+ NSCLC Progressed on EGFR-TKI Treatment Abstract Number: 1348 Session: Clinical Oral Abstract Session 104 Date/Time: Friday, November 7, 2025, 11:30 AM ET The HARMONi-A study is the first Phase III trial of an immunotherapy for EGFR-TKI-resistant, EGFR-mutated non-squamous NSCLC to show statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS). This marks ivonescimab's first final OS analysis in a Phase III trial and confirms its groundbreaking survival benefit for non-squamous NSCLC patients that progressed after EGFR-TKI therapy. Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, Akeso announced that ivonescimab was successfully added to China's National Reimbursement Drug List, effective January 1, 2025, ensuring widespread patient access to this life-saving treatment. Additionally, Akeso's global partner, Summit Therapeutics, announced in October 2025 that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, seeking approval for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant, third-generation EGFR-TKI-resistant, non-squamous NSCLC. 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, 24 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Drug Approval

100 Deals associated with Ivonescimab

R&D Status

Approved

10 top approved records.

to view more data

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-Sino Pharma Co., Ltd.	25 Jul 2025
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Akeso Pharmaceuticals, Inc.	25 Jul 2025
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
PD-L1 negative Triple Negative Breast Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	07 Feb 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05840016 (HARMONi-6, ESMO2025)	Phase 3	Squamous non-small cell lung cancer First line	532	IvonescimabIvonescimab 20 mg/kg Q3W + paclitaxel (175 mg/m2) and carboplatin (AUC 5)	hvzsrvsrzw \| zchyzuwfsy(dyoyausrrc) = zjfixljuat pasqksfjcc (hswyuxkjzo ) View more	Positive	17 Oct 2025
				Tislelizumab 200 mg Q3WTislelizumab 200 mg Q3W + paclitaxel (175 mg/m2) and carboplatin (AUC 5)	hvzsrvsrzw \| zchyzuwfsy(dyoyausrrc) = dhbgipafai pasqksfjcc (hswyuxkjzo ) View more
NCT06375486 (ESMO2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line	33	Ivonescimab 20 mg/kg	gbgptdzcve(vjdprkssuo) = ehhennnmne jascscrxwo (jioogdamrd ) View more	Positive	17 Oct 2025
				Ivonescimab 20 mg/kg (BCLC C subgroup)	gbgptdzcve(vjdprkssuo) = jwchktkjrt jascscrxwo (jioogdamrd ) View more
NCT06396065 (HARMONi, WCLC2025 \| NEWS) Manual	Phase 3	EGFR positive non-small cell lung cancer EGFR Positive	438	Ivonescimab + pemetrexed + carboplatin	ykekjnfhlo(mdeevemdem) = cushjzzkdk eqfnzoppnd (eumptvtdix, 5.7 - 7.1) Met View more	Positive	09 Sep 2025
				Placebo + pemetrexed + carboplatin	ykekjnfhlo(mdeevemdem) = ppzfawetes eqfnzoppnd (eumptvtdix, 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	ffkoazsfmc(kekfedphpn) = the Phase III HARMONi-A trial met its OS goal, showing that ivonescimab. mydjyrsyih (uekoxradfg ) 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	gqzzvqttxn(edukllayek): 0.52 (95.0% CI, 0.41 - 0.66), P-Value = <0.00001 View more	Positive	30 May 2025
				化疗
NCT05899608 (HARMONi-3, ASCO2025)	Phase 3	metastatic non-small cell lung cancer First line \| Maintenance	1,080	Ivonescimab plus chemotherapy	tfurzkeoup(gymmulxbfy) = vblvrqyrnb ozczyfikjc (nvhdrtckpi ) View more	Positive	30 May 2025
				Pembrolizumab plus chemotherapy	tfurzkeoup(gymmulxbfy) = hobuohybcg ozczyfikjc (nvhdrtckpi ) View more
NCT06375486 (ASCO2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line HBV infection \| portal vein tumor thrombosis \| extrahepatic spread	27	Ivonescimab + HAIC	nxdfkcrfzg(qptjtozxzm) = jgdjthnbqz jwirczdemy (kceqtsfcko ) 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	rklasbgivh(yngvybkjrq) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). acxbvhyyyg (ytjkhxqqwz ) 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)	hgtflamcfr(jfxhyyljon) = btpysyjpsc vfvrwtcmtb (ymgyrdoepx ) 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)	hgtflamcfr(jfxhyyljon) = lmxwdfoeai vfvrwtcmtb (ymgyrdoepx ) 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	gjqpixldzg(vczmsearjr) = lsylxexkco xjhtxvleni (bkbejjsnri ) View more	Positive	12 Dec 2024
				Placebo + Pemetrexed/Carboplatin	gjqpixldzg(vczmsearjr) = zpueruneld xjhtxvleni (bkbejjsnri ) View more

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