A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)

This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.

开始日期2025-03-24

申办/合作机构

Marengo Therapeutics, Inc.

NCT05592626

/ Recruiting临床1/2期

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.

开始日期2023-01-04

申办/合作机构

Marengo Therapeutics, Inc.

100 项与 Invikafusp alfa 相关的临床结果

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100 项与 Invikafusp alfa 相关的转化医学

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100 项与 Invikafusp alfa 相关的专利（医药）

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项与 Invikafusp alfa 相关的文献（医药）

2026-07-01·Journal for ImmunoTherapy of Cancer

PARP inhibition combined with a T-cell receptor β chain-directed antibody fusion molecule drives polyclonal antitumor immunity and tumor regression

Article

作者: Su, Zhen ; Pruitt, Margaret R ; Lee, Jonelle K ; Fabian, Kellsye P ; Hodge, James W ; Karzai, Fatima ; Hamilton, Duane H ; Rosato, Francesca ; Santiago-Sanchez, Ginette ; Moisan, Jacques ; Lee, Jung-Min ; Schlom, Jeffrey ; Gulley, James L ; Bayliffe, Andrew ; Katragadda, Madan ; Padget, Michelle R

Background:

Metastatic castration-resistant prostate cancer (mCRPC) remains an aggressive disease with limited response to systemic therapies despite androgen deprivation. Immune-excluded prostate tumors are typically resistant to immunotherapy. STAR0602 is a selective bifunctional T-cell agonist composed of an antibody targeting Vβ6 and Vβ10 T-cell receptor chains fused to human interleukin-2 that selectively expands Vβ6 + CD8 + memory T cells and has demonstrated clinical activity as a monotherapy in anti-programmed death-ligand 1-resistant tumors ( NCT05592626 ). We hypothesized that combining poly ADP-ribose polymerase (PARP) inhibition with Vβ-directed T-cell activation would enhance antitumor immunity and promote polyclonal T-cell responses in immune-excluded prostate cancer.

Methods:

The antitumor activity of the PARP inhibitor olaparib combined with mSTAR1302, the murine surrogate of STAR0602, was evaluated in TRAMP-C2 and RM-1 prostate tumor models. Tumor growth, survival, and immune responses were assessed by flow cytometry and functional depletion studies. The role of tumor-intrinsic TRAIL-R2 signaling was evaluated using a TRAIL-R2 knockout TRAMP-C2 model, and clinical relevance was explored by assessing TRAIL-R2 expression in tumor samples from patients treated with olaparib in a Phase 2 clinical trial ( NCT02484404 ).

Results:

Combination therapy with olaparib and mSTAR1302 induced significant tumor regression and improved survival compared with either agent alone. Treatment increased tumor-infiltrating lymphocytes, expanded activated Vβ13 + CD4 + and Vβ13 + CD8 + T cells, reduced immunosuppressive populations, and enriched stem-like progenitor exhausted CD8 + T cells. Depletion studies demonstrated that Vβ13 + CD4 + T cells, Vβ13 + CD8 + T cells, natural killer cells, and interferon-γ were required for therapeutic efficacy. TRAIL-R2 knockout experiments demonstrated that tumor-intrinsic TRAIL-R2 signaling contributes to the antitumor activity of the combination. Mechanistically, these findings support a model in which PARP inhibition sensitizes tumors while mSTAR1302-mediated Vβ13 + T-cell expansion initiates a broader polyclonal antitumor immune response associated with antigen spreading and recognition of multiple tumor antigens and neoepitopes.

Conclusions:

These findings suggest that combining tumor-sensitizing therapies with selective T-cell activation may represent a broader strategy to overcome immune exclusion in solid tumors. Together, these results provide mechanistic rationale for clinical evaluation of olaparib in combination with STAR0602 in patients with mCRPC who have progressed on androgen deprivation therapy.

2025-10-01·Journal for ImmunoTherapy of Cancer

Combination of a novel TCR Vβ chain-directed selective T cell activator with standard of care therapy for head and neck cancer improves antitumor responses and promotes regression of checkpoint-refractory tumor models

Article

Background:

Immune checkpoint blockade (ICB) treatment, alone or in combination with standard anticancer therapies, has led to important progress in the treatment of head and neck squamous cell carcinoma (HNSCC). Yet, a significant proportion of patients with carcinogen-associated HNSCC (human papillomavirus (HPV) − ) develop disease relapse or progression. Effective treatments for patients who have failed standard of care (SOC) treatment are lacking. STAR0602, a selective, bifunctional T cell agonist comprising an antibody targeting Vβ6 and Vβ10 T cell receptors fused to human interleukin-2, has demonstrated clinical activity in anti-programmed death-ligand 1 resistant tumors. A murine surrogate molecule, mSTAR1302, has been shown to induce tumor regression in multiple syngeneic tumor models and enhance antitumor activity in ICB-refractory settings. This study investigates the therapeutic benefit of mSTAR1302 combined with SOC in the mouse oral carcinoma (MOC)1 and MOC2 HNSCC tumor models.

Methods:

C57BL/6 mice bearing MOC1 or MOC2 tumors were treated weekly with mSTAR1302, cisplatin, and α-programmed cell death protein 1 (PD-1) antibody to determine antitumor efficacy and survival benefit. Immune populations and their effector functions were characterized by flow cytometry and cytokine assays. The tumor microenvironment’s immune architecture was analyzed by multiplex immunofluorescence. Gene expression analysis was conducted to gain an understanding of the mechanism of action of the combination therapy.

Results:

Combination therapy with mSTAR1302, cisplatin, and α-PD-1 promoted robust antitumor activity, higher numbers of mice with complete resolution of tumors, and significantly prolonged survival compared with mSTAR1302 monotherapy or SOC treatment in MOC1 and MOC2 tumors. Tumor-free animals from cohorts treated with the combination therapy demonstrated protection against tumor rechallenge and an overall increase in antigen-specific T cells. Tumor growth inhibition was associated with the expansion of Vβ13 CD8 + and CD4 + T cells, characterized by heightened cytotoxic and effector potentials, in both the tumor and the periphery. The therapeutic effect elicited by the combination therapy was strongly dependent on interferon-γ expression. Thus, the combination of mSTAR1302 and α-PD-1 enabled control of tumors that progressed following platinum-containing treatment.

Conclusion:

These findings provide a rationale for the combination of STAR0602 and SOC therapy in the clinical setting for patients with recurrent or metastatic HPV − HNSCC.

2023-11-29·Science translational medicine1区 · 医学

A T cell receptor β chain–directed antibody fusion molecule activates and expands subsets of T cells to promote antitumor activity

1区 · 医学

Article

作者: Renee N. Donahue ; Andrew Bayliffe ; Jacques Moisan ; Jessica Lowry ; Allart Stoop ; Sangeetha Palakurthi ; Roya Servattalab ; Madan Katragadda ; Jian Tang ; E. John Wherry ; Zhen Su ; James L. Gulley ; Yo-Ting Tsai ; Jeffrey Schlom ; Raj Chopra ; Karunya Srinivasan ; Gurkan Guntas ; Jonathan Hsu ; Wei Huang ; Ke Liu

Despite the success of programmed cell death-1 (PD-1) and PD-1 ligand (PD-L1) inhibitors in treating solid tumors, only a proportion of patients respond. Here, we describe a first-in-class bifunctional therapeutic molecule, STAR0602, that comprises an antibody targeting germline Vβ6 and Vβ10 T cell receptors (TCRs) fused to human interleukin-2 (IL-2) and simultaneously engages a nonclonal mode of TCR activation with costimulation to promote activation and expansion of αβ T cell subsets expressing distinct variable β (Vβ) TCR chains. In solution, STAR0602 binds IL-2 receptors in cis with Vβ6/Vβ10 TCRs on the same T cell, promoting expansion of human Vβ6 and Vβ10 CD4 + and CD8 + T cells that acquire an atypical central memory phenotype. Monotherapy with a mouse surrogate molecule induced durable tumor regression across six murine solid tumor models, including several refractory to anti–PD-1. Analysis of murine tumor-infiltrating lymphocyte (TIL) transcriptomes revealed that expanded Vβ T cells acquired a distinct effector memory phenotype with suppression of genes associated with T cell exhaustion and TCR signaling repression. Sequencing of TIL TCRs also revealed an increased T cell repertoire diversity within targeted Vβ T cell subsets, suggesting clonal revival of tumor T cell responses. These immunological and antitumor effects in mice were recapitulated in studies of STAR0602 in nonhuman primates and human ex vivo models, wherein STAR0602 boosted human antigen-specific T cell responses and killing of tumor organoids. Thus, STAR0602 represents a distinct class of T cell–activating molecules with the potential to deliver enhanced antitumor activity in checkpoint inhibitor–refractory settings.

项与 Invikafusp alfa 相关的新闻（医药）

2026-07-20

·PRNewswire

Marengo Secures ESMO 2026 Oral Presentation for Key Phase 2 Invikafusp Alfa Data in PD-1-Resistant Solid Tumors and Appoints Pembrolizumab Development Leader Eric Rubin, M.D., to Scientific Advisory Board

Updated STARt-001 results will highlight invikafusp alfa's single-agent activity in PD-1–resistant tumors using a biomarker-enrichment strategy Eric Rubin, former Senior Vice President of Global Clinical Oncology at Merck, who led the initial development of pembrolizumab (KEYTRUDA®) through its global regulatory approvals, joins Marengo to guide invikafusp alfa's next phase CAMBRIDGE, Mass., July 20, 2026 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies, today announced that key Phase 2 data from the ongoing STARt-001 study of invikafusp alfa, a first-in-class bispecific dual T-cell agonist, have been selected for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026. The presentation will evaluate invikafusp alfa's single-agent activity in patients whose cancers have progressed following PD-1–directed treatment, using biomarker-enriched cohorts to identify patients most likely to benefit. The company also appointed renowned oncology drug developer Eric Rubin, M.D., to its Scientific Advisory Board. The ESMO presentation will feature updated clinical and translational data from tumor mutational burden-high (TMB-H) patients with advanced solid tumors that are refractory or resistant to PD-1–directed therapy. Building on data reported at SITC 2025, the results will further assess whether selective activation of Vβ6/Vβ10 T-cell subsets in vivo can generate single-agent activity across biomarker-enriched tumor types after PD-1 resistance. "Selection of our Phase 2 data for an ESMO oral presentation reflects the encouraging clinical efficacy signal from the ongoing Phase 2 study of invikafusp alfa and its differentiated biology," said Zhen Su, M.D., M.B.A., Chief Executive Officer of Marengo Therapeutics. "STARt-001 is designed to test single-agent activity after PD-1–directed treatment has stopped working, using a biomarker-enriched strategy such as TMB-H. These studies will help us determine whether selective activation of Vβ6/Vβ10 T-cell subsets can support a broader pan-tumor development strategy. Eric led the initial development of KEYTRUDA® and its broad immuno-oncology backbone development strategy, and his experience will be invaluable as we rigorously evaluate invikafusp alfa's potential." Dr. Rubin's appointment strengthens Marengo's scientific leadership in precision T-cell activation research as invikafusp alfa enters its next stage of development. His experience leading the initial development of KEYTRUDA® and large-scale oncology clinical programs will inform Marengo's strategy for evaluating invikafusp alfa for single-agent activity in biomarker-selected, heavily pretreated PD-1–resistant cancers and, over time, as a potential combination backbone in larger and earlier-line settings. "Invikafusp alfa is one of the more compelling novel immunotherapy approaches I have seen in recent years," said Eric Rubin, M.D. "Its precision T-cell agonist mechanism provides a strong rationale for testing single-agent activity after PD-1 resistance while avoiding broad activation of the entire T-cell compartment. The biomarker-enriched design of STARt-001 should help define the patients and tumor settings in which this approach may offer the greatest benefit and inform its potential role in future combination strategies." Dr. Rubin brings more than 35 years of cancer drug-development experience across academic and industry settings, including leading large-scale oncology clinical programs. Most recently, he was Senior Vice President of Global Clinical Oncology at Merck, where he held several senior leadership roles during his 16-year tenure and led the initial development of pembrolizumab (KEYTRUDA®). Earlier, he served on the faculty of Dana-Farber Cancer Institute and as Director of Investigational Therapeutics at Rutgers Cancer Institute of New Jersey, with a research focus on oncology translational science. Dr. Rubin has authored more than 100 peer-reviewed publications and served on national research and policy committees, including for the National Cancer Institute, American Cancer Society, American Association for Cancer Research and American Society of Clinical Oncology. Presentation Details: Title: START-001: Phase 2 results of invikafusp alfa, a first-in-class T cell receptor β-chain–targeted bispecific antibody, as monotherapy in patients with TMB-H solid tumors resistant to immune checkpoint blockade (ICB) Conference: ESMO Annual Meeting 2026 Session Category and Title: Proffered paper: Investigational immunotherapy Session Date and Time: Friday October 23 2026, 1:30 - 3:00 PM CET Presentation Number: #4703 Presenter: Dr. Elena Garralda About Marengo Therapeutics Marengo Therapeutics, Inc. is a clinical-stage biotechnology company developing TCR-targeting antibodies that selectively modulate disease-relevant T-cell subsets for cancer and autoimmune diseases. Its three proprietary platforms—Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (TriSTAR) and T Cell Depletor (MSTAR)—are designed to target the right T cells in the right patients. To learn more, visit marengotx.com. About Invikafusp alfa (STAR0602) Invikafusp alfa (STAR0602), the lead candidate from Marengo's STAR™ platform, is designed to selectively activate Vβ6/Vβ10 T-cell subsets found across cancers by combining non-clonal TCR activation with an IL-2 signal in a single molecule. This precision approach is intended to generate durable antitumor immunity while limiting broader systemic immune activation. Marengo is evaluating invikafusp alfa's single-agent activity in biomarker-selected, PD-1–resistant cancers and its longer-term potential as a combination backbone. About the STARt-001 Clinical Study STARt-001 is a global Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with advanced, antigen-rich solid tumors that are refractory or resistant to PD-1–directed therapy. The Phase 2 portion uses biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and help identify patients most likely to benefit. For more information, visit ClinicalTrials.gov (NCT05592626). Marengo Contacts: Media | Peg Rusconi | [email protected] Investors | [email protected] SOURCE Marengo Therapeutics 21% more press release views with Request a Demo

临床2期免疫疗法高管变更ASCO会议

2026-04-28

·BioSpace

AACR 2026: Combo therapies by Moderna, Marengo show promise in skin, breast cancer

iStock, Wirestock Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response. Combinations continue to be a primary focus in cancer drug development, as researchers seek out therapeutic cocktails that target tumor cells with optimum efficiency while also mitigating side effects and potential drug resistance. Indeed, the next wave of combo therapies was on display at the American Association for Cancer Research’s annual meeting in San Diego last week. Companies including Moderna, Marengo Therapeutics and Akeso presented new data at AACR showcasing new uses for existing combinations, as well as blends of experimental therapies with tried-and-true treatments like chemotherapy and more recently approved drugs. A combination approach is “very, very important,” Zhen Su, a physician-scientist and CEO of Marengo, told BioSpace , pointing as an example to the “transformative care” now available to patients with certain types of lung cancer and multiple myeloma thanks to high-powered drug combos. “For frontline cancer, the treatment’s oftentimes a combination therapy because tumors are not easy to tackle, and sometimes you need a multi-modality approach to really hit tumors from different angles,” Su said. Such combos might include a chemotherapy or antibody-drug conjugate (ADC) that can give a tumor “a big hit from the get-go,” he said, alongside an immunotherapy capable of activating cancer-fighting T cells. When experimental meets approved At AACR, Marengo shared initial data from a Phase 2 study of invikafusp alfa, an investigational dual T cell agonist, in combination with Gilead Sciences’ ADC Trodelvy, which is FDA-approved for certain forms of heavily pretreated breast cancer. Of 10 patients with heavily pretreated metastatic breast cancer, two had confirmed complete responses to the combo, two had confirmed partial responses and six saw their disease remain stable. The drug cocktail is one of the first to combine a precision immunotherapy with a precision ADC, Su said, bringing “two of the most potent modalities into a tumor and [lighting] up a fire in their cancer.” The results so far, he continued, are a sign of “the next frontier,” an exciting new phase in the industry after his nearly three decades as a drug developer. Marengo plans to continue expanding the trial and, “if we continue to see the benefits we’re seeing,” will potentially seek FDA Fast Track designation for the combo in breast cancer before moving into a pivotal trial. Invikafusp alfa already holds the designation as a monotherapy in advanced colorectal cancer. Also unveiling combo data at AACR last week was Moderna, specifically, early results from a Phase 2 trial of its investigational antigen therapy mRNA-4359 in combination with Merck’s blockbuster immunotherapy Keytruda as a first-line treatment for locally advanced and metastatic melanoma. As of Dec. 1, 2025, two of 12 patients achieved a complete response, while eight had a partial response, for an overall response rate of 83%. Cancer AACR 2026: Moderna, Revolution, Zymeworks and BeOne showcase new data Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer. April 21, 2026 · 4 min read · Tristan Manalac Read more There are several reasons for mRNA-4359’s promise in melanoma, David Berman, Moderna’s recently appointed chief development officer, told BioSpace via email. For one, he said, “this is a novel dual mechanism therapy where we activate T cells to kill cancer cells and recalibrate the tumor microenvironment to a more immune favorable state.” Berman also pointed to the benefits shown in a study of the combo among patients previously treated with immune checkpoint inhibitors and in late-stage data “from another company using a similar approach.” Following Monday’s AACR presentation, in a video posted to Moderna’s website, Berman called the early trial results “quite intriguing,” while noting that “it’s hard to tease apart” the contributions of each component of the drug cocktail. Therefore, the next steps will be to determine if, in the larger cohort of patients who have progressed on checkpoint inhibitors, there is sufficient reason to believe that mRNA-4359 is bringing additional activity, he said. Those data should arrive “over the next year.” In a Monday note to investors, Leerink Partners said that while the patient sample is very small, the 83% ORR “represents a promising signal,” though the analysts cautioned that it is “unlikely to garner meaningful investor enthusiasm.” Hits and misses Another promising drug is a combination of Akeso’s PD-1/CTLA-4 bispecific antibody cadonilimab with chemotherapy. The Chinese biotech is evaluating the combo in the Phase 2 Compassion-26 study as a first-line treatment for advanced cases of pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer. Data presented at AACR showed an objective response rate of just under 34% and disease control rate of 96.4% among 56 patients. The drug combination appeared to be especially effective in patients with locally advanced disease, with a median overall survival rate of more than 23 months and median progression-free survival of 11.1 months, compared to 10.5 months and 7.2 months, respectively, among those with metastatic disease. “The efficacy of cadonilimab in hard-to-treat tumors is driven by its innovative molecular design and novel mechanism of action,” a company spokesperson told BioSpace via email. “It harnesses the therapeutic benefits of both PD-1 and CTLA-4 pathways while overcoming the traditional efficacy and safety limitations of each target.” This translates into breakthrough clinical value, the spokesperson continued. “For example, it addresses the toxicity challenges that have historically limited the use of CTLA-4 agents and improves response in PD-L1 low/negative populations where PD-1/L1 inhibitors often underperform.” With these attributes, Akeso’s spokesperson added, “cadonilimab is well-positioned as a backbone agent to combine with novel therapies.” Cell therapy Agenus cancer cocktail records 0% response rate, missing midstage goal An investigational cocktail was tied to a 0% overall response rate in patients with gastroesophageal cancer, but developers Agenus and MiNK Therapeutics aren’t giving up on the program just yet. April 20, 2026 · 2 min read · Gabrielle Masson Read more Less successful, meanwhile, were results from a Phase 2 study of Agenus’ experimental immunotherapies botensilimab and balstilimab plus MiNK Therapeutics’ allogeneic cell therapy agenT-797, alongside the approved VEGFR2 antagonist Cyramza and chemotherapy. The cocktail elicited a 0% response rate among the study’s 15 eligible gastroesophageal adenocarcinoma patients. Despite missing the study’s primary endpoint, Agenus remained optimistic, suggesting in an April 17 press release that the secondary factors of durability and survival may in fact “be the most clinically relevant endpoints” among the study’s particular population. The combo was tied to a 73% stable disease rate, while three patients experienced overall survival of more than 20 months. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! Clinical trial results, research news, the latest in cancer, cell and gene therapy hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "674f4dc0-7371-4190-86cc-e1afd00b08ea", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

临床结果临床2期免疫疗法

2026-04-27

·Briinsight

【深度】AACR 2026 硝烟散尽：当“卷王”ADC 遇上 AI，下一场医药“诺曼底登陆”在哪？

圣地亚哥的四月，太平洋的海风依然凉爽，但对于刚刚从 AACR 2026 会场走出来的医药人来说，空气中弥漫的不是海水的味道，而是浓烈的“焦虑”与“兴奋”交织的荷尔蒙。如果你还在盯着某个单一靶点的“首次披露”，那你可能已经输了。今年的 AACR，不再是那种“PPT 讲故事”的狂欢，而是实打实的“肌肉秀”。当 ADC（抗体偶联药物）的管线在管中甚至出现了重叠，当 AI 诊疗不再是展台上的模型，而是真真切切地预测了患者对免疫治疗的反应时，行业规则已经变了：在这个“去泡沫”的 2026 年，单纯的“新分子”不再是护身符，只有“差异化的组合拳”与“精准的患者筛选”，才是通往资本市场的唯一入场券。今天，Briinsight 团队带你复盘这场变革，看透 AACR 2026 背后的产业新逻辑。01. ADC 的“内卷”终局：从盲目追逐到精准突围如果说过去三年 ADC 是“只要研发就能拿钱”，那么 2026 年的 AACR 则给这一赛道泼了一盆冷静的水。在这一轮的报告中，我们发现“ADC+X”的联合方案占据了主导地位。Marengo Therapeutics 与 Gilead 的联手（Invikafusp alfa + Trodelvy）成了全场最佳，不是因为它用了什么颠覆性靶点，而是它完美解决了“免疫冷肿瘤”的问题。给投资者的启示：别再为单纯的 Nectin-4 或 HER2 追高了。谁能通过联用（ADC+免疫检查点/小分子），在三阴性乳腺癌这类硬骨头中打出“完全缓解（CR）”，谁才是真正的赢家。那种还在试图仅凭单药在红海中厮杀的项目，价值正在急速缩水。 02. 合成致死：告别“单打独斗”的时代 AACR 现场，WEE1 与 PKMYT1 抑制剂（Zedoresertib + Lunresertib）组合数据的披露，引发了业内不小的骚动。在抗癌药物开发中，我们习惯了“靶点阻断”，但 2026 年的主旋律是“系统锁定”。通过协同阻断细胞周期检查点，制药巨头们展示了如何让那些带有特定突变（如 CCNE1）的实体瘤“无处遁形”。这不仅是技术的胜利，更是对肿瘤耐药性机制的精准降维打击。这意味着，小分子药物的开发逻辑已经完成了从“找靶点”到“找互补”的范式转移。03. AI 不再是“PPT 装饰”，而是“临床医生” 以前我们聊 AI 制药，聊的是降本增效；今年 AACR，AI 聊的是“预测未来”。 Path-IO 模型在 NSCLC（非小细胞肺癌）免疫治疗预测中的表现，震惊了现场不少临床专家。通过分析肿瘤微环境的空间特征，AI 能够直接筛选出“谁对免疫治疗有效”。这背后是一个深刻的行业信号：临床研究的门槛被拉高了。未来，如果你的临床试验没有伴随精准的 AI 预测工具，或者无法通过影像组学筛选患者，那么你在高昂的临床费用下，极大概率会面临“阴性结果”的风险。 04. 真实世界研究：新药的“试金石” Atezolizumab（T 药）在辅助治疗中披露的 63.8% 的 2 年 DFS 数据，成为了会议的另一道风景线。在这一届 AACR 上，药企们不再仅仅满足于在临床试验的“温室”里谈疗效，而是通过 RWD（真实世界数据）来证明药物在复杂临床实践中的韧性。这对于那些正处于商业化早期的生物医药公司来说，是一个重要的风向标：监管机构和支付方越来越看重药物在“战场”上的真实表现，而非仅仅是理想化试验环境下的数据。结语：医药寒冬后的“春天法则” AACR 2026 的硝烟散去，留给我们最深刻的思考是：生物医药进入了“硬核整合”时代。在这个时代，光有技术是不够的。你需要：懂组合：懂得如何将现有管线像搭积木一样组合出协同效应。懂 AI：利用数字化工具，在临床试验启动前就锁死胜率。懂患者：像关注临床终点一样，关注药物在真实世界中的可及性。这是一场洗牌，也是一场新生。对于深耕行业的投资者和研发者而言，那些看似冷静的临床数据背后，藏着的正是未来三年的黄金机会。 Briinsight 始终与你同行，透过 AACR 的喧嚣，捕捉那些改变行业命运的“微小震动”。你认为 ADC 下一个必须要攻克的‘耐药难关’是什么？欢迎在评论区留下你的看法。我们一起见证医药史上的疯狂一年！高质量观点，我们会精选置顶。我们将持续输出：洞察行业变局，预判未来先机。我们持续深耕医疗健康赛道，为您提供：深度解读：穿透表象，还原商业底层逻辑。标的拆解：拆解并购核心，寻找估值锚点。趋势研判：捕捉投融资风向，预警行业巨震。把复杂问题，讲清楚。 #AACR2026 #ADC药物 #肿瘤免疫治疗 #AI医疗 #合成致死 #临床数据解读 #生物医药投资 AACR-26 现场直击：逆天！肺癌免疫治疗“有效率”也能预判？MD安德森推出最强AI插件，PD-L1或将跌落神坛！ AACR-26现场直击：肿瘤“禁区”终结者？首款脑穿透分子胶NST-628惊艳AACR，难治性癌症患者迎来“生命之光”！ AACR-26 现场直击：打破实体瘤“死亡诅咒”！CAR-T之后，2026年诺奖级黑马登场：唤醒NK细胞灵魂，让晚期癌细胞“无处遁形”！ AACR-26 现场直击：1%的超低毒性！ADC赛道闯入“黑马”：Whitehawk三大王牌齐发，剑指实体瘤天花板 AACR-26 现场直击： |1500万美元狂砸！辉瑞“捐”出重磅药销售权，助力15位天才科学家冲击癌症治愈！ AACR-26 现场直击：| FDA“传奇老兵”公开炮轰，谁在毁掉全球新药审批的基石？ AACR-26 现场直击：| 抗癌药的“降维打击”来了？今天这几项重磅发布，可能改变千万人的命运！ AACR-26 | 肿瘤界的“超级碗”开战！AACR 2026三大重磅看点：KRAS成突破口，DAC能否取代ADC？ 👇 访问网站：https://www.briinsight.com 了解更多👇 👇 商务合作与咨询，敬请扫描二维码 👇 生物医药前沿洞察｜职业成长加速器聚焦创新药、制剂技术、CDMO、AI药物研发等领域的最新突破；专注生物医药研发、注册申报、临床进展与市场趋势解析；汇聚业内声音、人才资讯与实战经验，打造最具价值的行业交流平台。 👇 星标 Briinsight，轻松不迷路👇 Tips：亲爱的朋友，由于微信改版，有时我们会“走散”。为了不错过每一篇深度好文，记得点击 “Briinsight” 名片，进入主页并将我们设为星标 ⭐️。这样，我们的每一次推送都会准时和你相遇。

100 项与 Invikafusp alfa 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
实体瘤	临床2期	美国	Memorial Sloan Kettering Cancer Center	2025-05-30
晚期乳腺癌	临床2期	美国	Marengo Therapeutics, Inc.	2025-03-24
晚期乳腺癌	临床2期	加拿大	Marengo Therapeutics, Inc.	2025-03-24
三阴性乳腺癌	临床2期	美国	Marengo Therapeutics, Inc.	2025-03-24
三阴性乳腺癌	临床2期	加拿大	Marengo Therapeutics, Inc.	2025-03-24
腹部肿瘤	临床2期	美国	Marengo Therapeutics, Inc.	2023-01-04
腹部肿瘤	临床2期	加拿大	Marengo Therapeutics, Inc.	2023-01-04
腹部肿瘤	临床2期	法国	Marengo Therapeutics, Inc.	2023-01-04
腹部肿瘤	临床2期	西班牙	Marengo Therapeutics, Inc.	2023-01-04
晚期恶性实体瘤	临床2期	美国	Marengo Therapeutics, Inc.	2023-01-04

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06827613 (START-002, SABCS2025)	临床1/2期	三阴性乳腺癌 \| HR阳性/HER2阴性乳腺癌 PR Negative \| ER Positive \| HER2 Negative	25	Invikafusp alfa (STAR0602) + Sacituzumab govitecan (metastatic TNBC or HR+/HER2- MBC)	衊膚壓窪築糧齋鹽鑰壓(鏇齋窪鬱鑰蓋獵鑰鑰鑰) = 窪艱衊糧餘願膚衊製糧淵齋簾鏇遞遞壓窪廠襯 (積觸憲蓋願廠齋衊窪構 )	积极	2025-12-12
NCT05592626 (START-001, ESMO2025)	临床2期	实体瘤 TMB-H \| MSI-H	48	Invikafusp alfa 0.08 mg/kg (TMB-H/MSI-H solid tumors + CRC)	鏇願鏇鹹膚鏇網憲遞網(選窪鹹醖積顧餘餘鬱醖) = 衊窪獵鏇繭顧餘糧鏇膚淵廠蓋壓簾衊遞糧淵鏇 (衊製鏇餘願鑰憲鏇夢餘 ) 更多	积极	2025-10-17
NCT05592626 (START-001, PRNewswire)	临床1/2期	胃肠道肿瘤二线 TMB-H	17	Invikafusp alfa	遞顧觸構壓窪艱壓鹽壓(獵鹹範範獵製範築構製) = 衊遞鹹窪齋築簾廠壓蓋構憲鬱艱簾遞顧衊鏇鹹 (鑰鹹鏇壓鬱襯築蓋膚積 ) 更多	积极	2025-07-02
NCT05592626 (START-001, PRNewswire)	临床1/2期	胃肠道肿瘤二线 TMB-H	17	Invikafusp alfa	遞顧觸構壓窪艱壓鹽壓(獵鹹範範獵製範築構製) = 壓壓鑰製鏇鏇齋廠製壓構憲鬱艱簾遞顧衊鏇鹹 (鑰鹹鏇壓鬱襯築蓋膚積 )	积极	2025-07-02
NCT05592626 (START-001, AACR2025) 人工标引	临床1/2期	实体瘤 TMB-High	41	Invikafusp alfa OBDInvikafusp alfa OBD (either 0.08 or 0.12 mg/kg) monotherapy	網餘壓膚鑰憲觸繭簾願(齋餘鏇鏇獵構鬱餘衊廠) = 願遞鹹鏇鹽選遞夢製繭壓憲築艱構鹽簾鏇憲蓋 (顧襯顧顧觸艱糧積簾願 ) 更多	积极	2025-04-29
NCT05592626 (START001, SITC2024) 人工标引	临床1/2期	实体瘤	35	STAR0602	顧廠鏇積壓鏇鹽衊簾鏇(願餘齋蓋齋鑰糧夢願範) = All patients experienced grade 1 fever and 60% had grade 2 CRS without premedication with corticosteroids or tocilizumab. Other common TEAEs (mostly grades 1 and 2) included rash (51.4%) and thrombocytopenia (34.3%). 醖簾鏇獵齋鏇選衊淵窪 (膚選鑰鹹觸醖蓋積齋選 ) 更多	积极	2024-11-05