A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 70 to 80 sites worldwide.
Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2025-01-20

申办/合作机构

AbbVie, Inc.

NCT06093503

/ Withdrawn临床3期

Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how telisotuzumab vedotin in combination with osimertinib affects the disease state compared to standard of care in adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the epidermal growth factor receptor (EGFR) gene and that overexpresses the c-Met protein. Change in disease activity will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC that overexpresses the c-Met protein. Participants are randomly placed in one of the two groups to receive telisotuzumab vedotin and osimertinib or standard of care chemotherapy. Approximately 250 adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the EGFR gene and that overexpresses the c-Met protein will be enrolled in the study in approximately 180 sites worldwide.
Participants will receive intravenous telisotuzumab vedotin every 2 weeks in combination with oral osimertinib tablets daily or standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician). Overall duration of the study is estimated to be approximately 47 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2024-05-31

申办/合作机构

AbbVie, Inc.

NCT05513703

/ Terminated临床2期

Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2022-11-21

申办/合作机构

AbbVie, Inc.

100 项与 Telisotuzumab vedotin 相关的临床结果

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100 项与 Telisotuzumab vedotin 相关的转化医学

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100 项与 Telisotuzumab vedotin 相关的专利（医药）

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541

项与 Telisotuzumab vedotin 相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

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

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

2025-12-31·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Simmons, Quincey ; Velazquez, Roberto ; Tschantz, William R. ; Sagar, Vivek ; Hainzl, Dominik ; Barzaghi-Rinaudo, Patrizia ; Korn, Joshua ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

2025-09-01·DRUGS

Telisotuzumab Vedotin: First Approval

Review

作者: Blair, Hannah A

Telisotuzumab vedotin (telisotuzumab vedotin-tllv; EMRELIS^™), an antibody-drug conjugate (ADC) directed against c-mesenchymal-epithelial transition factor (c-MET) protein, is being developed by AbbVie for the treatment of solid tumours. On 14 May 2025, telisotuzumab vedotin received accelerated approval in the USA for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy. This article summarizes the milestones in the development of telisotuzumab vedotin leading to this first approval for NSCLC.

151

项与 Telisotuzumab vedotin 相关的新闻（医药）

2025-10-13

·PRNewswire

AbbVie to Present New Data at ESMO 2025 Reinforcing Leadership in Advancing Targeted Therapies for Solid Tumors

New data from telisotuzumab adizutecan (Temab-A) and ABBV-706 across pancreatic, colorectal, and solid tumors, highlight progress in AbbVie's growing ADC portfolio designed to target difficult-to-treat cancers. NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will unveil new data from its robust antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place October 17-21, in Berlin, Germany. Data from investigational and approved ADCs across AbbVie's portfolio such as telisotuzumab adizutecan (Temab-A),1-3 ABBV-706,4,5 and Emrelis™ (telisotuzumab vedotin),6 in patients with difficult-to-treat tumor types where there is urgent need for additional treatment options,7-15 will be featured in multiple presentations. "Despite recent progress in the treatment of advanced solid tumors, patients still face limited options and pressing unmet needs," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "The compelling data we are sharing at ESMO showcases how we are advancing targeted therapies across a range of solid tumors and highlights the potential of our portfolio." Key highlights AbbVie will present three oral presentations for Temab-A, a next-generation, investigational c-Met directed ADC with a novel topoisomerase 1 inhibitor (Top1i) payload. Phase 1 results with Temab-A both as a monotherapy and in combination across advanced, solid tumors will be presented: Combination with bevacizumab (Bev) in Colorectal Cancer (CRC): In biomarker unselected patients with advanced CRC who have received three or more prior lines of therapy (NCT05029882), treatment with 2.4 mg/kg dose of Temab-A plus Bev (n=30) achieved an objective response rate (ORR) of 26.7% compared to an ORR of 0% with trifluridine/tipiracil with Bev (the current standard of care (SOC), n = 20).1 Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 67% and 65% of patients, respectively.1 Monotherapy in MET-Amplified Solid Tumors: Among 100 patients with advanced MET-amplified solid tumors, including non-small cell lung cancer (NSCLC) (n=29), CRC (n=22), gastroesophageal adenocarcinoma (GEA) (n=14), and 16 other tumor types (n=35) who had progressed after SOC treatment (NCT05029882), Temab-A monotherapy achieved an ORR of 46% across all dose levels and tumor types with higher responses observed in patients with NSCLC (69%) and GEA (71%).2 The most common grade ≥3 TEAEs were anemia (40%) and neutropenia (34%).2 Monotherapy in Pancreatic Ductal Adenocarcinoma (PDAC ): Among 42 biomarker unselected patients with advanced/metastatic PDAC who experienced disease progression while receiving or after completing their first-line (1L) therapy (NCT06084481), Temab-A demonstrated an ORR of 24% overall and 40% in patients who received first-line gemcitabine-nab-paclitaxel treatment.3 Grade ≥3 TEAEs occurring in ≥10% of all patients were anemia (38%) and neutropenia (21%).3 "Temab-A continues to show meaningful clinical activity across an expanding range of solid tumors and patient populations, including patients with MET-amplification and increased c-Met expression as we have seen in previously presented data," said Vivek Subbiah, M.D., Chief, Early-Phase Drug Development, Sarah Cannon Research Institute and Temab-A investigator. "These data reinforce Temab-A's potential in multiple solid tumors and thereby warrant its further clinical investigation." AbbVie will also present new analysis from a Phase 1 study of ABBV-706, a SEZ6-directed ADC with a Top1i payload, in relapsed/refractory small cell lung cancer (R/R SCLC) (NCT05599984). A post hoc analysis on data from R/R SCLC patients enrolled in the study, whose tumors had progressed after two lines of therapy (n=80), was done to compare the anti-cancer effect of ABBV-706 monotherapy vs. platinum-based SOC. All patients in this group had received the platinum-based SOC treatment as first-line therapy (1L SOC). Progression-free survival (PFS) during 1L SOC and PFS with ABBV-706 monotherapy as a subsequent line of treatment were analyzed in the same patients by paired Kaplan-Meier analysis. The findings suggest that ABBV-706 may have the potential to replace the platinum-based SOC as a first-line treatment in SCLC.4 In the same trial, ABBV-706 treatment also resulted in rapid clearance of circulating tumor DNA (ctDNA) and circulating tumor cells (CTC). Patients with 100% ctDNA clearance had significantly higher PFS and overall survival (OS) vs. patients without ctDNA clearance.5 These data highlight the potential of ctDNA as an early response marker in SCLC.5 A Phase 2 study assessing ABBV-706 in combination with atezolizumab as replacement of platinum-based chemotherapy is currently ongoing (NCT07155174) in 1L SCLC. Details on key presentations at the ESMO 2025 Congress are available below and the full abstracts are available via the ESMO online program. Telisotuzumab adizutecan (Temab-A) and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Elahere™ (mirvetuximab soravtansine) and Emrelis™ (telisotuzumab vedotin) are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. Additional information on AbbVie clinical trials is available at . U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing information for ELAHERE™ (mirvetuximab soravtansine-gynx) Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn,Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Cecchini M, Cruz-Correa M, Han SW, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A) in Combination With Bevacizumab (Bev) in Patients (Pts) With 3+ Colorectal Cancer (CRC): Dose Expansion Results of a Phase 1 Study. Abstract 731MO presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Murciano-Goroff YR, Kuboki Y, Strickler J, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A) in Patients With MET-Amplified Advanced Solid Tumors: Results From a Phase 1 Study. Abstract 918O presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Harding JJ, Strickler J, Henry J, et al. Phase 1 Basket Study of Telisotuzumab Adizutecan (Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate (ADC): Results from Patients (Pts) With Pancreatic Ductal Adenocarcinoma (PDAC). Abstract 2214MO presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Bar J, Dowlati A, Byers LA, et al. Efficacy of ABBV-706 as second-line treatment for patients with platinum-refractory/resistant small cell lung cancer. Abstract 2777P presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Wang S, Wang L, Luo A, et al. ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with relapsed/refractory (R/R) small cell lung cancer (SCLC): Circulating biomarker and molecular response analyses. Abstract 2778P presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Mansfield AS, Goldman J, Lee SH, et al. Treatment outcomes in patients (pts) with advanced c-Met overexpressing (OE) EGFR wildtype (WT) nonsquamous (NSQ) NSCLC who had telisotuzumab vedotin (Teliso-V) dose modifications in the LUMINOSITY trial. Abstract 1948P presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Cassim S, Chepulis L, Keenan R. et al. Patient and carer perceived barriers to early presentation and diagnosis of lung cancer: a systematic review. BMC Cancer. 2019; 19, 25. doi:10.1186/s12885-018-5169-9 Shalata W, Naamneh R, Najjar W, et al. Current and Emerging Therapeutic Strategies for Limited- and Extensive-Stage Small-Cell Lung Cancer. Med Sci. 2025; 13(3):142. doi:10.3390/medsci13030142 Daamen LA, Molenaar IQ, and Groot VP. Recent Advances and Future Challenges in Pancreatic Cancer Care: Early Detection, Liquid Biopsies, Precision Medicine and Artificial Intelligence. J Clin Med. 2023; 12(23):7485. doi:10.3390/jcm12237485 Cereda V and D'Andrea MR. Pancreatic cancer: failures and hopes—a review of new promising treatment approaches. Explor Target Antitumor Ther. 2025;6:1002299. doi: 10.37349/etat.2025.1002299 Deboever N, Jones CM, Yamashita K, et al. Advances in diagnosis and management of cancer of the esophagus. BMJ. 2024; 385 :e074962 doi:10.1136/bmj-2023-074962 Huang J. Overcoming Therapeutic Barriers in Esophageal Cancer Management. J Cancer Clin Trials. 2025;10,289. doi:10.37421/2577-0535.2025.9.289. Nishimuni M, Claro LCL, and Braghiroli MFM. Advancements and challenges in gastric cancer: epidemiology, biomarkers, and therapeutic strategies. Surg Exp Pathol. 2024;7,19. doi.10.1186/s42047-024-00162-4 Li H, Shen M and Wang S. Current therapies and progress in the treatment of advanced gastric cancer. Front Oncol. 2024; 4:1327055. doi:10.3389/fonc.2024.1327055 Pathak PS, Chan G, Deming DA, et al.State-of-the-art management of colorectal cancer: Treatment advances and innovation. Am Soc Clin Oncol Educ Book, 2024; 44(3), p.e438466. doi:10.1200/EDBK_438466 SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床1期抗体药物偶联物临床2期ASCO会议

2025-10-13

·news.abbvie.com

AbbVie to Present New Data at ESMO 2025 Reinforcing Leadership in Advancing Targeted Therapies for Solid Tumors

Oncology R&D News New data from telisotuzumab adizutecan (Temab-A) and ABBV-706 across pancreatic, colorectal, and solid tumors, highlight progress in AbbVie's growing ADC portfolio designed to target difficult-to-treat cancers. NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will unveil new data from its robust antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place October 17-21, in Berlin, Germany. Data from investigational and approved ADCs across AbbVie's portfolio such as telisotuzumab adizutecan (Temab-A),1-3 ABBV-706,4,5 and Emrelis™ (telisotuzumab vedotin),6 in patients with difficult-to-treat tumor types where there is urgent need for additional treatment options,7-15 will be featured in multiple presentations. "Despite recent progress in the treatment of advanced solid tumors, patients still face limited options and pressing unmet needs," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "The compelling data we are sharing at ESMO showcases how we are advancing targeted therapies across a range of solid tumors and highlights the potential of our portfolio." Key highlights AbbVie will present three oral presentations for Temab-A, a next-generation, investigational c-Met directed ADC with a novel topoisomerase 1 inhibitor (Top1i) payload. Phase 1 results with Temab-A both as a monotherapy and in combination across advanced, solid tumors will be presented: Combination with bevacizumab (Bev) in Colorectal Cancer (CRC): In biomarker unselected patients with advanced CRC who have received three or more prior lines of therapy (NCT05029882), treatment with 2.4 mg/kg dose of Temab-A plus Bev (n=30) achieved an objective response rate (ORR) of 26.7% compared to an ORR of 0% with trifluridine/tipiracil with Bev (the current standard of care (SOC), n = 20).1 Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 67% and 65% of patients, respectively.1 Monotherapy in MET-Amplified Solid Tumors: Among 100 patients with advanced MET-amplified solid tumors, including non-small cell lung cancer (NSCLC) (n=29), CRC (n=22), gastroesophageal adenocarcinoma (GEA) (n=14), and 16 other tumor types (n=35) who had progressed after SOC treatment (NCT05029882), Temab-A monotherapy achieved an ORR of 46% across all dose levels and tumor types with higher responses observed in patients with NSCLC (69%) and GEA (71%).2 The most common grade ≥3 TEAEs were anemia (40%) and neutropenia (34%).2 Monotherapy in Pancreatic Ductal Adenocarcinoma (PDAC): Among 42 biomarker unselected patients with advanced/metastatic PDAC who experienced disease progression while receiving or after completing their first-line (1L) therapy (NCT06084481), Temab-A demonstrated an ORR of 24% overall and 40% in patients who received first-line gemcitabine-nab-paclitaxel treatment.3 Grade ≥3 TEAEs occurring in ≥10% of all patients were anemia (38%) and neutropenia (21%).3 "Temab-A continues to show meaningful clinical activity across an expanding range of solid tumors and patient populations, including patients with MET-amplification and increased c-Met expression as we have seen in previously presented data," said Vivek Subbiah, M.D., Chief, Early-Phase Drug Development, Sarah Cannon Research Institute and Temab-A investigator. "These data reinforce Temab-A's potential in multiple solid tumors and thereby warrant its further clinical investigation." AbbVie will also present new analysis from a Phase 1 study of ABBV-706, a SEZ6-directed ADC with a Top1i payload, in relapsed/refractory small cell lung cancer (R/R SCLC) (NCT05599984). A post hoc analysis on data from R/R SCLC patients enrolled in the study, whose tumors had progressed after two lines of therapy (n=80), was done to compare the anti-cancer effect of ABBV-706 monotherapy vs. platinum-based SOC. All patients in this group had received the platinum-based SOC treatment as first-line therapy (1L SOC). Progression-free survival (PFS) during 1L SOC and PFS with ABBV-706 monotherapy as a subsequent line of treatment were analyzed in the same patients by paired Kaplan-Meier analysis. The findings suggest that ABBV-706 may have the potential to replace the platinum-based SOC as a first-line treatment in SCLC.4 In the same trial, ABBV-706 treatment also resulted in rapid clearance of circulating tumor DNA (ctDNA) and circulating tumor cells (CTC). Patients with 100% ctDNA clearance had significantly higher PFS and overall survival (OS) vs. patients without ctDNA clearance.5 These data highlight the potential of ctDNA as an early response marker in SCLC.5 A Phase 2 study assessing ABBV-706 in combination with atezolizumab as replacement of platinum-based chemotherapy is currently ongoing (NCT07155174) in 1L SCLC. Details on key presentations at the ESMO 2025 Congress are available below and the full abstracts are available via the ESMO online program. Title Date/Time Session Abstract / Presentation Number Telisotuzumab Adizutecan (ABBV-400; Temab-A) in Patients With MET-Amplified Advanced Solid Tumors: Results From a Phase 1 Study Sunday, October 19 2:45 - 4:15 PM CEST Oral presentation Proffered paper session: Developmental therapeutics Room: Bremen Auditorium - Hall 6.2 918O Telisotuzumab Adizutecan (ABBV-400; Temab-A) in Combination With Bevacizumab (Bev) in Patients (Pts) With 3+ Colorectal Cancer (CRC): Dose Expansion Results of a Phase 1 Study Sunday, October 19 2:45 - 4:15 PM CEST Mini oral session 1: GI tumors,lower digestive Room: Cologne Auditorium - CityCube A 731MO Phase 1 Basket Study of Telisotuzumab Adizutecan (Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate (ADC): Results from Patients (Pts) With Pancreatic Ductal Adenocarcinoma (PDAC) Monday, October 20 8:30 – 10:00 AM CEST Mini oral session 2: GI tumours, upper digestive Room: Bonn Auditorium - Hall 7.1c 2214MO Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs. investigator's choice chemotherapy (ICC): Phase 3 MIRASOL trial Saturday, October 18 12:00 – 12:45 PM CEST Poster 1068P Efficacy of ABBV-706 as second-line treatment for patients with platinum-refractory/resistant small cell lung cancer Saturday, October 18 12:00 – 12:45 PM CEST Poster 2777P Real World Characteristics and Outcomes of Patients with Third Line or Later Metastatic Colorectal Cancer: Magnetic-101 Study Results Sunday, October 19 12:00 – 12:45 PM CEST E-Poster 873eP ABBV-706, a Seizure-Related Homolog Protein 6 (SEZ6)-Targeting Antibody-Drug Conjugate (ADC), in Patients (Pts) With Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC): Circulating Biomarker and Molecular Response Analyses Saturday, October 18 12:00 – 12:45 PM CEST Poster 2778P Seizure Related 6 Homolog (SEZ6) Expression Pattern and Prognostic Impact in a Real-World Cohort of Patients With Small Cell Lung Cancer Saturday, October 18 12:00 – 12:45 PM CEST E-Poster 2796eP Companion diagnostic assay for c-Met protein overexpression (OE) to identify patients (pts) who may benefit from telisotuzumab vedotin (Teliso-V) Saturday, October 18 12:00 – 12:45 PM CEST Poster 1951P Treatment outcomes in patients (pts) with advanced c- Met overexpressing (OE) EGFR wildtype (WT) nonsquamous (NSQ) NSCLC who had telisotuzumab vedotin (Teliso-V) dose modifications in the LUMINOSITY trial Saturday, October 18 12:00 – 12:45 PM CEST Poster 1948P Ocular surface disorders in patients with c-Met protein- overexpressing NSCLC treated with telisotuzumab vedotin in the LUMINOSITY study Saturday, October 18 12:00 – 12:45 PM CEST Poster 1950P METRIX: International Real-World Study of c-Met Protein Overexpression in Patients With Advanced /Metastatic NSCLC Saturday, October 18 12:00 – 12:45 PM CEST Poster 1923P Telisotuzumab adizutecan (Temab-A) and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Elahere™ (mirvetuximab soravtansine) and Emrelis™ (telisotuzumab vedotin) are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. Additional information on AbbVie clinical trials is available at https://www.clinicaltrials.gov/. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing information for ELAHERE™ (mirvetuximab soravtansine-gynx) Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Contacts: Media: Investors: Sourojit (Jit) Bhowmick, Ph.D. Liz Shea jit.bhowmick@abbvie.com liz.shea@abbvie.com Mabel Martinez mabel.martinez@abbvie.com SOURCE AbbVie

临床1期临床结果抗体药物偶联物临床2期

2025-09-30

·今日头条

2025三季度抗癌“弹药库”上新！中美11款抗癌新药扎堆获批

2025年第三季度，中美抗癌药研发均获显著进展，尤其在肺癌、血液肿瘤及部分实体瘤的精准治疗领域成果突出。中国在HER2突变非小细胞肺癌（NSCLC）与铂耐药卵巢癌领域实现关键突破，美国则在EGFR20号外显子插入突变（exon20ins）肺癌、复发难治性多发性骨髓瘤及H3K27M突变型弥漫中线胶质瘤（DMG，罕见脑瘤）等领域推出创新疗法。总之，本季度中美获批抗癌新药既填补了多个治疗领域空白，也推动肿瘤治疗向精准化、个体化深化；为帮助癌友们增强抗癌信心，下文将全面盘点2025年前三季度中美获批抗癌新药（注：以下信息仅供参考，具体用药方案请务必遵医嘱）。速览：2025第三季度中美已获批上市的抗癌新药从获批药物特征看，2025年第三季度获批的抗癌新药核心趋势有三：一是重度耐药患者获新希望，多款新药对经多线治疗后耐药进展的患者疗效明确，既能控制肿瘤进展、延长生存期，也填补了耐药阶段治疗空白；二是精准医学导向明确，几乎所有新药均围绕肿瘤特定基因突变或蛋白标志物开发（如EGFRexon20ins、HER2激活突变），通过基因检测精准识别后，可为患者匹配个体化方案；三是监管加速响应临床需求，加速审批成为抗癌药上市重要通道，美国FDA尤为突出，通过该通道推动多款药物落地，这既体现癌症患者未被满足的用药需求，也印证全球抗癌药研发水平提升——药物临床价值更明确、研发成功率更高。全面盘点：中国2025Q3获批上市的四款抗癌新药（一）瑞康曲妥珠单抗药物简介 ① 药物名称：瑞康曲妥珠单抗（商品名：艾维达®）。 ② 研发公司：恒瑞医药。 ③ 获批时间：2025年5月29日。 ④ 适应证：局部晚期或转移性非小细胞肺癌。药物详情瑞康曲妥珠单抗是一款靶向HER2的抗体偶联药物（ADC），由曲妥珠单抗、可裂解连接子及拓扑异构酶I抑制剂有效载荷SHR169265巧妙组合而成。2025年5月29日，该药获得国家药监局批准，单药用于成人存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌的治疗。临床研究数据瑞康曲妥珠单抗1/2期SHR-A1811-I-103临床研究第1期阶段临床研究数据显示，全剂量组经研究者评估确认的客观缓解率（ORR）为38.1%，疾病控制率（DCR）为90.5%，中位无进展生存期（PFS）为9.5个月，中位反应持续时间（DOR）为10.3个月。（二）苏维西塔单抗药物简介 ① 药物名称：苏维西塔单抗（suvemcitug，恩泽舒®）。 ② 研发公司：先声药业。 ③ 获批时间：2025年7月3日。 ④ 适应证：含铂化疗治疗失败的复发性卵巢癌、输卵管癌或原发性腹膜癌。药物详情苏维西塔单抗（suvemcitug，商品名：恩泽舒®）是新一代重组人源化抗VEGF兔单克隆抗体，可高度选择性结合人体VEGF，阻断其生物活性，从根源减少肿瘤血管生成，进而抑制肿瘤生长。 2025年7月3日，该药获中国国家药品监督管理局批准上市，适应症为与紫杉醇、多柔比星脂质体或拓扑替康联合，治疗铂耐药后接受过不超过1种系统治疗的成人复发性卵巢癌、输卵管癌或原发性腹膜癌。作为国内首个覆盖铂耐药卵巢癌全人群的靶向疗法，填补了该领域的临床空白。临床研究数据 2024年美国临床肿瘤学会（ASCO）年会上，苏维西塔单抗Ⅲ期SCORES临床试验（NCT04908787）数据得以公布。结果显示，经盲态独立审查委员会（BIRC）评估，苏维西塔单抗组中位无进展生存期（PFS）达5.49个月，显著长于安慰剂组的2.73个月（HR=0.46，P＜0.0001）；客观缓解率（ORR）方面，BIRC评估显示两组分别为26.0% vs 12.1%，研究者评估则为23.1% vs 8.6%。该数据证实，苏维西塔单抗对含铂化疗失败的复发性卵巢癌等疗效显著。（三）埃万妥单抗+拉泽替尼药物简介 ① 药物名称：埃万妥单抗注射液（Rybrevant，amivantamab-vmjw，锐珂®，JNJ6372）。 ② 研发公司：强生（埃万妥单抗）、再鼎医药（兰泽替尼）。 ③ 获批时间：2025年8月8日。 ④ 适应证：局部晚期或转移性非小细胞肺癌。药物详情埃万妥单抗是全球首款获批上市的EGFR/MET双特异性抗体，作为新型靶向药物，其可精准作用于激活及耐药相关的EGFR、MET突变与扩增。 2025年8月8日，强生宣布该药在中国获批一项新适应症：联合拉泽替尼（LAZCLUZE），用于携带EGFR（表皮生长因子受体）19号外显子缺失或21号外显子L858R置换突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。这是埃万妥单抗在中国获批的第三个肺癌适应症，也标志着EGFR经典突变NSCLC一线治疗正式进入“双抗+TKI”联合时代。临床研究数据埃万妥单抗新适应症获批，主要基于III期临床试验MARIPOSA（NCT04487080）的积极结果——该试验旨在评估埃万妥单抗联合兰泽替尼，对比奥希替尼、兰泽替尼（均为三代EGFRTKI单药）一线治疗EGFR突变晚期非小细胞肺癌（NSCLC）的疗效与安全性。中位随访37.8个月（范围0-48.1个月；数据截止2024年12月4日）时，埃万妥单抗联合兰泽替尼的中位总生存期（OS）尚未达到（NE；95%置信区间[CI]：42.9-NE），奥希替尼组中位OS为36.7个月（95%CI：33.4-41），风险比（HR）为0.75（95%CI：0.61-0.92；P=0.005，详见下图）。因联合组未达中位OS，基于OS指数分布假设，以奥希替尼组中位OS除以HR预测其OS；据此计算，联合组预计中位OS为48.9个月（36.7个月÷0.75），较奥希替尼组延长12.2个月，明确体现生存获益。（四）宗格替尼药物简介 ① 药物名称：宗格替尼（Zongertinib，BI 1810631，圣赫途®、Hernexeos®）。 ② 研发公司：勃林格殷格翰公司。 ③ 获批时间：2025年8月29日。 ④ 适应证：不可切除或转移性非小细胞肺癌。药物详情宗格替尼（Zongertinib）是一款新型、口服的HER2选择性酪氨酸激酶抑制剂（TKI），可与HER2酪氨酸激酶结构域（含外显子20插入突变）共价结合，且不影响野生型表皮生长因子受体。 2025年8月29日，该药获中国国家药品监督管理局（NMPA）附条件批准上市！用于存在HER2（ERBB2）激活突变，且既往接受过至少一种系统治疗的不可切除局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的治疗。作为全球首个口服HER2选择性酪氨酸激酶抑制剂，为HER2突变肺癌患者提供了新的靶向治疗选择。全面盘点：美国2025Q3获批上市的八款抗癌新药（一）宗格替尼（Zongertinib）药物简介 ① 药物名称：宗格替尼（Zongertinib，BI 1810631，圣赫途®、Hernexeos®）。 ② 研发公司：勃林格殷格翰公司。 ③ 获批时间：2025年8月29日。 ④ 适应证：不可切除或转移性非小细胞肺癌。药物详情宗格替尼于2025年8月8日率先获美国FDA加速批准，用于治疗经FDA批准检测证实存在HER2（ERBB2）酪氨酸激酶结构域（TKD）激活突变、且接受过全身治疗的不可切除或转移性非鳞状非小细胞肺癌（NSCLC）成人患者——该药既是首个口服HER2肺癌靶向药，也是全球首个针对该突变类型的口服小分子抑制剂。仅7天后（2025年8月15日），美国国家综合癌症网络（NCCN）便更新NSCLC临床实践指南，将宗格替尼片剂（Hernexeos）列为“已接受全身治疗的晚期/转移性HER2突变型NSCLC患者”的首选后续治疗方案；从FDA获批到纳入NCCN指南仅间隔11天，充分印证其临床价值。2025年8月29日，该药进一步获中国批准上市。临床研究数据宗格替尼本次获批主要基于BeamionLUNG-1（NCT04886804）Ⅰa/Ⅰb期研究的优异数据。结果显示：截至数据截止时：队列1确认客观缓解率（ORR）为71%（95%CI：60-80），中位缓解持续时间14.1个月（95%CI：6.9-无法评估），中位无进展生存期（PFS）12.4个月（95%CI：8.2-无法评估）；队列5确认ORR为48%（95%CI：32-65）；队列3确认ORR为30%（95%CI：15-52）（详见下图）。 ▲图源“N Engl J Med”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（二）他雷替尼（Taletrectinib）药物简介 ① 药物名称：他雷替尼（Taletrectinib，DS-6051b，AB106，达伯乐®，Ibtrozi）。 ② 研发公司：葆元生物。 ③ 获批时间：2025年6月11日。 ④ 适应证：ROS1阳性非小细胞肺癌。药物详情他雷替尼是一种口服、强效的、中枢神经系统活性的全新一代ROS1酪氨酸激酶抑制剂（TKI）抑制剂。2025年6月11日，获美国食品药品监督管理局（FDA）批准，用于成人局部晚期或转移性ROS1阳性非小细胞肺癌（NSCLC）的治疗。临床研究数据 2024年ASCO大会公布他雷替尼关键TRUST-I研究（NCT04395677）的振奋数据：在初治（未接受TKI治疗）队列（106例）中，客观缓解率（cORR）达90.6%（95%CI：83.33~95.38），即超90%患者治疗后肿瘤缩小超30%或完全消失；疾病控制率（DCR）达95.3%（95%CI：89.33~98.45），其中4例完全缓解（CR），24个月无进展生存率（PFS）为70.5%（95%CI：59.17~79.16）。在接受过1种ROS1抑制剂（未化疗）的队列中，客观缓解率（cORR）达51.5%（95%CI：38.88~64.01），疾病控制率（DCR）达83.3%（95%CI：72.13~91.38），中位无进展生存期（PFS）达7.6个月（95%CI：5.52~11.96）。 ▲图源“JCO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（三）舒沃替尼（Sunvozertinib）药物简介 ① 药物名称：舒沃替尼（Sunvozertinib，DZD9008，舒沃哲®，Zegfrovy®）。 ② 研发公司：迪哲医药。 ③ 获批时间：2025年7月2日。 ④ 适应证：EGFR exon20ins非小细胞肺癌。药物详情舒沃替尼是一款口服、不可逆、高选择性EGFR酪氨酸激酶抑制剂，可针对多种EGFR突变亚型，它是中国上市的首款国研EGFR靶向药。 2025年7月2日，该药获美国FDA批准，用于经含铂化疗进展、确认存在EGFR exon20ins的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者，成为全球首款在美国获批该适应证的中国创新药。临床研究数据舒沃替尼获FDA批准，主要基于1/2期WU-KONG1B部分（WU-KONG1B）试验（NCT03974022）的振奋数据。结果显示：在主要疗效人群中，总体缓解率（ORR）达46%（95%CI,35%-57%），缓解持续时间（DOR）为11.1个月（95%CI,8.2-无法评估）。（四）Teliso-V 药物简介 ① 药物名称：Teliso-V（Telisotuzumab vedotin，ABBV-399，Emrelis）。 ② 研发公司：艾伯维（AbbVie）。 ③ 获批时间：2025年5月14日。 ④ 适应证：高c-Met表达的非小细胞肺癌。药物详情 Telisotuzumab vedotin（Teliso-V，ABBV-399）是艾伯维（AbbVie）研发的靶向c-Met抗体-药物偶联物（ADC），搭载单甲基奥瑞他汀E（MMAE）细胞毒性载荷，可精准靶向高c-Met表达的非小细胞肺癌（NSCLC）患者。 2025年5月14日，该药获美国FDA加速批准，用于治疗既往接受过全身治疗的局部晚期或转移性、高c-Met蛋白过表达（OE）非鳞状NSCLC成人患者，同时成为全球首款c-Met靶向ADC药物。作为全球唯一获批该适应症的创新疗法，Teliso-V凭借“精准靶向+c-Met过表达”的双重优势，既开启该领域“专属治疗”新时代、填补临床空白，更让无数曾陷治疗困境的患者迎来从“无药可治”到“精准破局”的全新生存希望。临床研究数据 Teliso-V的获批基于在2024年ASCO大会上公布的Ⅱ期LUMINOSITY试验（NCT03539536）的重磅数据支持。研究共纳入172例Ⅰ/Ⅱ期非鳞状EGFR野生型非小细胞肺癌（NSCLC）患者，接受Teliso-V治疗。结果显示：全组患者的客观缓解率（ORR）达28.6%。其中，c-Met高表达亚组的ORR提升至34.6%（95%CI：24.2~46.2），c-Met中表达亚组的ORR为22.9%（95%CI：14.4~33.4）。由此可见，多数患者肿瘤体积呈现不同程度的缩小。（五）Dato-DXd 药物简介 ① 药物名称：Dato-DXd（Datopotamab deruxtecan，Datroway）。 ② 研发公司：第一三共株式会社。 ③ 获批时间：2025年6月23日（非小细胞肺癌）、2025年1月17日（乳腺癌）。 ④ 适应证：非小细胞肺癌、乳腺癌。药物详情 Dato-DXd是Trop-2靶向抗体-拓扑异构酶抑制剂偶联物。2025年1月17日，该药获美国FDA批准，用于治疗无法切除或转移性、激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（IHC0、IHC1+或IHC2+/ISH-）的成年乳腺癌患者，此类患者此前已接受过针对该转移性或不可切除疾病的内分泌治疗与化疗。 2025年6月23日，Dato-DXd再获FDA加速批准，用于治疗局部晚期或转移性EGFR突变非小细胞肺癌（NSCLC）成年患者，此类患者此前已接受过EGFR靶向治疗与铂类化疗。临床研究数据 Dato-DXd治疗非小细胞肺癌的研究结果显示：既往接受奥希替尼（Tagrisso；n=96）治疗的患者，客观缓解率（ORR）达44.8%，其中4.2%患者肿瘤靶病灶完全消失，达完全缓解（CR），疾病控制率（DCR）为85.4%；中位无进展生存期（PFS）5.7个月，总生存期（OS）14.7个月。其治疗乳腺癌的TROPION-Breast01研究则显示：半数患者肿瘤控制时间至少6.9个月（化疗组为4.9个月），36%患者肿瘤大幅缩小或消失（化疗组为23%）。（六）阿伐替尼+地法替尼联合疗法药物简介 ① 药物名称：阿伐替尼（Avutometinib）+地法替尼（Defactinib）。 ② 研发公司：Avmapki Fakzynja Co-pack，Verastem，Inc。 ③ 获批时间：2025年5月8日。 ④ 适应证：KRAS突变复发性低级别浆液性卵巢癌。药物详情阿伐替尼（Avutometinib）与地法替尼（Defactinib）均为靶向治疗药物：阿伐替尼可阻断MEK与RAF两条促癌生长通路，地法替尼则靶向抑制FAK通路。 2025年5月8日，该联合疗法获美国FDA加速批准，用于治疗既往接受过全身治疗的KRAS突变复发性低级别浆液性卵巢癌（LGSOC）成年患者，也是首个用于治疗该罕见难治性卵巢癌亚型的药物。临床研究数据该联合疗法本次获批，主要基于2025年3月妇科肿瘤学会年会上公布的2期临床试验结果。该试验入组患者均曾接受过至少一种化疗，且患有复发性可测量疾病。结果显示：44%携带KRAS突变的患者实现肿瘤缩小。（七）多达维普龙（Dordaviprone）药物简介 ① 药物名称：多达维普龙（Dordaviprone，Modeyso®）。 ② 研发公司：Jazz Pharmaceuticals。 ③ 获批时间：2025年8月6日。 ④ 适应证：H3K27M突变弥漫性中线胶质瘤（DMG）。药物详情多达维普龙（Dordaviprone，商品名：Modeyso®）是一款可穿透血脑屏障的小分子亚胺吡啶酮。2025年8月6日，该药获美国FDA加速批准上市，适用于1岁及以上、既往治疗后病情进展的H3K27M突变型弥漫中线胶质瘤（DMG）成人与儿科患者，同时也是首个针对该突变类型DMG的系统性疗法，为该罕见脑瘤患者带来新的希望与选择。阅读原文了解详情：全球首个靶向全身疗法来了！First-in-class新药获FDA批准，这款致命肿瘤从无药可医到多点救赎！临床研究数据多达维普龙获批主要基于《临床肿瘤学杂志》发表的5 项非随机临床试验汇总分析数据。结果显示：客观缓解率（ORR）20%（95% CI：10.0-33.7），疾病控制率（DCR）40%（95% CI：26.4-54.8），其中1 例完全缓解（CR）、9 例部分缓解（PR）、10 例达疾病稳定（SD）（详见下图）。中位缓解持续时间（DOR）11.2 个月（95% CI：3.8 - 未达到）。中位总生存期（OS）13.7 个月（95% CI：8.0-20.3），12 个月、24 个月总生存率分别为 57.3%（95% CI：41.4-70.3）、34.7%（95% CI：20.7-49.2）。（八）派安普利单抗（Penpulimab-kcqx）药物简介 ① 药物名称：派安普利单抗（AK105，Penpulimab-kcqx，Anike®，安尼可®）。 ② 研发公司：正大天晴康方生物医药。 ③ 获批时间：2025年4月24日（美国）、2025年3月14日（中国）。 ④ 适应证：复发或转移性鼻咽癌（NPC）。药物详情派安普利单抗（AK105，Penpulimab-kcqx，Anike®，安尼可®）是由正大天晴康方生物医药研发的一款抗程序性细胞死亡-1(PD-1)IgG1抗体。 2025年4月24日，该药获美国FDA批准两项适应症：一是联合顺铂或卡铂与吉西他滨，用于复发或转移性非角化性鼻咽癌（NPC）成人患者的一线治疗；二是单药治疗转移性非角化性鼻咽癌成人患者，此类患者需在铂基化疗及至少一种其他既往治疗后疾病进展。此前于2025年3月14日，派安普利单抗已获中国国家药品监督管理局（NMPA）批准，联合化疗用于复发或转移性鼻咽癌的一线治疗。临床研究数据 AK105-304研究显示，派安普利单抗联合化疗方案治疗后，半数患者的肿瘤控制时间至少9.6个月，单纯化疗的对照组则为7.0个月。小编寄语除上文提到的这些2025年第三季度已获批上市的抗癌新药外，还有诸多抗癌新药/新技术正在蓄势待发。我们期待2025年下半年有更多新药与技术突破审批关卡，为癌友带来翘首以盼的曙光。令人振奋的是，部分抗癌新药与前沿技术已率先在中国启动临床试验，这意味着国内患者有望获得免费试用最新药物的宝贵机会，在抗癌中抢占先机。想了解更多抗癌新药/新技术的患者，可将治疗经历、近期病理报告等资料，提交至全球肿瘤医生网医学部，进行初步评估。参考资料 [1]Arrillaga-Romany I,et al.ONC201 (Dordaviprone) in Recurrent H3 K27M-Mutant Diffuse Midline Glioma. J Clin Oncol. 2024 May 1;42(13):1542-1552. https://ascopubs.org/doi/10.1200/JCO.23.01134 #方舟基因宝藏计划#

抗体药物偶联物上市批准申请上市加速审批临床2期

100 项与 Telisotuzumab vedotin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11344	-	-	DB15104

研发状态

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适应症	国家/地区	公司	日期
c-Met 阳性的非鳞状非小细胞肺癌	美国	AbbVie, Inc.	2025-05-14

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期非鳞状非小细胞肺癌	临床3期	-	AbbVie, Inc.	2024-05-31
非鳞状非小细胞肺癌	临床3期	日本	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	阿根廷	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	澳大利亚	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	奥地利	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	比利时	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	巴西	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	保加利亚	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	加拿大	AbbVie, Inc.	2022-01-02
非鳞状非小细胞肺癌	临床3期	智利	AbbVie, Inc.	2022-01-02

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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


NCT05513703 (CTgov)	临床2期	转移性非鳞状非小细胞肺癌 \| c-Met 阳性的非鳞状非小细胞肺癌	9	Telisotuzumab Vedotin	選網築壓醖願鹽襯艱淵 = 糧觸衊醖廠顧膚鬱糧觸選廠醖糧鬱獵壓簾鏇積 (糧鹹餘糧簾鹽廠鏇顧積, 醖襯簾積膚膚壓選衊獵 ~ 夢艱獵鑰鬱積鹹製選衊) 更多	-	2025-10-24
NCT03539536 (LUMINOSITY, WCLC2025)	临床2期	鳞状细胞肺癌三线 \| 二线 MET overexpression	168	Telisotuzumab Vedotin 1.9 mg/kg (c-Met OE Total；No PN ≥3)	蓋鹹範範遞襯餘衊築艱(鏇願鏇遞艱膚糧憲選襯) = 繭糧蓋選製鹹網齋積鹽繭網觸廠糧餘膚襯網願 (夢鹽遞鬱壓鑰膚鬱餘鬱 ) 更多	积极	2025-09-08
				Telisotuzumab Vedotin 1.9 mg/kg (c-Met OE Total；PN ≥3)	蓋鹹範範遞襯餘衊築艱(鏇願鏇遞艱膚糧憲選襯) = 蓋製構獵艱構鑰簾網鹽繭網觸廠糧餘膚襯網願 (夢鹽遞鬱壓鑰膚鬱餘鬱 ) 更多
NCT03539536 (LUMINOSITY, ASCO2025)	临床2期	c-Met阳性非小细胞肺癌二线 c-Met overexpression \| KRAS \| BRAF ... 更多	83	Teliso-V 1.9 mg/kg	構顧廠顧積淵選遞構淵(襯齋鏇齋膚積鹽齋築獵) = 鬱積餘蓋遞憲鹹鹽網蓋糧鏇簾獵願網艱齋醖壓 (鬱築窪蓋餘襯遞夢製鬱 ) 更多	积极	2025-05-30
				Placebo	淵窪築餘築夢蓋憲憲齋(顧夢膚網艱餘鑰襯鹽窪) = 蓋簾顧鬱襯壓觸壓憲醖鏇繭願願簾淵築願糧淵 (網衊願獵憲糧範憲願糧 ) 更多
NCT03539536 (LUMINOSITY, FDA_CDER) 人工标引	临床2期	c-Met阳性非小细胞肺癌 MET Overexpression	84	EMRELIS (high c-Met protein overexpression)	膚鏇鹹夢願遞鏇襯簾觸(窪鏇願齋憲淵艱鹹獵製) = 齋鬱簾齋鹽簾醖繭餘製糧壓築鏇衊顧醖網範鏇 (願餘衊範範憲鏇選膚蓋, 24 ~ 46) 更多	积极	2025-05-14
NCT03539536 (LUMINOSITY, ESMO_ELCC2025) 人工标引	临床2期	c-Met阳性非小细胞肺癌 \| 晚期非小细胞肺癌 EGFR Gene Mutation Negative \| MET Overexpression	172	Telisotuzumab vedotin 1.9 mg/kg (c-Met high: ≥50% 3+)	製積築醖鏇範選蓋襯積(製顧築簾構蓋膚鹽糧簾) = 鏇餘鑰憲鹽窪蓋夢選壓遞齋願夢蓋窪範餘壓壓 (淵鹽蓋鬱鹹製廠鹹鑰簾, 24.5 ~ 45.7) 更多	积极	2025-03-26
				Telisotuzumab vedotin 1.9 mg/kg (c-Met intermediate [int]: 25 to <50% 3+)	製積築醖鏇範選蓋襯積(製顧築簾構蓋膚鹽糧簾) = 蓋願夢蓋築範獵廠遞膚遞齋願夢蓋窪範餘壓壓 (淵鹽蓋鬱鹹製廠鹹鑰簾, 15.2 ~ 34.3) 更多
NCT02099058 (Pubmed \| Ann Oncol) 人工标引	临床1期	非小细胞肺癌二线 EGFR Mutation \| MET Overexpression	38	Telisotuzumab vedotin + osimertinib	壓築鹽顧艱顧觸鑰範網(遞膚繭築鏇積築壓鹹鹽) = peripheral sensory neuropathy (50%), peripheral edema (32%), and nausea (24%) 鏇積窪壓憲艱襯範壓餘 (積製觸製鏇觸鹹簾製壓 ) 更多	积极	2025-01-01
NCT03539536 (ESMO2024)	临床2期	c-Met 阳性的非鳞状非小细胞肺癌	-	Telisotuzumab vedotin	願襯積觸網襯鹽廠齋簾(餘鬱鏇簾積鏇選壓齋齋) = 簾觸廠構鏇製鹹範艱餘選憲襯憲壓獵廠艱簾醖 (憲選獵鹹遞簾顧顧夢蓋 )	-	2024-09-14
				Placebo	願襯積觸網襯鹽廠齋簾(餘鬱鏇簾積鏇選壓齋齋) = 觸蓋衊築選簾齋壓鬱範選憲襯憲壓獵廠艱簾醖 (憲選獵鹹遞簾顧顧夢蓋 )
NCT02099058 (WCLC2024) 人工标引	临床1期	c-Met阳性非小细胞肺癌 MET Overexpression	30	Teliso-v (c-Met-positive tumor cells with 3+ intensity)	鹹醖選製鬱鹽構鏇窪醖(築願鹹願簾窪範網觸淵) = 築淵獵製鹽襯廠繭膚憲鹽窪繭膚夢廠齋製襯繭 (積鏇選繭簾鹹夢夢網築 )	积极	2024-09-09
				Teliso-v (below (A cutoff value of 25% c-Met-positive tumor cells with 3+ intensity))	鹹醖選製鬱鹽構鏇窪醖(築願鹹願簾窪範網觸淵) = 膚窪築願餘簾壓夢製遞鹽窪繭膚夢廠齋製襯繭 (積鏇選繭簾鹹夢夢網築 )
NCT03539536 (LUMINOSITY, Pubmed) 人工标引	临床2期	c-Met阳性非小细胞肺癌 c-Met protein-overexpressing	172	Telisotuzumab vedotin (Teliso-V)	觸淵淵顧築繭顧餘齋餘(膚蓋築蓋繭製願夢構廠) = 淵觸鑰網艱獵選簾鏇醖選淵範夢廠簾範鏇衊構 (壓蓋夢憲構製網獵齋壓, 21.7 ~ 36.2) 更多	积极	2024-06-06
				Telisotuzumab vedotin (c-Met high)	觸淵淵顧築繭顧餘齋餘(膚蓋築蓋繭製願夢構廠) = 窪選繭獵艱夢選廠廠衊選淵範夢廠簾範鏇衊構 (壓蓋夢憲構製網獵齋壓, 24.2 ~ 46.2) 更多
NCT03539536 (LUMINOSITY, ASCO2024) 人工标引	临床2期	非小细胞肺癌 \| c-Met 阳性的非鳞状非小细胞肺癌三线 c-Met protein overexpression	172	Telisotuzumab vedotin (c-Met High)	糧醖鏇糧範壓獵獵蓋醖(簾構鏇簾簾壓遞獵糧鑰) = 醖齋夢壓憲膚餘壓遞積鏇艱糧蓋鑰選構積蓋夢 (鬱遞積願顧淵觸願簾顧, 24.2 ~ 46.2) 更多	积极	2024-05-24
				Telisotuzumab vedotin (c-Met Int)	糧醖鏇糧範壓獵獵蓋醖(簾構鏇簾簾壓遞獵糧鑰) = 鏇積構選襯淵糧衊艱憲鏇艱糧蓋鑰選構積蓋夢 (鬱遞積願顧淵觸願簾顧, 14.4 ~ 33.4) 更多