Additionally, high levels of MET amplification have also been reported in those who have NSCLC and tumors that harbor EGFR-activating mutations, who have experienced disease progression on EGFR TKIs. Telisotuzumab Vedotin Plus Erlotinib Shows Encouraging Activity in 10 , 12 , 13 Tisotumab vedotin received accelerated approval from the US Food and Drug Administration in September 2021 for treatment of adult patients with recurrent or metastatic cervical cancer who have . Sign in. Epub 2019 Jun 11. Bethesda, MD 20894, Web Policies Lung-MAP S1400K was designed to evaluate the response to telisotuzumab vedotin, an antibody-drug conjugate targeting c-MET, in patients with c-MET-positive squamous cell carcinoma (SCC). Telisotuzumab vedotin (teliso-V) in combination with erlotinib (Tarceva) induced promising outcomes in patients with advanced, EGFR -mutated, c-MET-positive non-small cell lung cancer (NSCLC . This application was granted priority review. 1 Proposed mechanism of action View Details Ladiratuzumab vedotin is an investigational agent. D. Ross Camidge, Jair Bar, Hidehito Horinouchi, Jonathan W. Goldman, Fedor Vladimirovich Moiseenko, Elena Filippova, Irfan Cicin, Penelope Ann Bradbury, Nathalie Daaboul, Pascale www-search.liangyihui.net Trastuzumab deruxtecan (DS-8201a; T-DXd) is an anti-HER2 ADC in which trastuzumab is conjugated with DXd, a novel topoisomerase I inhibitor payload. Disitamab vedotin | Seagen Development Pipeline This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population (s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group (s) to further evaluate efficacy in the selected population (s) (Stage 2). The site is secure. Accessed January 5, 2022. Dr. Kelly reports research grants and personal fees for Advisory Board from AbbVie outside this submitted work, personal fees from AstraZeneca for participation in Advisory Board and DMC meeting, research grant (drug only) and personal fees for Advisory Board from Bristol Meyers Squibb, research funding (drug only) and personal fees for DMC meeting from Genentech, personal fees for Advisory Board from Pfizer outside the submitted work. OncClub: Join the Chat on Trending Trials in Cancer, 2023 nominations are open for Giants of Cancer Care, Complimentary print subscription for home or office delivery, In-person and virtual events just for HCPs, Subscribe to our eNewsletter for breaking news and curated content, https://clinicaltrials.gov/ct2/show/NCT03539536. 2021 Jun 15;19(6):342. doi: 10.3390/md19060342. Seagen - Dedicated to revolutionizing cancer care 4 /5. Telisotuzumab vedotin plus erlotinib was safe and effective in EGFR-mutant, c-MET + non-small cell lung cancer (NSCLC). Strong Efficacy and Safety Data Observed With Telisotuzumab Vedotin for Previously, the agent has demonstrated antitumor activity in both MET-amplified and c-Metoverexpressing tumor models. Pipeline - Enfortumab Vedotin (PADCEV) - Seagen Seagen does not necessarily endorse the organization associated with this link and takes no responsibility for the content contained therein. Garcia-Robledo JE, Rosell R, Ruz-Patio A, Sotelo C, Arrieta O, Zatarain-Barrn L, Ordoez C, Jaller E, Rojas L, Russo A, de Miguel-Prez D, Rolfo C, Cardona AF. Risk and benefit for umbrella trials in oncology: a systematic review and meta-analysis. 2022 Jan-Dec;16:17534666211066064. doi: 10.1177/17534666211066064. Teliso-V (ABBV-399), an anti-c-Met antibody-drug conjugate, delivers a cytotoxic payload (monomethyl auristatin E) into c-Met OE tumor cells. The Internet site that you have requested may not be optimized to your screen size. |c-MetNSCLCTelisotuzumab vedotin Disclaimer, National Library of Medicine Read More Sharsti Sandall, Ph.D. Its potential activity combined with programmed cell death protein-1 inhibitors has not been previously evaluated. A Study to Assess Disease Activity and Adverse Events of Intravenous Accessibility Very difficult. Telisotuzumab Vedotin Demonstrates Efficacy and Tolerability in Expanded Access to Telisotuzumab Vedotin - Full Text View The primary endpoint was response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Seagen is an industry leader in ADC research and the use of this technology in the treatment of cancer. All rights reserved. Unless otherwise specified, all product names appearing in this internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. Sixty-nine percent of patients had received bevacizumab as part of prior systemic therapy. Patients with central nervous system (CNS) metastases are only eligible if they had received definitive therapy, such as surgery or radiotherapy. Dr. Ramalingam reports personal fees for Advisory board from AbbVie, Amgen, BMS, Genentech, Lilly, Takeda and Loxo and grants from AstraZeneca, Merck, and Tesaro outside the submitted work. The FDA granted a breakthrough therapy designation to telisotuzumab vedotin for use in patients with advanced or metastatic EGFR wild-type, nonsquamous nonsmall cell lung cancer who have high levels of c-Met overexpression and whose disease has progressed on, or after, platinum-based chemotherapy. Most metastatic breast cancers express LIV-1, which also has been detected in a number of other cancers, including melanoma, prostate, ovarian, uterine, and cervical cancers. The .gov means its official. The duration of treatment with erlotinib was found to be longer in those with EGFR-mutant disease vs those without that mutation. a promising objective response rate (orr) and a tolerable safety profile were observed with telisotuzumab vedotin (teliso-v; abbv-399) monotherapy to treat patients with previously treated c-met-positive advanced non-small cell lung cancer (nsclc), according to data from a phase 2 trial (nct03539536) at the american association for cancer November 10, 2022 - Supplement: Conference Highlights ESMO 2022 - EPOV This indication is approved under accelerated approval based on tumor response rate and durability of response. Proposed mechanism of action 2021 Apr;10(7):2350-2358. doi: 10.1002/cam4.3815. Seagen Reports Second Quarter 2022 Financial Results Seagen - Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK In a phase 1/1b study (NCT02099058) in patients (pts) with c-Met OE NSCLC, Teliso-V alone or in combination with erlotinib demonstrated an acceptable safety profile and antitumor activity. Our Mission In it for innovation As a pioneer in antibody-drug conjugates (ADCs), Seagen has led the way in novel cancer therapeutics for more than 20 years. 2022 Jul 8;20(1):219. doi: 10.1186/s12916-022-02420-2. received milestone payment triggered by abbvie initiating a phase 3 trial of telisotuzumab vedotin (abbv- 399): seagen received a $12 million milestone payment under its antibody drug. Lifastuzumab Vedotin | RG-7599 | DNIB0600A Target Phosphate-sodium cotransporter SLC34A2 (solute carrier family 34 sodium phosphate member 2, sodium/phosphate cotransporter 2B, NaPi2b, NaPi3b, NAPI-3B). Todays announcement marks an important step in our mission to advance new oncology treatments across tumor types to improve standards of care for patients with cancer.. The information provided on this site is in response to unsolicited requests for information from . 8600 Rockville Pike a novel, investigational antibody-drug conjugate directed to HER2. A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET The DCRs with the combination in these subsets were 86.2% (95% CI, 68.3%-96.1%) and 85.7% (95% CI, 42.1%-99.6%), respectively. Product labeling includes a boxed warning for ocular toxicity. official website and that any information you provide is encrypted Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS. Background: Teliso-V is an anti-c-Met antibody conjugated with a tubulin inhibitor MMAE. Dr. Arnold reports grants from AbbVie for other clinical trials, outside the submitted work. Approximately 698 adult participants with c-Met overexpressing NSCLC will be . Epub 2018 Oct 4. The relationship between tissue factor and cancer progression: insights from bench and bedside. Clinical trial design in the era of precision medicine. Later enrollment required presence of an EGFR -activating mutation ( EGFR -M +) and progression on a prior EGFR TKI. Telisotuzumab Vedotin (ABBV 399 / ABBV-399 / ABT 399) Drug Description This activation is thought to be the primary driver of high levels of MET amplification or MET exon 14 skipping mutations in some cases of NSCLC. Telisotuzumab vedotin failed to meet the pre-specified response needed to justify continuing enrollment to S1400K. First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. Camidge DR, Morgensztern D, Heist RS, Barve M, Vokes E, Goldman JW, Hong DS, Bauer TM, Strickler JH, Angevin E, Motwani M, Parikh A, Sun Z, Bach BA, Wu J, Komarnitsky PB, Kelly K. Clin Cancer Res. Cocco E, Varughese J, Buza N, et al. Patients received tisotumab vedotin-tftv 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity. A total of 3 patients experienced a TEAE that resulted in death; 2 of these patients experienced progressive disease and 1 died from hemoptysis. The median overall and progression-free survival was 5.6 and 2.4 months, respectively. Keywords provided by AbbVie: Antibody-drug conjugates in solid tumors: a look into novel targets Do you want to continue to the external site and leave Seagen.com? Introduction: Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate that has exhibited antitumor activity as monotherapy in NSCLC. 2020 Dec;21(12):1589-1601. doi: 10.1016/S1470-2045(20)30475-7. received milestone payment triggered by abbvie initiating a phase 3 trial of telisotuzumab vedotin (abbv- 399): seagen received a $12 million milestone payment under its antibody drug conjugate (adc) technology licensing agreement with abbvie following the initiation of a phase 3 study of abbvie's telisotuzumab vedotin for the treatment of From left to right, best change in tumor measurements included in the plot are displayed as: Would you like email updates of new search results? Patients with NSCLC have a high unmet need and telisotuzumab vedotin has the potential to provide them with an additional treatment option to manage their disease, Mohamed Zaki, MD, PhD, vice president and global head of oncology clinical development at AbbVie, stated in a press release. Pneumonitis was an unanticipated toxicity observed in patients with SCC. However, he noted, the patient population was smaller than originally planned, the BRAF-mutant subset was underrepresented, and the control arm underperformed in comparison to adjuvant nivolumab in . Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib Purpose: Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate. north chicago, ill., jan. 4, 2022 /prnewswire/ -- abbvie (nyse: abbv) announced today that the u.s. food and drug administration (fda) granted breakthrough therapy designation (btd) to investigational telisotuzumab vedotin (teliso-v) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (egfr) wild type, Borghaei H, Redman MW, Kelly K, Waqar SN, Robert F, Kiefer GJ, Stella PJ, Minichiello K, Gandara DR, Herbst RS, Papadimitrakopoulou VA. Clin Lung Cancer. The Internet site that you have requested may not be optimized to your screen size. The site is secure. Tisotumab vedotin is designed to target tissue factor (TF) using our proprietary antibodydrug conjugate (ADC) technology. The study was sponsored by the Division of Cancer Treatment and Diagnosis, NCI, and the brentuximab vedotin was provided by Seagen under a Cooperative Research and Development Agreement with NCI. You are now leaving the Seagen site. Antibody-drug conjugate; Lung-MAP; Squamous cell carcinoma; Telisotuzumab vedotin; c-MET. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. There were 3 grade 5 events (2 pneumonitis, in Cohort 2, and 1 bronchopulmonary hemorrhage, in Cohort 1). Telisotuzumab vedotin (ABBV-399) | AbbVie Laboratory of Professor David Dolphin in the area of porphyrin chemistry associated with photodynamic therapy of cancer. Seagen is a global biotechnology company dedicated to revolutionizing cancer care. The main efficacy outcome measures were confirmed objective response rate (ORR) as assessed by an independent review committee (IRC) using RECIST v1.1 and duration of response (DOR). U10 CA180868/CA/NCI NIH HHS/United States, UG1 CA189971/CA/NCI NIH HHS/United States, UG1 CA189873/CA/NCI NIH HHS/United States, UL1 TR001863/TR/NCATS NIH HHS/United States, U10 CA180821/CA/NCI NIH HHS/United States, UG1 CA189952/CA/NCI NIH HHS/United States, UM1 CA186704/CA/NCI NIH HHS/United States, UG1 CA189858/CA/NCI NIH HHS/United States, UG1 CA189830/CA/NCI NIH HHS/United States, UG1 CA239767/CA/NCI NIH HHS/United States, U10 CA180828/CA/NCI NIH HHS/United States, U10 CA180820/CA/NCI NIH HHS/United States, UG1 CA189808/CA/NCI NIH HHS/United States, UG1 CA189997/CA/NCI NIH HHS/United States, U10 CA180819/CA/NCI NIH HHS/United States, UG1 CA233339/CA/NCI NIH HHS/United States, UG1 CA189804/CA/NCI NIH HHS/United States, P30 CA093373/CA/NCI NIH HHS/United States, U10 CA180888/CA/NCI NIH HHS/United States, UG1 CA189958/CA/NCI NIH HHS/United States, NCI CPTC Antibody Characterization Program. Previously, the ADC was evaluated in combination with erlotinib (Tarceva) or nivolumab (Opdivo) in patients with c-Metpositive NSCLC, as part of a phase 1/1b trial (NCT02099058).2 The multicenter, open-label trial enrolled patients with advanced NSCLC not amenable to resection or other approved options who had c-Met overexpression and a documented MET exon 14 skipping mutation or MET amplification. Ladiratuzumab vedotin targets LIV-1 using our proprietary antibody-drug conjugate (ADC) technology. Easy. Telisotuzumab vedotin (ABBV-399, ABT-700; ABBVie) is an antibody-drug conjugate composed of telisotuzumab, a monoclonal antibody against the tumor-associated antigen and proto-oncogene, MET receptor tyrosine kinase conjugated to the cytotoxic agent monomethyl auristatin E (MMAE) via a valine-citrulline (vc) peptide linker . An in-house version of the EGFR antibody cetuximab (Patent US6,217,866 B1) was generated from the published primary sequences and produced in CHO-K1 cells at Regeneron. The median age among all 36 patients was 65 years (range, 34-83), 61% were female, and 69% had an ECOG performance status of 1. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie. LIV-1 is expressed in most metastatic breast cancers, as well as in melanoma, and prostate, ovarian, uterine, and cervical cancers. In the phase 1, dose-expansion portion of the trial, single-agent telisotuzumab vedotin was examined at escalating intravenous doses, going from 0.15 mg/kg every 3 weeks to 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 1.8 mg/kg, 2.4 mg/kg, 3.0 mg/kg, up to 3.3 mg/kg in patients with c-Metpositive NSCLC. Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1 protein utilizing Seattle Genetics' proprietary ADC technology. the ev-201 trial (nct03219333) is a single-arm, dual-cohort, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a pd-1 or pd-l1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and TF is highly expressed on many solid tumors, including ovarian, prostate, bladder, esophageal, endometrial, and lung tumors. 1 NL: Measurements for patients who had progressive disease at their first assessment based on new lesions are labeled by NL. Two responses (response rate of 9%; 95% confidence interval, 0%-20%) were reported in cohort 1 (1 complete and 1 unconfirmed partial response), whereas 10 patients had stable disease, with a disease control rate of 52%. Patients with previously treated SCC with c-MET-positive tumors (H score 150, Ventana SP44 assay) were enrolled into 2 cohorts: Cohort 1 (immune checkpoint inhibitor-naive) and Cohort 2 (immune checkpoint inhibitor refractory). News release. Dr. Redman, Dr. Stinchcombe, Dr. Leighl, Dr. Tanna, Dr. Raddin, Dr. Minichiello, and Dr. Bradley report no relevant conflicts of interest. Availability will depend on territory eligibility. We're developing transformative therapies that make a meaningful difference in people's lives. ClinicalTrials.gov. geek prank hacker screen deploying a net web application to iis with powershell Van den Berg YW, Osanto S, Reitsma PH, Versteeg HH. Population pharmacokinetic analysis for tisotumab vedotin in patients Interim analysis was planned after 20 evaluable patients, with 3 responses needed to continue enrollment. Pipeline - Ladiratuzumab Vedotin - Seagen Telisotuzumab vedotin is a humanized monoclonal antibody that targets c-Met and is conjugated to monomethyl auristatin E (MMAE). Before Telisotuzumab Vedotin Shows Promising Antitumor Activity in Certain An official website of the United States government. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) being developed for treatment of solid tumors known to express TF. Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. Forty-nine patients (14% of screened patients) were assigned to S1400K, 28 patients enrolled (15 in Cohort 1 and 13 in Cohort 2), and 23 were eligible. If you are a resident of a country other than those to which the site is directed, please return to AbbVie.com or contact your local AbbVie affiliate to obtain the appropriate product information for your country of residence. Most participants (97%) had nonsquamous histology and 3% had squamous histology. Accessed January 5, 2022. Telisotuzumab vedotin monotherapy demonstrated a promising objective response rate and has a tolerable safety profile in patients with previously treated c-Met-positive advanced non-small cell lung cancer, according to findings from a phase 2 trial presented in a poster at the American Association for Cancer Research Annual Meeting 2021. For information on the COVID-19 pandemic, see the following resources: Follow the Oncology Center of Excellence on Twitter @FDAOncology. A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET The response rate seen was lower than that described in the phase I clinical trial of telisotuzumab vedotin in c-MET-positive NSCLC, where 3 of 16 c-MET-positive patients with NSCLC treated with telisotuzumab vedotin at a dose of 2.4 to 3.0 mg/kg had a partial response; all patients with response had squamous histology. D. Ross Camidge, MD, PhD. AbbVie announces US FDA granted breakthrough therapy designation (BTD) to telisotuzumab vedotin (teliso-V) for previously treated non-small cell lung cancer. Secondary endpoints included progression-free survival, overall survival, response within cohort, duration of response, and toxicities. 0 rating. Epub 2020 Oct 27. Federal government websites often end in .gov or .mil. Efficacy was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. The ADC is internalized and has been shown to release MMAE, which binds to tubulin and causes cell death through the inhibition of mitosis. 2022. News | Astellas Pharma Inc. Telisotuzumab vedotinc-Met auristatin EMMAE ADCMMAE MMAE METc-Met This resource link is for informational purposes only. Stage 1 of the trial will examine the ADC as second- and third-line treatment in this population, and then investigators will expand the groups to further assess the efficacy of the agent in select patient populations. The primary end point of the trial is ORR, and key secondary end points include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival. Telisotuzumab vedotin is a first-in-class antibody drug conjugate that uses a cleavable linker to combine a recombinant c-Met-targeting humanized monoclonal antibody (ABT-700) and MMAE, which is a potent inhibitor of microtubule polymerization. The University of British Columbia. The recommended phase 2 dose of the ADC was established to be 2.7 mg/kg, given every 3 weeks. ClinicalTrials.gov NCT03574753. 1,2,3 Tisotumab vedotin is being developed in collaboration with Genmab. Abstract CT179: Telisotuzumab vedotin (teliso-v) monotherapy in Clipboard, Search History, and several other advanced features are temporarily unavailable. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCEs Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Pipeline - Tisotumab Vedotin - Seagen Please enable it to take advantage of the complete set of features! Telisotuzumab vedotin 2.7 mg/kg was administered intravenously every 3 weeks until disease progression or unacceptable toxicity. Epub 2021 Aug 23. A cell-surface receptor kinase that is encoded by the MET proto-oncogene, c-Met binds hepatocyte growth factor (HGF).2 Aberrant activation of the c-Met/HGF axis through MET amplification, transcription, and constitutive activation has been reported in several cancers and is associated with poor outcomes. Response assessments were performed every 6 weeks. CD30-targeting brentuximab vedotin was then approved in 2011 for patients with Hodgkin's lymphoma, followed by the approval of erb-b2 receptor tyrosine kinase 2 (HER2)-targeting trastuzumab emtansine (T-DM1) for patients with HER2-positive metastatic breast cancer in 2013. Tivdak (tisotumab vedotin-tftv) for injection 40 mg - Seagen. Telisotuzumab vedotin 2.7 mg/kg was administered intravenously every 3 weeks until disease progression or unacceptable toxicity. Target cMet. The FDA has granted a breakthrough therapy designation to telisotuzumab vedotin (ABBV-399; teliso-V) for use in patients with advanced or metastatic EGFR wild-type, nonsquamous non-small cell. First-in-Human Phase I, Dose-Escalation and -Expansion Study of 2022 Aug 31;14(1):101. doi: 10.1186/s13073-022-01102-1. On September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Fujiwara Y, Kenmotsu H, Yamamoto N, Shimizu T, Yonemori K, Ocampo C, Parikh A, Okubo S, Fukasawa K, Murakami H. Cancer Med. Telisotuzumab vedotin 2.7 mg/kg was administered intravenously every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Potential Indication Region Phase (1, 2, 3, Submitted) Telisotuzumab Vedotin Shows Promising Efficacy and Safety Results for c Results of the phase 1b study of ABBV-399 (telisotuzumab vedotin; teliso-v) in combination with erlotinib in patients with c-Met+ non-small cell lung cancer by EGFR mutation status. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAs MedWatch Reporting System or by calling 1-800-FDA-1088. 2 Clarke DriveSuite 100Cranbury, NJ 08512. Previous anticancer therapies included platinum-based treatment (67%), checkpoint inhibitors (28%), docetaxel (17%), c-Met inhibitor (67%), and an EGFR TKI (83%).
Can I Use Shampoo To Wash My Car, Google/model-viewer Typescript, Gentleman Agreement Jaipur, Gans Concludes That Poverty Persists Because:, Ashe County High School Address, Dallas Cowboys Crossbody Bag, Butterfly Hug Method Pdf,