The median progression-free survival (PFS) for all patients was 5.9 months (95% CI, 2.8-not reached [NR]). Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830202. Type of Molecule Biologic Target cMet Product Type New Indication 29, 30 Capmatinib inhibits MET kinase activity with an average IC 50 value of 0.13 nM, and a cell-based IC 50 of 0.3-0.7 nM in lung cancer cell lines. Median duration of exposure to erlotinib was 20.3 weeks (range, 3.1-110.4) with patients given a median of 5.5 treatment cycles (range, 2-33). over 1 year ago. c-Met as a target for personalized therapy. 2022 MJH Life Sciences and Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways. Final gross price and currency may vary according to local VAT and billing address. Its potential activity combined with programmed cell death protein-1 inhibitors has not been previously evaluated. Disclaimer, National Library of Medicine In the study cohort, 53% were defined as c-MET high with a confirmed histology score greater than 225, while MET amplification was found in 6 patients. On June 10, 2019, the Food and Drug Administration granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. The ORR for EGFR-mutated patients (n = 28) was 32.1% (95% CI, 15.9%-52.4%). AbbVie announces US FDA granted breakthrough therapy designation (BTD) to telisotuzumab vedotin (Teliso-V) for previously treated non-small cell lung cancer. Fujiwara Y, Kenmotsu H, Yamamoto N, Shimizu T, Yonemori K, Ocampo C, Parikh A, Okubo S, Fukasawa K, Murakami H. Cancer Med. Availability will depend on territory eligibility. Systemic Analysis and Review of Nivolumab-ipilimumab Combination as a Rescue Strategy for Renal Cell Carcinoma After Treatment With Anti-PD-1/PD-L1 Therapy. TELISOTUZUMAB VEDOTIN [WHO-DD] Sources: Common Name English Classification Tree Code System Code; Source: NCI_THESAURUS C1512. ). Strickler JH, Weekes CD, Nemunaitis J, Ramanathan RK, Heist RS, Morgensztern D, Angevin E, Bauer TM, Yue H, Motwani M, Parikh A, Reilly EB, Afar D, Naumovski L, Kelly K. J Clin Oncol. Epub 2021 Aug 23. Four patients were positive for EGFR-M, 1 patient had EGFR-wild-type, and 3 patients had a rare/unknown EGFR mutation. Of the 25 patients who achieved partial or complete response to P+BR, 16 (64%) had response durations of at least six months and 12 (48%) had response durations of at least 12 months. Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors. Transl Oncogenomics. Approval was based on Study GO29365 (NCT02257567), an open-label, multicenter clinical trial that included a cohort of 80patients with relapsed or refractory DLBCL after at least one prior regimen. For general information, Learn About Clinical Studies. Thirty-three percent received a third-generation EGFR TKI as their last prior therapy. Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate that has exhibited antitumor activity as monotherapy in NSCLC. In this study, all enrolled adult patients had been previously treated with tyrosine kinase inhibitors and given 2.7 mg/kg of telisotuzumab vedotin intravenously once every 3 weeks. The aim of this phase 2 trial (NCT03539536) is to explore safety and efficacy of teliso-V in cohorts (based on histopathology and EGFR mutation) and subgroups (based on c-Met expression) of patients with c-Met+ advanced NSCLC (stage 1), followed by expansion into an appropriately selected . Careers. clinical trials of the intervention/treatment, U.S. FDA: Expanded Access (Compassionate Use), U.S. Department of Health and Human Services. Patients were heavily pretreated. DB15104. Telisotuzumab vedotin is an anti-c-MET antibody-drug conjugate (ADC) composed of the monoclonal antibody that is linked to monomethyl auriastatin E (MMAE). Nivolumab, a fully human programmed cell death protein-1 (PD-1) inhibitor antibody, is approved in the United States, Europe, . To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Telisotuzumab vedotin in combination with erlotinib induced promising outcomes in patients with advanced, EGFR-mutated, c-MET-positive nonsmall cell lung cancer who were contraindicated for surgery or other approved therapies. Personalized medicine for non-small cell lung cancer: where are we now and where can we go? Introduction: Unable to load your collection due to an error, Unable to load your delegates due to an error. Bookshelf Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin. by admin. 2017;16:555565. 0 rating. Type. Grade 3 or higher AEs occurred in 27 patients with the most common being pulmonary embolism (14%), hypokalemia (10%), diarrhea (7%), malignant neoplasm progression (7%), peripheral sensory neuropathy (7%), and hypophosphatemia (7%). Nov 07, 2022 ueno summer festival 2022 Comments Off on abbvie 2021 annual report ueno summer festival 2022 Comments Off on abbvie 2021 annual report Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Oncology (Cancer) / Hematologic Malignancies Approval Notifications, Verified Clinical Benefit | Cancer Accelerated Approvals, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma, View full prescribing information for POLIVY, Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O. Telisotuzumab vedotin is not approved by any regulatory authorities, and its efficacy and safety have not been established yet. An official website of the United States government. Mol Cancer Ther. telisotuzumab vedotin (teliso-v, formerly abbv-399) is a first-in-class antibody-drug conjugate (adc) composed of the anti-c-met humanized monoclonal antibody abt-700 coupled to cytotoxic monomethyl auristatin e (mmae) through a valine-citrulline linker with a drug:antibody ratio of approximately three. The pharmacokinetic profile of Teliso-V plus nivolumab was similar to Teliso-V monotherapy. Follow the Oncology Center of Excellence on Twitter@FDAOncology. on Sat Jun 26 17:08:19 UTC 2021. 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). We do not sell or distribute actual drugs. AbbVie. Why Should I Register and Submit Results? HEPATOCYTE GROWTH FACTOR RECEPTOR. JAMA. Four ADCs are currently FDA-approved for the treatment of solid tumors: trastuzumab emtansine and trastuzumab deruxtecan, both anti-HER2; enfortumab vedotin, targeting Nectin-4; and sacituzumab govitecan, active against Trop2 (Table 1 ). It is on the World Health Organization's List of It was developed by Chugai Pharmaceutical Co. Japan, which is part of the Hoffmann-La Roche group. 2021 Apr;10(7):2350-2358. doi: 10.1002/cam4.3815. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. 2019;322:764774. All 42 patients were included in the safety analysis; 36 were evaluable for efficacy. abbvie 2021 annual report. Main exclusion criteria included any prior anti-cancer therapy, uncontrolled central nervous system metastases, or any medical condition that would put the patient at an unacceptably high risk for toxicity. . Premedicate with an antihistamine and antipyretic, and administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus. TELISOTUZUMAB. Efficacy was based on complete response (CR) rate and response duration, as determined by an independent review committee. Carril-Ajuria L, Lora D, Carretero-Gonzlez A, Martn-Sobern M, Rioja-Viera P, Castellano D, de Velasco G. Clin Genitourin Cancer. ClinicalTrials.gov Identifier: NCT04830202, 18 Years and older (Adult, Older Adult), Western Heamatology and Oncology Clinics /ID# 243364, West Perth, Western Australia, Australia, 6005, Hong Kong United Oncology Centre /ID# 241857. in pretreated patients with egfr wild-type nsclc, telisotuzumab vedotin achieved an orr of 54% in a met-high expressing cohort and 25% in a met-intermediate cohort. Duration of response was NR at the time of data cutoff. Easy. Drug: Telisotuzumab vedotin Intravenous Infusion Other Name: ABBV-399 Eligibility Criteria Inclusion Criteria: - The participant must not be eligible for a telisotuzumab vedotin clinical trial. Very difficult. This study examined the safety, pharmacokinetics, and preliminary efficacy in patients with c-Metpositive NSCLC treated with the c-Mettargeting drug telisotuzumab vedotin in combination with the EGFR TKI erlotinib. Capmatinib (INC280, INCB28060; Novartis) is a highly selective and potent type Ib MET inhibitor with in vitro and in vivo activities against preclinical cancer models with MET activation. 1.9, or 2.2 mg/kg, every 2 wk) plus nivolumab (3 mg/kg, 240 mg, or per locally approved label). AbbVie; January 4, 2022. Looking at patients with EGFR mutation-positive disease, the ORR was 32.1% (95% CI, 15.9%-52.4%) with a DCR of 85.7% (95% CI, 67.3%-96%). The overall response rate (ORR) for all patients was 30.6% (95% CI, 16.3%-48.1%) and the disease control rate (DCR) was 86.1% (95% CI, 70.5%-95.3%). Thirteen patients were also confirmed to have T790M mutations with 6 patients having c-Met-high mutations and 7 with lower c-Met expression in their NSCLC. Its potential activity combined with programmed cell death protein-1 inhibitors has not been previously evaluated. 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. Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate that has exhibited antitumor activity as monotherapy in NSCLC. News release. News release. Methods: NCI CPTC Antibody Characterization Program, Arbour K.C., Riely G.J. The FDA granted a breakthrough therapy designation to telisotuzumab vedotin for use in patients with advanced or metastatic EGFR wild-type, nonsquamous non-small cell lung cancer who have high levels of c-Met overexpression and whose disease has progressed on, or after, platinum-based chemotherapy. Median PFS was 6.8 months (95% CI, 4.3-NR) for patients with non-T790M mutated tumors and for those whose T790M status was unknown vs 3.7 months (95% CI, 1.4-NR) for those with T790M mutated tumors. Twenty-eight patients had EGFR-mutant disease, 5 had EGFR wild-type disease, and 3 had rare or unknown EGFR status. Molecular Formula C68-H106-N11-O15-S All Classifications Links to Resources Names & Synonyms Registry Numbers Telisotuzumab Vedotin Plus Erlotinib in c-Met Protein-Expressing NSCLC. Thirty (83%) received a first-/second-generation EGFR TKI across all lines and 16 (44%) received a third generation EGFR TKI. telisotuzumab vedotin nsclc. Other serious AEs related to treatment included decreased appetite, dehydration, hemoptysis, peripheral neuropathy, and pneumonia, among 2% of patients each. Thirty-five (97%) had nonsquamous disease. Groups. Ferrara R, Imbimbo M, Malouf R, Paget-Bailly S, Calais F, Marchal C, Westeel V. Cochrane Database Syst Rev. Availability will depend on territory eligibility. 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, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This indication was granted accelerated approval based on complete response rate. Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate. The most common adverse reactions with P+BR (incidence at least 20%) included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia. Eligible patients had to have archival tumor tissue available for biomarker analysis and conrmation of c-Met overexpression, MET exon 14 skipping mutations, or MET amplication, as determined by a central/local site laboratory. Introduction Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate that has shown antitumor activity as monotherapy in non-small cell lung cancer (NSCLC). Programmed death-ligand 1 (PD-L1) status was evaluated in the efficacy population (PD-L1-positive [PD-L1+]: n = 15; PD-L1-negative [PD-L1-]: n = 9; PD-L1-unknown: n = 3). The FDA has granted a breakthrough therapy designation to telisotuzumab vedotin (teliso-V) for patients with advanced or metastatic EGFR wild-type nonsquamous non-small cell lung cancer with high levels of c-Met overexpression who have progressed on a platinum-based therapy, according to a press release from AbbVie. -. 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). This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Difficult. Generic Name. January 4, 2022. Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA's Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation. In January 2022, the FDA granted a breakthrough therapy designation to telisotuzumab vedotin for patients with advanced or metastatic EGFR wild-type, nonsquamous NSCLC who have high levels of c-Met overexpression and whose disease has progressed on, or after, platinum-based chemotherapy. Project Facilitate: The Oncology Center of Excellence program for Expanded AccessFor 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. Information provided by (Responsible Party): This is an expanded access program (EAP) for eligible participants. Telisotuzumab vedotin will be administered via intravenous (IV) infusion every 14 days until the patient experiences disease progression or meets study discontinuation criteria. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. Phase Ib study of telisotuzumab vedotin in combination with erlotinib in patients with c-met protein-expressing non-small-cell lung cancer. Before sharing sensitive information, make sure you're on a federal government site. Apply to this Phase 3 clinical trial treating Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Carcinoma (NSCLC). Patients also needed to have an ECOG performance status of 0 to 2 and adequate bone marrow, renal, and hepatic function. The University of British Columbia. - Abstract. Serious AEs observed in at least 5% of patients included malignant neoplasm progression (7%),and pneumonia, dehydration, and pulmonary embolism (5% each). Response assessments were performed every 6 weeks. TELISOTUZUMAB VEDOTIN Drug Record Summary; Interactions; Claims; TELISOTUZUMAB VEDOTIN chembl:CHEMBL3990032 Alternate Names: ABBV-399 ABT-399 TELISOTUZUMAB VEDOTIN PR-1420682 . Sources: JAX-CKB TTD. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 14 teliso-v targets c-met-expressing tumor cells with specific and high-affinity binding, and it mediates the delivery of mmae directly to tumor cells. Methods: In a phase 1b study (NCT02099058), adult patients (18 y) with advanced NSCLC received combination therapy . AbbVie announces US FDA granted breakthrough therapy designation (BTD) to telisotuzumab vedotin (teliso-V) for previously treated non-small cell lung cancer. -, Salgia R. MET in lung cancer: biomarker selection based on scientific rationale. Ultimately, the most common AE that led to either dose reductions, interruptions, or discontinuation was peripheral neuropathy at 10%, 21%, and 21%, respectively. Curr Oncol Rep. 2022 Oct 5. doi: 10.1007/s11912-022-01334-9. Findings from a phase 1/1b study multicenter, open-label study (NCT02099058) of 42 patients with confirmed c-MET overexpression,METexon 14 skipping mutations, orMETamplification, in their disease showed that along with promising efficacy results, the combination therapy had an acceptable toxicity profile. All patients experienced at least 1 adverse event (AE), most commonly peripheral sensory neuropathy (43%), dermatitisacneiform (38%), diarrhea (33%), and hypoalbuminemia (33%). Telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate targeting c-Met, has shown a tolerable safety profile and antitumor activity as monotherapy. Tisotumab vedotin. This site needs JavaScript to work properly. Name Type Language; TELISOTUZUMAB VEDOTIN: Locators: INN . 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. 70 amivantamab is a. Antibody-drug conjugate; Nivolumab; Nonsmall cell lung cancer; Telisotuzumab vedotin; c-Met. The most common any grade adverse events (AEs) observed by researchers were peripheral sensory neuropathy (43%), dermatitis acneiform (38%), diarrhea (33%), and hypoalbuminemia (33%). 2022 MJH Life Sciences , Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways. Aug 1986 - Sep 19871 year 2 months. Results: Telisotuzumab vedotin (Teliso-V; ABBV-399) is an anti-c-Met ADC composed of the monoclonal antibody ABT-700 and the microtubule inhibitor monomethyl auristatin E (MMAE). Best percentage reduction in ( A ) target lesions and ( B ), MeSH The best overall response rate (complete and partial responses) was 63% with P+BR compared with 25% with BR. The primary objective was to assess safety and tolerability; secondary objectives included the . Accessed October 28, 2022. A description of FDA expedited programs is in theGuidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Pronunciation of TELISOTUZUMAB VEDOTIN with 1 audio pronunciations. CONJUGATE -> PARENT QA085PMU8Q. Any grade treatment-related adverse events (TRAEs) linked to the use of telisotuzumab vedotin were seen in 37 patients, including peripheral sensory neuropathy (36%) and peripheral neuropathy (19%). The median progression-free survival in the entire population was 5.9 months (95% CI, 2.8-not reached [NR]) and the duration of response was NR at the time of data cutoff. In conclusion, the combination of telisotuzumab vedotin plus erlotinib showed an acceptable safety profile and encouraging antitumor activity in heavily pretreated patients, especially in [EGFR mutation-positive, c-Met-positive] NSCLC in which previous EGFR TKIs failed, the researchers wrote. Approval Year Unknown. The ORR was 25.0% in the subset of patients with intermediate c-Met expression.2, 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. 1. doi: 10.1002/14651858.CD013257.pub2. 2 Clarke DriveSuite 100Cranbury, NJ 08512. Camidge DR, Barlesi F, Goldman JW, et al. Three (7%) patients reported at least 1 serious TRAE including decreased appetite, dehydration, hemoptysis, peripheral neuropathy, and pneumonia (2% each). Among those with a confirmed EGFR mutation, 16 (44%) had Del19, 12 (33%) had L858R, and 2 (6%) had rare mutations. This drug was developed by ImClone Systems Inc. Adis is an information provider. Polatuzumab vedotin-piiq, 1.8 mg/kg by intravenous infusion, was given on day 2 of cycle 1 and on day 1 of subsequent cycles. and will be provided after review and approval of a research proposal and . 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. 15 engagement of c-met by teliso-v results in the internalization of the adc -, Garajov I., Giovannetti E., Biasco G., Peters G.J. In conclusion, telisotuzumab vedotin demonstrated a manageable safety profile, with antitumor activity in Japanese patients with advanced solid tumors; the recommended phase 2 dose was confirmed as 2.7 mg/kg every 3 weeks. Thirteen (31%) experienced grade 3 or higher TRAEs, most commonly hypophosphatemia and peripheral sensory neuropathy (7% each). Bendamustine (90mg/m2 intravenously) was administered on days 2 and 3 of cycle 1 and on days 1 and 2 of subsequent cycles. Choosing to participate in a study is an important personal decision. All rights reserved. and transmitted securely. The objective response rate was 7.4%, with two patients (PD-L1+, c-Met immunohistochemistry H-score 190, n = 1; PD-L1-, c-Met H-score 290, n = 1) having a confirmed partial response. 8600 Rockville Pike A phase II study to identify the target Non-Small Cell Lung Cancer (NSCLC) patients 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) (update June 2020). 2022 MJH Life Sciences and OncLive - Clinical Oncology News, Cancer Expert Insights. Substance Class: Protein Created. The .gov means its official. Findings from the ongoing phase 2 LUMINOSITY trial (Study M14-239; NCT03539536) showed that treatment telisotuzumab vedotin as a monotherapy in the second- or third-line setting elicited an ORR of 53.8%. As of January 2020, a total of 37 patients received treatment with Teliso-V (safety population) in combination with nivolumab; 27 patients (efficacy population) were c-Met immunohistochemistry-positive. 2022 MJH Life Sciences and OncLive - Clinical Oncology News, Cancer Expert Insights. The FDA has granted a breakthrough therapy designation to telisotuzumab vedotin (ABBV-399) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy, according to a press release by AbbVie. TELISOTUZUMAB VEDOTIN. Background. Telisotuzumab vedotin is under clinical development and is not approved by regulatory health authorities. 4 /5. PMC Telisotuzumab vedotin is a first-in-class antibody drug conjugate that uses a cleavable linker to combine a recombinant c-Mettargeting humanized monoclonal antibody (ABT-700) and MMAE, which is a potent inhibitor of microtubule polymerization. Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).. Twenty patients had stable disease, 10 had a partial response, 5 patients had progressive disease, and only 1 patient had a complete response with that patient also having c-Met-positive disease and an EGFR-activating mutation. The primary objective was to assess safety and tolerability; secondary objectives included the evaluation of antitumor activity. Pulmonary embolism (14%) was the most common such AE, followed by hypokalemia (10%), and diarrhea, malignant neoplasm progression, peripheral sensory neuropathy, and hypophosphatemia (7% each). Assessments continued until documented disease progression, start of new anticancer therapy, death, or withdrawal of consent. Epub 2021 Mar 6. The median patient age was 65 years (range, 34-80). Editorial: Recent Approval of Sotorasib as the First Targeted Therapy for KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC). The prescribing information includes warnings and precautions for peripheral neuropathy, infusion-related reactions, myelosuppression, serious and opportunistic infections, progressive multifocal leukoencephalopathy, tumor lysis syndrome, hepatotoxicity, and embryo-fetal toxicity. ClinicalTrials.gov registration number: NCT03311477. 109281. 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. The site is secure. Check out recent approvals at the OCEs podcast,Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.). on Sat . Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated. Its potential activity combined with programmed cell death protein-1 inhibitors has not been previously evaluated. Investigators conducted radiographic tumor assessments via computed tomography or magnetic resonance imaging within 28 days of treatment initiation and once every 6 weeks thereafter. Eligibility Gender All Eligibility Age Minimum: 18 Years Countries Australia Hong Kong Israel Contacts ABBVIE CALL CENTER 844-663-3742 At the end of therapy, the CR rate was 40% (95% CI: 25-57%) with P+BR compared with 18% (95% CI: 7-33%) with BR alone. Go to Brief Summary: This is an expanded access program (EAP) for eligible participants. Background: Teliso-V is an anti-c-Met antibody conjugated with a tubulin inhibitor MMAE. Combination therapy with Teliso-V plus nivolumab was well tolerated in patients with c-Met+ NSCLC with limited antitumor activity. Twenty-seven (64%) patients experience grade 3 or higher AEs. However, grade 3 or greater TRAEs occurred in 13 patients with the most common also being peripheral sensory neuropathy (7%) and hypophosphatemia (7%). Find technical definitions and synonyms by letter for drugs/agents used to treat patients with cancer or conditions related to cancer. Telisotuzumab vedotin (teliso-V) in combination with erlotinib (Tarceva) induced promising outcomes in patients with advanced, EGFR-mutated, c-MET-positive nonsmall cell lung cancer (NSCLC) who were contraindicated for surgery or other approved therapies, according to findings from a phase 1b study (NCT02099058).1. The median duration to exposure to treatment lasted at 18.1 weeks (range, 3.1-99.1) with patients receiving a median of 7 treatment cycles (range, 2-34). Telisotuzumab vedotin is a MET -targeting antibody-drug conjugate that has demonstrated a good treatment response in patients with EGFR wild-type MET-overexpressing non-squamous non-small cell lung cancer. The site is secure. Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate that has exhibited antitumor activity as monotherapy in NSCLC. Abstract. europepmc.org on june 10, 2019, the food and drug administration granted accelerated approval to polatuzumab vedotin-piiq (polivy, genentech, inc.), a cd79b-directed antibody-drug conjugate indicated in. Conclusions: Telisotuzumab vedotin (ABBV-399) Telisotuzumab vedotin (ABBV-399) is an antibody drug conjugate (ADC) targeting cMet that is being investigated to treat non-small cell lung cancer. EGFR Exon 19 Deletion, EGFR L858R, and MET Expression are the most frequent biomarker inclusion criteria for .
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