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

Start Date30 Jan 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06093503 / WithdrawnPhase 3

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.

Start Date31 May 2024

Sponsor / Collaborator

AbbVie, Inc.

CTR20221935 / RecruitingPhase 3

一项比较Telisotuzumab Vedotin（ABBV-399）和多西他赛治疗既往接受过治疗的c-Met过表达、EGFR野生型、局部晚期/转移性非鳞状非小细胞肺癌受试者的3期开放、随机、对照、全球研究

[Translation] A Phase 3, open-label, randomized, controlled, global study comparing telisotuzumab vedotin (ABBV-399) and docetaxel in previously treated subjects with c-Met-overexpressing, EGFR wild-type, locally advanced/metastatic non-squamous non-small cell lung cancer

主要目的是确定与多西他赛治疗相比，telisotuzumab vedotin是否能够改善以下人群的无疾病进展生存期（PFS，根据ICR评估）和/或总生存期（OS）： - c-Met高度过表达、EGFR野生型、非鳞状NSCLC受试者和 - 所有c-Met过表达、EGFR野生型、非鳞状NSCLC受试者次要目的是确定：-总缓解率（ORR）；-缓解持续时间（DoR）；-根据研究者评估的无疾病进展生存期（PFS）；-通过欧洲癌症研究与治疗组织生存质量调查问卷肺癌模块13（EORTC QLQ-LC13）的咳嗽、疼痛和呼吸困难项目，测量咳嗽、疼痛或呼吸困难出现恶化的时间；-通过EORTC QLQ-核心30（EORTC QLQ-C30）的身体功能领域，测量身体功能出现恶化的时间；-通过EORTC-QLQ-C30的总体健康状况/生存质量领域，测量生存质量相对于基线的变化；-安全性和耐受性。

[Translation]

The primary objective was to determine whether telisotuzumab vedotin improves progression-free survival (PFS, as assessed by ICR) and/or overall survival (OS) compared with docetaxel in: - c-Met-highly overexpressing, EGFR wild-type, non-squamous NSCLC subjects and - all c-Met-overexpressing, EGFR wild-type, non-squamous NSCLC subjects The secondary objectives were to determine: - overall response rate (ORR); - duration of response (DoR); - progression-free survival (PFS) as assessed by investigators; - time to worsening of cough, pain or dyspnea as measured by the cough, pain and dyspnea items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13); - time to worsening of physical function as measured by the physical function domain of the EORTC QLQ-Core 30 (EORTC QLQ-C30); - change from baseline in quality of life as measured by the global health status/quality of life domain of the EORTC-QLQ-C30; - safety and tolerability.

Start Date21 Apr 2023

Sponsor / Collaborator

BSP Pharmaceuticals SpA

[+2]

100 Clinical Results associated with Telisotuzumab vedotin

100 Translational Medicine associated with Telisotuzumab vedotin

100 Patents (Medical) associated with Telisotuzumab vedotin

Literatures (Medical) associated with Telisotuzumab vedotin

01 Sep 2024·JOURNAL OF CLINICAL ONCOLOGY

Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein–Overexpressing Advanced Nonsquamous EGFR -Wildtype Non–Small Cell Lung Cancer in the Phase II LUMINOSITY Trial

Article

Author: Tomasini, Pascale ; Bradbury, Penelope ; Nishino, Kazumi ; Katgi, Nuran ; Ansell, Peter ; Li, Martha ; Bolotin, Ellen ; Girard, Nicolas ; Baik, Christina ; Camidge, D. Ross ; Baijal, Shobhit ; Looman, Jim ; Cuppens, Kristof ; Zer, Alona ; Xia, Summer ; Liu, Chunling ; Cicin, Irfan ; Horinouchi, Hidehito ; Ratajczak, Christine ; Moskovitz, Mor ; Moiseenko, Fedor ; Lu, Shun ; Lee, Se-Hoon ; Mansfield, Aaron S. ; Ciuleanu, Tudor ; Daaboul, Nathalie ; Planchard, David ; Filippova, Elena ; Wu, Shang-Yin ; Bar, Jair ; Han, Ji-Youn ; Kuo, Chih-Hsi ; Goldman, Jonathan

PURPOSE:

Telisotuzumab vedotin (Teliso-V) is a c-Met–directed antibody-drug conjugate with a monomethyl auristatin E cytotoxic payload. The phase II LUMINOSITY trial (ClinicalTrials.gov identifier: NCT03539536 ) aimed to identify the optimal c-Met protein–overexpressing non–small cell lung cancer (NSCLC) population for treatment with Teliso-V (stage I) and expand the selected group for efficacy evaluation (stage II). Stage II enrolled patients with nonsquamous epidermal growth factor receptor ( EGFR )-wildtype NSCLC.

METHODS:

Eligible patients had locally advanced/metastatic c-Met protein–overexpressing NSCLC and ≤2 previous lines of therapy (including ≤1 line of systemic chemotherapy). c-Met protein overexpression in nonsquamous EGFR -wildtype NSCLC was defined as ≥25% tumor cells with 3+ staining (high [≥50% 3+]; intermediate [≥25%–<50%]). Teliso-V was administered at 1.9 mg/kg once every 2 weeks. The primary end point was overall response rate (ORR) by independent central review.

RESULTS:

In total, 172 patients with nonsquamous EGFR -wildtype NSCLC received Teliso-V in stages I and II. ORR was 28.6% (95% CI, 21.7 to 36.2; c-Met high, 34.6% [95% CI, 24.2 to 46.2]; c-Met intermediate, 22.9% [95% CI, 14.4 to 33.4]). The median duration of response was 8.3 months (95% CI, 5.6 to 11.3; c-Met high, 9.0 [95% CI, 4.2 to 13.0]; c-Met intermediate: 7.2 [95% CI, 5.3 to 11.5]). The median overall survival was 14.5 months (95% CI, 9.9 to 16.6; c-Met high, 14.6 [95% CI, 9.2 to 25.6]; c-Met intermediate, 14.2 [95% CI, 9.6 to 16.6]). The median progression-free survival was 5.7 months (95% CI, 4.6 to 6.9; c-Met high, 5.5 [95% CI, 4.1 to 8.3]; c-Met intermediate: 6.0 [95% CI, 4.5 to 8.1]). Most common any-grade treatment-related adverse events (AEs) were peripheral sensory neuropathy (30%), peripheral edema (16%), and fatigue (14%); the most common grade ≥3 AE was peripheral sensory neuropathy (7%).

CONCLUSION:

Teliso-V was associated with durable responses in c-Met protein–overexpressing nonsquamous EGFR -wildtype NSCLC, especially in those with high c-Met. AEs were generally manageable.

01 Aug 2023·Translational lung cancer research

Telisotuzumab vedotin with erlotinib in the treatment of non-small cell lung cancer: a well MET combination?

Communications

Author: Subramanian, Janakiraman ; Kujtan, Lara

10 Feb 2023·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein–Expressing Non–Small-Cell Lung Cancer

Article

Author: Vokes, Everett ; Angevin, Eric ; Parikh, Apurvasena ; Su, Wu-Chou ; Blot, Vincent ; Dunbar, Martin ; Morgensztern, Daniel ; Goldman, Jonathan W. ; Motwani, Monica ; Spira, Alex ; Wu, Jun ; Camidge, D. Ross ; Heist, Rebecca ; Barlesi, Fabrice ; Hong, David S. ; Strickler, John H. ; Noon, Elysa ; Kelly, Karen

PURPOSE:

Overexpression of c-Met protein and epidermal growth factor receptor ( EGFR) mutations can co-occur in non–small-cell lung cancer (NSCLC), providing strong rationale for dual targeting. 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. Herein, we report the results of a phase Ib study (ClinicalTrials.gov identifier: NCT02099058 ) evaluating Teliso-V plus erlotinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with c-Met–positive (+) NSCLC.

PATIENTS AND METHODS:

This study evaluated Teliso-V (2.7 mg/kg once every 21 days) plus erlotinib (150 mg once daily) in adult patients (age ≥ 18 years) with c-Met+ NSCLC. Later enrollment required presence of an EGFR-activating mutation ( EGFR-M +) and progression on a prior EGFR TKI. End points included safety, pharmacokinetics, objective response rate (ORR), and progression-free survival (PFS). The efficacy-evaluable population consisted of c-Met+ patients (confirmed histology [H]-score ≥ 150) who had at least one postbaseline scan; c-Met+ patients with H-scores ≥ 225 were classified as c-Met high.

RESULTS:

As of January 2020, 42 patients were enrolled (N = 36 efficacy-evaluable). Neuropathies were the most common any-grade adverse events reported, with 24 of 42 patients (57%) experiencing at least one event. The pharmacokinetic profile of Teliso-V plus erlotinib was similar to Teliso-V monotherapy. Median PFS for all efficacy-evaluable patients was 5.9 months (95% CI, 2.8 to not reached). ORR for EGFR-M + patients (n = 28) was 32.1%. Of EGFR-M + patients, those who were c-Met high (n = 15) had an ORR of 52.6%. Median PFS was 6.8 months for non-T790M+ and for those whose T790M status was unknown, versus 3.7 months for T790M+.

CONCLUSION:

Teliso-V plus erlotinib showed encouraging antitumor activity and acceptable toxicity in EGFR TKI-pretreated patients with EGFR-M+, c-Met+ NSCLC.

News (Medical) associated with Telisotuzumab vedotin

30 Oct 2024

·www.prnewswire.com

AbbVie Reports Third-Quarter 2024 Financial Results

Reports Third-Quarter Diluted EPS of $0.88 on a GAAP Basis, a Decrease of 12.0 Percent; Adjusted Diluted EPS of $3.00, an Increase of 1.7 Percent; These Results Include an Unfavorable Impact of $0.04 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Third-Quarter Net Revenues of $14.460 Billion, an Increase of 3.8 Percent on a Reported Basis or 4.9 Percent on an Operational Basis Third-Quarter Global Net Revenues from the Immunology Portfolio Were $7.046 Billion, an Increase of 3.9 Percent on a Reported Basis, or 4.8 Percent on an Operational Basis; Global Humira Net Revenues Were $2.227 Billion; Global Skyrizi Net Revenues Were $3.205 Billion; Global Rinvoq Net Revenues Were $1.614 Billion Third-Quarter Global Net Revenues from the Oncology Portfolio Were $1.687 Billion, an Increase of 11.6 Percent on a Reported Basis, or 13.0 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $828 Million; Global Venclexta Net Revenues Were $677 Million Third-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.363 Billion, an Increase of 15.6 Percent on a Reported Basis, or 16.0 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $848 Million; Global Vraylar Net Revenues Were $875 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $445 Million Third-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.239 Billion, a Decrease of 0.1 Percent on a Reported Basis, or an Increase of 1.8 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $671 Million; Global Juvederm Net Revenues Were $258 Million Successfully Completed Acquisition of Cerevel, Adding Pipeline of Highly Complementary Assets to AbbVie's Existing Neuroscience Portfolio Raises 2024 Adjusted Diluted EPS Guidance Range from $10.67 - $10.87 to $10.90 - $10.94, which Includes an Unfavorable Impact of $0.64 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Third Quarter 2024 Announces 2025 Dividend Increase of 5.8 Percent, Beginning with Dividend Payable in February 2025 NORTH CHICAGO, Ill., Oct. 30, 2024 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2024. "We delivered another quarter of strong commercial execution and significant pipeline progress," said Robert A. Michael, chief executive officer, AbbVie. "Based upon the momentum of AbbVie's business and our confidence in the long-term growth outlook, we are once again raising our full-year guidance and are increasing our quarterly dividend." Third -Quarter Results Worldwide net revenues were $14.460 billion, an increase of 3.8 percent on a reported basis, or 4.9 percent on an operational basis. Global net revenues from the immunology portfolio were $7.046 billion, an increase of 3.9 percent on a reported basis, or 4.8 percent on an operational basis. Global Humira net revenues of $2.227 billion decreased 37.2 percent on a reported basis, or 36.5 percent on an operational basis. U.S. Humira net revenues were $1.765 billion, a decrease of 41.6 percent. Internationally, Humira net revenues were $462 million, a decrease of 12.4 percent on a reported basis, or 7.8 percent on an operational basis. Global Skyrizi net revenues were $3.205 billion, an increase of 50.8 percent on a reported basis, or 51.5 percent on an operational basis. Global Rinvoq net revenues were $1.614 billion, an increase of 45.3 percent on a reported basis, or 47.4 percent on an operational basis. Global net revenues from the oncology portfolio were $1.687 billion, an increase of 11.6 percent on a reported basis, or 13.0 percent on an operational basis. Global Imbruvica net revenues were $828 million, a decrease of 8.8 percent, with U.S. net revenues of $618 million and international profit sharing of $210 million. Global Venclexta net revenues were $677 million, an increase of 14.8 percent on a reported basis, or 18.2 percent on an operational basis. Global Elahere net revenues were $139 million. Global net revenues from the neuroscience portfolio were $2.363 billion, an increase of 15.6 percent on a reported basis, or 16.0 percent on an operational basis. Global Botox Therapeutic net revenues were $848 million, an increase of 13.4 percent on a reported basis, or 14.4 percent on an operational basis. Global Vraylar net revenues were $875 million, an increase of 16.6 percent. Global Ubrelvy net revenues were $269 million, an increase of 15.3 percent. Global Qulipta net revenues were $176 million, an increase of 33.6 percent. Global net revenues from the aesthetics portfolio were $1.239 billion, a decrease of 0.1 percent on a reported basis, or an increase of 1.8 percent on an operational basis. Global Botox Cosmetic net revenues were $671 million, an increase of 8.2 percent on a reported basis, or 9.9 percent on an operational basis. Global Juvederm net revenues were $258 million, a decrease of 19.7 percent on a reported basis, or 16.9 percent on an operational basis. On a GAAP basis, the gross margin ratio in the third quarter was 70.9 percent. The adjusted gross margin ratio was 84.4 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 29.1 percent of net revenues. The adjusted SG&A expense was 23.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 14.7 percent of net revenues. The adjusted R&D expense was 14.2 percent of net revenues. Acquired IPR&D and milestones expense was 0.6 percent of net revenues. On a GAAP basis, the operating margin in the third quarter was 26.5 percent. The adjusted operating margin was 46.7 percent. Net interest expense was $591 million. On a GAAP basis, the tax rate in the quarter was 25.0 percent. The adjusted tax rate was 16.2 percent. Diluted EPS in the third quarter was $0.88 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.00. These results include an unfavorable impact of $0.04 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced that it completed its acquisition of Cerevel, adding a pipeline of highly complementary assets to AbbVie's existing neuroscience portfolio. Cerevel's pipeline includes emraclidine, a potential best-in-class, next-generation antipsychotic, that is being studied for the treatment of schizophrenia; tavapadon, a first-in-class dopamine D1/D5 selective partial agonist for the management of Parkinson's disease (PD); as well as CVL-354, a potential best-in-class kappa opioid receptor (KOR) antagonist being studied for the treatment of major depressive disorder (MDD). Cerevel is a strong strategic fit for AbbVie and has potential to meaningfully impact revenue into the next decade. AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-1 trial evaluating tavapadon as a fixed-dose monotherapy treatment in early PD. In the study, tavapadon met the primary endpoint, demonstrating a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. Tavapadon also met the key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score. Full results from the TEMPO-1 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for PD. Topline results from TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are expected by the end of 2024. AbbVie announced the U.S. Food and Drug Administration (FDA) approved Vyalev (foscarbidopa and foslevodopa) as the first subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced PD. The approval was supported by results from a pivotal Phase 3 head-to-head, randomized and controlled clinical trial that demonstrated a statistically significant improvement in "on" time without troublesome dyskinesia and decreased "off" time, compared to oral immediate-release carbidopa/levodopa (CD/LD). AbbVie and Aliada Therapeutics announced a definitive agreement under which AbbVie will acquire Aliada, a biotechnology company advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. Aliada's lead investigational asset utilizing this delivery technology, ALIA-1758, is an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer's disease (AD). The acquisition also allows AbbVie to utilize Aliada's novel BBB-crossing technology to enhance discovery and development efforts across neuroscience. AbbVie and Gedeon Richter announced a new discovery, co-development and license agreement to advance novel targets for the potential treatment of neuropsychiatric conditions. This collaboration expands upon the success of nearly two decades of partnership on CNS projects. AbbVie announced the European Commission (EC) approved Skyrizi (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapy. The approval was supported by data from two pivotal Phase 3 trials in which Skyrizi achieved the primary endpoint of clinical remission as well as key secondary endpoints. This marketing authorization for Skyrizi marks its fourth approved indication in the European Union (EU). Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. At the European Academy of Dermatology and Venerology (EADV) Congress 2024, AbbVie shared more than 30 presentations that showcased the depth and strength of AbbVie's dermatology portfolio. Presentations highlighted data for Rinvoq (upadacitinib), Skyrizi and lutikizumab across a multitude of dermatological conditions. AbbVie announced that the EC granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of prior therapy. Tepkinly is the first subcutaneous bispecific antibody conditionally approved as a monotherapy in the EU to treat both r/r FL and r/r diffuse large B-cell lymphoma (DLBCL), after two or more lines of prior therapy. The EC approval is supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Tepkinly in adult patients with r/r FL. Tepkinly is being co-developed by AbbVie and Genmab. AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization of Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens. The CHMP's opinion is supported by results of the Phase 3 MIRASOL clinical trial and the EC decision on this indication for Elahere is anticipated later this year. AbbVie announced submission of a Biologics License Application (BLA) to the FDA for accelerated approval (AA) of Teliso-V (telisotuzumab vedotin) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. The BLA is supported by data from the Phase 2 LUMINOSITY clinical trial and review of the BLA will be conducted under FDA's Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program. There are currently no approved anti-cancer therapies specifically for c-Met overexpressing NSCLC and if approved, Teliso-V would be the first-in-class therapy for this patient population. At the European Society for Medical Oncology (ESMO) Congress 2024, AbbVie showcased new data from its innovative antibody-drug conjugate (ADC) platform in tumor types with high unmet needs. Highlights included full data from the primary analysis of the positive, single-arm Phase 2 PICCOLO trial, evaluating Elahere for high FRα expressing platinum-sensitive ovarian cancer (PSOC); patient reported outcomes from the Phase 2 LUMINOSITY trial, evaluating Teliso-V in advanced NSCLC; as well as new safety and efficacy data in pre-treated patients with advanced NSCLC and gastroesophageal (GEA) cancer, from a Phase 1 study of ABBV-400 (telisotuzumab adizutecan). Allergan Aesthetics announced the FDA approved Botox Cosmetic (onabotulinumtoxinA) for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults. Botox Cosmetic is the first product with four aesthetic indication areas: forehead lines, frown lines, crow's feet lines, and now platysma bands, making it the first product of its kind to go beyond the face. Allergan Aesthetics announced the launch of Botox Cosmetic for the treatment of masseter muscle prominence (MMP) in China. The approval is supported by Botox Cosmetic's well-established safety profile as well as clinical trial data that demonstrated Botox Cosmetic is effective in reducing the prominence of the masseter muscle. Botox Cosmetic is the first neurotoxin approved in China for MMP, the largest global MMP market. Allergan Aesthetics intends to develop Botox Cosmetic treatment for MMP in additional global markets and expand the use of Botox Cosmetic in the lower face. At the American Society for Dermal Surgery (ASDS), Allergan Aesthetics presented a total of 12 abstracts that showcased its commitment to patient outcomes and detailed insights and understanding of key concerns across differentiated patient segments. Highlights included four Best of Cosmetic Abstracts as well as a panel discussion on the impact of social media on patient experience and expectations when considering aesthetic treatment. Full-Year 2024 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.67 - $10.87 to $10.90 - $10.94, which includes an unfavorable impact of $0.64 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2024. The company's 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2024, as both cannot be reliably forecasted. Any potential IPR&D and milestones expense related to the recently announced acquisition of Aliada Therapeutics is also excluded from AbbVie's 2024 adjusted diluted EPS guidance, as the transaction is expected to close in the fourth quarter of 2024. Company Declares Dividend Increase of 5.8 Percent AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.55 per share to $1.64 per share beginning with the dividend payable on February 14, 2025 to shareholders of record as of January 15, 2025. This reflects an increase of approximately 5.8 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by 310 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. About AbbVie AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our third-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2024 and 2023 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. 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, and changes to laws and regulations applicable to our industry. 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 2023 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. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3License out/inAcquisition

04 Oct 2024

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FDA Approves 16 New Cancer Treatments as Global Cancer Rates Skyrocket

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Oct. 4, 2024 /PRNewswire/ -- USA News Group News Commentary – While some forms of cancer are seeing death rates fall, the world is witnessing a global surge in cancers among patients under 50. New cases are rising 79% overall, with the fastest rise in windpipe and prostate cancers and the heaviest death toll for cancers of the breast, windpipe, lung, bowel, and stomach. According to the United Nations, cancer rates are set to rise 77% by 2050. In an effort to fight back against cancer, researchers are working on new therapies and making gains, with the FDA issuing 16 oncology approvals between July and September 2024. Behind the scenes, biotech developers are making advancements, with recent market updates coming from: O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), AbbVie (NYSE: ABBV), BeiGene, Ltd. (NASDAQ: BGNE), HUTCHMED (China) Limited (NASDAQ: HCM), and Enliven Therapeutics, Inc. (NASDAQ: ELVN). According to analysts at Spherical Insights, the global oncology drug market is poised to grow at a CAGR of 11.5% towards US$564.50 billion by 2033. As well, the Global AI in Oncology Market is growing at a rapid 35% CAGR, towards US$13.6 billion by 2032. Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently announced key progress and upcoming studies for its flagship asset pelareorep, an intravenously delivered immunotherapeutic agent in its ongoing trials for breast and pancreatic cancer treatment. Recent clinical efficacy results from Oncolytics' BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated FDA approval. As well, Oncolytics states in the corporate update that key milestones in its gastrointestinal cancer clinical trials are expected in 2025, with potential for new registration-enabling studies. "We're excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "Having treated well over 100 HR+/HER2- metastatic breast cancer patients in multiple clinical studies, these results provide the basis for a development path leading to an accelerated approval. The BRACELET-1 results, combined with recent feedback from the FDA, give us confidence in our development approach, and we look forward to initiating a clinical trial designed to support the approval of pelareorep as a novel breast cancer therapeutic." The strong efficacy results from BRACELET-1 provide the foundation for a large clinical study designed to support an accelerated approval. Early in 2025, Oncolytics plans to submit to the FDA a pelareorep + paclitaxel combination therapy breast cancer trial. The study will enroll approximately 180 patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on antibody-drug conjugates (ADCs) like Enhertu, who are not eligible for ADCs, or who cannot tolerate ADCs, which represents a patient population of approximately 55,000 patients in the US. The study design has sufficient statistical power to deliver a p-value of < 0.05 with a progression-free survival (PFS) benefit of ≥4.3 months. Notably, the BRACELET-1 study demonstrated a 5.7-month benefit for the pelareorep + paclitaxel arm compared to chemotherapy alone. Enrollment in the registration-enabling study is expected to commence in the first half of 2025. "With the continuing evolution of breast cancer treatment, we have designed our breast cancer program with the guidance of leading experts in the field," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. " Our plan is designed to obtain a regulatory approval with fewer patients, in a shorter time, and requiring less funding than traditional regulatory pathways. Our thorough understanding of pelareorep's mechanism of action makes us confident that pelareorep-based combination therapy will continue to deliver strong clinical benefits to HR+/HER- breast cancer patients within the current treatment approach." Oncolytics anticipates several key milestones in 2025. In the first half of the year, the company plans to initiate a registrational study of pelareorep combined with paclitaxel in HR+/HER2- breast cancer. Also expected in H1 2025 are safety run-in data from cohort 5 of the GOBLET study, which is investigating pelareorep and modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab, in newly diagnosed pancreatic cancer, as well as updated efficacy data from cohort 4 of the GOBLET study focused on pelareorep and atezolizumab in second-line or later anal cancer. Once the master protocol has been finalized with the Global Coalition for Adaptive Research ( GCAR) for the pelareorep combination therapy, Oncolytics intends to approach the FDA before the end of the year. In the second half of 2025, Oncolytics expects initial efficacy results from cohort 5 of the GOBLET study in pancreatic cancer patients. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: AbbVie (NYSE: ABBV), a leading global pharmaceutical company, recently announced the submission of a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. With approximately 85% of lung cancers classified as NSCLC, and lung cancer as the leading cause of cancer-related deaths in the world, Teliso-V is being evaluated with patients with a particular type of NSCLC patient with a c-Met protein overexpression that's associated with a poor prognosis. "Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis," said Roopal Thakkar, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie. "We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology." BeiGene, Ltd. (NASDAQ: BGNE), a global oncology company, recently announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) recognized the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (>1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 >1%. The committee reviewed efficacy and safety data from the Phase 3 RATIONALE-305 (G/GEJ) and RATIONALE-306 (ESCC) studies, as well as other pivotal studies from the two other PD-1 inhibitors approved in these indications. "The vote by ODAC members to recommend a class-level cut-off of PD-L1 expression for PD-1 inhibitors used in the treatment of gastric/GEJ cancers and ESCC will help to establish a standard for clinicians and the patients they treat," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We look forward to working with the FDA as it completes its review of our BLAs for TEVIMBRA, and we strive to bring this therapy to applicable patients in the U.S." HUTCHMED (China) Limited (NASDAQ: HCM), a Hong-Kong-based international targeted therapeutics and immunotherapies developer for cancer and immunological diseases, recently announced that its partner Takeda received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and market FRUZAQLA (fruquintinib) for previously treated metastatic colorectal cancer (CRC). " Takeda has now obtained approval in Japan for FRUZAQLA®, demonstrating the strength of our global data package and the potential of this novel medicine to provide a much-needed treatment option to patients with metastatic CRC," said Dr Weiguo Su, CEO and CSO of HUTCHMED. " Takeda has been a leader in metastatic CRC treatment in Japan for over a decade and we are confident that it is well placed to bring FRUZAQLA® to patients in Japan." Enliven Therapeutics, Inc. (NASDAQ: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, recently announced positive data from the Phase 1 clinical trial evaluating ELVN-001, a potent, highly selective, potentially best-in-class small molecule kinase inhibitor, in patients with chronic myeloid leukemia (CML) that has failed, or the patient is intolerant to or not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377). "We continue to see categorical improvements in molecular response, and the drug remains well-tolerated with an encouraging safety profile," said presenting investigator Fabian Lang, M.D., from Goethe University Hospital Frankfurt. "Despite recent advancements in the CML treatment paradigm, there continues to be a need for more efficacious and better tolerated active-site TKIs, especially for patients who have failed treatment with allosteric inhibitors. I remain excited to see the progress of ELVN-001 as the trial continues." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyDrug ApprovalClinical ResultPhase 1Phase 3

27 Sep 2024

·www.prnewswire.com

AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer

- Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. - Biologics License Application (BLA) submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial (M14-239). Review of the BLA will be conducted under FDA's Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program. - There are currently no approved anti-cancer therapies specifically for c-Met overexpressing NSCLC and if approved Teliso-V would be the first-in-class therapy for this patient population. NORTH CHICAGO, Ill., Sept. 27, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. Approximately 85% of lung cancers are classified as NSCLC1 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world.2 The c-Met protein is a receptor tyrosine kinase found to be overexpressed in approximately 25% of advanced EGFR wild type, nonsquamous NSCLC patients3 and is associated with a poor prognosis.4,5,6 Teliso-V is being evaluated within this patient population who currently have very limited treatment options. "Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology." In December 2021, Teliso-V was granted Breakthrough Therapy Designation by the FDA. The BLA submission is supported by data from Phase 2 LUMINOSITY trial (Study M14-239), an ongoing study designed to characterize the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations. Data from the LUMINOSITY study were recently presented at the 2024 American Society of Clinical Oncology congress and topline data from this trial were shared in 2023. Teliso-V is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites. Additional information on clinical trials for Teliso-V is available at . About Telisotuzumab Vedotin (Teliso-V) Teliso-V is an investigational, first-in-class, c-Met protein directed antibody-drug conjugate (ADC) designed to target c-Met overexpressing tumors. c-Met is a receptor tyrosine kinase that can be overexpressed in many solid tumors including NSCLC. Further information on clinical trials for Teliso-V is available at . Teliso-V is not approved by any health regulatory authority. About the LUMINOSITY Trial The LUMINOSITY trial (M14-239), is an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second-line or third-line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DoR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS). About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for patients 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 including antibody-drug conjugates (ADCs), immuno-oncology, bi-specific antibody and 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 and solid tumors. We are evaluating more than 20 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 . 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 – 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. 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, and changes to laws and regulations applicable to our industry. 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 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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: 1 National Cancer Institute. Non-small cell lung cancer treatment – health professional version. . Accessed December 8, 2021. 2 Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2024;74(3):229-63. 3 Ansell PJ, Baijal S, Liede A, et al. Prevalence and Characterization of c-MET–Overexpressing Non-small Cell Lung Cancer (NSCLC) Across Clinical Trial Samples and Real-world Patient Cohorts From the City of Hope National Medical Center. Cancer Research UK (CRUK) - Lung Cancer Conference; Manchester, UK2022. 4 Liang H, Wang M. MET Oncogene in Non-Small Cell Lung Cancer: Mechanism of MET Dysregulation and Agents Targeting the HGF/c-Met Axis. Onco Targets Ther. 2020;13:2491-510. 5 Park S, Choi YL, Sung CO, et al. High MET copy number and MET overexpression: poor outcome in non-small cell lung cancer patients. Histol Histopathol. 2012;27(2):197-207. 6 Guo B, Cen H, Tan X, et al. Prognostic value of MET gene copy number and protein expression in patients with surgically resected non-small cell lung cancer: a meta-analysis of published literatures. PLoS One. 2014;9(6):e99399. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2ASCOPhase 3Accelerated ApprovalBreakthrough Therapy

100 Deals associated with Telisotuzumab vedotin

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KEGG	Wiki	ATC	Drug Bank
D11344	-	-	DB15104

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
c-Met positive non-small cell lung cancer	NDA/BLA	US	AbbVie, Inc.	27 Sep 2024
Non-squamous non-small cell lung cancer	NDA/BLA	US	AbbVie, Inc.	27 Sep 2024
Non-Small Cell Lung Cancer	Phase 3	-	AbbVie, Inc.	31 May 2024
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	-	AbbVie, Inc.	30 Jan 2025
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	US	AbbVie, Inc.	21 Nov 2022
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	JP	AbbVie, Inc.	21 Nov 2022
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	AU	AbbVie, Inc.	21 Nov 2022
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	FR	AbbVie, Inc.	21 Nov 2022
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	DE	AbbVie, Inc.	21 Nov 2022
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	IL	AbbVie, Inc.	21 Nov 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02099058 (WCLC2024) Manual	Phase 1	c-Met positive non-small cell lung cancer MET Overexpression	30	Teliso-v (above (A cutoff value of 25% c-Met-positive tumor cells with 3+ intensity))	nivoezljxt(pnvisixwqa) = vzlwjzitju lveecsvsbb (nxpowiqyov )	Positive	09 Sep 2024
NCT02099058 (WCLC2024) Manual	Phase 1		30	Teliso-v (below (A cutoff value of 25% c-Met-positive tumor cells with 3+ intensity))	nivoezljxt(pnvisixwqa) = dbxyhkinzz lveecsvsbb (nxpowiqyov )	Positive	09 Sep 2024
NCT03539536 (LUMINOSITY, Pubmed) Manual	Phase 2	c-Met positive non-small cell lung cancer c-Met protein-overexpressing	172	Telisotuzumab vedotin	arilybcifi(hvfsyuneax) = klltonnnrr kukigalsaa (rcnsahaofh, 21.7 - 36.2) View more	Positive	06 Jun 2024
NCT03539536 (LUMINOSITY, Pubmed) Manual	Phase 2		172	Telisotuzumab vedotin (c-Met high)	arilybcifi(hvfsyuneax) = fzngqvuomx kukigalsaa (rcnsahaofh, 24.2 - 46.2) View more	Positive	06 Jun 2024
NCT03539536 (LUMINOSITY, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer Third line c-Met protein overexpression	172	Telisotuzumab vedotin (c-Met High)	wtjqkynehi(dxrbakgwxr) = choiivuipn stllewjbtf (onafsbbwfa, 24.2 - 46.2) View more	Positive	24 May 2024
NCT03539536 (LUMINOSITY, ASCO2024) Manual	Phase 2		172	Telisotuzumab vedotin (c-Met Int)	wtjqkynehi(dxrbakgwxr) = uuiwtjhcsk stllewjbtf (onafsbbwfa, 14.4 - 33.4) View more	Positive	24 May 2024
ESMO_ASIA2023	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR-mut \| c-Met overexpressing	41	Telisotuzumab vedotin (Teliso-V) + Osimertinib	hhaqniaknc(ytlqlmzfnc) = jtpkfsydfw ietjcfcxhp (mkfljtcsrs ) View more	-	03 Dec 2023
NCT04928846 (TeliMET NSCLC-01, ESMO_ASIA2023)	Phase 3	EGFR positive Non-squamous non-small cell lung cancer c-Met overexpressing \| EGFR wildtype	-	Teliso-V	epuouprmjy(wgukzsocfr) = zwluixjgip msdfqtfeib (byqntpakmr ) View more	-	02 Dec 2023
NCT03539536 (LUMINOSITY, PRNewswire) Manual	Phase 2	c-Met positive non-small cell lung cancer c-MET Amplification	-	Telisotuzumab-vedotin (c-Met High)	dieoincgpi(ylcjbzaryw) = oxgqlofufa hrbggqxxgr (jllzctbpsa ) View more	Positive	29 Nov 2023
NCT04928846 (TeliMET NSCLC-01, ESMO2023)	Phase 3	Non-squamous non-small cell lung cancer	698	Teliso-V	axucxsiolb(vqbuirxsps) = gtjxvywyfi qlgljbccig (gsdccqfvyt, 24 - 51)	-	23 Oct 2023
NCT05513703 (ASCO2023)	Phase 2	MET gene amplification Non-small Cell Lung Cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	70	Teliso-V	wzmanhgzch(eaxfkebbjl) = qumvgajtbw lrglqfpsor (zhnepxdcpo )	-	31 May 2023
NCT03539536 (LUMINOSITY, ASCO2023)	Phase 2	Non-Small Cell Lung Cancer	52	telisotuzumab vedotin (MET amplification)	lqppvwdbie(jdtihhprjs) = fnwdwusoub jxbevydktu (lyusaomfao )	Positive	31 May 2023
NCT03539536 (LUMINOSITY, AACR2023) Manual	Phase 2	Non-squamous non-small cell lung cancer Second line MET Overexpression	10	telisotuzumab vedotin	flvvgifybz(xaxxamzmzf) = cmnbnierbe xcvcxecesm (lowvlvpqhm ) View more	Positive	14 Apr 2023

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