c-Met positive stomach adenocarcinoma

– 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, IL, USA I September 27, 2024 I 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 NSCLC 1 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 patients 3 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 www.clinicaltrials.gov . 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 https://clinicaltrials.gov/ . 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 http://www.abbvie.com/oncology . 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 www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) , and YouTube. References: 1 National Cancer Institute. Non-small cell lung cancer treatment – health professional version. https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc. 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

- 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

LUMINOSITY trial demonstrated compelling clinical benefits across key endpoints Teliso-V is an investigational first-in-class, c-Met protein directed antibody-drug conjugate (ADC) being studied in patients with previously treated non-small cell lung cancer (NSCLC) with c-Met overexpression Data from the study will be presented at a future medical meeting and we will discuss with global health authorities the potential to support an accelerated approval NORTH CHICAGO, Ill., Nov. 29, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today topline results from the single-arm Phase 2 LUMINOSITY trial evaluating telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor (EGFR) wild type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The results demonstrated a compelling overall response rate per independent central review (ICR) of 35 percent and 23 percent across c-Met High and c-Met Intermediate patients respectively. In addition, other endpoints demonstrated meaningful clinical outcomes including median duration of response per ICR of 9 months and 7.2 months and a median overall survival of 14.6 months and 14.2 months across c-Met High and c-Met Intermediate patients respectively. The safety profile of Teliso-V was consistent with previous findings and no new safety concerns were identified. Adverse events with Teliso-V monotherapy were generally well managed and tolerated. Full data from the LUMINOSITY study will be presented at a future medical meeting and we will discuss with global health authorities the potential to support an accelerated approval. Approximately 85% of lung cancers are classified as NSCLC1 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women throughout the world.2 C-Met protein overexpression is found in approximately 25% of advanced EGFR wild type NSCLC patients3 and is associated with a poor prognosis for these patients.4,5,6 Teliso-V, an investigational ADC, is being studied in this patient population who have very limited treatment options and where there are currently no approved therapies. "The results of the Phase 2 LUMINOSITY trial are encouraging for those patients with non-small cell lung cancer with c-Met overexpression as there is a critical need for better care and additional therapy options for them," said Ross Camidge, MD, PhD, University of Colorado Cancer Center, United States, and Principal Investigator for the trial. "Today's announcement also provides confidence as we continue to enroll patients into the Phase 3 TeliMET NSCLC-01 trial and expand our understanding of Teliso-V's potential." "Results from the Phase 2 LUMINOSITY trial mark an important step forward for AbbVie's mission to advance new oncology treatments across our ADC program targeting solid tumor types with critical patient needs," said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie. Teliso-V is being evaluated as a monotherapy in patients with previously treated c-Met overexpressing EGFR wild type nonsquamous NSCLC in the randomized Phase 3 study TeliMET NSCLC-01, which is currently enrolling. Teliso-V has also been granted several designations around the world including Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and Taiwanese health authorities, SAKIGAKE designation in Japan by the Ministry of Health, Labour and Welfare (MHLW), as well as being awarded an Innovation Passport by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). About Telisotuzumab-Vedotin (Teliso-V) Teliso-V is an investigational first-in-class, c-Met protein directed antibody-drug conjugate (ADC) targeting patients with c-Met overexpressing tumors. C-Met is a receptor tyrosine kinase that is overexpressed in many solid tumors including NSCLC. Teliso-V is being evaluated as a monotherapy in patients with previously treated c-Met overexpressing EGFR wild type non squamous NSCLC in the randomized Phase 3 study TeliMET NSCLC-01, which is currently enrolling. In addition, it is being evaluated in combination with osimertinib in the ongoing Phase 1 study M14-237, and as a monotherapy in the Phase 2 LUMINOSITY study. Further information on clinical trials for Teliso-V is available at . Currently there are no approved cancer therapies specifically for patients with c-Met overexpressing NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy have not been established. 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 multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 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 2022 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. 1. National Cancer Institute. Non-small cell lung cancer treatment – health professional version. . Accessed December 8, 2021. 2. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313. PMID: 30207593. 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