AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer
AbbVie has submitted a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V). This investigational antibody-drug conjugate is intended for adult patients with previously treated, locally advanced or metastatic EGFR wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
Key points:
- Teliso-V could be the first-in-class therapy for c-Met overexpressing NSCLC
- c-Met protein is overexpressed in about 25% of advanced EGFR wild type, nonsquamous NSCLC patients
- The BLA is supported by data from the Phase 2 LUMINOSITY trial
- Teliso-V received FDA Breakthrough Therapy Designation in December 2021
- A Phase 3 confirmatory study, TeliMET NSCLC-01, is currently underway
AbbVie ha presentato una Domanda di Licenza per Prodotti Biologici (BLA) alla FDA per l'approvazione accelerata di telisotuzumab vedotin (Teliso-V). Questo anticorpo-coniugato sperimentale è destinato a pazienti adulti con cancro polmonare non a piccole cellule (NSCLC) non squamoso, localmente avanzato o metastatico, di tipo selvatico EGFR già trattato, con sovraespressione della proteina c-Met.
Punti chiave:
- Teliso-V potrebbe essere la prima terapia della sua classe per NSCLC con sovraespressione di c-Met
- La proteina c-Met è sovraespressa in circa il 25% dei pazienti con NSCLC avanzato di tipo selvatico EGFR non squamoso
- La BLA è supportata da dati dello studio di Fase 2 LUMINOSITY
- Teliso-V ha ricevuto la Designazione di Terapia Innovativa dalla FDA nel dicembre 2021
- Attualmente è in corso uno studio di conferma di Fase 3, TeliMET NSCLC-01
AbbVie ha presentado una Solicitud de Licencia de Productos Biológicos (BLA) a la FDA para la aprobación acelerada de telisotuzumab vedotin (Teliso-V). Este conjugado anticuerpo-fármaco en investigación está destinado a pacientes adultos con cáncer pulmonar no microcítico (NSCLC) no escamoso, localmente avanzado o metastásico, de tipo salvaje EGFR previamente tratados, con sobreexpresión de la proteína c-Met.
Puntos clave:
- Teliso-V podría ser la terapia de primera clase para NSCLC con sobreexpresión de c-Met
- La proteína c-Met está sobreexpresada en aproximadamente el 25% de los pacientes con NSCLC avanzado de tipo salvaje EGFR no escamoso
- La BLA está respaldada por datos del ensayo de Fase 2 LUMINOSITY
- Teliso-V recibió la Designación de Terapia Innovadora de la FDA en diciembre de 2021
- Actualmente se está llevando a cabo un estudio de confirmación de Fase 3, TeliMET NSCLC-01
AbbVie는 생물학적 제품 면허 신청(BLA)을 FDA에 제출하여 텔리소투주맙 베도틴(Teliso-V)의 신속 승인을 요청했습니다. 이 실험적인 항체-약물 접합체는 이전 치료를 받은 성인 환자들에 대한 것이며, 국소 진행성 또는 전이성 EGFR 와일드 타입 비편평 비소세포 폐암(NSCLC) 및 c-Met 단백질 과발현을 목표로 하고 있습니다.
주요 사항:
- Teliso-V는 c-Met 과발현 NSCLC에 대한 최초의 치료제가 될 수 있습니다.
- c-Met 단백질은 진단된 EGFR 와일드 타입 비편평 NSCLC 환자의 약 25%에서 과발현됩니다.
- BLA는 2상 LUMINOSITY 시험의 데이터로 뒷받침됩니다.
- Teliso-V는 2021년 12월 FDA의 혁신 치료 지정(Breakthrough Therapy Designation)을 받았습니다.
- 현재 TeliMET NSCLC-01이라는 3상 확증 연구가 진행 중입니다.
AbbVie a soumis une Demande de Licence Biologique (BLA) à la FDA pour l'approbation accélérée de telisotuzumab vedotin (Teliso-V). Cet anticorps-conjugué expérimental est destiné aux patients adultes présentant un cancer du poumon non à petites cellules (NSCLC) non squameux, localement avancé ou métastatique, de type sauvage EGFR, ayant déjà été traités, avec une surexpression de la protéine c-Met.
Points clés :
- Teliso-V pourrait être le premier traitement de sa catégorie pour le NSCLC surexprimant c-Met.
- La protéine c-Met est surexprimée chez environ 25 % des patients atteints de NSCLC avancé de type sauvage EGFR non squameux.
- La BLA est soutenue par les données de l'essai de phase 2 LUMINOSITY.
- Teliso-V a reçu la désignation de thérapie révolutionnaire de la FDA en décembre 2021.
- Une étude de confirmation de phase 3, TeliMET NSCLC-01, est actuellement en cours.
AbbVie hat einen Biologics License Application (BLA) bei der FDA für die beschleunigte Zulassung von telisotuzumab vedotin (Teliso-V) eingereicht. Dieses experimentelle Antikörper-Wirkstoff-Konjugat ist für erwachsene Patienten bestimmt, die zuvor behandelt wurden und an lokal fortgeschrittenem oder metastasiertem, EGFR-Wildtyp, nicht-squamösen, nicht-kleinzelligem Lungenkrebs (NSCLC) mit c-Met-Protein-Überexpression leiden.
Wichtige Punkte:
- Teliso-V könnte die erste Therapie ihrer Art für c-Met-überexprimierendes NSCLC sein.
- Das c-Met-Protein ist bei etwa 25% der Patienten mit fortgeschrittenem EGFR-Wildtyp, nicht-squamösem NSCLC überexprimiert.
- Die BLA stützt sich auf Daten aus der Phase-2-Studie LUMINOSITY.
- Teliso-V erhielt im Dezember 2021 die Breakthrough-Therapie-Bezeichnung der FDA.
- Aktuell wird eine Phase-3-Bestätigungsstudie, TeliMET NSCLC-01, durchgeführt.
- Potential first-in-class therapy for c-Met overexpressing NSCLC
- FDA Breakthrough Therapy Designation received in December 2021
- BLA submission for accelerated approval
- Ongoing Phase 3 confirmatory study (TeliMET NSCLC-01)
- None.
Insights
The submission of a Biologics License Application (BLA) for Teliso-V represents a significant milestone for AbbVie in the treatment of non-small cell lung cancer (NSCLC). This antibody-drug conjugate targets c-Met protein overexpression, present in about
Key points to consider:
- If approved, Teliso-V would be the first-in-class therapy for c-Met overexpressing NSCLC, addressing an unmet medical need.
- The FDA's Breakthrough Therapy Designation and use of the Real-Time Oncology Review program suggest potential for an expedited approval process.
- The ongoing Phase 3 TeliMET NSCLC-01 study will be important for confirming the efficacy and potentially converting the accelerated approval to a full approval.
While promising, investors should note that approval is not guaranteed and the drug's commercial success will depend on factors such as pricing, reimbursement and competition from other emerging therapies in the NSCLC space.
The BLA submission for Teliso-V is a positive development for AbbVie's oncology portfolio and could potentially impact the company's future revenue streams. Key financial considerations include:
- Market opportunity: With NSCLC being the most common form of lung cancer and c-Met overexpression present in a significant subset, the potential patient population is substantial.
- Revenue diversification: If approved, Teliso-V could help AbbVie reduce its reliance on Humira, which has faced biosimilar competition.
- R&D investment: The development of Teliso-V represents a significant R&D investment, which could start paying off if the drug receives approval and achieves commercial success.
Investors should monitor the FDA review process closely, as approval could positively impact AbbVie's stock price. However, it's important to consider that the full financial impact may not be immediate, as market penetration and sales ramp-up will take time post-approval.
- 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.
Approximately
"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.
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. 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
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.
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FAQ
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