Imfinzi mejoró OS y PFS en SCLC en etapa limitada
Renk AG
n / a
07:46 20/03/24
05 de abril de 2024
Imfinzi significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial
First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial
Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca's Imfinzi (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following concurrent chemoradiotherapy (cCRT) compared to placebo after cCRT.
Small cell lung cancer (SCLC) is a highly aggressive form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy and radiotherapy in LS-SCLC patients.1,2 The prognosis is particularly poor for LS-SCLC, as only 15 - 30% of these patients will be alive five years after diagnosis.3
Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Center, The Netherlands, and principal investigator in the trial said: "Many patients treated for limited-stage small cell lung cancer face disease recurrence and the standard of care has remained unchanged for decades. ADRIATIC is the first global Phase III immunotherapy trial to deliver significant, clinically meaningful improvement in supervivencia in this setting, marking a breakthrough for patients with this devastating disease."
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These exciting results build on the transformative efficacy of Imfinzi in extensive-stage small cell lung cancer and demonstrate the potential to bring a curative-intent immunotherapy treatment to this earlier-stage setting of small cell lung cancer for the first time. These data, together with the PACIFIC data in unresectable, Stage III non-small cell lung cancer, underscore the pioneering role of Imfinzi in the treatment of early lung cancer following chemoradiotherapy."
El perfil de seguridad para Imfinzi was consistent with its known profile, and no new safety signals were identified.
These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
The second experimental arm testing the efficacy of Imjudo (tremelimumab) added to Imfinzi as a secondary endpoint remains blinded and will continue to the next planned analysis.
Imfinzi is approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage SCLC (ES-SCLC) based on the CASPIAN Phase III trial. Imfinzi is also the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III cáncer de pulmón de células no pequeñas (CPCNP) in patients whose disease has not progressed after CRT based on the PACIFIC Phase III trial.
Notas:
Cáncer de pulmón de células pequeñas
Lung cancer is the leading cause of cancer death among men and women and accounts for about one-fifth of all cancer deaths.4 Lung cancer is broadly split into NSCLC and SCLC, with about 15% of cases classified as SCLC.5
LS-SCLC (Stage I-III) is classified as SCLC that is generally only in one lung or one side of the chest.6 LS-SCLC accounts for approximately 30% of SCLC diagnoses and the prognosis remains poor despite curative-intent treatment with standard-of-care cCRT.7
ADRIÁTICO
The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi más Imjudo versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose of Imfinzi con o sin Imjudo 75mg every four weeks for up to four doses/cycles each, followed by Imfinzi every four weeks for up to 24 months.
The dual primary endpoints are PFS and OS for Imfinzi monotherapy versus placebo. Key secondary endpoints included OS and PFS for Imfinzi más Imjudo versus placebo, safety and quality of life medidas. The trial incluye 164 centres in 19 countries across North and South América, Europa y Asia
Imfinzi
Imfinzi (durvalumab) es un anticuerpo monoclonal humano que se une a la proteína PD-L1 y bloquea la interacción de PD-L1 con las proteínas PD-1 y CD80, contrarrestando las tácticas de evasión inmunológica del tumor y liberando la inhibición de las respuestas inmunitarias.
In addition to its indications in unresectable, Stage III NSCLC and ES-SCLC, Imfinzi is currently approved in a number of countries in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC.
Imfinzi is also approved in a number of countries in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU and in previously treated patients with advanced bladder cancer in a small number of countries.
Desde la primera aprobación en mayo de 2017, más de 220,000 XNUMX pacientes han sido tratados con Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal cancers and other solid tumours.
Imjudo
Imjudo (tremelimumab) es un anticuerpo monoclonal humano que se dirige a la actividad de la proteína 4 asociada a los linfocitos T citotóxicos (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.
In addition to its approved indications in combination with Imfinzi in liver and lung cancers, the combination of Imjudo y Imfinzi is being evaluated across multiple tumour types including locoregional HCC (EMERALD-3) and bladder cancer (VOLGA and NILE).
AstraZeneca en cáncer de pulmón
AstraZeneca está trabajando para acercar a los pacientes con cáncer de pulmón a la cura a través de la detección y el tratamiento de la enfermedad en etapa temprana, al mismo tiempo que amplía los límites de la ciencia para mejorar los resultados en entornos resistentes y avanzados. Mediante la definición de nuevos objetivos terapéuticos y la investigación de enfoques innovadores, la Compañía tiene como objetivo hacer coincidir los medicamentos con los pacientes que pueden beneficiarse más.
La cartera integral de la compañía incluye medicamentos líderes contra el cáncer de pulmón y la próxima ola de innovaciones, que incluyen Tagrisso (osimertinib) y Iressa (gefitinib); Imfinzi y Imjudo; Enhertu (trastuzumab deruxtecan) y datopotamab deruxtecan en colaboración con Daiichi Sankyo; Orpatías (savolitinib) en colaboración con HUTCHMED; así como una cartera de posibles nuevos medicamentos y combinaciones a través de diversos mecanismos de acción.
AstraZeneca es miembro fundador de Lung Ambition Alliance, una coalición global que trabaja para acelerar la innovación y brindar mejoras significativas para las personas con cáncer de pulmón, incluido el tratamiento y más allá.
AstraZeneca en inmunooncología (IO)
AstraZeneca es pionera en la introducción del concepto de inmunoterapia en áreas clínicas específicas de gran necesidad médica no cubierta. La empresa cuenta con una cartera de IO completa y diversa y una cartera anclada en inmunoterapias diseñadas para superar la evasión de la respuesta inmunitaria antitumoral y estimular el sistema inmunitario del cuerpo para atacar los tumores.
AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
AstraZeneca en oncología
AstraZeneca está liderando una revolución en oncología con la ambición de proporcionar curas para el cáncer en todas sus formas, siguiendo la ciencia para comprender el cáncer y todas sus complejidades para descubrir, desarrollar y entregar medicamentos que cambian la vida de los pacientes.
El De la empresa focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca tiene la visión de redefinir la atención del cáncer y, algún día, eliminar el cáncer como causa de muerte.
AstraZeneca
AstraZeneca (LSE / STO / Nasdaq: AZN) es una empresa biofarmacéutica mundial dirigida por la ciencia que se centra en el descubrimiento, el desarrollo y la comercialización de medicamentos recetados en oncología, enfermedades raras y biofarmacéuticos, incluidos los de enfermedades cardiovasculares, renales y metabólicas y respiratorias. E inmunología. Con sede en Cambridge, Reino Unido, AstraZeneca opera en más de 100 países y sus medicamentos innovadores son utilizados por millones de pacientes en todo el mundo. Por favor visita astrazeneca.com y sigue a la Compañía en las redes sociales @AstraZeneca.
Contacto
Para obtener detalles sobre cómo ponerse en contacto con el equipo de relaciones con inversores, haga clic en esta página. Para contactos de medios, haga clic en esta página.
Referencias
1. National Cancer Institute. NCI Dictionary - Small Cell Lung Cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. Consultado Abril 2024.
2. Qin A and Kalemkerian GP. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? Práctica J Oncol. 2018;14(6):369-370.
3. Bebb DG, et al. Symptoms and Experiences with Small Cell Lung Cancer: A Mixed Methods Study of Patients and Caregivers. Pulm Ther. 2023: 9; 435-450.
4. Organización Mundial de la Salud. Agencia Internacional para la Investigación sobre el Cáncer. Hoja informativa sobre los pulmones. Disponible en: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Consultado en abril de 2024.
5. LUNGevity Foundation. Types of Lung Cancer. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Consultado en abril de 2024.
6. American Cancer Society. Treatment Choices by Stage for Small Cell Lung Cancer. Available at: https://www.cancer.org/cancer/lung-cancer/treating-small-cell/by-stage.html. Consultado Abril 2024.
7. Senan S, et al. ADRIATIC: A phase III trial of durvalumab ± tremelimumab after concurrent chemoradiation for patients with limited stage small cell lung cancer. Ana Oncol. 2019;30(suppl. 2):ii25.
Adrián Kemp
Secretaria de Empresa
AstraZenecaPLC
RNS puede usar su dirección IP para confirmar el cumplimiento de los términos y condiciones, para analizar cómo interactúa con la información contenida en esta comunicación y para compartir dicho análisis de forma anónima con otros como parte de nuestros servicios comerciales. Para obtener más información sobre cómo RNS y la Bolsa de Valores de Londres utilizan los datos personales que nos proporciona, consulte nuestra Política de privacidad.