FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy
Roche has received FDA approval for Tecentriq Hybreza, the first subcutaneous anti-PD-(L)1 cancer immunotherapy. This new formulation offers greater flexibility in treatment options, reducing administration time from 30-60 minutes to approximately seven minutes. It's approved for all adult indications of IV Tecentriq in the U.S., including certain types of lung, liver, skin, and soft tissue cancers.
The approval is based on the IMscin001 study, which showed comparable efficacy and safety to the IV formulation. The IMscin002 study revealed that 71% of patients preferred Tecentriq Hybreza over IV administration, with 79% choosing to continue treatment with the subcutaneous option. This development aligns with Roche's commitment to improving patient experience and offering diverse treatment options.
Roche ha ricevuto l'approvazione della FDA per Tecentriq Hybreza, la prima immunoterapia oncologica anti-PD-(L)1 sottocutanea. Questa nuova formulazione offre maggiore flessibilità nelle opzioni di trattamento, riducendo il tempo di somministrazione da 30-60 minuti a circa sette minuti. È approvata per tutte le indicazioni per adulti di Tecentriq IV negli Stati Uniti, inclusi alcuni tipi di cancro ai polmoni, al fegato, alla pelle e ai tessuti molli.
L'approvazione si basa sullo studio IMscin001, che ha mostrato un'efficacia e una sicurezza comparabili rispetto alla formulazione IV. Lo studio IMscin002 ha rivelato che il 71% dei pazienti preferiva Tecentriq Hybreza rispetto alla somministrazione IV, con il 79% che sceglieva di continuare il trattamento con l'opzione sottocutanea. Questo sviluppo è in linea con l'impegno di Roche a migliorare l'esperienza del paziente e a offrire opzioni di trattamento diversificate.
Roche ha recibido la aprobación de la FDA para Tecentriq Hybreza, la primera inmunoterapia anticancerígena anti-PD-(L)1 bajo la piel. Esta nueva formulación ofrece mayor flexibilidad en las opciones de tratamiento, reduciendo el tiempo de administración de 30-60 minutos a aproximadamente siete minutos. Está aprobada para todas las indicaciones en adultos de Tecentriq IV en EE. UU., incluidos ciertos tipos de cáncer de pulmón, hígado, piel y tejidos blandos.
La aprobación se basa en el estudio IMscin001, que demostró una eficacia y seguridad comparables a la formulación IV. El estudio IMscin002 reveló que el 71% de los pacientes prefería Tecentriq Hybreza en lugar de la administración IV, y el 79% eligió continuar el tratamiento con la opción subcutánea. Este desarrollo está alineado con el compromiso de Roche de mejorar la experiencia del paciente y ofrecer opciones de tratamiento diversas.
로슈는 Tecentriq Hybreza에 대해 FDA 승인을 받았습니다. 이는 첫 번째 피하 주사용 항-PD-(L)1 암 면역 요법입니다. 이 새로운 제형은 더 큰 유연성을 제공하여 치료 시간도 30-60분에서 약 7분으로 단축됩니다. 미국에서 IV Tecentriq의 모든 성인 적응증에 대해 승인되었으며, 여기에는 특정 유형의 폐, 간, 피부 및 연조직 암이 포함됩니다.
이번 승인은 IMscin001 연구에 기반을 두고 있으며, IV 제형과 유사한 효능과 안전성을 보여주었습니다. IMscin002 연구는 71%의 환자가 IV 투여보다 Tecentriq Hybreza를 선호했다고 밝혔으며, 79%는 피하 옵션으로 치료를 계속하기를 선택했습니다. 이 발전은 환자 경험을 개선하고 다양한 치료 옵션을 제공하겠다는 로슈의 약속과 일치합니다.
Roche a reçu l'approbation de la FDA pour Tecentriq Hybreza, la première immunothérapie anticancéreuse anti-PD-(L)1 sous-cutanée. Cette nouvelle formulation offre une plus grande flexibilité dans les options de traitement, réduisant le temps d'administration de 30-60 minutes à environ sept minutes. Elle est approuvée pour toutes les indications adultes de Tecentriq IV aux États-Unis, y compris certains types de cancers du poumon, du foie, de la peau et des tissus mous.
L'approbation est fondée sur l'étude IMscin001, qui a montré une efficacité et une sécurité comparables à la formulation IV. L'étude IMscin002 a révélé que 71% des patients préféraient Tecentriq Hybreza plutôt que l'administration IV, 79% choisissant de continuer le traitement avec l'option sous-cutanée. Ce développement est en accord avec l'engagement de Roche à améliorer l'expérience des patients et à offrir des options de traitement variées.
Roche hat die FDA-Zulassung für Tecentriq Hybreza erhalten, die erste subkutane Anti-PD-(L)1-Krebsimmuntherapie. Diese neue Formulierung bietet größere Flexibilität bei den Behandlungsoptionen und verkürzt die Verabreichungszeit von 30-60 Minuten auf etwa sieben Minuten. Sie ist in den USA für alle Erwachsenengebrauchsindikationen von IV Tecentriq zugelassen, einschließlich bestimmter Arten von Lungen-, Leber-, Haut- und Weichgewebskrebs.
Die Zulassung basiert auf der IMscin001-Studie, die eine vergleichbare Wirksamkeit und Sicherheit zur IV-Formulierung zeigte. Die IMscin002-Studie ergab, dass 71% der Patienten Tecentriq Hybreza der IV-Verabreichung vorzogen, während 79% weiterhin die subkutane Option wählten. Diese Entwicklung steht im Einklang mit Roches Engagement, das Patientenerlebnis zu verbessern und vielfältige Behandlungsoptionen anzubieten.
- FDA approval of Tecentriq Hybreza, the first subcutaneous anti-PD-(L)1 cancer immunotherapy
- Reduced treatment time from 30-60 minutes to approximately 7 minutes
- Approved for all adult indications of IV Tecentriq in the U.S.
- 71% of patients preferred Tecentriq Hybreza over IV administration in the IMscin002 study
- 79% of patients chose to continue treatment with Tecentriq Hybreza after experiencing both formulations
- None.
- Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
(IV) Tecentriq1,2 - New subcutaneous (SC) option reduces treatment time to approximately seven minutes, compared with 30-60 minutes for IV infusion2
Basel, 13 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).2 It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer.3
“By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients faster and in more accessible settings.”
“This approval represents a significant option to improve the patient experience,” said Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation. “When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option."
The FDA approval is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.1,2 The Phase II IMscin002 study showed that
Developing new formulations of our medicines is part of our commitment to improve the patient experience and support people living with different illnesses at every step of their treatment journey. With Tecentriq Hybreza and Roche’s 13 other subcutaneous therapies – available across various diseases – we offer additional administration options to meet the diverse preferences of patients.
The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (outside the U.S. marketed as Tecentriq SC).5 Regulatory reviews in other countries and regions are ongoing.
About the IMscin001 study
IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of Tecentriq Hybreza, compared with Tecentriq IV, in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The study enrolled 371 patients. The study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum Ctrough and model-predicted area under the curve. Efficacy, as measured by the objective response rate, progression-free survival, overall survival and duration of response, was similar between the SC and IV treatment arms and consistent with the known profile of Tecentriq IV. The safety profile of Tecentriq Hybreza was also consistent with that of Tecentriq IV.1,2
About the IMscin002 study
IMscin002 is a Phase II, global crossover study evaluating patient preference between the SC and IV formulations of Tecentriq. The study enrolled 179 patients, including people with PD-L1- positive resected Stage II-IIIB NSCLC who have completed adjuvant platinum-based chemo- therapy without evidence of disease recurrence, and untreated patients with PD-L1-high Stage IV NSCLC. The study met its primary endpoint, showing that
About Tecentriq Hybreza
Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream.
Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS). In addition to intravenous infusion, Tecentriq has been approved as a subcutaneous formulation in 50 countries (outside the U.S. marketed as Tecentriq SC). The approved indications for Tecentriq Hybreza and Tecentriq SC mirror those of Tecentriq IV.
About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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References
[1] Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34(8):693-702.
[2] Burotto M, et al. IMscin001 Part 2 updated results: Efficacy, safety, immunogenicity and patient-reported outcomes (PROs) from the randomised Phase III study comparing atezolizumab (atezo) subcutaneous (SC) vs intravenous (IV) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Presented at ESMO 2023 Congress. Poster #1447P, on display 23 October 2023.
[3] FDA - U.S. Food and Drug Administration. Tecentriq: highlights of prescribing information. Last updated April 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761034s053lbl.pdf. Accessed July 2024.
[4] Cappuzzo F, et al. Primary results from IMscin002: A study to evaluate patient- and healthcare professional reported preferences for atezolizumab subcutaneous vs intravenous for the treatment of NSCLC. Presented at ELCC on 21 March 2024. Abstract 244MO.
[5] Roche. Roche’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes. Last updated 29 August 2024. https://www.roche.com/media/releases/med-cor-2023-08-29b. Accessed July 2024.
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