European Commission approves Roche’s Tecentriq SC, the EU's first
PD-(L)1 cancer immunotherapy subcutaneous injection for multiple
cancer types
- Subcutaneous (SC) injection
offers the potential for a faster, more convenient alternative to
intravenous (IV) infusion and is preferred by cancer
patients, nurses and
physicians1-5
- Tecentriq SC reduces
treatment time by approximately 80%, compared with standard IV
infusion6
- Roche is working closely
with national health systems in Europe to ensure patients can
access Tecentriq SC as quickly as possible
Basel, 16 January 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the European Commission has granted marketing
authorisation for Tecentriq® SC (atezolizumab), the European Union
(EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous (under
the skin) injection. Last year, more than 38,000 people in the EU
received Tecentriq to treat different types of lung, liver, bladder
and breast cancer.7 Until now, Tecentriq has been given directly
into patients’ veins by IV infusion which takes approximately 30-60
minutes.6 The new subcutaneous injection will cut treatment time to
approximately seven minutes, with most injections taking between
four and eight minutes.6 The marketing authorisation applies to all
approved indications of Tecentriq IV.7
“We are pleased to introduce the first subcutaneous PD-L1 cancer
immunotherapy in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s
Chief Medical Officer and Head of Global Product Development.
“Giving Tecentriq subcutaneously provides more flexibility to
patients, while also helping to free up resources in constrained
healthcare systems.”
“Ensuring the best possible quality of life is crucial for
people living with cancer,” said Dr. Enriqueta Felip, Head of
the Thoracic Cancer Unit of Vall d'Hebron Hospital, Spain. “The
availability of a subcutaneous cancer immunotherapy option that can
minimise the time receiving treatment and even allow for treatment
outside of a hospital will undoubtedly make a significant
difference to patients and their loved ones.”
The 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.6,8 90% of healthcare
professionals who were surveyed as part of the study agreed that
the SC formulation is easy to administer and 75% said it could save
time for healthcare teams compared with the IV formulation.6
In addition to offering shorter treatment time, Tecentriq SC may
be administered by a healthcare professional outside of the
hospital, in a community care setting or at a patient's home,
depending on national regulations and health systems. Roche is in
discussion with several providers in Europe to include Tecentriq SC
in cancer homecare initiatives where possible.
About the IMscin001 studyIMscin001 is a Phase
IB/III, global, multicentre, randomised study evaluating the
pharmacokinetics, safety and efficacy of Tecentriq SC, 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 overall 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 SC was
also consistent with that of Tecentriq IV.6,8
About Tecentriq SC (subcutaneous)Tecentriq®
(atezolizumab) in Tecentriq SC is the same monoclonal antibody as
in Tecentriq IV. It has been designed to bind with a protein called
programmed death ligand-1 (PD-L1), which is 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 activation of T-cells. Tecentriq is
a cancer immunotherapy that has the potential to be used across a
broad range of cancers.
Tecentriq SC combines Tecentriq with Halozyme Therapeutics’
Enhanze® drug delivery technology. 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 SC was first approved in Great Britain in August 2023.
The approved indications for Tecentriq SC mirror those of Tecentriq
IV.
The standard IV formulation of Tecentriq is approved for
some of the most aggressive and difficult-to-treat forms of cancer.
Tecentriq IV 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 IV 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).
About Roche in cancer immunotherapyTo learn
more about Roche’s scientific-led approach to cancer immunotherapy,
please follow this link:
https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy
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.
All trademarks used or mentioned in this release are protected
by law. References[1] Rummel M, et al.
Preference for subcutaneous or intravenous administration of
rituximab among patients with untreated CD20+ diffuse large B-cell
lymphoma or follicular lymphoma: results from a prospective,
randomized, open-label, crossover study (PrefMab). Ann Oncol.
2017;28(4):836-842.[2] De Cock E, et al. A time and motion study of
subcutaneous versus intravenous trastuzumab in patients with
HER2-positive early breast cancer. Cancer Med. 2016;5(3):389-97.[3]
O’Shaugnessy, J. Patient (pt) preference for the
pertuzumab-trastuzumab fixed-dose combination for subcutaneous use
(PH FDC SC) in HER2-positive early breast cancer (EBC): Primary
analysis of the open-label, randomised crossover PHranceSCa study.
Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.[4] Pivot X, et
al. Efficacy and safety of subcutaneous trastuzumab and intravenous
trastuzumab as part of adjuvant therapy for HER2-positive early
breast cancer: final analysis of the randomised, two-cohort PrefHer
study. Eur J Cancer. 2017;86:82-90.[5] Denys H, et al. Safety and
tolerability of subcutaneous trastuzumab at home administration,
results of the phase IIIb open-label BELIS study in HER2-positive
early breast cancer. Breast Cancer Res Treat.
2020;181(1):97-105.[6] Burotto M, Zvirbule Z, Alvarez R, et al.
IMscin001 Part 2 updated results: Efficacy, safety, immunogenicity,
healthcare provider perspectives and patient-reported outcomes from
the randomised Phase III study of atezolizumab subcutaneous vs
intravenous in patients with locally advanced or metastatic
non-small cell lung cancer. Presented at ESMO; 23 October 2023.
Poster #1447P.[7] European Medicines Agency. Tecentriq,
INN-atezolizumab. SmPC. [Internet; last updated 25 July 2023; cited
December 2023] Available from:
https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf.
[8] 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.
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