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
29 Agosto 2023 - 11:00AM
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
- Tecentriq
subcutaneous (SC) is now approved in Great Britain for all
indications of intravenous
Tecentriq, including certain types of
lung, bladder, breast and liver cancer, offering a faster, more
convenient option to receive treatment
- Administered under the skin
within approx. seven minutes, Tecentriq
SC saves time for patients and helps conserve resources in
healthcare systems1
- Evaluations by the FDA, EMA
and other health authorities globally are ongoing
Basel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that Tecentriq® SC (atezolizumab) has been approved
by the Medicines and Healthcare products Regulatory Agency (MHRA)
in Great Britain. It will be provided by the National Health
Service (NHS) England. Injecting Tecentriq subcutaneously (under
the skin) takes approximately seven minutes, compared with 30-60
minutes for intravenous (IV) infusion. Tecentriq SC will be
available to patients in Great Britain for all indications in which
the IV formulation of Tecentriq has been previously approved,
including certain types of lung, bladder, breast and liver
cancer.2
Tecentriq SC is Roche’s fourth subcutaneous cancer therapy.3-5
Multiple oncology studies suggest that the majority of cancer
patients generally prefer SC over IV administration due to reduced
discomfort, ease of administration and shorter duration of
treatment.6-10 “Cancer immunotherapy has transformed the way we
treat cancer. Giving Tecentriq subcutaneously now offers patients a
faster and more flexible treatment option and can free up resources
for healthcare systems, while maintaining its established safety
profile,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “We are working
with health authorities globally to bring this option to many more
patients around the world.”
The MHRA regulatory approval is the first for Tecentriq SC
worldwide. It 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.11 While the IMscin001
trial was conducted within the hospital setting, Tecentriq SC may
be suitable for out of hospital administration by a healthcare
professional.
For Northern Ireland, the Tecentriq SC marketing authorisation
application is currently under assessment by the European Medicines
Agency (EMA). Evaluations by the US Food and Drug Administration
(FDA) and other health authorities globally are also ongoing.
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 NSCLC for whom prior platinum therapy has
failed. The study enrolled 371 patients.
In August 2022, part 2 of 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 and
progression-free survival, 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.11
About Tecentriq SC
(subcutaneous)Tecentriq SC combines Tecentriq with
Halozyme Therapeutics’ Enhanze® drug delivery technology.
Tecentriq is a monoclonal antibody 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 as a foundational combination partner with other
immunotherapies, targeted medicines and various chemotherapies
across a broad range of cancers.
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) non-small cell lung cancer (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).
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 thirteenth 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] Anderson, K C, et al.
Humanistic and economic impact of subcutaneous versus intravenous
administration of oncology biologics. Future Oncol.
2019;15(28):3267-3281.[2] UK Electronic Medicines Compendium (EMC).
Tecentriq: package leaflet. Last updated 5 July 2022.
https://www.medicines.org.uk/emc/files/pil.8442.pdf Accessed April
2023.[3]. UK EMC. Phesgo SC: package leaflet. Last updated 16 March
2022. https://www.medicines.org.uk/emc/files/pil.11989.pdf Accessed
April 2023.[4] UK EMC. Herceptin SC: package leaflet. Last updated
28 September 2021.
https://www.medicines.org.uk/emc/files/pil.1227.pdf Accessed April
2023. [5] UK EMC. MabThera: package leaflet. Last updated 24
January 2022. https://www.medicines.org.uk/emc/files/pil.5333.pdf
Accessed April 2023.[6] 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.[7]
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.[8] 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[9] 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.[10] 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.[11] Burotto M,
Zvirbule Z, Mochalova A, et al. IMscin001 (Part 2: Randomized Phase
III): Pharmacokinetics (PK), efficacy and safety of atezolizumab
subcutaneous (SC) vs intravenous (IV) in previously treated locally
advanced or metastatic non-small cell lung cancer (NSCLC).
Presented at ESMO IO; 7-9 Dec 2022. Abstract #61MO.Roche
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