Roche’s subcutaneous injection of Tecentriq recommended by the EU’s
CHMP for multiple cancer types
- If approved, Tecentriq
subcutaneous (SC) would be the first injectable PD-(L)1 cancer
immunotherapy in the EU, cutting treatment time by approx.
80%1
- The CHMP recommended
Tecentriq SC for all indications of intravenous (IV) Tecentriq,
including certain types of lung, liver, bladder and breast
cancer2
- A majority of healthcare
professionals surveyed in the IMscin001 study found that the SC
formulation is easy to administer and could save time compared with
IV1
Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) has recommended the
approval of subcutaneous (SC, or under the skin) Tecentriq®
(atezolizumab). Tecentriq SC can be injected in approximately seven
minutes, with most injections taking between four and eight minutes
compared with 30-60 minutes for intravenous (IV) infusion, which
can free up time for patients, healthcare teams and caregivers.1
The CHMP recommended Tecentriq SC for all indications in which
Tecentriq IV has been previously approved, including certain types
of lung, liver, bladder and breast cancer.2 A final decision on its
approval is expected from the European Commission in the near
future.
“Tecentriq has helped to treat more than 430,000 people
diagnosed with some of the most aggressive forms of cancer,” said
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head
of Global Product Development. “Subcutaneous administration offers
a faster and more convenient alternative to IV infusion. The CHMP’s
recommendation brings us a step closer to offering the first
subcutaneous PD-L1 cancer immunotherapy treatment to patients in
the EU.”
The CHMP’s positive opinion 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.3
Roche recently presented mature overall survival (OS) data with a
median follow-up of 9.5 months at the European Society for Medical
Oncology (ESMO) Congress 2023. The updated analysis confirmed the
earlier results and showed that OS and other efficacy endpoints
were consistent between the SC and IV treatment arms.1 A majority
of healthcare professionals who were surveyed as part of the study
agreed that the SC formulation is easy to administer (90%) and that
it could save time for healthcare teams compared with the IV
formulation (75%).1
Tecentriq SC, which recently received its first marketing
authorisation in Great Britain, was developed to provide patients
with an alternative to the IV administration of Tecentriq and the
potential for treatment outside of the hospital setting. It is
Roche’s fourth subcutaneous cancer therapy.4-6 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.7-11
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.
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 progression-free survival (PFS), objective
response rates (ORR) and OS, 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.
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) 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] 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.[2] European Medicines Agency.
Tecentriq, INN-atezolizumab. SmPC. [Internet; last updated 25 July
2023; cited October 2023] Available from:
https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf.
[3] 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.[4] Phesgo,
INN-pertuzumab/trastuzumab. SmPC. [Internet; last updated 02 March
2023; cited October 2023] Available from:
https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf.[5]
European Medicines Agency. Herceptin, INN-trastuzumab. SmPC.
[Internet; last updated 17 March 2023; cited October 2023]
Available from:
https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf.
[6] European Medicines Agency. MabThera, INN-rituximab. SmPC.
[Internet; last updated 22 March 2023; cited October 2023]
Available from:
https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf.
[7] 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.[8] 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.[9] 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.[10] 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.[11] 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.
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