FDA approves Roche’s Tecentriq Hybreza, the first and only
subcutaneous anti-PD-(L)1 cancer immunotherapy
- 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 71% of patients preferred Tecentriq
Hybreza over intravenous atezolizumab, and the most common reasons
were less time in the clinic, increased comfort during treatment
and reduced emotional distress.4 4 out of 5 patients
(79%) chose Tecentriq Hybreza to continue their treatment, after
experiencing both formulations.4
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 71% of
participants preferred the SC formulation (21% preferred IV and 8%
stated no preference); 79% opted for Tecentriq Hybreza to complete
their treatment, after experiencing both formulations of Tecentriq.
The study confirmed that switching between Tecentriq Hybreza and
Tecentriq IV was well tolerated, with no new safety
signals.4
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.
All trademarks used or mentioned in this release are protected
by law.
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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