Halozyme Announces Roche Receives European Commission Approval of Tecentriq® SC with ENHANZE® Representing the EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy for Multiple Cancer Types
- European Commission authorization of Tecentriq® SC co-formulated with ENHANZE®
- Reduction of treatment time by approximately 80%
- First subcutaneous PD-(L)1 cancer immunotherapy in Europe
- Comparable levels of Tecentriq® in the blood when administered subcutaneously
- None.
Insights
The European Commission's authorization of Tecentriq® SC co-formulated with ENHANZE® marks a significant advancement in the administration of cancer immunotherapy. The subcutaneous injection method, which drastically reduces treatment time from approximately 30-60 minutes to just 7 minutes, represents a major improvement in terms of patient convenience and the potential reduction of healthcare system bottlenecks. This is particularly relevant for the treatment of cancers where PD-(L)1 inhibitors are used, as these therapies are typically administered repeatedly over the course of treatment.
From a medical research perspective, the pivotal data from the Phase IB/III IMscin001 study is crucial as it demonstrates that the efficacy and safety profile of the subcutaneous formulation is consistent with the intravenous version. This suggests that patients will not be sacrificing treatment quality for convenience. Moreover, the positive feedback from healthcare professionals about the ease of administration suggests that the adoption rate of the SC formulation could be high, potentially leading to a broader impact on treatment practices across the EU.
The introduction of Tecentriq® SC has implications beyond patient care; it has the potential to significantly impact healthcare economics within the EU. The reduced treatment time and the possibility of administration in non-hospital settings can lead to a decrease in healthcare resource utilization, such as freeing up hospital beds and reducing the burden on healthcare professionals. This is particularly pertinent in the context of constrained healthcare systems where efficiency and cost-effectiveness are paramount.
Furthermore, the authorization of the first subcutaneous PD-(L)1 cancer immunotherapy in Europe could set a precedent for other treatments, potentially leading to a shift in how biologic therapies are administered. This could eventually result in systemic changes within healthcare delivery models, emphasizing outpatient care and home-based treatments, which could lead to cost savings for healthcare systems and insurers, as well as increased accessibility for patients.
Halozyme's proprietary rHuPH20 enzyme, which facilitates the subcutaneous delivery of Tecentriq®, could see increased demand as the market for subcutaneous formulations expands. The approval by the European Commission not only opens up the EU market for this particular treatment but also signals potential for Halozyme's ENHANZE® technology to be applied to other biologic drugs seeking to improve patient experience and administration efficiency.
From a market perspective, Halozyme's stock (NASDAQ: HALO) could experience positive movement as investors respond to the expanded market opportunity and potential for increased licensing agreements. The broader impact on the biopharmaceutical sector could include increased R&D into subcutaneous formulations and delivery technologies, as companies strive to meet patient and healthcare provider preferences for more convenient treatment options.
Reduces treatment time by approximately
Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to IV infusion and is preferred by patients and healthcare practitioners1 - 6
Tecentriq® SC reduces treatment time to approximately 7 minutes, compared to an IV infusion which can take approximately 30 to 60 minutes. In addition, it may be administered by a healthcare professional outside of the hospital, in a community care setting or at home, depending on national regulations and health systems.
"As the first subcutaneous PD-(L)1 cancer immunotherapy in
The EC approval follows 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. The study found
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including Hylenex® and XYOSTED® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's ENHANZE® drug delivery technology including the possible benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE® including lowering the treatment burden for patients and alleviating pressure on health care system resources, including potential out-of-hospital administration of Tecentriq® SC. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts (including anticipated regulatory submissions, PDUFA dates, potential regulatory approvals, indications and product launches). These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
617-877-9710
samantha.gaspar@teneo.com
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.
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SOURCE Halozyme Therapeutics, Inc.
FAQ
What is the significance of the European Commission marketing authorization of Tecentriq® SC co-formulated with ENHANZE®?
How much does Tecentriq® SC reduce treatment time compared to standard intravenous infusion?
What are the key findings from the Phase IB/III IMscin001 study?
What did the healthcare professionals say about the subcutaneous formulation of Tecentriq®?
