Halozyme Therapeutics Inc (HALO)

[Fred Kadiddlehopper]

Roche files for subcu Tecentriq
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Phase III results show Roche's subcutaneous formulation of Tecentriq is comparable to intravenous Tecentriq and delivered in minutes

Administered under the skin, the subcutaneous formulation reduces time spent receiving treatment to approx. seven minutes, compared with 30-60 minutes for IV infusion1

Roche has submitted data from the IMscin001 study to health authorities, seeking approval for the subcutaneous option across all approved indications of IV Tecentriq

If approved, Tecentriq would be Roche’s fourth subcutaneous cancer therapy,2-4 helping to improve the treatment experience for patients. In addition, it could save resources for healthcare systems5-10
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Basel, 1 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new pivotal data from the Phase III IMscin001 study, evaluating the investigational subcutaneous formulation of Tecentriq® (atezolizumab), a cancer immunotherapy approved for various tumour types.1 Data showed comparable exposure (levels of the molecule in the blood) and similar safety and efficacy for Tecentriq, when administered subcutaneously (injected under the skin), compared to standard IV infusion, in people with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).



The data will be presented in a mini-oral abstract session at 09:55 CET on Thursday 8 December, at the ESMO Immuno-Oncology Congress 2022 (Abstract #61MO).11



If approved by health authorities, Roche aims to bring this innovation to patients who may benefit from treatment with Tecentriq across multiple tumour types. Data from IMscin001 have been submitted to health authorities globally.



“Checkpoint inhibitors have been transformational for people with cancer, but IV administration can be long and arduous for patients and increase strain on infusion centres,” said Dr. Mauricio Burotto, Medical Director, Bradford Hill Investigación Clínica. “Subcutaneous administration could allow patients to be treated much more quickly and easily compared to IV, improving their overall treatment experience, and reducing waiting lists and treatment delays.”



“These data show that the subcutaneous formulation of Tecentriq can deliver similar benefits to IV administration, without compromising on safety, while offering a faster and more flexible treatment option,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We're excited about the potential of this new formulation to improve both the treatment experience for patients and save resources for healthcare systems.”



Multiple oncology studies suggest that the majority of cancer patients generally prefer to receive treatment subcutaneously due to reduced discomfort, ease of administration and shorter duration of treatment, compared to IV infusion.5-9



While the IMscin001 trial was conducted within the hospital setting, the subcutaneous formulation may be appropriate for out of hospital administration by a healthcare professional.



About the IMscin001 study and data
IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed. The study enrolled 371 patients.



In August, 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.11 The geometric mean ratios were 1.05 for observed serum Ctrough (the concentration of drug in the blood immediately before the next dose is administered; 90% CI: 0.88-1.24) and 0.87 for model-predicted area under the curve (a measure of overall exposure to the drug; AUC; 90% CI: 0.83-0.92).11



Efficacy, as measured by the overall response rate and progression-free survival, was similar between the subcutaneous and IV treatment arms and consistent with the known profile of IV Tecentriq.11 The safety profile of the subcutaneous formulation was also consistent with that of IV Tecentriq.11



About the subcutaneous formulation of Tecentriq
The investigational subcutaneous formulation 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, and enables the subcutaneous formulation to be rapidly dispersed and absorbed into the bloodstream.



IV Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. IV Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). IV 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, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.



About Roche in cancer immunotherapy
To 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] Tecentriq: highlights of prescribing information, US FDA 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf. Accessed November 2022.
[2] MabThera SC / Rituxan Hycela: highlights of prescribing information, US FDA 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf. Accessed November 2022.
[3] Herceptin SC / Herceptin Hylecta: highlights of prescribing information, US FDA 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106s000lbl.pdf . Accessed November 2022.
[4] Phesgo: highlights of prescribing information, US FDA 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Accessed November 2022.
[5] 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.
[6] 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.
[7] 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.
[8] 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.
[9] 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.
[10] Anderson, K C, et al. Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics. Future Oncol. 2019;15(28):3267-3281
[11] Burotto M, 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.


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