Tecentriq SC is now approved in Singapore for all indications of intravenous Tecentriq, including certain types of lung, breast and liver cancer, offering a faster, more convenient option to receive treatment.
Tecentriq SC is the first anti-PD-(L)1 cancer immunotherapy that can be administered under the skin (subcutaneous). With a treatment time of within approximately seven minutes, it saves time for patients and helps conserve resources in healthcare systems.1
It is the first cancer immunotherapy approved for subcutaneous administration of lung cancer treatment.
Approval of Tecentriq SC can enhance existing home- and community-based cancer care delivery and is in line with Singapore’s growing shift towards decentralised care.2-3
SINGAPORE, 01 July 2024 — Roche announced today that Tecentriq® SC (atezolizumab) has been approved by the Singapore Health Sciences Authority (HSA) for all indications in which the intravenous (IV) formulation of Tecentriq has been previously approved, including certain types of lung, breast and liver cancer.4 Tecentriq SC is Roche’s fourth subcutaneous cancer therapy,5-7 and the world’s first injectable anti-PD-(L)1 cancer immunotherapy.
Injecting Tecentriq subcutaneously takes approximately seven minutes, compared with 30-60 minutes for IV infusion. Tecentriq SC also requires no aseptic preparation or dilution, saving valuable time for pharmacists. In the IMscin001 trial, it was found to produce comparable serum drug concentrations as Tecentriq IV with a similar safety and efficacy profile.8 Multiple oncology studies suggest that the majority of cancer patients generally prefer to receive treatment subcutaneously due to reduced pain and discomfort, ease of administration and shorter duration of treatment, compared to IV infusion.9-14 In Singapore, SC formulations of key breast cancer medicines have already enabled successful delivery of care in the community and at home via the NCIS On The Go and NCCS Home Care programmes, respectively.15-16
“Cancer immunotherapy treatments such as Tecentriq have 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 Yeoh Ying Ying, General Manager of Roche Pharmaceuticals Singapore. “Tecentriq SC’s approval in Singapore is part of Roche’s commitment to delivering medicines that meet the diverse needs and preferences of patients.”
Tecentriq SC is currently under review for subsidy and coverage under public funding mechanisms such as MediShield and MediSave.
IMscin001 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.8
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. Blocking the PD-1/PD-L1 pathway removes the inhibition of T-cells, thereby boosting immune response. 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.4
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 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) hepatocellular carcinoma (HCC) and triple-negative breast cancer (TNBC).4
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
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 clinical practice.
Roche Singapore started operations in 1973 and has grown over 50 years into a local leader in innovative medicines and diagnostics across multiple disease areas. Today, Roche Singapore employs more than 1,000 people across its pharmaceuticals, diagnostics and manufacturing divisions.
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M-SG-00001504-04-2024
References
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Chong C. Some patients can now be hospitalised at home and be cared for via teleconsultations, home visits. The Straits Times.
Tan J. Subsidised hospital care in the comfort of home from April 1; new hospital in Tengah by early 2030s. The Straits Times.
Singapore prescribing information. [URL available on 31 May 2024]
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Trastuzumab [herceptin]. National Drug Formulary (NDF). Accessed May 7, 2024.
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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 [published correction appears in Ann Oncol. 2024 May;35(5):482]. Ann Oncol. 2023;34(8):693-702. doi:10.1016/j.annonc.2023.05.009
De Cock E, Pivot X, Hauser N, 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):389-397. doi:10.1002/cam4.573
O'Shaughnessy J, Sousa S, Cruz J, et al. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. Eur J Cancer. 2021;152:223-232. doi:10.1016/j.ejca.2021.03.047
Pivot X, Verma S, Fallowfield L, 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. European Journal of Cancer. 2017;86:82-90. doi:10.1016/j.ejca.2017.08.019
Rummel M, Kim TM, Aversa F, 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. doi:10.1093/annonc/mdw685
Denys H, Martinez-Mena CL, Martens MT, 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. doi:10.1007/s10549-020-05604-7
Cappuzzo F, Zvirbule Z, Korbenfeld E, 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 non-small cell lung cancer. Presented at: 2024 European Lung Cancer Congress; March 20-23, 2024; Prague, Czech Republic. Abstract 244MO.
NCIS On The Go Programme. National University Cancer Institute, Singapore. Accessed May 7, 2024.
Subbiah D. Bringing cancer care to the home. National Cancer Centre Singapore. Accessed May 7, 2024.
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