FDA Approves Roche's Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

Tecentriq Hybreza offers patients and physicians greater flexibility in treatment options while demonstrating safety and efficacy consistent with intravenous
(IV) Tecentriq^1,2
New subcutaneous (SC) option shortens treatment time to approximately seven minutes, compared to 30-60 minutes for IV infusion²

Basel, September 13, 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza^TM (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 to 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).² It will be available for all intravenous indications of Tecentriq approved in the U.S. for adults, including certain types of lung, liver, skin and soft tissue cancers.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 in treatment administration,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche. “We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and allows patients to be treated more quickly and in more accessible settings.”

“This approval is an important 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 important 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 that Tecentriq blood levels were comparable with subcutaneous administration and that the safety and efficacy profile was consistent with the intravenous formulation.^1,2 The Phase II IMscin002 study found that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab. The most common reasons for this were shorter hospital stay, greater comfort during treatment, and less emotional distress.⁴ 4 out of 5 patients (79%) chose to continue their treatment with Tecentriq Hybreza, after trying both formulations.⁴

Developing new formulations of our medicines is part of our commitment to improving the patient experience and supporting people with different diseases at every step of their treatment journey. With Tecentriq Hybreza and Roche’s 13 other subcutaneous therapies – available across different diseases – we offer additional delivery options to meet diverse patient preferences.

The subcutaneous formulation of Tecentriq received its first global approval in the UK in August 2023 and is now approved in 50 countries (marketed as Tecentriq SC outside the US).⁵ Regulatory reviews are still ongoing in other countries and regions.

About the IMscin001 study
IMscin001 is a Phase IB/III, global, multicenter, randomized study evaluating the pharmacokinetics, safety, and efficacy of Tecentriq Hybreza compared to Tecentriq IV in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) who failed prior platinum therapy. The study enrolled 371 patients. The study met its primary endpoints, demonstrating comparable levels of Tecentriq in blood over a defined dosing interval based on established pharmacokinetic measurements; observed serum C_Through and model-predicted area under the curve. Efficacy, as measured by objective response rate, progression-free survival, overall survival, and duration of response, was comparable 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 those with PD-L1-positive resected Stage II-IIIB NSCLC who completed adjuvant platinum-based chemotherapy 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% indicated no preference); 79% chose Tecentriq Hybreza to complete their treatment, after experiencing both formulations of Tecentriq. The study confirmed that the switch 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 to a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable T cell reactivation. Tecentriq may also affect normal cells.

The Enhanze drug delivery technology is based on a patented recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily breaks down 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, giving Tecentriq room to penetrate, allowing it to be rapidly distributed and absorbed into the bloodstream.

Tecentriq is approved for some of the most aggressive and difficult to treat cancers. Tecentriq was the first cancer immunotherapy approved for the treatment of certain types of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC), and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries worldwide, either alone or in combination with targeted therapies and/or chemotherapies, for several types 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 tissue sarcoma (ASPS). In addition to intravenous infusion, Tecentriq is approved as a subcutaneous formulation in 50 countries (marketed as Tecentriq SC outside the U.S.). 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 evidence-based approach to cancer immunotherapy, click on this link.

About Roche
Founded in Basel, Switzerland, in 1896 as one of the first industrial manufacturers of branded medicines, Roche has grown to become the world’s largest biotechnology company and the global leader in in vitro diagnostics. The company is committed to scientific excellence to discover and develop medicines and diagnostics to improve and save lives around the world. We are a pioneer in personalized medicine and aim to continue to transform the way healthcare is delivered to have an even greater impact. To provide the best care for every person, we collaborate with many stakeholders and combine our strengths in diagnostics and pharmacy with data insights from clinical practice.

In recognition of our commitment to taking a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical 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 where we operate.

Genentech, in the United States, is wholly owned by the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, visit www.roche.nl.

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References
(1) Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 Part 2: a randomized phase III, open-label, multicenter study evaluating the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous in previously treated locally advanced or metastatic non-small cell lung cancer and a comparison of pharmacokinetics 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 randomized phase III trial comparing atezolizumab (atezo) subcutaneous (SC) versus intravenous (IV) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Presented at the ESMO 2023 Congress. Poster #1447P, on display October 23, 2023.
(3) FDA – US Food and Drug Administration. Tecentriq: Prescribing Information Highlights. 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 of IMscin002: A study to evaluate patient- and healthcare professional-reported preferences for atezolizumab subcutaneous versus intravenous for the treatment of NSCLC. Presented at ELCC on March 21, 2024. Abstract 244MO.
(5) Roche. Roche’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in the UK, 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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