FDA Approves Subcutaneous Tecentriq Hybreza for All Adult Indications of IV Form of Tecentriq

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The FDA has approved Roche’s Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), making it the first and only subcutaneous (SC) PD-L1 inhibitor immunotherapy available in the United States. According to the company, the new formulation offers a significant improvement in administration, allowing for SC injection in just seven minutes, compared to the 30–60-minute intravenous (IV) infusion. The approval was based on results from the Phase IB/III IMscin001 study. Additionally, the Phase II IMscin002 trial demonstrated that a majority of patients preferred Tecentriq Hybreza over IV infusion.¹

“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, MD, PhD, chief medical officer, head, global product development, in a press release. “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.”

The global, multicenter, randomized IMscin001study evaluated 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. Consisting of 371 patients, the study’s primary endpoint was 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. Efficiacy was measured by objective response rate, progression-free survival, overall survival, and duration of response.

The global crossover IMscin002 study evaluated patient preference between the SC and IV formulations of Tecentriq. This study enrolled 179 patients, including patients 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 primary endpoint of the study was patients showing a preference for the SC formulation of the treatment.

Results from the IMscin001 study demonstrated comparable safety, efficacy, and blood concentration levels between the SC and IV forms. Additionally, results from the IMscin002 study found that 71% of patients expressed a preference for Tecentriq Hybreza, citing reduced clinic time, increased comfort, and less emotional distress. Further, 79% of patients chose Tecentriq Hybreza to finish treatment after receiving both formulations of Tecentriq.

In both studies, Tecentriq was well tolerated, with no new safety signals identified. Common adverse events (AEs) associated with Tecentriq include immune-mediated pneumonitis; immune-mediated colitis; immune-mediated hepatitis; immune-mediated endocrinopathies; nephritis with renal dysfunction; rash; dermatitis; myocarditis; pericarditis; vasculitis; meningitis; encephalitis; myelitis and demyelination; myasthenic syndrome/myasthenia gravis; Guillain-Barré syndrome; nerve paresis; autoimmune neuropathy; pancreatitis; and a number of infusion-related reactions. Currently, the risk level of Tecentriq for nursing mothers is unknown. Additionally, there are currently no data on the treatment in pregnant women. However, animal studies have found that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus, resulting in fetal death.²

“This approval represents a significant option to improve the patient experience,” said Ann Fish-Steagall, RN, SVP, patient services, LUNGevity Foundation, in the press release. “When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option."

Tecentriq’s subcutaneous formulation was first approved in the UK last year and is now approved in 50 different countries. Currently, regulatory reviews in multiple regions are in progress.¹

References

1. FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy. Roche. September 13, 2024. Accessed September 13, 2024. https://www.roche.com/media/releases/med-cor-2024-09-13

2. Important Safety Information and Indications. Tecentriq. Accessed September 13, 2024. https://www.tecentriq-hcp.com/#:~:text=The%20most%20common%20adverse%20reactions,23%25)%2C%20hypothyroidism%20(22%25)