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

Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), a subcutaneous formulation of the PD-L1 inhibitor Tecentriq. This new method of administration allows the drug to be injected under the skin in approximately seven minutes, compared to the 30-60 minutes required for intravenous (IV) infusion. Tecentriq Hybreza will be available for all IV-approved indications of Tecentriq in the United States, including various types of lung, liver, skin, and soft tissue cancers.

Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, expressed that Tecentriq Hybreza provides patients and physicians with greater flexibility and choice in treatment administration. The new subcutaneous formulation offers the same safety and efficacy as the traditional IV method but can be administered more quickly and in more settings.

Ann Fish-Steagall, senior vice president of Patient Services at the LUNGevity Foundation, highlighted the significance of this approval, noting that it improves the patient experience by offering more treatment options, thus empowering patients to make decisions about their care.

The FDA's approval is based on pivotal data from the Phase IB/III IMscin001 study. This study demonstrated that the levels of Tecentriq in the blood were comparable when administered subcutaneously and intravenously. The safety and efficacy profiles were also consistent between the two methods. Additionally, the Phase II IMscin002 study revealed that 71% of patients preferred the subcutaneous formulation, citing less time in the clinic, increased comfort, and reduced emotional distress as the main reasons. After trying both formulations, 79% of participants chose to continue their treatment with Tecentriq Hybreza.

Roche's new subcutaneous option reflects the company's commitment to enhancing the patient experience and offering more flexible treatment options. Tecentriq Hybreza joins Roche's portfolio of 13 other subcutaneous therapies available for various diseases, providing patients with diverse administration choices to better suit their needs.

The subcutaneous version of Tecentriq was first approved in Great Britain in August 2023 and has since received approval in 50 countries. Regulatory reviews are ongoing in other regions.

The IMscin001 study, which included 371 patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC), met its primary endpoints of demonstrating comparable pharmacokinetic levels of Tecentriq in the blood. The efficacy, measured by objective response rate, progression-free survival, overall survival, and duration of response, was similar between the subcutaneous and IV formulations. The safety profile was also consistent with the IV version.

The IMscin002 study, a global crossover trial, evaluated patient preference between the subcutaneous and IV formulations of Tecentriq. It included 179 patients with PD-L1-positive resected Stage II-IIIB NSCLC who had completed adjuvant platinum-based chemotherapy, and untreated patients with PD-L1-high Stage IV NSCLC. The study confirmed that 71% of participants preferred the subcutaneous formulation, and 79% opted to continue with Tecentriq Hybreza after experiencing both methods. Switching between the two formulations was well tolerated, with no new safety concerns.

Tecentriq Hybreza utilizes Halozyme Therapeutics’ Enhanze® drug delivery technology, based on recombinant human hyaluronidase PH20 (rHuPH20). This enzyme temporarily degrades hyaluronan in the subcutaneous space, increasing tissue permeability and allowing Tecentriq to be rapidly dispersed and absorbed into the bloodstream.

Tecentriq has been approved for treating some of the most challenging forms of cancer. It was the first immunotherapy approved for early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and hepatocellular carcinoma (HCC). The drug is also approved globally for various metastatic cancers, either alone or in combination with other therapies. The approved indications for Tecentriq Hybreza and Tecentriq SC are consistent with those for Tecentriq IV.