| Drug Name |
TECENTRIQ HYBREZA™ (atezolizumab and hyaluronidase-tqjs) |
| Active Ingredient |
atezolizumab and hyaluronidase |
| Date of Approval |
September 12, 2024 |
| Manufacturer |
Genentech, Inc. |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: TECENTRIQ HYBREZA™ is indicated for the treatment of:
Non-small cell lung cancer (NSCLC)
- As adjuvant therapy after resection and chemotherapy
- For metastatic cases with high PD-L1 expression, alone or with chemotherapy
Extensive-stage small cell lung cancer (SCLC)
- In combination with carboplatin and etoposide
Unresectable or metastatic hepatocellular carcinoma
- In combination with bevacizumab
BRAF V600 mutation-positive melanoma
- In combination with cobimetinib and vemurafenib
Unresectable or metastatic alveolar soft part sarcoma |
| Therapeutic Class |
Monoclonal Antibody
Programmed death-ligand 1 (PD-L1) blocking antibody and endoglycosidase combination |
| Formulation |
Injection: 1,875 mg atezolizumab and 30,000 units hyaluronidase per 15 mL (125 mg/2,000 units per mL) solution in a single-dose vial |
| MoA |
TECENTRIQ HYBREZA™ combines atezolizumab and hyaluronidase-tqjs to enhance immune response against tumors. Atezolizumab, a monoclonal antibody, binds to PD-L1, which is often expressed on tumor cells and immune cells, and blocks its interaction with PD-1 and B7.1 receptors. This releases the inhibition of T-cell activity, promoting cytotoxic T-cell function and cytokine production, thereby activating the immune system to target tumors. Hyaluronidase-tqjs temporarily increases the permeability of subcutaneous(SQ) tissue, enhancing drug absorption by depolymerizing hyaluronan in the extracellular matrix. |
| Dosing and Administration |
TECENTRIQ HYBREZA™ is recommended to be administered SQ in the thigh at a dosage of 15 mL, which contains 1,875 mg of atezolizumab and 30,000 units of hyaluronidase. The injection should be given over approximately 7 minutes every 3 weeks. Please note that TECENTRIQ HYBREZA™ is not intended for intravenous (IV) administration. To optimize patient comfort and minimize complications, injection sites should be alternated between thighs, and avoid areas exhibiting redness, bruising, or tenderness. |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
TECENTRIQ HYBREZA™ is the first and only PD-L1 inhibitor available for SQ injection in the U.S., offering a faster 7-minute administration compared to the 30-60 minutes required for intravenous (IV) infusion. Phase 2 of the IMscin002 study showed that 71% of patients preferred SQ atezolizumab and hyaluronidase-tqjs over IV, citing increased comfort, reduced emotional stress, and shorter clinic visits. After experiencing both methods, 79% of patients chose the SQ formulation.
Approved for all adult indications of IV Tecentriq®, TECENTRIQ HYBREZA™ maintains the same safety and efficacy profile while providing greater flexibility for cancer treatment. |
| Expected Market Launch Date |
Data Unavailable |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
The IV formulation currently costs $8062 for a 840mg/14mL supply. Cost data on the SQ formulation is currently unavailable. |
| Product Discontinuation |
N/A |
| Clinical Trials |
The SQ injection of atezolizumab and hyaluronidase-tqjs was evaluated in IMSCIN001 (NCT03735121), an open-label, multi-center, international, randomized trial in adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. A total of 371 patients were randomized (2:1) to receive SQ atezolizumab and hyaluronidase-tqjs or IV atezolizumab until disease progression or unacceptable toxicity.
The primary outcome measure was atezolizumab exposure, with coprimary pharmacokinetic endpoints of Cycle 1 Ctrough and AUC0-21days. Additional descriptive efficacy outcome measures were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). The geometric mean ratio (GMR) (90% CI) of SQ atezolizumab and IV atezolizumab for Cycle 1 Ctrough was 1.05 (0.88, 1.24) and AUC0-21days was 0.87 (0.83, 0.92), which met the lower limit of the GMR (90% CI) above the pre-specified threshold of 0.8 for comparability. No notable differences in ORR, PFS or OS were observed between the different formulations. The confirmed ORR was 9% (95% CI: 5, 13) in the SQ atezolizumab and hyaluronidase-tqjs arm and 8% (95% CI: 4, 14) in the IV atezolizumab arm.
The most common adverse reactions of any grade (≥ 10%) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. |
| Sources |
Tecentriq prices. Drugs.com. https://www.drugs.com/price-guide/tecentriq. Accessed September 13, 2024.
Genentech. Tecentriq Hybreza Prescribing Information. [https://www.gene.com/download/pdf/tecentriq_hybreza_prescribing.pdf](https://www.gene.com/download/pdf/tecentriq_hybreza_prescribing.pdf). Accessed September 13, 2024.
U.S. Food and Drug Administration. FDA Approves Atezolizumab and Hyaluronidase-tqjs Subcutaneous Injection. [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-and-hyaluronidase-tqjs-subcutaneous-injection](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-and-hyaluronidase-tqjs-subcutaneous-injection). Accessed September 13, 2024.
Drugs.com. Tecentriq Hybreza History. [https://www.drugs.com/history/tecentriq-hybreza.html](https://www.drugs.com/history/tecentriq-hybreza.html). Accessed September 13, 2024.
BioSpace. FDA Approves Roche's Tecentriq Hybreza: The First and Only Subcutaneous Anti-PD-L1 Cancer Immunotherapy. [https://www.biospace.com/press-releases/fda-approves-roches-tecentriq-hybreza-the-first-and-only-subcutaneous-anti-pd-l1-cancer-immunotherapy](https://www.biospace.com/press-releases/fda-approves-roches-tecentriq-hybreza-the-first-and-only-subcutaneous-anti-pd-l1-cancer-immunotherapy). Accessed September 13, 2024.
GlobeNewswire. FDA Approves Roche's Tecentriq Hybreza: Subcutaneous Anti-PD-L1 Cancer Immunotherapy. [https://ml-eu.globenewswire.com/Resource/Download/4f6915b1-0996-4014-9b1e-d2002d216028](https://ml-eu.globenewswire.com/Resource/Download/4f6915b1-0996-4014-9b1e-d2002d216028). Accessed September 13, 2024.
U.S. Food and Drug Administration. Tecentriq Label Information. [https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s043lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s043lbl.pdf). Accessed September 13, 2024.
NTB Communications. FDA Approves Roche’s Tecentriq Hybreza: Subcutaneous Anti-PD-L1 Cancer Immunotherapy. [https://kommunikasjon.ntb.no/pressemelding/18239063/fda-approves-roches-tecentriq-hybreza-the-first-and-only-subcutaneous-anti-pd-l1-cancer-immunotherapy?publisherId=4954260&lang=en](https://kommunikasjon.ntb.no/pressemelding/18239063/fda-approves-roches-tecentriq-hybreza-the-first-and-only-subcutaneous-anti-pd-l1-cancer-immunotherapy?publisherId=4954260&lang=en). Accessed September 13, 2024. |