Initial US Approval:
2024
Key Clinical Studies:
IMscin001 (NCT03735121); IMpower010 (NCT02486718); IMpower110 (NCT02409342); IMpower150 (NCT02366143); IMpower130 (NCT02367781); OAK (NCT02008227); IMpower133 (NCT02763579); IMbrave150 (NCT03434379); IMspire150 (NCT02908672); ML39345 (NCT03141684); IMscin002 (NCT03735121)
Drug Class/Description:
Programmed death-ligand 1 (PD-L1) blocking antibody, and Endoglycosidase
Indications and Usage:
Non-Small Cell Lung Cancer (NSCLC):
- as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
- for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
- in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- in combination with paclitaxel protein-bound and carboplatin for the firstline treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
- for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ HYBREZA.
Small Cell Lung Cancer (SCLC)
- in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Hepatocellular Carcinoma (HCC)
- in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy.
Melanoma
- in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as determined by an FDA-approved test.
Alveolar Soft Part Sarcoma (ASPS)
- for the treatment of adult patients with unresectable or metastatic ASPS.
Dosage Administration:
TECENTRIQ HYBREZA has different recommended dosage and administration than intravenous atezolizumab products.
- TECENTRIQ HYBREZA is not indicated for use in pediatric patients.
- TECENTRIQ HYBREZA is for subcutaneous use in the thigh only.
- Do not administer TECENTRIQ HYBREZA intravenously.
- Recommended dosage: TECENTRIQ HYBREZA 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks.
- TECENTRIQ HYBREZA must be administered by a healthcare professional.
NSCLC Dosage
- In the adjuvant setting, administer TECENTRIQ HYBREZA following resection and up to 4 cycles of platinum-based chemotherapy every 3 weeks for up to 1 year.
- In the metastatic setting, administer TECENTRIQ HYBREZA every 3 weeks.
- When administering with chemotherapy with or without bevacizumab, administer TECENTRIQ HYBREZA prior to chemotherapy and bevacizumab when given on the same day.
SCLC Dosage
- Administer TECENTRIQ HYBREZA every 3 weeks. When administering with carboplatin and etoposide, administer TECENTRIQ HYBREZA prior to chemotherapy when given on the same day.
HCC Dosage
- Administer TECENTRIQ HYBREZA every 3 weeks.
- Administer TECENTRIQ HYBREZA prior to bevacizumab when given on the same day. Bevacizumab is administered intravenously at 15 mg/kg every 3 weeks.
Melanoma Dosage
- Following completion of a 28-day cycle of cobimetinib and vemurafenib, administer TECENTRIQ HYBREZA every 3 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily.
ASPS Dosage
- Administer TECENTRIQ HYBREZA every 3 weeks.
Dosage Forms and Strengths:
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.
Contraindications:
TECENTRIQ HYBREZA is contraindicated in patients with known hypersensitivity to hyaluronidase or any of its excipients.
Warnings and Precautions:
Immune-Mediated Adverse Reactions:
- Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immunemediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
- Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
- Withhold or permanently discontinue based on severity and type of reaction.
Infusion-Related Reactions:
- Pause or slow the rate of injection, or permanently discontinue based on severity of the reaction.
Complications of Allogeneic HSCT:
- Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. Follow patients closely for evidence of transplant-related complications and intervene promptly.
Embryo-Fetal Toxicity:
- Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception."
Adverse Reactions:
Most common adverse reactions (AR) (≥ 10%) with TECENTRIQ HYBREZA as monotherapy in patients with NSCLC were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
- Safety of TECENTRIQ HYBREZA for the approved NSCLC, EC-SCLC, HCC, melanoma and ASPS indications is based on safety of intravenous atezolizumab in these populations.
Most common AR with intravenous atezolizumab are presented below by indication and regimen:
Most common AR (≥ 20%) as monotherapy were:
- First-line NSCLC: fatigue/asthenia.
- Metastatic NSCLC: fatigue/asthenia, cough, decreased appetite, dyspnea, and myalgia/pain.
- ASPS: musculoskeletal pain, fatigue, rash, cough, headache, nausea, hypertension, vomiting, constipation, dyspnea, dizziness, hemorrhage, diarrhea, insomnia, abdominal pain hypothyroidism, pyrexia, anxiety, arrhythmia and decreased appetite.
Most common AR (≥ 20%) in combination with other antineoplastic drugs were:
- NSCLC (with bevacizumab, paclitaxel, and carboplatin): neuropathy fatigue/asthenia, alopecia, myalgia, nausea, diarrhea, constipation, decreased appetite, arthralgia, hypertension, rash, cough.
- Non-squamous NSCLC (with paclitaxel protein-bound and carboplatin): fatigue/asthenia, nausea, diarrhea, myalgia/pain, constipation, neuropathy, alopecia, dyspnea, decreased appetite, cough, vomiting and rash.
- SCLC (with carboplatin and etoposide): fatigue/asthenia, nausea, alopecia, decreased appetite, constipation and vomiting.
- HCC (with bevacizumab): hypertension, fatigue and proteinuria.
- Melanoma (with cobimetinib and vemurafenib): rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction."
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted from:
https://www.gene.com/download/pdf/tecentriq_hybreza_prescribing.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
