Atezolizumab is a Monoclonal Antibody owned by F. Hoffmann-La Roche, and is involved in 474 clinical trials, of which 112 were completed, 330 are ongoing, and 32 are planned.

Atezolizumab (RG7446) is an anti-PD-L1 (programmed cell death–1 ligand 1) monoclonal antibody. Programmed death receptor ligand 1 (PD-L1, also called B7-H1) is a B7 family member. PD-L1 does not interact with either CD28 or CTLA-4. This receptor, programmed death receptor 1 (PD-1), has been shown to negatively regulate T-cell receptor (TCR) signaling. Negative regulatory mechanisms within the solid tumor micro-environment inhibit anti tumor T-cell function, leading to evasion from immune attack. One inhibitory mechanism is up-regulation of programmed death-ligand 1 (PD-L1) expressed on tumor or stromal cells which binds to programmed death-1 (PD-1) on activated T cells. Upon ligating its receptor, PD-L1 has been decreased TCR-mediated proliferation and cytokine production. Thus, PD-L1 might play an important role in tumor suppression.

The revenue for Atezolizumab is expected to reach a total of $111.1bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Atezolizumab NPV Report.

Atezolizumab was originated by Genentech USA and is currently owned by F. Hoffmann-La Roche.

Atezolizumab Overview

Atezolizumab (Tecentriq) is an antineoplastic agent. It is formulated as solution concentrate for intravenous route of administration. Tecentriq is indicated for the treatment of  urothelial bladder cancer (second line), for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities, locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy, and in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations, and in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC), and in combination with chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test and in combination with abraxane, paclitaxel and carboplatin is indicated for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations, and in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (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, and in combination with bevacizumab (Tecentriq and Avastin) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Tecentriq in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Tecentriq as monotherapy, is indicated for the first-line treatment of patients with metastatic non-small lung cancer (nsclc) whose tumours have high pd-l1 expression (pd-l1 stained > 50% of tumour cells {tcs} or pdl-1 stained tumour-infiltrating immune cells (ics) covering > 10% of the tumour area) as deterimined by avalidated test and who do not have EGFR or ALK genomic tumour aberrations. Tecentriq is indicated for the treatment of PD-L1 positive, hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer, homologous-recombination deficient (HRD) HER positive breast cancer, ovarian and uterine cancer.

Atezolizumab (RG7446) is under development for the treatment of poorly differentiated extrapulmonary small cell neuroendocrine carcinomas (NEC), recurrent glioblastoma, gliosarcoma, Recurrent and metastatic esophageal squamous cell carcinoma, advanced follicular lymphoma, advanced rectal cancer, metastatic neuroendocrine tumor of the lung, metastatic hepatocellular carcinoma, chronic myeloid leukemia, head and neck cancer squamous cell carcinoma including oropharynx, oral cavity, larynx, or hypopharyngeal cancers, advanced cutaneous squamous cell carcinoma, metastatic breast cancer, advanced esophageal squamous cell carcinoma, relapsed, refractory and treatment-naive acute myeloid leukemia, brain metastasis, locally advanced or metastatic solid malignancies, thymic cancer, treatment-naive non-metastatic cutaneous melanoma, metastatic hepatocellular carcinoma, recurrent glioblastoma multiforme (GBM), metastatic breast cancer and HER positive and PD-L1 positive breast cancer, mycosis fungoides and sezary syndrome patients associated cutaneous T-cell lymphoma, triple-negative breast cancer, early breast cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, metastatic melanoma, cutaneous t-cell lymphoma, recurrent, metastatic pancreatic ductal adenocarcinoma, advanced/recurrent endometrial cancer, chronic myelomonocytic leukemia, metastatic mucosal melanoma, persistent and metastatic cervical cancer, head and neck squamous cell carcinoma, small cell lung cancer (first line therapy, relapsed or refractory), glioblastoma, anaplastic thyroid carcinoma, soft tissue sarcoma including liposarcoma, penile cancer, leiomyosarcoma, myxofibrosarcoma, undifferentiated pleomorphic sarcoma (UPS), angiosarcoma, translocation sarcoma, uterine cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, squamous and non-squamous non-small cell lung cancer PDL-1 selected patients, muscle invasive bladder cancer, appendiceal adenocarcinoma, pleural mesothelioma, pancreatic neuroendocrine tumor, merkel cell carcinoma, non muscle invasive bladder cancer, anal cancer, metastatic colorectal cancer, metastatic melanoma, metastatic renal cell carcinoma, renal medullary carcinoma, Malignant rhabdoid tumor, Atypical teratoid rhabdoid tumor, Poorly differentiated chordoma, Epithelioid sarcoma, muscle invasive urothelial cancer , Other SMARCB1 or SMARCA4 deficient tumors and metastatic non-small cell lung cancer as second and third line therapy.

It is also under development for metastatic adenocarcinoma of the stomach or gastroesophageal junction and metastatic pancreatic cancer. It is also under development in combination with obinutuzumab and ibrutinib for the treatment of relapsed, refractory and untreated chronic lymphocytic leukemia (CLL).

It is also under development in combination with obinutuzumab and rituximab for the treatment of relapsed and refractory mantle cell lymphoma, marginal zone lymphoma and Waldenstrom macroglobulinemia. The drug candidate is a monoclonal antibody. It is a new molecular entity (NME). The drug candidate is also under development for the treatment of newly diagnosed glioblastoma, second line treatment of gastric cancer, esophageal cancer, nasopharyngeal cancer hepatocellular carcinoma, cholangiocarcinoma (second and third line therapy), prostate cancer as adjuvant therapy and urothelial bladder cancer and first line for metastatic urothelial carcinoma. It is under development for the treatment of renal cell carcinoma as adjuvant therapy. It is under development for metastatic muscle invasive bladder cancer and gallbladder carcinoma. It is also administered by oral route. Tecentriq (atezolizumab (genetic recombination) for the adjuvant treatment of PD-L1-positive non-small cell lung cancer (NSCLC) in adults.

It was under development for colorectal cancer, myelodysplatic syndrome, hepatocellular carcinoma and metastatic renal cell carcinoma. The drug candidate in combination with obinutuzumab or tazemetostat was under development for the treatment of relapsed/refractory follicular lymphoma, relapsed or refractory hodgkin lymphoma, diffuse large B-cell lymphoma, rhabdomyosarcoma, Ewing sarcoma, soft tissue sarcoma, osteosarcoma, Hodgkin’s lymphoma, Wilms' tumor, neuroblastoma, and non-Hodgkin’s lymphoma.

F. Hoffmann-La Roche Overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

The company reported revenues of (Swiss Francs) CHF62,801 million for the fiscal year ended December 2021 (FY2021), an increase of 7.7% over FY2020. In FY2021, the company’s operating margin was 28.9%, compared to an operating margin of 31.8% in FY2020. In FY2021, the company recorded a net margin of 22.2%, compared to a net margin of 24.5% in FY2020.

Quick View – Atezolizumab

Report Segments
  • Innovator (NME)
Drug Name
  • Atezolizumab
Administration Pathway
  • Intravenous
  • Oral
  • Subcutaneous
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.