GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Atezolizumab overview
Atezolizumab (Tecentriq) is an antineoplastic agent. It is formulated as solution concentrate for intravenous and solution for subcutaneous 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, idiopathic pulmonary fibrosis, 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, urethral cancer, colon cancer and ureter cancer. 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 primary mediastinal B-cell lymphoma, 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, healthcare professionals, commercial laboratories, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.