Likelihood of Approval and Phase Transition Success Rate Model – Atezolizumab in Melanoma

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Atezolizumab in Melanoma

Empower your strategies with our Likelihood of Approval and Phase Transition Success Rate Model – Atezolizumab in Melanoma report and make more profitable business decisions.

This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.


Atezolizumab in Melanoma Drug Details:

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, 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.

Report Coverage

The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.

The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.

Quick View – Atezolizumab LOA Data
Report Segments
· Drug type

· Intervention type

Drug Name
· Atezolizumab
Administration Pathway
· Intravenous| Oral| Subcutaneous
Therapeutic Areas
· Oncology| Respiratory

Key Manufacturers
· F. Hoffmann-La Roche Ltd
Drug Development Status
· Marketed

Reasons to Buy

  • Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
  • Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
  • Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
  • Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.

Scope

  • Drug Details: Drug name, Drug type, Intervention type
  • Administration Pathway
  • Therapeutic Areas
  • Key Manufacturers
  • Drug Development Status

This is an on-demand report that will be delivered upon request. The report will be delivered within 2 business days of the purchase, excluding weekends and holidays. Certain sections of the report may be removed or altered based on data availability and relevance.

Frequently asked questions

    The probability of a drug ultimately receiving market authorization

    The probability of a drug’s advancement to the next stage of clinical development

    GlobalData’s  Drug-Specific Likelihood of Approval (LoA) calculates the  Phase Transition Success Rate (PTSR) and  Likelihood of Approval (LoA) customized to individual drug. The model uses a combination of  Machine Learning (ML) and a  GlobalData proprietary algorithm to process data points from the  Drugs, Clinical Trials, Regulatory Milestones, Company, and  Financial databases.

     

    Inclusion

    Data Scope:

    • Drugs which have been approved in the past 10 years
    • Drugs which have failed during clinical development in the past 18 years
    • Drugs which are currently in development

    Drug Phase Scope:

    • Phase I, Phase II, Phase III, and Pre-Registration development stage

    Drug Geography Scope:

    • Drugs must meet one of the following criteria to be included in the model:
    • The developer has specified the US as an intended market for approval.
    • The developer has not specified any country as an intended market for approval, i.e. the “Drug Geography” is listed as “Global”

    Drug Type Scope:

    • Innovator drugs and biosimilars

    Entity Type Scope:

    Only drugs in development by companies are included in the model.

    Exclusion

    • Diagnostics, Imaging Agents, Biomarkers, stents and other drug delivery devices (covered in GlobalData’s Medical Intelligence Center).
    • Nutraceuticals, dietary supplements, alternative medicines, imaging agents, radio emitter, transplants, transfusions, fillers, cosmetics, probiotics, antiseptics, antacids, mobilizing agents, veterinary drugs and drugs not seeking approval.
    • Generic drugs
    • Innovative drugs in Preclinical or Discovery Stage.
    • Pipeline drugs sponsored by a Government or Institution.
    • Drugs with a specific Drug Geography not the United States.

     

lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Atezolizumab in Melanoma
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