Spartalizumab is under clinical development by Novartis and currently in Phase II for Gastrointestinal Stromal Tumor (GIST). According to GlobalData, Phase II drugs for Gastrointestinal Stromal Tumor (GIST) have a 41% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Spartalizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Spartalizumab overview

Spartalizumab (PDR-001) is under development for the treatment of clear cell renal cell carcinoma, advanced solid tumors including malignant melanoma, non small cell lung cancer (NSCLC), metastatic squamous cell anal carcinoma, hepatocellular carcinoma, ocular melanoma, triple negative breast cancer, renal cell cancer, anaplastic thyroid cancer, recurrent or metastatic nasopharyngeal carcinoma, metastatic microsatellite stable colorectal cancer, esophageal squamous cell carcinoma, gastrointestinal stromal cancer, recurrent head and neck cancer squamous cell carcinoma, endometrial cancer, recurrent glioblastoma, advanced pancreatic cancer, relapsed and refractory multiple myeloma, gastrointestinal stromal tumor, metastatic ovarian cancer, de novo, myelodysplastic syndrome, relapsed and refractory acute myeloid leukemia. The monoclonal antibody is administered as intravenous infusion and is directed against programmed death 1 protein (PD-1). It is a humanized anti-programmed death-1 (PD-1) IgG4 antibody. It was also under development for neuroendocrine gastroenteropancreatic tumors (gep-net) and neuroendocrine tumors. It is a new molecular entity (NME).

It was under development for diffuse large B-cell lymphoma, BRAF V600 mutation-positive cutaneous melanoma and locoregional solid malignancies.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

For a complete picture of Spartalizumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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

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.