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.

Ipilimumab + nivolumab overview

Nivolumab and Ipilimumab (Opdivo and Yervoy) a drug regimen is a recombinant human IgG4 anti-PD-1 monoclonal antibody. It is formulated as solution concentrate for intravenous route of administration. Opdivo and Yervoy drug regimen is indicated to treat advanced metastatic melanoma and for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma, and unresectable malignant melanoma. Opdivo and Yervoy combination is indicated for treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. nivolumab (Opdivo) in combination with ipilimumab (Yervoy), as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and also nivolumab in combination with ipilimumab ( and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Opdivo in combination with Yervoy for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. Opdivo in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%. Opdivo in combination with Yervoy is indicated for the first-line treatment of unresectable, advanced or recurrent esophageal cancer in adults. Opdivo in combination with Yervoy as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) colorectal cancer (CRC).

The drug candidate is under development for the treatment of recurrent endometrial carcinoma, metastatic adenocarcinoma of the pancreas, metastatic or recurrent squamous-cell lung cancer (SqLC), glioblastoma multiforme, gliosarcoma, neuroendocrine carcinoma, intrahepatic cholangiocarcinoma, gallbladder carcinoma, uterine clear cell carcinoma, vulva squamous cell carcinoma and vaginal squamous cell carcinoma, advanced rectal adenocarcinoma, cutaneous squamous cell carcinoma, relapsed and refractory multiple myeloma, recurrent metastatic head and neck squamous cell cancer, recurrent or progressive high grade glioblastoma, cutaneous melanoma, epithelial ovarian cancer, fallopian tube cancer and peritoneal cancer second and third line therapy (intraperitoneal route), metastatic uveal melanoma, recurrent head and neck cancer squamous cell carcinoma, esophageal squamous cell carcinoma, gastric cancer or gastric-esophageal cancer, renal cell carcinoma, salivary gland cancer, melanoma, HER2 negative, triple negative breast cancer, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, papillary renal cell carcinoma, NET of the pancreas, lung or gastrointestinal (GI) tract, Kaposi sarcoma, metastatic homologous-recombination deficient (HRD) castration-resistant prostate cancer (mCRPC), metastatic pancreatic cancer, metastatic colorectal cancer, biliary tract carcinoma, head and neck squamous cell cancer, metastatic uveal melanoma, metastatic urothelial cancer, bladder cancer, anal, vulvar, penile, colorectal, cervical, esophageal cancer, adenoid and non-adenoid cystic carcinoma, meningioma, dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma, metastatic merkel cell carcinoma, nasopharyngeal carcinoma, adenocarcinoma of the gastroesophageal junction, medullary and anaplastic thyroid cancer, adrenocortical carcinoma, metastatic castration resistant prostate cancer, diffuse intrinsic pontine glioma (DIPG), high grade glioma (HGG), medulloblastoma, muscle invasive bladder cancer, metastatic basal cell carcinoma, ependymoma, angiosarcoma (AS), alveolar soft part sarcoma (ASPS), clear cell sarcoma (CCSA), desmoplastic small round cell tumor (DSRCT), sclerosing epithelioid fibrosarcoma (SEF), perivascular epithelioid cell tumor (PEComa), intimal sarcoma (IS), extraskeletal myxoid chondrosarcoma (EMC), solitary fibrous tumor (SFT), epithelioid hemangioendothelioma (EHE), inflammatory myofibroblastic tumor (IMT), epithelioid sarcoma (ES), fibrosarcoma (FS), SMARCA-4 deficient sarcoma, malign peripheral nerve sheath tumors (MPNST), chordoma, virus positive/negative solid carcinoma and malignant pleural mesothelioma. It was also under development for the treatment of epithelial ovarian cancer, small cell lung cancer, recurrent glioblastoma, fallopian tube cancer, melanoma, hepatic tumor, Wilms" tumor, neuroblastoma, non-rhabdomyosarcoma, head and neck cancer and peritoneal cancer. it is administered through intraperitoneal route.

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company. It is engaged in the discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, immunology, cardiovascular, and fibrotic diseases. The company offers its products across the world to wholesalers, retail pharmacies, medical professionals, hospitals and government entities. The company has an operational presence in the US, Switzerland, Puerto Rico, Ireland, and the Netherlands. The company conducts research to focus on the discovery and development of novel medicines that address diseases in areas of unmet medical need. BMS is headquartered in Princeton, New Jersey, the US.

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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.