Nivolumab is under clinical development by Ono Pharmaceutical and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Nivolumab’s likelihood of approval (LoA) and phase transition for Cervical Cancer took place on 21 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Nivolumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Nivolumab overview

Nivolumab (Opdivo, Opdyta) is a human IgG4 anti-PD-1 monoclonal antibody. Opdivo is formulated as solution and concentrate solution for intravenous and subcutaneous route of administration. Nivolumab is indicated for the treatment of unresectable melanoma. Opdivo as a single agent is indicated for the treatment of patients with  unresectable or metastatic melanoma and disease progression following ipilimumab and, if  BRAF V600 mutation positive, a BRAF inhibitor. Opdivo is indicated for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC)  with progression on or after platinum-based chemotherapy. Opdivo in combination with ipilimumab, is indicated for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. Nivolumab as an adjuvant is indicated for the treatment of urothelial carcinoma. Opdivo is also indicated to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. Opdivo is also indicated for the treatment  of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Opdivo is indicated as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma. Opdivo as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma. Opdivo in combination with ipilimumab is indicated for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. Opdivo indicated for the treatment of patients with classical Hodgkin lymphoma  (cHL) that has relapsed or progressed after autologous  hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. It is indicated for treatment of recurrent or metastatic squamous cell carcinoma of head and neck. It is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan and for the treatment of adult patients with advanced or metastatic hepatocellular carcinoma (hcc) who are intolerant to or have progressed on sorafenib therapy, and metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy, and in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 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, for the treatment of head and neck squamous cell carcinoma, and as the treatment of patients treated with more than two systemic treatment options for advanced or recurrent adenocarcinoma of the stomach or gastroesophageal junction, and is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) metastatic colorectal cancer after prior fuoropyrimidine-based therapy in combination with oxaplatin or irinotecan. Opdivo is indicated for the adjuvant  treatment of completely resected esophageal or gastroesophageal  junction cancer with residual pathologic disease in patients who  have received neoadjuvant chemoradiotherapy (CRT). Opdivo in combination with Cabometyx is indicated for the treatment of unresectable or metastatic renal cell carcinoma (RCC) in adults, also indicated for the treatment of relapsed or refractory classical Hodgkin lymphoma in children. Opdivo indicated as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT) and complete resection and indicated as adjuvant therapy in patients with muscle-invasive bladder carcinoma (MIBC) at a high risk of recurrence after undergoing radical resection. Opdivo in combination therapy with ipilimumab indicated in the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan for adult patients and in combination with cabozantinib as the first-line treatment in patients with advanced renal cell carcinoma and also in combination therapy with bevacizumab and chemotherapy as the first-line treatment in adult patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Opdivo is indicated as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

Nivolumab (ONO-4538) is under development for the treatment of neurofibromatosis type 1 (NF1), esophageal squamous cell carcinoma (ESCC), metastatic neuroendocrine prostate cancer (NEPC), metastatic pancreatic cancer, advanced metastatic uveal melanoma, malignant peripheral nerve sheath tumors (MPNST), medullary thyroid carcinoma, duodenal cancer, gallbladder cancer, bile duct cancer, extrahepatic bile duct cancer, metastatic kirsten rat sarcoma positive (KRAS+) lung adenocarcinoma, neuroendocrine gastroenteropancreatic tumors, poorly-differentiated neuroendocrine carcinoma of pancreas, natural killer t-cell lymphomas, marginal zone lymphoma, advanced or metastativ squamous cell carcinoma of the skin, basaloid squamous cell carcinoma, neuroblastoma, relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma, renal cell carcinoma, homologous-recombination deficient (HRD) epithelial ovarian cancers including fallopian tube cancer and peritoneal cancer, lung adenocarcinoma, metastatic colorectal cancer, relapsed and refractory multiple myeloma, cutaneous melanoma, recurrent or metastatic squamous cell carcinoma of head and neck, nasopharyngeal carcinoma, newly diagnosed oral cavity squamous cell carcinoma, relapsed and refractory primary mediastinal B-cell lymphoma, oral leukoplakia, HPV-associated oropharynx squamous cell carcinoma, refractory metastatic squamous cell carcinoma of the anal canal, diffuse large B-cell lymphoma, unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer), chronic myelogenous leukemia, thymic carcinoma, small-cell lung cancer, non-muscle invasive bladder cancer, pediatric Hodgkin lymphoma, biliary tract cancer, virus-positive negative solid carcinoma, endometrial cancer, cervix cancer, chemo-refractory germ cell tumors, soft tissue sarcoma, sepsis, hepatocellular carcinoma, papillary renal cell carcinoma, relapsed or refractory follicular lymphoma, relapsed or refractory hematologic malignancy, B cell lymphoma, T cell lymphoma, peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) refractory/ relapsed acute myeloid leukemia, pediatric Hodgkin lymphoma,  EBV-positive lymphoproliferative disorders like post-transplantation lymphoproliferative disorder, lymphomatoid granulomatosis, chronic leukemia, non-squamous non-small cell lung cancer and selected refractory or relapsed malignancies, pancreatic cancer, gastric cancer, neuroendocrine tumor, colon cancer, leiomyosarcoma, chondrosarcoma, osteosarcoma, pleomorphic liposarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (UPS/MFH), angiosarcoma, chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), urothelial cancer, triple negative breast cancer and metastatic castration-resistant prostate cancer (mCRPC), hepatitis C infection, metastatic pancreatic ductal adenocarcinoma, gorlin syndrome, undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma,  human papilloma virus infections and merkel cell cancer, relapsed/refractory primary central nervous system lymphoma (PCNSL) and relapsed/refractory primary testicular lymphoma, uterine body cancer and gastric cancer as adjuvant therapy. It is under development for the treatment of oral proliferative verrucous leukoplakia, signet-ring cell carcinoma, papillary adenocarcinoma, gastric or gastroesophageal junction (GEJ) cancers as first line, second line therapy, resected esophageal cancer (esophageal adenocarcinoma), diffuse intrinsic pontine glioma (DIPG), high grade glioma (HGG), medulloblastoma, ependymoma, meningioma, sezary syndrome, Mycosis fungoides and chordoma. It is under development as intrathecal injection for the treatment of leptomeningeal disease as intralesional injection for kaposi sarcoma. It is under development for the treatment of metastatic non-squamous NSCLC with and without the necessity of radiotherapy in 2nd-line or 3rd-line treatment. It is under development for epithelial ovarian cancer as third line therapy in combination with Oregovomab. It is under development for the treatment of muscle-invasive bladder cancer as second line therapy. It is under development for the treatment of hormone-sensitive prostate cancer as second line therapy. It is administered through intraperitonial route for the treatment of peritoneal cancer, cervical cancer and fallopian tube cancer as third line therapy. It was under development for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC. Opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Opdivo (nivolumab) in combination with Yervoy as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

It is also under development for the treatment of melanoma, lung, bladder, breast, ovarian, prostate cancers and sarcoma.

Ono Pharmaceutical overview

Ono Pharmaceutical focuses on the research, development, manufacture and sale of prescription pharmaceuticals and diagnostic reagents. Its product portfolio includes medicines for the treatment of type II diabetes, overactive bladder, osteoporosis, cancer, chemotherapy-induced nausea and vomiting, osteoporosis, Alzheimer’s disease, peripheral circulatory disorder, bronchial asthma and allergic rhinitis, among others. The company offers products in various formulations such as capsules, tablets, injections, patches, dry syrup and intravenous infusions. Ono Pharmaceutical has three manufacturing facilities; Joto Product Development Center, Yamaguchi Plant, and Fujiyama Plant. It offers products in the Americas, Europe, and Asia. Ono Pharmaceutical is headquartered in Osaka, Japan.

Quick View Nivolumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Nivolumab
Administration Pathway
  • Intralesional
  • Intraperitoneal
  • Intrathecal
  • Intravenous
  • Intravenous Drip
  • Subcutaneous
Therapeutic Areas
  • Genetic Disorders
  • Infectious Disease
  • Mouth and Dental Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.