Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 55 |
| INN | Tremelimumab |
| Status | Approved |
| Drug code(s) | CP-675,206 |
| Brand name | Imjudo |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse-derived (Xenomouse) |
| Target(s) | CTLA-4 |
| Indications of clinical studies | Small cell lung cancer, Colorectal Neoplasms, Malignant Mesothelioma, Prostate cancer, Bladder cancer, Melanoma, Hepatocellular Carcinoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2001 |
| Start of Phase 2 | |
| Start of Phase 3 | March 15, 2006 |
| Date BLA/NDA submitted to FDA | November 15, 2021 |
| Year of first approval (global) | 2022 |
| Date of first US approval | October 21, 2022 |
| INN, US product name | Tremelimumab, Tremelimumab-actl |
| US or EU approved indications | Unresectable hepatocellular carcinoma; treatment for adult patients with metastatic non-small cell lung cancer with no anaplastic lymphoma kinase genomic tumor aberrations or epidermal growth factor receptor mutation. |
| Company | Pfizer |
| Licensee/Partner | AstraZeneca |
| Comments about company or candidate | Feb 2023: AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of 1st-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) and Imfinzi in combination with Imjudo and platinum-based chemotherapy for the treatment of adult patients with metastatic (Stage IV) non-small cell lung cancer. Oct 24, 2022: AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with unresectable hepatocellular carcinoma BLA submission for liver cancer announced April 25, 2022; priority review; PDUFA date in Q4 2022. EMA started application review Dec 24, 2021. Listed in AZ pipeline dated July 2021; not listed in Pfizer pipeline dated July 28, 2021. First BLA was submitted Nov 15, 2021; 2nd (761289) was submitted on Feb 23, 2022 and approved on Oct 21, 2022. Aug 2020: Starting previously treated liver cancer patients on a single, 300-mg initial dose of tremelimumab and following up with PD-L1 therapy Imfinzi helped patients live a median 18.7 months in a phase 2 study, AstraZeneca said ahead of the American Society of Clinical Onocolgy (ASCO) virtual annual meeting. Tremelimumab and anti-PD-L1 durvalumab (Imfinzi) were granted Orphan Drug designation in the US for the treatment of hepatocellular carcinoma (HCC), and tremelimumab was also granted Orphan Drug designation for HCC in the EU. August 21, 2019: AstraZeneca today announced final overall survival (OS) results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients. The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumour mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumour, and tumours with high levels of TMB may be more visible to the immune system. In the primary analysis population of patients whose blood TMB was 20 or more mutations per megabase (mut/Mb), the combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving OS compared to SoC chemotherapy. As of the end of 2018, tremelimumab + Iminzi combo studies in NSCLC and HNSCC were removed from AZ pipeline. April 2018: the combination of Imfinzi plus tremelimumab did not result in a statistically-significant survival benefit in the Phase 3 ARCTIC study. Phase 3 studies in liver and kidney cancer started recruiting in Oct 2017 and July 2018, respectively. Feb 2017: AZ remains committed” to developing durvalumab both on its own and in combo with tremelimumab for patients with recurrent metastatic HNSCC: “Through the delivery of the phase 3 randomized controlled clinical Eagle trial (in second-line HNSCC) with data expected in 2018, and the phase 3 randomized controlled clinical Kestrel trial (in first-line HNSCC) with data expected in H2 2017.Three Phase 3 studies recruiting, 3 not yet recruiting as of Sep 2015. Phase 2 NCT01655888 recruiting patients as of June 2013; Phase 2 study in mesothelioma amended to make it a Phase 2/3 study. US orphan designation for malignant mesothelioma, hepatocellular carcinoma. |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
Immune checkpoint target. CTLA=cytotoxic T lymphocyte-assoc. antigen
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |