AstraZeneca gets CDSCO nod to conduct Phase III CT of antineoplastic FDCs drug
New Delhi: Suggesting to increase the number of subjects in clinical trial to 34, from the proposed 24 subjects in India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to pharmaceutical major, AstraZeneca to conduct the Phase III clinical trial of the anti-neoplastic fixed-dose combination drug Durvalumab plus Tremelimumab plus Lenvatinib.
This came after the firm presented the proposed Phase III clinical trial protocol no- D910VC00001, version: 1.0 dated 05Nov2021 (EMERALD-3) before the committee.
Durvalumab is an antineoplastic monoclonal antibody that works by helping immune system to reduce or stop the growth of cancer. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune checkpoint inhibitor for cancer treatment. It is mainly indicated to treat urothelial carcinoma and locally advanced, unresectable non-small cell lung cancer(NSCLC). It is of use in non-small cell lung cancer (NSCLC) that spread to nearby tissues and cannot be removed by surgery but has not worsened after being treated with other chemotherapy medications and radiation treatments.
Tremelimumab is also a monoclonal antibody drug, used in the treatment that helps the immune system fight cancer. It targets the T Cell receptor protein cytotoxic T-lymphocyte-associated protein 4 (CTLA4). CTLA4 is an inhibitory receptor and member of the immunoglobulin superfamily, which plays a key role in the downregulation of the immune system. The clinical trials of tremelimumab have shown that it helps control several different types of cancer including lung cancer and mesothelioma.
Lenvatinib is a kinase inhibitor, which works by blocking the action of an abnormal protein that signals cancer cells to multiply. It is a targeted therapy that targets and binds to the tyrosine kinase receptors and inhibits vascular epidermal growth factor receptor (VEGFR), vascular endothelial growth factor (VEGF), and inhibits other kinase receptors that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression.
Durvalumab plus Tremelimumab has achieved positive results in urothelial cancer and non-small cell cancer. This combination has also significantly improved overall survival in patients with advanced, unresectable hepatocellular carcinoma, the most common type of liver cancer. Durvalumab in combination with Tremelimumab and Lenvatinib can improve the management strategy of many types of cancers.
At the recent SEC meeting for Oncology & Hematology, the expert panel reviewed the protocol for conducting a phase III clinical trial of the FDC anti-neoplastic drug Durvalumab plus Tremelimumab plus Lenvatinib in detail.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed trial.
In addition, considering the high prevalence of the disease in the country, the committee suggested increasing the number of subjects to 34, from the proposed 24 subjects in India.
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