Labcorp gets CDSCO nod to conduct a study on anticancer drug

This nod came after Labcorp presented Phase III-SAMETA study vide protocol no. D5086C00001 version 1.0 dated 26-FEB-2021 and addendum IND-1, version: 1.0 dated 18-OCT-2021 before the committee.

Savolitinib is an orally bioavailable inhibitor of the c-Met receptor tyrosine kinase with potential antineoplastic activity. Savolitinib selectively binds to and inhibits the activation of c-Met in an ATP-competitive manner, and disrupts c-Met signal transduction pathways. This may result in cell growth inhibition in tumors that overexpress the c-Met protein. C-Met encodes the hepatocyte growth factor receptor tyrosine kinase and plays an important role in tumor cell proliferation, survival, invasion, and metastasis, and tumor angiogenesis; this protein is overexpressed or mutated in a variety of cancers.

Durvalumab is an anti-cancer ("antineoplastic") drug. This medication is classified as an anti-PD-L1 monoclonal antibody. Durvalumab is used to treat urothelial cancers that are locally advanced or metastatic in patients who have disease progression during or following platinum containing chemotherapy or who have disease progression within 12 months of neo-adjuvant or adjuvant treatment with platinum containing chemotherapy. In addition, it is also used for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Sunitinib is a receptor tyrosine kinase inhibitor and chemotherapeutic agent used for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST).

At the 120th SEC meeting for Oncology and Hematology held on March 9th, 2022, the committee reviewed the protocol presented by the drug major Labcorp for conducting a study of anti-neoplastic drug Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab.

While assessing the risk versus benefit, the committee observed that, overall, the benefit/risk assessment supports the further investigation of Savolitinib plus Durvalumab versus Sunitinib in participants with MET-driven, unresectable, and locally advanced or metastatic papillary renal cell carcinoma (PRCC).

In addition, in line with innovations vs. existing therapeutic options, the expert panel found the SAMETA study is designed to evaluate the efficacy and safety of the Savolitinib plus Durvalumab combination compared with Sunitinib in first-line participants with unresectable and locally advanced or metastatic PRCC that is MET driven without co-occurring FH mutations.

The committee further noted that the study will also investigate the contribution of Durvalumab to the Savolitinib plus Durvalumab combination.

Furthermore, in line with unmet medical need, the committee also observed that available antitumor therapies have all been approved for the broader condition, renal cell carcinoma (RCC), with limited efficacy data obtained in PRCC. Effective therapies for PRCC represent an unmet medical need.

After detailed deliberation, the committee recommended the grant of permission to conduct the study.