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March 18, 2021updated 19 Mar 2021 2:57pm

Eli Lilly’s Phase II merestinib plunges 2 points after data shows no PFS improvement in 1L biliary tract cancer

The Likelihood of Approval (LoA) of Eli Lilly’s (NYSE:LLY) Phase II merestinib in front-line (1L) biliary tract cancer dropped by 2 points as of 22 February, according to GlobalData’s LoA data.

By Reynald Castañeda

The Likelihood of Approval (LoA) of Eli Lilly’s (NYSE:LLY) Phase II merestinib in front-line (1L) biliary tract cancer dropped by 2 points as of 22 February, according to GlobalData’s LoA data. The decrease is on the heels of the Phase II trial reporting that merestinib, in combination with the chemotherapy duo gemcitabine and cisplatin (gem-cis), failed to demonstrate progression-free survival (PFS) improvement, the trial’s primary endpoint.

Data from the 309-patient Phase II trial (NCT02711553) was first revealed on January 2020 at the ASCO Gastrointestinal Cancers Symposium (abstract no 477). The trial investigated if merestinib or Eli Lilly’s own Cyramza (ramucirumab), would improve upon gem-cis efficacy. In the merestinib arm, the PFS was 6.97 months (p=0.6417), which was 6.47 months with Cyramza (p=0.4821). Patients who only received gem-cis had a PFS of 6.64 months. Neither merestinib nor Cyramza delivered enhancements in secondary endpoints overall survival and overall response rate (Valle, J, et. al, Journal of Clinical Oncology 38, no. 4_suppl (February 01, 2020) 477-477).

Merestinib initially had an LoA of 3%. And, based on GlobalData’s analysis using a combination of machine learning and a proprietary algorithm, the LoA then went down to 1% due to the Phase II data. Merestinib inhibits proto-oncogene c-Met and has potential antineoplastic activity. Cyramza is a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist with FDA approval in gastric, colorectal, and non-small cell lung cancers, as well as in hepatocellular carcinoma.

Reynald Castaneda is Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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