BERLIN (dpa-AFX) - Merck KGaA (MKGAY.PK) announced new and updated results from expansion cohorts of two ongoing M7824 Phase I clinical trials (NCT02517398 and NCT02699515) at the ESMO (European Society for Medical Oncology) 2018 Congress in Munich, October 19-23.
New data presented include the first presentation of results for M7824 in advanced squamous cell carcinoma of the head and neck (SCCHN), biliary tract cancer (BTC) and esophageal cancers (esophageal squamous cell carcinoma [ESCC] and esophageal adenocarcinoma [EAC]).
In addition, updated data for M7824 in non-small cell lung cancer (NSCLC) and gastric cancer add to the growing evidence for M7824's clinical anti-tumor activity in a number of challenging cancers.
New data from an ongoing Phase I expansion cohort (32 patients, NCT02517398) showed signs of promising early clinical activity in patients with refractory metastatic second-line SCCHN, especially in HPV-positive SCCHN patients. As presented during the Proffered Paper Head and Neck cancers session, the overall response rate (ORR) was 15.6%, with a numerically higher ORR in HPV-positive patients (36.4%, 4/11 patients experienced a partial response), with two additional delayed responses resulting in a 54.5% clinical response rate for the HPV-positive population.
Updated results from an ongoing Phase I trial (NCT02517398) in patients with previously treated, advanced NSCLC, demonstrated an ORR of 37.0% (10/27 patients) and progression free survival of 9.5 months in patients with PD-L1+ tumors (?1%). In patients with high PD-L1+ expressing tumors (cut-off of ?80% using the 73-10 assay; ?80% cut-off with 73-10 assay is most comparable to ?50% cut-off with the 22C3 test based on internal comparability studies), ORR was 85.7% (6/7 patients).
Grade 3 TRAEs occurred in 23 patients (28.8%) and Grade 4 TRAEs occurred in 2 patients (2.5%): hypokalemia and decreased blood magnesium and increased amylase and lipase levels. The most common TRAEs were pruritus (21.3%), maculopapular rash (18.8%), decreased appetite (12.5%), asthenia (11.3%) and rash (10.0%).
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