Keytruda29 Jan 2021 11:27
I would expect some update on this combination before too long.
Following successful completion of the Part A safety phase, the Part B cohort expansion phase of the trial is enrolling at multiple sites, and will assess the clinical benefit of the combination of MRx0518 and KEYTRUDA in addition to safety, in up to 30 additional patients per tumour type. The study is open-label and 4D pharma expects to make periodic announcements on progress and updated results as appropriate.
The trial is enrolling heavily pre-treated metastatic patients with selected solid tumours refractory to ICIs. Eligible patients must have experienced at least stable disease on previous ICI therapy (as a monotherapy or combination) but eventually progressed, as confirmed by two radiological scans =4 weeks apart in the absence of rapid clinical progression and within 12 weeks of last dose of ICI. Patients are treated with 1 capsule of MRx0518 twice daily and pembrolizumab every 3 weeks for up to 35 cycles (approximately 2 years) or until disease progression. Tumour response is assessed every 9 weeks per the RECIST 1.1 criteria. The primary objective of Part B is to evaluate safety of the combination. Secondary objectives were to evaluate efficacy via overall response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival (PFS).