4D pharma has reported positive interim results from the Part B of Phase I/II clinical trial of MRx0518 in combination with Keytruda (pembrolizumab) for renal cell carcinoma (RCC).
Findings showed that the RCC group of the trial has met its primary efficacy endpoint even before concluding the subject enrolment.
MRx0518 is a live biotherapeutic drug candidate while Keytruda is an anti-programmed cell death protein 1 (PD-1) treatment of Merck (MSD).
The trial underway is assessing heavily pre-treated metastatic solid tumour patients who have advanced following treatment with an immune checkpoint inhibitor (ICI) previously.
It is being carried out in partnership with Merck.
Over three out of 30 subjects per tumour group attaining clinical benefit is the primary efficacy endpoint for the Part B portion of the trial.
The clinical benefit was defined as complete response, partial response, or stable disease for a minimum of six months.
So far, Part B enrolled 20 subjects, of which four of the 16 evaluable participants attained clinical benefit. All these four patients had a minimum of six months of stable disease.
As against a target of 120 subjects with RCC, non-small cell lung cancer, bladder cancer and head and neck squamous cell carcinoma, the trial has currently enrolled 47 subjects.
Furthermore, MRx0518 demonstrated to be safe and well-tolerated in the trial.
The company plans to hold talks with partners and its Genitourinary Cancers Advisory Board on MRx0518’s development path and a trial in ICI-refractory RCC patients.
It will continue to enrol subjects into the trial of MRx0518 plus Keytruda for RCC as well as the three tumour groups and could be extended into various other ICI resistance types.
4D pharma chief scientific officer Dr Alex Stevenson said: “Today’s results in renal cell carcinoma, meeting the predefined primary efficacy endpoint early in this difficult to treat population, marks another important step forward for MRx0518 and the increasing importance of the microbiome in cancer treatment.
“Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC.”
The company obtained approval from the US Food and Drug Administration to commence a Phase I trial for its two live biotherapeutics for Parkinson’s disease in February this year.