Novel Drug-Keytruda Combo Meets Goal for Kidney Cancer Outcomes Before Trial Enrollment Ends

An ongoing phase 1/2 clinical trial is showing that combining the novel agent MRx0518 with the immunotherapy drug Keytruda (pembrolizumab) is promising in treating patients with renal cell carcinoma (RCC), a type of kidney cancer, that has progressed on a prior checkpoint inhibitor.

While Part B of the study has not yet completed patient enrollment, it already reached its main efficacy endpoint in patients with RCC: four out of the first 16 patients enrolled have already achieved clinical benefit with six months or more of stable disease.

"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," said Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma, the manufacturer of MRX0518, in a statement.

The ongoing study is still enrolling patients with solid tumors that responded to immune checkpoint inhibition but then relapsed. Researchers are planning on enrolling a total of 120 patients with the following malignancies: RCC, non-small cell lung cancer, bladder cancer and head and neck squamous cell carcinoma.

The goal of Part B of the study is to determine if at least three out of 30 patients per cancer type will experience clinical benefit from the two-drug combination of MRX0518 and Keytruda. Study investigators defined clinical benefit as complete response (when there is no evidence of disease after treatment is administered), partial response (when the cancer shrinks as a result of the treatment) or stable disease for six months or longer.

In Part A of the trial, 42% of patients on MRx0518 plus Keytruda achieved a clinical benefit, and the two-drug combination had a favorable safety profile.

"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."

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