4D Pharma (DDDD ) has published positive results from a phase II/III study of MRx0518 in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients.
The ongoing study, which forms part of a collaboration with Merck & Co, is being conducted in heavily pre-treated metastatic patients with solid tumours who have previously experienced clinical benefit on prior ICI therapy and have subsequently developed progressive disease.
MRx0518 is 4D Pharma’s single strain Live Biotherapeutic product in development for the treatment of cancer which is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumours.
The company confirmed today that in the second part of its signal finding study of MRx0518 in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with solid tumours that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group has met its primary efficacy endpoint ahead of enrollment completion.
4D Pharma explained that the primary efficacy endpoint for the Part B phase of the study is more than three out of 30 patients per tumour group achieving clinical benefit, which is defined as complete response, partial response, or stable disease for at least six months.
This part of study has enrolled 20 patients with RCC, of which four of the first 16 evaluable patients have achieved clinical benefit, each achieving at least 6 months of stable disease.
To date, Part B of the study has enrolled 47 patients of up to a total of 120 patients with RCC, non-small cell lung cancer, bladder cancer, and head and neck squamous cell carcinoma. The Company confirmed today that MRx0518 continues to prove as both “safe and well tolerated.”
Commenting today, Dr. Alex Stevenson, Chief Scientific Officer of 4D Pharma 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."
After successfully achieving its efficacy target, 4D pharma now intends to discuss its next steps with partners and its Genitourinary Cancers Advisory Board regarding the development path of MRx0518, as well as a potentially pivotal study in patients with ICI-refractory RCC.
It said it will continue to recruit patients into the ongoing study of MRx0518 and Keytruda in RCC and the three tumour groups, with potential expansion into other types of ICI resistance.
Follow News & Updates from 4D Pharma: