4D pharma announces positive interim results from the Phase I/II study of the combination of MRx0518 and KEYTRUDA(R) (pembrolizumab) for the treatment of renal cell carcinoma

4D pharma announces positive interim results from the Phase I/II study of the combination of MRx0518 and KEYTRUDA(R) (pembrolizumab) for the treatment of renal cell carcinoma

1. Primary Efficacy Endpoint Met Early in Renal Cell Carcinoma Group in Part B of Study
2. Company to Host Conference Call and Webcast Today March 23, 10:00 am EST (2:00 pm GMT) 

Leeds, UK, March 23, 2022 – 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces that in Part B of its signal finding study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab), in patients with solid tumors 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.

The ongoing study is being conducted in heavily pre-treated metastatic patients with solid tumors who have previously experienced clinical benefit on prior ICI therapy and subsequently developed progressive disease. The study is being conducted in collaboration with MSD (Merck and Co., Inc., Kenilworth, NJ, USA). The primary efficacy endpoint for Part B of the study is more than three out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least six months.

Part B of the study has to date enrolled 20 patients with RCC, of which four out of the first 16 evaluable patients have achieved clinical benefit, each having achieved 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. MRx0518 continues to be safe and well tolerated.

“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,” commented Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. “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.”

4D pharma intends to discuss next steps with partners and its Genitourinary Cancers Advisory Board regarding the development path of MRx0518 and a potentially pivotal study in patients with ICI-refractory RCC. 4D pharma will continue to recruit patients into the ongoing study of MRx0518 and Keytruda in RCC and the three tumor groups, with potential expansion into other types of ICI resistance.

KEYTRUDA(R) is a registered trademark of Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., Kenilworth, NJ, USA.