On 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, reported that in Part B of its signal finding study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (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 (Press release, 4d Pharma, MAR 23, 2022, View Source [SID1234610651]).
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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 & 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 is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Conference Call & Webcast Information
4D pharma will host a conference call and live webcast on Wednesday, March 23, 2022, at 10:00 am ET (2:00 pm GMT) to discuss the interim results of the Phase I/II study of the combination of MRx0518 and Keytruda for the treatment of renal cell carcinoma.
4D pharma management will be joined by key opinion leaders (KOLs) Dr. Petros Grivas, Associate Professor Clinical Research Division at the Fred Hutchinson Cancer Research Center, and Dr. Scott T. Tagawa, Professor of Medicine and Urology at Weill Cornell Medicine, both members of the 4D pharma’s Genitourinary Cancers Advisory Board.
To access the live webcast, please visit the ‘Events’ section of the 4D pharma website. To access audio only, please dial (866) 939-3921 (United States) and (678) 302-3550 (International) and reference Confirmation Number 50287940. A replay of the webcast and accompanying slides will be available on the 4D pharma website following the event.