rns26 Aug 2020 08:06
(the "Company" or "4D")
4D pharma announces comprehensive clinical benefit data from Part A of combination trial of MRx0518 and Keytruda®
Leeds, UK, August 26, 2020 - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces the complete clinical benefit analysis from Part A of its Phase I/II clinical trial of Live Biotherapeutic candidate MRx0518 in combination with immune checkpoint inhibitor (ICI) Keytruda® (pembrolizumab), the anti-PD-1 therapy of MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, in heavily pre-treated patients with solid tumours.
In 12 patients with metastatic renal cell carcinoma (mRCC) and metastatic non-small cell lung cancer (mNSCLC), the combination of MRx0518 with KEYTRUDA achieved a disease control rate (DCR) of 42%, with five of 12 patients experiencing a clinically meaningful benefit from the combination. Three patients experienced partial responses (PR), defined as target tumour shrinkage of 30% or greater - an objective response rate (ORR) of 25%. MRx0518 in combination with KEYTRUDA induced durable stable disease (SD) of six months or greater in an additional two patients (17%). Median duration of treatment for the five patients experiencing clinical benefit is now 13.2 months, with four of these patients currently ongoing.
As previously reported, MRx0518 demonstrated a highly favourable safety profile, with no treatment-related serious adverse events (SAEs) or drug discontinuations and, importantly, no increase of immune-related adverse events (irAEs) commonly associated with ICI therapy.
Prof. Jaap Verweij, Emeritus Professor of Medical Oncology, at Erasmus University Medical Center in Rotterdam, the Netherlands, former chair of the Response Evaluation Criteria in Solid Tumors (RECIST) working group, and an advisor to the Company said, "Having been a clinical investigator on over 150 early stage trials with a wide variety of anti-cancer agents, I believe that these results are extremely encouraging, particularly given the novelty of the approach and the durability of clinical benefit observed."
Dr Alex Stevenson, Chief Scientific Officer, 4D pharma, commented, "The disease control rate observed in part A of the study, at 42%, far exceeds the 10% threshold for success agreed with our partner MSD for the cohort expansion phase, boding well for the outcome of the ongoing Part B of the study. This is ground-breaking for the microbiome in immuno-oncology. Considering the advanced stage of disease of the patients in the study, end of line patients who have previously failed on a checkpoint inhibitor and have little to no remaining treatment options, these results are very promising."
He added, "We believe that, while this is a small study, these efficacy and safety results in such a difficult-to-treat population are notable. To achieve these results while maintaining a very clean safety profile is to our
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