On September 5, 2021 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that updated data from its Phase 1 ADP-A2AFP trial for patients with liver cancer at ILCA (Press release, Adaptimmune, SEP 5, 2021, View Source [SID1234587253]).
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"We have seen significant antitumor activity with this first-generation product targeting AFP that is encouraging for the potential of cell therapy for the treatment of liver cancer in these heavily pre-treated patients with late-stage disease," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "We reported a complete response in one patient, and tumor reductions with stable disease that has lasted more than 16 weeks in two patients as well as disease control in most patients at the target dose. We are continuing the expansion phase and will update when new data becomes available."
"Despite the recent advances, we need more and better systemic therapies for liver cancer," said Dr. Bruno Sangro of Clinica Universidad de Navarra. "The first results from this cell therapy trial are of great interest since they indicate obvious antitumor activity in some patients. This treatment has generally been safely applied even to cirrhotic patients."
Oral Presentation Today at ILCA
Dr. Bruno Sangro presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation today at ILCA. A replay will be available through the congress web site.
Topline results from the ADP-A2AFP Phase 1 trial as of the April 5, 2021 data cutoff
Efficacy
Thirteen patients with advanced hepatocellular carcinoma (HCC) received ADP-A2AFP in Cohort 3 and expansion
The best overall responses in Cohort 3 and expansion (per RECIST v1.1) included 1 complete response (reported in 2020), 6 stable disease and 4 progressive disease. 2 patients did not have scan results at the time of data cut-off
The disease control rate for patients with at least one scan was 7/11 (64%) and 2 patients had stable disease lasting beyond 16 weeks
Safety
ADP-A2AFP has an acceptable safety profile with no reports of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities
Adverse events (AEs) reported in 2 or more patients and considered related to T-cell infusion included neutropenia, leukopenia, lymphopenia, pyrexia, anemia, cytokine release syndrome, febrile neutropenia, thrombocytopenia, aspartate aminotransferase increased, and alanine aminotransferase increased
Two patients reported a total of 3 treatment-related serious AEs including cytokine release syndrome (Grade 1), infusion-related reaction (Grade 2), and febrile neutropenia (Grade 3)
Conclusions
Antitumor activity, with one complete response, sustained decreases in serum AFP, and best overall response of stable disease observed in 6 patients, indicate that ADP-A2AFP is an active product in HCC
ADP-A2AFP up to doses of 10 billion transduced cells has been associated with an acceptable safety profile
Overview of Trial Design
This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with liver cancer (hepatocellular carcinoma) or other AFP-expressing tumors, who are not amenable to transplant, resection, or loco-regional therapy, and who failed or were intolerant to or refused standard-of-care treatment
Dose escalation is complete, and this trial is intended to treat up to 25 patients with doses up to 10 billion transduced cells in the expansion phase