- One complete response, and a disease control rate of 64% with stable disease for ≥16 weeks in two patients, as of the data cutoff -
- Data presented today at the
“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
“Despite the recent advances, we need more and better systemic therapies for liver cancer,” said Dr.
Oral Presentation Today at ILCA
Dr.
Topline results from the ADP-A2AFP Phase 1 trial as of the
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
About
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the
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