LONDON - Autolus Therapeutics plc (NASDAQ:AUTL), a biopharmaceutical company focused on T cell therapies for cancer, has reported encouraging data from its FELIX study on the treatment of adult B-cell Acute Lymphoblastic Leukemia (ALL) with obecabtagene autoleucel (obe-cel). The findings were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The study showed that 40% of patients who responded to obe-cel are in ongoing remission without the need for subsequent stem cell transplant (SCT) or other therapy. Additionally, the data revealed that the persistence of CAR T cells, which are a component of the therapy, is associated with improved event-free survival.
Dr. Christian Itin, CEO of Autolus, expressed satisfaction with the potential for long-term survival outcomes observed in the trial. The median event-free survival was reported at 11.9 months, with an overall survival median of 23.8 months. The 12-month event-free survival rate was estimated at 49.5%, with an overall survival rate of 61.1%.
The study also found that consolidative SCT did not appear to improve event-free or overall survival for patients post-obe-cel. In contrast, ongoing CAR T cell persistence and B-cell aplasia were both linked to better event-free survival outcomes.
The results of the FELIX trial have been submitted to the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date set for November 16, 2024. Autolus will host a conference call and webcast to discuss the data on Saturday, June 1, 2024.
Obe-cel is a CD19 CAR T cell therapy designed to minimize the activation of the programmed T cells, potentially reducing toxicity and improving persistence. The FELIX trial enrolled patients across multiple centers in the United States, United Kingdom, and Europe.
This report is based on a press release statement from Autolus Therapeutics plc.
InvestingPro Insights
Autolus Therapeutics plc (NASDAQ:AUTL) has recently drawn attention with promising results from its FELIX study, but what does the financial data say about the company's performance and outlook? According to InvestingPro, AUTL is trading at a high revenue valuation multiple, with a price-to-book ratio in the last twelve months as of Q1 2024 at 1.82. Despite an impressive quarterly revenue growth of 681.04% in Q1 2024, analysts have revised their earnings downwards for the upcoming period, signaling caution.
InvestingPro data shows a market capitalization of $1.06 billion for Autolus, underlining its significant presence in the biopharmaceutical sector. However, the company is grappling with weak gross profit margins, with a strikingly negative gross profit margin of -1143.03% in the last twelve months as of Q1 2024. This could be a red flag for potential investors, as it suggests challenges in controlling costs relative to revenues.
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