Results of Adaptimmune's SPEARHEAD-1 Trial with Afami-cel in Advanced Sarcomas Published in the Lancet

Rhea-AI Summary

Adaptimmune Therapeutics plc (ADAP) announces the publication of pivotal Phase 2 data with afami-cel in The Lancet, showcasing promising results in treating advanced synovial sarcoma and myxoid/round cell liposarcoma. The study demonstrates a 39% overall response rate in synovial sarcoma, indicating potential life extension and reduced chemotherapy dependence.

Insights

Oncology Doctor

The publication of Phase 2 data in a prestigious journal like The Lancet is a significant step for Adaptimmune Therapeutics and the field of oncology. It indicates a level of confidence in the data's validity and potential impact on treatment paradigms. Afami-cel's 39% overall response rate in synovial sarcoma patients is noteworthy, especially when considering the limited treatment options currently available for advanced sarcomas. These results may suggest a shift towards personalized cell therapies in oncology, which could improve patient outcomes and reduce reliance on traditional chemotherapy.

However, it's important to interpret these results within the context of the trial's design and the broader landscape of cancer treatment. While the response rate is promising, the long-term benefits, potential side effects and overall survival rates need thorough examination in subsequent studies. Additionally, the cost-effectiveness of such treatments must be evaluated, as cell therapies can be expensive to produce and administer.

Medical Research Analyst

From a research perspective, the SPEARHEAD-1 trial results are pivotal in advancing the understanding of cell therapy in solid tumors. Engineered T-cell therapies like afami-cel represent a growing area of interest, with the potential to target tumors more precisely than conventional methods. The translational results published provide a foundation for further research and development in this space.

It's important to note that the durability of responses and the quality of life improvements for patients are key factors in the success of new therapies. The ability of afami-cel to allow patients to go off chemotherapy, as reported, could represent a significant improvement in treatment experience. However, the scalability of manufacturing and the logistical challenges of delivering cell therapies to a broader patient population must be considered as these therapies advance towards commercialization.

Financial Analyst

The publication of positive trial results can have a substantial impact on a biotech company's stock performance and investor confidence. Adaptimmune's announcement underscores the potential market opportunity for afami-cel in treating advanced sarcomas, a space with high unmet medical needs. If afami-cel receives regulatory approval, it could command significant market share and provide a new revenue stream for the company.

Investors should monitor the progress of afami-cel's clinical development and any signals from regulatory bodies. While the results are promising, the path to market approval is complex and includes rigorous safety and efficacy assessments. Furthermore, the competitive landscape, including emerging therapies and potential market size, will influence the financial implications of afami-cel's success.

Philadelphia, Pennsylvania and Oxford, United Kindgom--(Newsfile Corp. - March 27, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that The Lancet published the company's pivotal Phase 2 data with afami-cel. The article, titled "SPEARHEAD-1: a single-arm phase 2 trial of afamitresgene autoleucel (afami-cel) in advanced synovial sarcoma and myxoid/round cell liposarcoma," details clinical and translational results from afami-cel's SPEARHEAD-1 trial (NCT04044768).

Dennis Williams, PharmD., Senior Vice President, Late-Stage Development, Adaptimmune: "It is exciting to see the Lancet share the afami-cel SPEARHEAD-1 trial results in advanced sarcomas with the broader clinical and research communities. The study further demonstrates the ability of engineered T-cell therapies to effectively target solid tumors and we are eager to introduce the first engineered T-cell therapy, afami-cel, to more patients later this year."

Dr. Sandra D'Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, lead author of the publication: "The reported findings are clinically impactful, considering the current standard of care and limited therapies available in advanced sarcomas. Treatment with afami-cel resulted in 39% overall response rate in synovial sarcoma with durable responses. These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy. The publication of this data further validates the potential of afami-cel to offer a new tool to address the unmet needs of people diagnosed with these often-devastating diseases."

About Afami-cel (afamitresgene autoleucel): On January 31, 2024, Adaptimmune announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024.

In the SPEARHEAD-1 trial, 44 patients with advanced synovial sarcoma were treated with a single dose of afami-cel after undergoing lymphodepleting chemotherapy with cyclophosphamide and fludarabine. Safety findings were overall consistent with those previously observed in advanced cancer patients undergoing lymphodepleting chemotherapy and cell therapy. Haematologic toxicities were the most common adverse events. Low grade cytokine release syndrome occurred in most patients and was managed with standard treatments.

About Synovial Sarcoma: There are more than 50 different types of soft tissue sarcomas which are categorised by tumors that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.¹ Synovial sarcoma accounts for approximately 5% to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue cases in the U.S. each year).² One third of patients with synovial sarcoma will be diagnosed under the age of 30.2 The five-year survival rate for people with metastatic disease is just 20% and most people undergoing standard of care treatment for advanced disease experience recurrence and go through multiple lines of therapy, often exhausting all options.³

1. https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/soft-tissue-sarcoma.html.
2. Synovial Sarcoma - NCI (cancer.gov).
3. Aytekin MN, et al. J Orthop Surg (Hong Kong). 2020;28(2).

About Adaptimmune
Adaptimmune is a cell therapy company working to redefine how cancer is treated. With personalized medicines that radically improve the patient's experience with the therapy as much as the therapy itself, Adaptimmune is tackling difficult-to-treat solid tumor cancers so that patients and families may experience more unforgettable and important personal moments. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types.

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 Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended 31 December, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Dr. Sandra D'Angelo has financial interests related to Adaptimmune.

Adaptimmune Contact

Investor Relations
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
T : +1 215 825 9310
M : +1 215 460 8920
Juli.Miller@adaptimmune.com

Media Relations
Dana Lynch, Senior Director of Corporate Communications
M: +1 267 990 1217
Dana.Lynch@adaptimmune.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/203159

FAQ

What is the title of the article published by The Lancet regarding Adaptimmune Therapeutics plc's Phase 2 data with afami-cel?

The article is titled 'SPEARHEAD-1: a single-arm phase 2 trial of afamitresgene autoleucel (afami-cel) in advanced synovial sarcoma and myxoid/round cell liposarcoma.'

What is the ticker symbol for Adaptimmune Therapeutics plc?

The ticker symbol for Adaptimmune Therapeutics plc is ADAP.

What was the overall response rate in synovial sarcoma observed in the afami-cel trial?

The trial reported a 39% overall response rate in synovial sarcoma.

Who is the lead author of the publication in The Lancet regarding afami-cel's trial results?

Dr. Sandra D'Angelo, M.D., Sarcoma Medical Oncology at Memorial Sloan Kettering Cancer Center, is the lead author of the publication.

What are the potential benefits of treatment with afami-cel according to the publication?

Treatment with afami-cel has the potential to extend life and allow responders to discontinue chemotherapy.