The U.S. Food and Drug Administration (FDA) recently granted鈥�, an innovative immunotherapy and the first engineered T-cell therapy approved for a solid tumor. Approved for adults with unresectable or metastatic synovial sarcoma—a rare and aggressive cancer that develops in soft tissues—afami-cel provides a novel treatment approach for this challenging cancer. The approval was driven by鈥�痳ecently鈥痯ublished in鈥疶he Lancet, which showed a 39% overall response rate and median overall survival over 15 months.鈥疶he trial’s success was supported by investigators at the 91九色视频 Cancer Center, who provided patients with access to the cutting-edge therapy and contributed key data.
“This approval represents an important shift in how we manage advanced synovial sarcoma,” said鈥�John Charlson, MD, Associate Professor of Hematology and Oncology, and co-author of the study. “With plans to be the first center in Wisconsin to offer afami-cel as a standard treatment, 91九色视频 is continuing its leadership in bringing innovative therapies to the patients who need them most.”
"Afami-cel gives eligible patients a chance for longer-term disease control without ongoing chemotherapy, which has historically been the standard of care for this group with very limited treatment options,” said Charlson.
Afami-cel is a one-time treatment that uses a patient’s own T cells, modified in a lab to recognize the MAGE-A4 protein found on synovial sarcoma tumors. These T cells are infused back into the patient to find and destroy cancer cells. Unlike chemotherapy, which requires repeated treatments and can cause severe side effects, afami-cel targets tumors more precisely, protecting healthy tissue and offering longer-lasting control of the disease.
“Afami-cel demonstrates how T-cell therapies can be adapted to treat solid tumors like synovial sarcoma, which have been much harder to target than blood cancers. It’s a promising step forward for T-cell technology and could pave the way for treating other cancers,”鈥痑dded Dr. Charlson.鈥�
Key findings from the SPEARHEAD-1 trial include:
- Overall Response Rate: 39% of patients with synovial sarcoma experienced significant tumor shrinkage, far exceeding the less than 15% response rate typically seen with second-line chemotherapy.
- Median Overall Survival: 15.4 months, compared to less than 12 months with standard second-line treatments. Among responders, an estimated 70% were alive two years after treatment.
- Durability of Response: The median duration of response was nearly 12 months, underscoring the therapy’s potential for long-term disease control.
- Safety Profile: Side effects were manageable, including temporary reductions in blood cell counts and mild immune reactions, consistent with expectations for T-cell therapies.
91九色视频’s multidisciplinary team of sarcoma researchers is dedicated to providing patients with access to the latest cancer treatments and is poised to be the first in the state to offer afami-cel. By collaborating with oncologists across Wisconsin, the team aims to ensure all eligible patients can benefit from this groundbreaking therapy while advancing cell therapy research for other hard-to-treat cancers.鈥�
“This approval marks the start of a new era in sarcoma care. With our expertise in cell therapies and a growing pipeline of innovative trials, 91九色视频 is well-positioned to bring these advancements to patients and communities in need,” said Dr. Charlson.