, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, 

 covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, supported by Adaptimmune Therapeutics, we had the pleasure of speaking with Allison Betof Warner, MD, PhD, about the FDA approval of afamitresgene autoleucel (afami-cel; Tecelra) for patients with advanced synovial sarcoma. Dr Warner is an assistant professor of medicine (oncology) in the Department of Medicine in the Division of Medical Oncology at Stanford University in California, where she is also the director of Solid Tumor Cellular Therapy. 

On August 2, 2024, the FDA granted accelerated approval to afami-cel for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy; have are HLA-A*02:01P–, -A*02:02P–, -A*02:03P–, or -A*02:06P–positive disease; and whose tumors express MAGE-A4. This regulatory decision was backed by findings from cohort 1 of the phase 2 SPEARHEAD-1 trial (NCT04044768), in which patients who received afami-cel (n = 44) had an overall response rate of 43% per independent review, including a complete response rate of 4.5%. 

In our exclusive interview, Dr Warner discussed the significance of this approval, key findings from the pivotal SPEARHEAD-1 trial, and the importance of multidisciplinary collaboration when administering cell therapies.

That’s all we have for today! Thank you for listening to this episode of 

, supported by Adaptimmune Therapeutics. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

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Podcasts

Dr Warner discusses the FDA approval of afami-cel for patients with advanced synovial sarcoma and key findings from the pivotal SPEARHEAD-1 trial.

FDA Approval Insights: Afami-Cel for Pretreated, Unresectable or Metastatic Synovial Sarcoma

Allison Betof Warner, MD, PhD, assistant professor and assistant attending at Memorial Sloan Kettering Cancer Center, discusses the excitement surrounding the findings from the COMBI-i trial that was presented at the 2019 ASCO Annual Meeting. This trial investigated the combination of PD-1 inhibitor spartalizumab with dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with advanced 

The findings demonstrated a confirmed complete response rate of 40%, which is a number that has not been seen in the field of melanoma before. The combination also appears durable, says Warner. Targeted therapies are known for having great responses upfront but tend not to be long lasting. The combination of immunotherapy appears to make this treatment durable, she notes.

There were also concerns about overlapping toxicities in this triplet regimen. However, there were not any huge safety signals, and most patients can tolerate the combination.

Videos

Allison Betof Warner, MD, PhD, discusses the excitement surrounding the findings from the COMBI-i trial that was presented at the 2019 ASCO Annual Meeting. This trial investigated the combination of PD-1 inhibitor spartalizumab with dabrafenib plus trametinib in patients with advanced BRAF V6000mutant melanoma.

Allison Betof Warner, MD, PhD

Articles

FDA Approval Insights: Afami-Cel for Pretreated, Unresectable or Metastatic Synovial Sarcoma

Dr. Warner Discusses Findings from COMBI-i Trial in Melanoma