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AGAVE-201 Study - FDA Approval of Axatilimab for Chronic Graft-versus-Host Disease (cGVHD)


Key points:

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•  Axatilimab’s Breakthrough in Chronic GVHD: Axatilimab, a monoclonal antibody, showed a 50% response rate in heavily pre-treated patients, improving quality of life.
•  Drastic Reduction in GVHD Mortality Rates: Advances in GVHD prophylaxis have reduced mortality from 12% to 0.04%, offering new hope for transplant patients.
•  Key side effects of Axatilimab include liver function changes and periorbital edema.

In this episode of the Oncology Brothers Podcast, Drs. Rahul and Rohit Gosain had the pleasure of welcoming Dr. Shernan Holtan from Roswell Park Comprehensive Cancer Center to discuss a significant advancement in the treatment of chronic graft-versus-host disease (GVHD) following allogeneic transplant.

We began by exploring the complexities of GVHD, differentiating between acute and chronic forms, and highlighting the historical challenges in managing this condition. Dr. Holtan emphasized the remarkable improvements in graft-versus-host disease prophylaxis, which have drastically reduced mortality rates from around 12% to just 0.04%. This transformation in care has opened new avenues for patients considering transplant.

The focal point of our discussion was Axatilimab, a novel monoclonal antibody recently approved for chronic GVHD based on the AGAVE-201 study. Dr. Holtan provided insights into the study's design, revealing that Axatilimab targets myeloid cells, specifically pro-fibrotic macrophages, marking a shift from traditional immunosuppressants that primarily target T and B cells. The results showed a 50% overall response rate in patients with extensive prior therapies, demonstrating meaningful improvements in quality of life, even if not all responses were classified as complete.

We also delved into the safety profile of Axatilimab, discussing potential side effects such as significant changes in liver function tests and periorbital edema, as well as the importance of monitoring patients closely during treatment. Dr. Holtan stressed the need for community oncologists to be aware of these effects and to collaborate with transplant centers for optimal patient care.

In summary, this episode highlighted the exciting developments in chronic GVHD treatment, the importance of clinical trials, and the need for community oncologists to stay informed about new therapies like Axatilimab. We hope our listeners find this information valuable as they navigate the complexities of oncology care. Thank you for joining us, and be sure to check out our other episodes for more discussions on recent advancements in cancer treatment.