Replimune's stock plummeted 77.2% after the FDA unexpectedly rejected its experimental melanoma drug, citing insufficient data from midstage studies, which surprised investors and analysts who had anticipated approval based on positive preliminary results.
Iovance Biotherapeutics' stock surged after the FDA granted accelerated approval to its T cell immunotherapy, Amtagvi, for treating advanced melanoma. Amtagvi is the first one-time T cell therapy approved for solid tumor cancer and the first treatment option for advanced melanoma that has progressed after prior anti-PD-1/L1 therapy. The approval addresses the unmet needs of melanoma patients and provides a significant commercial opportunity for Iovance. The company is also evaluating Amtagvi for frontline advanced melanoma and other solid tumors. However, the approval comes with a boxed warning for treatment-related risks.
A world-first clinical trial has found that fecal microbiota transplants (FMT) from healthy donors are safe and show promise in improving the response to immunotherapy in patients with advanced melanoma. The study involved administering approximately 40 fecal transplant capsules orally to 20 melanoma patients before they started immunotherapy treatment. The combination of fecal transplants and immunotherapy was found to be safe, and 65% of patients who retained the donors' microbiome had a clinical response to the treatment. The study highlights the potential of targeting the microbiome to enhance the effectiveness of immunotherapy in melanoma patients.