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$Sutro Biopharma(STRO.US$ Completion of enrollment for Part One of the Phase II/III REFRaME-O1 trial for Luvelta and the anticipation of an update that could affirm its potential, which is estimated to be significantly greater than its competitor, Elahere, in platinum-resistant ovarian cancer (PROC). Bancroft highlights Luvelta’s ability to serve a wider PROC patient base, with the potential to address about 80% of patients expressing folate receptor alpha (FRα), in contrast to Elahere which is limited to approximately 35%.
Additionally, Sutro Biopharma’s strategic expansion of the trial with plans to increase the number of active sites significantly, which could lead to more comprehensive data and a solid foundation for seeking FDA Accelerated Approval. The lack of Elahere’s availability in the EU further strengthens Sutro’s position in capturing a broader patient population. It’s possible that the upcoming interim analysis of the REFRaME-O1 trial might bolster the case for Accelerated Approval based on outcomes such as objective response rate, duration of response, and safety, setting a positive course for full approval that hinges on progression-free survival and overall survival metrics.
Additionally, Sutro Biopharma’s strategic expansion of the trial with plans to increase the number of active sites significantly, which could lead to more comprehensive data and a solid foundation for seeking FDA Accelerated Approval. The lack of Elahere’s availability in the EU further strengthens Sutro’s position in capturing a broader patient population. It’s possible that the upcoming interim analysis of the REFRaME-O1 trial might bolster the case for Accelerated Approval based on outcomes such as objective response rate, duration of response, and safety, setting a positive course for full approval that hinges on progression-free survival and overall survival metrics.
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