(Solid Tumors) Is Pralsetinib Effective? ARROW Phase 1/2 Trial Results

• September 12, 2022
• 1 min read

On August 12, 2022, Vivek Subbiah and colleagues from The University of Texas MD Anderson Cancer Center published results in Nature Medicine from the ARROW Phase 1/2 clinical trial evaluating the efficacy and safety of pralsetinib monotherapy in patients with RET fusion-positive advanced solid tumors.

Trial Design:

The ARROW Phase 1/2 trial enrolled previously treated patients with RET fusion-positive advanced solid tumors ineligible for standard treatment (N=29) who received pralsetinib monotherapy. The primary endpoint was objective response rate (ORR).

Results (N=23 evaluable):

• ORR: 57%
• Complete response (CR): 13%
• Partial response (PR): 43%
• Median duration of response: 11.7 months
• Median PFS: 7 months
• Median OS: 14 months
• Grade 3+ adverse events: neutropenia 31%, anemia 14%

Conclusion: Based on the ARROW Phase 1/2 trial results, Vivek Subbiah and colleagues concluded that pralsetinib monotherapy demonstrated rapid, potent, and durable anti-tumor activity with acceptable tolerability in patients with RET fusion-positive advanced solid tumors.

Source: https://www.nature.com/articles/s41591-022-01931-y

Solid Tumors | RET Fusion | Pralsetinib | ARROW Trial

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