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( Faiza Ahmed ),( Israr Khan ),( Nazma Hanif ),( Alaa Hamdan ),( Mohammad Ali Zaidi ),( Zeynep Yukselen ),( Umer Salman ),( Sakshi Mishra ),( Jack Michel ),( Muhammad Haris Khan ),( Andre Thompson ),( 대한결핵 및 호흡기학회 2021 대한결핵 및 호흡기학회 추계학술대회 초록집 Vol.129 No.-
Background Pralsetinib and selpercatinib are anticancer drugs targeting RET fusions (oncogenic drivers) in non-small cell lung cancer (NSCLC). The US FDA approved both drugs in 2020 for the treatment of RET-fusion positive NSCLC. Methods We assessed the efficacy & safety of pralsetinib versus selpercatinib in RET fusion-positive NSCLC in two clinical trials: phase1/2 ARROW trial (n=354) and phase 1/2 LIBRETTO-001 trial (n=144). Results In patients who had previously received platinum-based therapy (n=105), Drilon et al., 2020 showed an overall response rate (ORR) of 64% (95% CI, 54-73) and a median duration of response (mDOR) of 17.5 months (95% CI, 12.0-NE) with selpercatinib in phase 1/2 LIBRETTO-001 trial. Furthermore, a complete response (CR) of 2%, partial response (PR) of 62%, stable disease (SD) of 29%, and median progression-free survival (mPFS) of 16.5 months ( 95% CI, 13.7 - NE) were reported. Treatment naive patients (n=39) demonstrated an ORR of 85% (95% CI, 70-94) and PR of 85%. The responses were determined by the independent review committee. Lee et al., 2019 (n=111) demonstrated a rapid lowering of RET circulating tumor DNA (ctDNA) in 81% of NSCLC patients with pralsetinib therapy. A phase 1/2 ARROW trial (n= 116) exhibited a median follow-up of 8.8 months in patients who received pralsetinib 400 mg daily. Additionally, ORR was 65%, CR 6%, disease control rate 93 (95% CI, 87 - 97), and resulted in overall tumor size reduction in 96% of patients. Refer to (Table 1) for further details. Conclusion Pralsetinib and Selpercatinib have shown promising anti-tumor activity and an acceptable safety profile in RET fusion-positive NSCLC. However, we cannot draw a firm conclusion regarding which one is better due to insufficient data. Clinical trials, including AcceleRET, are still ongoing, and data is pending. Further comparative studies are needed to derive meaningful survival outcomes.
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