Clinical Trial Information for GAVRETO

Study design in the RET+ NSCLC population1

Efficacy and safety with GAVRETO (400 mg orally once daily) were evaluated in patients with RET fusion+ mNSCLC in the ARROW study, a phase 1/2, nonrandomized, open-label, single-arm, multicohort, multicenter clinical trial. Patients with asymptomatic central nervous system metastases, including patients with stable or decreasing steroid use within 2 weeks prior to study entry, were enrolled.

The major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR), as assessed by a blinded independent central review (BICR) according to RECIST v1.1.

mNSCLC=metastatic non–small cell lung cancer; RECIST=Response Evaluation Criteria in Solid Tumors; RET+=rearranged during transfection positive.

GAVRETO was studied in first-line and previously treated RET+ mNSCLC patient populations similar to those seen in real-world practice1,33

  Treatment-naïve patients (n=27) Previously platinum-treated patients (n=87)
Median age (range), years 65 years (30-87) 60 years (28-85)
Gender 52% female, 48% male 49% female, 51% male
Race/ethnicity 59% White, 33% Asian, 4% Hispanic/Latino 53% White, 35% Asian, 6% Hispanic/Latino
ECOG status 0-1: 96%
2: 4%
0-1: 94%
2: 6%
RET fusion partner 70% KIF5B, 11% CCDC6 75% KIF5B, 17% CCDC6
History of or current
brain metastases
at baseline
37% 43%
Prior therapy - 45% PD-1/PD-L1 inhibitor
25% prior kinase inhibitors
Patient identification 67% NGS
  • 41% tumor samples
  • 22% blood or plasma
  • 4% unknown
33% FISH
77% NGS
  • 45% tumor samples
  • 26% blood or plasma
  • 6% unknown
21% FISH
2% other

ECOG=Eastern Cooperative Oncology Group; FISH=fluorescence in situ hybridization; NGS=next-generation sequencing; PD-1=programmed cell-death protein 1; PD-L1=programmed death-ligand 1.

NCCN Guideline Recommendations
See guideline recommendations for pralsetinib (GAVRETO)
Safety for GAVRETO
See RET+ mNSCLC safety for GAVRETO

Explore the safety results for all RET+ mNSCLC patients studied.