GAVRETO™ demonstrated robust and durable response with or without prior therapy1

NCCN

Recommended

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend pralsetinib (GAVRETO) as a preferred first-line treatment option for RET fusion-positive metastatic NSCLC (NCCN Category 2A).*2

*See the NCCN Guidelines® for NSCLC for detailed recommendations, including other preferred options.

ARROW study design in the NSCLC population

Efficacy and safety with GAVRETO (400 mg orally once daily) was 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.

See baseline characteristics

Efficacy results with GAVRETO

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.

TREATMENT-NAIVE PATIENTS

TREATMENT NAIVE PATIENTS (n=27) TREATMENT NAIVE PATIENTS (n=27)

PREVIOUSLY PLATINUM-TREATED PATIENTS

PREVIOUSLY PLATINUM-TREATED PATIENTS (n=87) PREVIOUSLY PLATINUM-TREATED PATIENTS (n=87)

GAVRETO demonstrated consistent response across previously platinum-treated subgroups1,3

CNS ACTIVITY CNS ACTIVITY
PRIOR PD 1/PD L1 INHIBITOR PRIOR PD 1/PD L1 INHIBITOR

Demographic characteristics in the NSCLC population at baseline1,3

Treatment-naive patients (n=27) Previously platinum-treated patients (n=87)
Median age 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
Brain metastases at baseline 37% 43%
Prior therapy Per protocol, patients were not eligible for platinum-based chemotherapy, based on an investigator assessment2 Chemotherapy. 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

CI=confidence interval; CNS=central nervous system; CR=complete response; ECOG=Eastern Cooperative Oncology Group; FISH=fluorescence in situ hybridization; mNSCLC=metastatic non–small cell lung cancer; NCCN=National Comprehensive Cancer Network®; NE=not estimable; NGS=next generation sequencing; PD-1/PD-L1=programmed cell death protein 1/programmed death ligand 1; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors.

*Calculated using the proportion of responders with an observed duration of response at least 6 months or greater.