GAVRETO demonstrated robust and durable response regardless of prior therapy in RET+ advanced thyroid cancers1

ARROW study design in the thyroid cancer population

Efficacy and safety with GAVRETO (400 mg orally once daily) was evaluated in patients with advanced or metastatic RET-mutant+ MTC and RET fusion+ thyroid cancer in the ARROW study, a phase 1/2, nonrandomized, open-label, single-arm, multicohort, multicenter clinical trial.

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.

In advanced or metastatic RET-mutant MTC

CABOZANTINIB AND VANDETANIB-NAÏVE

TREATMENT NAÏVE PATIENTS (n=21) TREATMENT NAÏVE PATIENTS (n=21)

PRIOR CABOZANTINIB AND/OR VANDETANIB

PREVIOUSLY PLATINUM-TREATED PATIENTS (n=55) PREVIOUSLY PLATINUM-TREATED PATIENTS (n=55)

In advanced or metastatic RET fusion+ thyroid cancer

TREATMENT NAIVE PATIENTS (n=9) TREATMENT NAIVE PATIENTS (n=9)

Demographic characteristics in the advanced thyroid cancer population at baseline

MTC: cabozantinib and
vandetanib-naïve patients
(n=29)
MTC: previously cabozantinib
and/or vandetanib treated
patients
(n=55)
RET fusion-positive
thyroid cancer§
(n=9)
Median age 61 years (19-81) 59 years (25-83) 61 years (46-74)
Gender 28% female
72% male
31% female
69% male
33% female
67% male
Race/ethnicity 76% White
17% Asian
3.4% Hispanic/Latino
78% White
5% Asian
5% Hispanic/Latino
78% White
22% Asian
11% Hispanic/Latino
ECOG status 0-1: 100% 0-1: 95%
2: 5%
0-1: 100%
History of CNS metastases at baseline 14% 7% 56%
Patient Identification 90% NGS
  • 52% tumor sample
  • 35% plasma
  • 3.4% blood
10% PCR
73% NGS
  • 55% tumor sample
  • 18% plasma
26% PCR
2% other
89% NGS
11% FISH

CI=confidence interval; CR=complete response; ECOG=Eastern Cooperative Oncology Group; MTC=medullary thyroid cancer; NCCN=National Comprehensive Cancer Network®; NE=not estimable; NR=not reached; PR=partial response; PTC=papillary thyroid cancer; RAI=radioactive iodine; RECIST=Response Evaluation Criteria in Solid Tumors; RET=rearranged during transfection.

* Calculated using the proportion of responders with an observed duration of response at least 6 months or greater.
97% of patients had metastatic disease. 28% had received up to 3 lines of prior systemic therapy (including 10% PD-1/PD-L1 inhibitors, 10% radioactive iodine, 3.4% kinase inhibitors).
Patients had received a median of 2 prior therapies (range 1-7). The primary mutations in RET-mutant MTC previously treated with cabozantinib or vandetanib are described in Table 10 of the Full Prescribing Information for GAVRETO.
§ All patients had papillary thyroid cancer. All patients had metastatic disease. Patients had received a median of 2 prior therapies (range 1-8). Prior systemic treatments included prior radioactive iodine (100%) and prior sorafenib and/or lenvatinib (56%).