Response rate by NTRK gene fusion partner
Intracranial response
Study design and patient characteristics

ROZLYTREK showed responses across all tumor types studied in the efficacy-evaluable population 1

  • Among the subset of patients who received prior systemic therapy for metastatic disease, the ORR was 53%, similar to that seen in the overall population

aResponse rates are reflective of actual response.

CI=confidence interval; MASC=mammary analogue secretory carcinoma; NA=not available; NSCLC=non-small cell lung cancer; ORR=overall response rate; PR=partial response.

N=size of efficacy-evaluable population; n=number of patients studied within each tumor type.

ROZLYTREK duration of response across all tumor types studied in the efficacy-evaluable population 1

b+ denotes ongoing response.
cResponse duration were based on additional 5 months’ follow-up after primary analysis of ORR. Median duration of follow-up from the time of first response was 18.2 months at time of data cutoff (October 31, 2018). 1,4
n=number of responders.
DOR=duration of response; MASC=mammary analogue secretory carcinoma; NSCLC=non-small cell lung cancer.

Congestive Heart Failure

  • Congestive heart failure (CHF) occurred in 12 patients (3.4%), including Grade 3 (2.3%). The median time to onset was 2 months (range: 11 days to 12 months). Of these 12 patients, ROZLYTREK was interrupted in 6 (50%) and discontinued in 2 (17%). CHF resolved in 6 patients (50%) following interruption or discontinuation of ROZLYTREK and institution of appropriate medical management. In addition, myocarditis in the absence of CHF was documented in 0.3% of patients.

ROZLYTREK demonstrates inhibition of NTRK1, NTRK2, and NTRK3 gene fusion proteins, irrespective of tumor type 1

NTRK1, NTRK2, and NTRK3 genes encode for the receptor tyrosine kinases TRKA, TRKB, and TRKC, respectively

aResponse rates are reflective of actual response.
BICR=blinded independent central review; CI=confidence interval; CNS=central nervous system; DOR=duration of response; NA=not applicable; NE=not evaluable; NTRK=neurotrophic tyrosine receptor kinase; ORR=overall response rate; PD=progressive disease; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease; TRK=tropomyosin receptor kinase.

ROZLYTREK demonstrated responses in the CNS 1

  • Among the 54 adult patients, 4 had measurable CNS metastases at baseline and had not received radiation therapy to the brain within 2 months of study entry
  • Intracranial responses according to RECIST v1.1 were evaluated by BICR

QT Interval Prolongation

  • In patients who received ROZLYTREK across the clinical trials, 3.1% of patients with at least one post-baseline ECG assessment experienced QTcF interval prolongation of >60 ms after starting ROZLYTREK and 0.6% had a QTcF interval >500 ms.
  • Monitor patients who already have or who are at significant risk of developing QTc interval prolongation, including those with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure, and those taking other medicinal products associated with QT prolongation. Assess QT interval and electrolytes at baseline and periodically during treatment, adjusting frequency based upon risk factors such as congestive heart failure, electrolyte abnormalities, or concomitant medications known to prolong the QTc interval. Based on the severity of QTc interval prolongation, withhold ROZLYTREK and then resume at same or reduced dose, or permanently discontinue.

Efficacy was studied across multiple tumor types 1

eORR, DOR, and intracranial response were measured according to RECIST v1.1 and evaluated by BICR.

In the efficacy-evaluable population, NTRK gene fusions were detected by NGS in 52 patients, and by other nucleic acid-based tests in 2 patients.1f

fThere is no FDA-approved companion diagnostic for the detection of NTRK gene fusions.

gAlso studied in additional tumor types. 4
hIncludes ovarian cancer and endometrial cancer. 4
BICR=blinded independent central review; DOR=duration of response; FDA=US Food and Drug Administration; MASC=mammary analogue secretory carcinoma; NGS=next-generation sequencing; NTRK=neurotrophic tyrosine receptor kinase; ORR=overall response rate; RECIST=Response Evaluation Criteria in Solid Tumors.

ROZLYTREK was studied in NTRK gene fusion+ patients 1

CNS=central nervous system; ECOG=Eastern Cooperative Oncology Group; NTRK=neurotrophic tyrosine receptor kinase; PS=performance status.

Safety profile
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ROZLYTREK Dosing and Administration

Dosing and Administration

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ROZLYTREK Safety Profile

Safety Profile

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