- 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.
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,
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
- 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.
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.