of response** N = 41
Range (months) 1.6+, 33.2+
% with duration ≥ 6 months 73%
% with duration ≥ 9 months*** 63%
% with duration ≥ 12 months**** 39%
+ Denotes ongoing response.
*Includes one pediatric patient with unresectable infantile fibrosarcoma who underwent resection following partialresponse and who remained disease-free at data cutoff. **Median duration of response not reached at time of data cutoff.
***3 patients with an ongoing response were followed < 9 months from onset of response. ****
10 patients with an ongoing response were followed < 12 months from onset of response.
Table 5 Efficacy Results by Tumor Type
Tumor Type
Patients
(N=55)
ORR DOR
% 95% CI Range
(months)
Soft tissue sarcoma 11 91% (59%, 100%) 3.6, 33.2+
Salivary gland 12 83% (52%, 98%) 7.7, 27.9+
Infantile
fibrosarcoma 7 100% (59%, 100%) 1.4+, 10.2+
Thyroid 5 100% (48%, 100%) 3.7, 27.0+
Lung 4 75% (19%, 99%) 8.2, 20.3+
Melanoma 4 50% NA 1.9, 17.5+*
Colon 4 25% NA 5.6*
Gastrointestinal
stromal tumor
3 100% (29%, 100%) 9.5, 17.3
Cholangiocarcinoma 2 SD, NE NA NA
Appendix 1 SD NA NA
Breast 1 PD NA NA
Pancreas 1 SD NA NA
NA = not applicable due to small numbers or lack of response; CR = complete response; PR = partial response;
NE = not eva luable; SD = stable disease; PD = progressive disease.
+ Denotes ongoing response. * Observed values at data cutoff, not a range.
Table 6 Efficacy Results by NTRK Fusion Partner
NTRK Partner*
Patients
(N=55)
ORR DOR
% 95% CI
Range
(months)
ETV6-NTRK3 25 84% (64%, 96%) 3.7, 27.9+
TPM3-NTRK1 9 56% (21%, 86%) 3.7, 10.3+
LMNA-NTRK1 5 40% NA 5.6, 33.2+
Inferred ETV6-
NTRK3
3 100% (29%, 100%) 1.4+, 2.7**
IRF2BP2-NTRK1 2 CR, PR NA 3.7, 20.3+
SQSTM1-NTRK1 2 PR, PR NA 9.9, 12.9+
PDE4DIP-NTRK1 1 PR NA 3.6+ ***
PPL-NTRK1 1 CR NA 12.0+ ***
STRN-NTRK2 1 PR NA 5.6 ***
TPM4-NTRK3 1 CR NA 23.6 ***
TPR-NTRK1 1 PR NA 8.2 ***
TRIM63-NTRK1 1 PR NA 1.9+ ***
CTRC-NTRK1 1 SD NA NA
GON4L-NTRK1 1 NE NA NA
PLEKHA6-NTRK1 1 SD NA NA
CR = complete response; PR = partial response; NE = not eva luable; SD = stable disease; NA = not applicable.
+ Denotes ongoing response. * Fusion partners identified in the primary analysis set (N=55) may not represent all potential fusion partners. ** Duration of response censored at the time of surgery for one pediatric patient with unresectable infantilefibrosarcoma who underwent resection following partial response and who remained disease-free at data cutoff. ***
Observed values at data cutoff, not a range.
16 HOW SUPPLIED/STORAGE AND HANDLING
Capsules
25 mg: Hard gelatin opaque white capsule size #2 with blue printing of “LOXO” and “LARO
25 mg” on the body of the capsule.
• 60 count bottle NDC# 71777-390-01
100 mg: Hard gelatin opaque white capsule size #0 with blue printing of “LOXO” and “LARO
100 mg” on the body of the capsule.
• 60 count bottle NDC# 71777-391-01
Store capsules at room temperature 20°C to 25°C (68°F to 77°F); temperature excursionsbetween 15°C and 30°C (59°F to 86°F) are permitted [see USP Controlled Room Temperature].
Oral Solution
20 mg/mL: Clear yellow to orange solution.
• 100 mL bottle NDC# 71777-392-01
Refrigerate oral solution at 2°C to 8°C (36°F to 46°F). Do not freeze.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information andI |
