er of patients
Abbreviations: ALK=anaplastic lymphoma kinase; NSCLC=non-small cell lung cancer.
*Chemotherapy administered in the metastatic setting.
Prior crizotinib and no prior chemotherapy* 29
Prior crizotinib and 1–2 lines of prior chemotherapy* 35
Prior ALK inhibitor (not crizotinib) with or without prior chemotherapy* 28
Two prior ALK inhibitors with or without prior chemotherapy* 75
Three prior ALK inhibitors with or without prior chemotherapy* 48
Total 215
Efficacy results for Study B7461001 are summarized in Tables 5 and 6.
Table 5 Efficacy Results in Study B7461001
Efficacy Parameter Overall
N=215
Abbreviations: CI=confidence interval; N=number of patients.
*
Per Independent Central Review.
†
Using exact method based on binomial distribution.
‡
Estimated using the Kaplan Meier method.
Overall response rate* (95% CI)† 48% (42, 55)
Complete response 4%
Partial response 44%
Duration of response
Median, months‡ (95% CI) 12.5 (8.4, 23.7)
An assessment of intracranial ORR and the duration of response for CNS metastases in the subgroup of 89 patients in Study B7461001 with baseline measurable lesions in the CNS according to RECIST v1.1 are summarized in Table 6. Of these, 56 (63%) patients received prior brain radiation, including 42 patients (47%) who completed brain radiation treatment at least 6 months before starting treatment with LORBRENA.
Table 6 Intracranial Response Rate in Patients with Measurable Intracranial Lesions in Study B7461001
Efficacy Parameter Intracranial
N=89
Abbreviations: CI=confidence interval; N=number of patients; NR=not reached.
*
Per Independent Central Review.
†
Using exact method based on binomial distribution.
‡
Estimated using the Kaplan-Meier method.
Intracranial response rate* (95% CI)† 60% (49, 70)
Complete response 21%
Partial response 38%
Duration of response
Median, months‡ (95% CI) 19.5 (12.4, NR)
In exploratory analyses conducted in subgroups defined by prior therapy, the response rates to LORBRENA were:
ORR = 39% (95% CI: 30, 48) in 119 patients who received crizotinib and at least one other ALK inhibitor, with or without prior chemotherapy
ORR = 31% (95% CI: 9, 61) in 13 patients who received alectinib as their only ALK inhibitor, with or without prior chemotherapy
ORR = 46% (95% CI: 19, 75) in 13 patients who received ceritinib as their only ALK inhibitor, with or without prior chemotherapy
16 HOW SUPPLIED/STORAGE AND HANDLING
Table 7 describes the available strengths and package configurations for LORBRENA:
Table 7 LORBRENA Tablets
Package Configuration Strength
(mg) NDC Description
30 count bottle with a child-resistant closure 25 0069-0227-01 8 mm round, tan, immediate release film-coated, debossed with "Pfizer" on one side and "25" and "LLN" on the other side
30 count bottle with a child-resistant closure 100 0069-0231-01 8.5 mm × 17 mm oval, lavender, immediate release, film-coated, debossed with "Pfizer" on one side and "LLN 100" on the other side
Store at 20°C to 25°C (68°F to 77°F); excursion |
