Xalkori (Page 7 of 9)

14.2 Relapsed or Refractory, Systemic ALK-Positive Anaplastic Large Cell Lymphoma

The efficacy of XALKORI was evaluated in Study ADVL0912 (NCT00939770), a multicenter, single arm, open-label study in patients 1 to ≤21 years of age that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment. ALK-positive status (confirmation of an ALK fusion) was determined locally by immunohistochemistry or fluorescence in situ hybridization. The study excluded patients with primary cutaneous ALCL or central nervous system involvement by lymphoma.

Patients received XALKORI 280 mg/m2 (20 patients) or 165 mg/m2 (6 patients) orally twice daily until disease progression or unacceptable toxicity. Patients were permitted to discontinue XALKORI to undergo hematopoietic stem cell transplantation (HSCT).

Of the 26 patients evaluated, the median age was 11 years (range: 3 to 20); 69% were male, 54% were White, 19% Black, 8% Asian. Patient enrollment by age category was 4 patients from 3 to <6 years, 11 patients from 6 to <12 years, 7 patients from 12 to <18 years, and 4 patients from 18 to ≤21 years.

All patients had received multi-agent systemic therapy, 2 (8%) had received a prior HSCT and 4 (15%) had received at least 3 prior therapies.

Efficacy was based on objective response rate and duration of response, as assessed by an independent review committee (Table 18). The median time to first response was 3.9 weeks (range: 3.5 to 9.1 weeks).

Table 18. Efficacy in Relapsed or Refractory, Systemic ALK-Positive ALCL
Efficacy Parameter N=26
CI=confidence interval; N/n=number of patients
*
Based on Lugano Classification.
95% CI based on Wilson score method.
Of 23 patients with objective response, 2 had disease progression and the remainder (91% of responding patients) were censored.

Objective response rate (95% CI, %) * ,

88% (71, 96)

Complete response, n

21 (81%)

Partial response, n

2 (8%)

Duration of response

Patients maintaining response at 3 months, n/N

13/23 (57%)

Patients maintaining response at 6 months, n/N

9/23 (39%)

Patients maintaining response at 12 months, n/N

5/23 (22%)

14.3 Unresectable, Recurrent, or Refractory ALK-Positive Inflammatory Myofibroblastic Tumor

Pediatric Patients with ALK-positive IMT

Study ADVL0912

The efficacy of XALKORI was evaluated in Study ADVL0912 (NCT00939770), a multicenter, single-arm, open-label study in patients 1 to ≤21 years of age that included 14 pediatric patients with unresectable, recurrent, or refractory ALK-positive IMT. Patients were required to have an ALK fusion determined locally by immunohistochemistry or fluorescence in situ hybridization. Patients (n=12) received XALKORI 280 mg/m2 twice daily until disease progression or unacceptable toxicity. Two patients received a lower dose.

The demographic characteristics were median age 6.5 years (range: 2 to 13); 64% female; 71% White; 7% Black, 21% unknown; 21% Hispanic; and 71% had a Lansky/Karnofsky Score of 100. Patient enrollment by age was 4 patients from 2 to <6 years, 8 patients from 6 to <12 years, and 2 patients from 12 to <18 years.

A total of 12 (86%) patients received prior therapy. The most common prior therapy was surgery (57%).

The major efficacy outcome was objective response rate according to RECIST version 1.0 as assessed by an independent review committee (Table 19).

Table 19. Efficacy in Pediatric Patients with Unresectable, Recurrent, or Relapsed ALK-Positive IMT
Efficacy Parameter N=14
CI=confidence interval; N/n=number of patients.
*
95% CI based on Clopper–Pearson exact method.
Estimated using descriptive statistics.

Objective response rate (95% CI, %) *

86% (57, 98)

Complete response, n (%)

5 (36)

Partial response n (%)

7 (50)

Duration of response

N=12

≥6 months, n (%)

7 (58)

≥12 months, n (%)

7 (58)

Adult Patients with ALK-positive IMT

Study A8081013

The efficacy of XALKORI was evaluated in Study A8081013 (NCT01121588), a multicenter, single-arm, open-label study that included 7 adult patients with unresectable, recurrent, or refractory ALK-positive IMT. ALK fusion was determined locally by immunohistochemistry or fluorescence in situ hybridization. Patients received XALKORI 250 mg twice daily.

The demographic characteristics were median age 38 years (range: 23 to 73); 57% male; 57% White, 43% Asian; and 86% ECOG performance status of 0 or 1. Two (29%) patients had at least one prior systemic treatment.

The major efficacy outcome was objective response rate according to RECIST version 1.1 per investigator assessment. For the 7 patients with ALK-positive IMT, 5 experienced a response including 1 complete response. The DOR was ≥6 months for all 5 patients and ≥12 months for 2 patients.

16 HOW SUPPLIED/STORAGE AND HANDLING

250 mg capsulesHard gelatin capsule with pink opaque cap and body, printed with black ink “Pfizer” on the cap, “CRZ 250” on the body; available in:

Bottles of 60 capsules:

NDC 0069-8140-20

200 mg capsulesHard gelatin capsule with pink opaque cap and white opaque body, printed with black ink “Pfizer” on the cap, “CRZ 200” on the body; available in:

Bottles of 60 capsules:

NDC 0069-8141-20

Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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