nbsp; Complete Response (CR) 0
Very Good Partial Response (VGPR), (%) 11.1
Partial Response (PR), (%) 50.8
Median duration of response, months (range) NR (2.8+, 18.8+)
The median time to response was 1.2 months (range, 0.7-13.4 months).
14.4 Marginal Zone Lymphoma
The safety and efficacy of IMBRUVICA in MZL were eva luated in Study PCYC-1121-CA (referred to as Study 1121) (NCT01980628), an open-label, multi-center, single-arm trial of patients who received at least one prior therapy. The efficacy analysis included 63 patients with 3 sub-types of MZL: mucosa-associated lymphoid tissue (MALT; N=32), nodal (N=17), and splenic (N=14). The median age was 66 years (range, 30 to 92 years), 59% were female, and 84% were Caucasian. Ninety two percent of patients had a baseline ECOG performance status of 0 or 1 and 8% had ECOG performance status 2. The median time since diagnosis was 3.8 years, and the median number of prior treatments was 2 (range, 1 to 9 treatments).
IMBRUVICA was administered orally at 560 mg once daily until disease progression or unacceptable toxicity. The responses were assessed by investigators and an IRC using criteria adopted from the International Working Group criteria for malignant lymphoma. Responses per IRC are shown in TABLE 21.
Table 21: Overall Response Rate (ORR) and Duration of Response (DOR) Based on IRC Assessment in Patients with MZL in Study 1121
Total (N=63)
CI = confidence interval; NR = not reached
Median follow-up time on study = 19.4 months
Response rate (CR + PR), (%) 46.0%
95% CI (%) (33.4, 59.1)
Complete Response (CR), (%) 3.2
Partial Response (PR), (%) 42.9
Median duration of response, months (range) NR (16.7, NR)
The median time to response was 4.5 months (range, 2.3 to 16.4 months). Overall response rates were 46.9%, 41.2%, and 50.0% for the 3 MZL sub-types (MALT, nodal, splenic), respectively.
14.5 Chronic Graft versus Host Disease
The safety and efficacy of IMBRUVICA in cGVHD were eva luated in Study PCYC-1129-CA (referred to as Study 1129) (NCT02195869), an open-label, multi-center, single-arm trial of 42 patients with cGVHD after failure of first line corticosteroid therapy and requiring additional therapy. The median age was 56 years (range, 19 to 74 years), 52% were male, and 93% were Caucasian. The most common underlying malignancies leading to transplantation were acute lymphocytic leukemia, acute myeloid leukemia, and CLL. The median time since cGVHD diagnosis was 14 months, the median number of prior cGVHD treatments was 2 (range, 1 to 3 treatments), and 60% of patients had a Karnofsky performance score of ≤ 80. The majority of patients (88 %) had at least 2 organs involved at baseline, with the most commonly involved organs being mouth (86%), skin (81%), and gastrointestinal tract (33%). The median daily corticosteroid dose (prednisone or prednisone equivalent) at baseline was 0.3 mg/kg/day, and 52% of patients were receiving ongoing immunosuppressants in addition to systemic corticosteroids at baseline. Prophylaxis for infections were managed per institutional guidelines with 79% of patients receiving combinations of sulfonamides and trimethoprim and 64% receiving triazole derivatives.
IMBRUVICA was administered orally at 420 mg once daily. The responses were assessed by investigators using the 2005 National Institute of Health (NIH) Consensus Panel Response Criteria |
