ry 2 weeks for up to 12 months or until unacceptable toxicity or disease progression. Tumor assessments were performed at Weeks 6, 12 and 16, then every 8 weeks for the first year and every 12 weeks thereafter. The major efficacy outcome measures were confirmed Objective Response Rate (ORR) according to RECIST v1.1 as assessed by Blinded Independent Central Review (BICR), and duration of response (DoR).
In Study 1, the median age was 67 years (range: 34 to 88), 72% were male, 64% were Caucasian. Sixty-six percent (66%) of patients had visceral metastasis (bone, liver, or lung), including 34% with liver metastasis. Lymph node only metastasis were present in 13% of patients. Sixty-six percent (66%) of patients had ECOG score of 1 and 41% of patients had a baseline creatinine clearance of <60 mL/min. The Bellmunt risk score (which includes ECOG score, baseline hemoglobin, and liver metastases) was 0 in 23%, 1 in 38%, 2 in 29%, and 3 in 9% of patients. Twenty percent (20%) of patients had disease progression following platinum-containing neo-adjuvant or adjuvant chemotherapy as their only prior line of therapy. Seventy percent (70%) of patients received prior cisplatin, 30% prior carboplatin and 35% received ≥2 prior lines of systemic therapy.
Tumor specimens were eva luated prospectively for PD-L1 expression on tumor cells (TC) and immune cells (IC) at a central laboratory using the VENTANA PD-L1 (SP263) Assay. Of the 182 patients, 95 were classified as PD-L1 high (if ICs involve >1% of the tumor area, TC ≥25% or IC ≥25%; if ICs involve ≤1% of the tumor area, TC ≥25% or IC=100%), 73 as PD-L1 low/negative (did not meet criterion for PD-L1 high), and samples for 14 patients were not eva luable.
Table 4 summarizes the results in Study 1. The median follow-up time was 5.6 months. In 37 patients who had received only neoadjuvant or adjuvant therapy prior to study entry, nine patients (24%) responded.
Among the total 31 responding patients, 14 patients (45%) had ongoing responses of 6 months or longer and five patients (16%) had ongoing responses of 12 months or longer.
Table 4. Efficacy Results for Study 1
All Patients
N = 182 PD-L1 High
N = 95 PD-L1 Low/Negative
N = 73 PD-L1 NE
N = 14
Objective Response Rate by BICR n (%) (95% CI)
31 (17.0%)
(11.9, 23.3)
25 (26.3%)
(17.8, 36.4)
3 (4.1%)
(0.9, 11.5)
3 (21.4%)
(4.7, 50.8)
Complete Response
5
3
1
1
Partial Response
26
22
2
2
Median Duration of Response months
(range)
NR
(0.9+, 19.9+)
NR
(0.9+, 19.9+)
12.3
(1.9+, 12.3)
NR
(2.3+, 2.6+)
BICR = Blinded Independent Central Review; NE = Not eva luable; NR = Not Reached, + denotes a censored value
CLOSE
16 HOW SUPPLIED/STORAGE AND HANDLING
IMFINZI (durvalumab) Injection is a clear to opalescent, colorless to slightly yellow solution supplied in a carton containing one single-dose vial either as:
•
500 mg/10 mL (NDC 0310-4611-50)
•
120 mg/2.4 mL (NDC 0310-4500-12)
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Do not freeze. Do not shake.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or disc |
