respectively. The PFS and OS hazard ratios in patients who were younger than 65 years old (n=853) were 0.62 (95% CI: 0.52, 0.74) and 0.66 (95% CI: 0.52, 0.83), respectively. In patients ≥ 65 years old (n=138), the hazard ratios for PFS and OS were 1.06 (95% CI: 0.68, 1.66) and 1.05 (95% CI: 0.58, 1.91), respectively.
Table 8 Summary of Efficacy from Study 1
KADCYLA
N= 495
Lapatinib +Capecitabine
N= 496
PFS: progression-free survival; OR: objective response
* Stratified by world region (United States, Western Europe, other), number of prior chemotherapeutic regimens for locally advanced or metastatic disease (0-1 vs. >1), and visceral vs. non-visceral disease. † The second interim analysis for OS was conducted when 331 events were observed and the results are presented in this table.
Progression-Free Survival
(independent review)
Number (%) of patients with event
265 (53.5%)
304 (61.3%)
Median duration of PFS (months)
9.6
6.4
Hazard Ratio (stratified*)
0.650
95% CI for Hazard Ratio
(0.549, 0.771)
p-value (Log-Rank test, stratified*)
<0.0001
Overall Survival †
Number (%) of patients who died
149 (30.1%)
182 (36.7%)
Median duration of survival (months)
30.9
25.1
Hazard Ratio (stratified*)
0.682
95% CI for Hazard Ratio
(0.548, 0.849)
p-value (Log-Rank test*)
0.0006
Objective Response Rate
(independent review)
Patients with measurable disease
397
389
Number of patients with OR (%)
173 (43.6%)
120 (30.8%)
Difference (95% CI)
12.7% (6.0, 19.4)
Duration of Objective Response (months)
Number of patients with OR
173
120
Median duration (95% CI)
12.6 (8.4, 20.8)
6.5 (5.5, 7.2)
Figure 1 Kaplan-Meier Curve of IRC-Assessed Progression-Free Survival for Study 1
Figure 2 Kaplan-Meier Curve of Overall Survival for Study 1
15 REFERENCES
1.OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied/Storage
KADCYLA (ado-trastuzumab emtansine) is supplied as:
Carton Contents
NDC
One 100 mg vial, single use vial
NDC 50242-088-01
One 160 mg vial, single use vial
NDC 50242-087-01
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution. Do not freeze or shake.
16.2 Special Handling
Follow procedures for proper handling and disposal of anticancer drugs1.
17 PATIENT COUNSELING INFORMATION
•Inform patients of the possibility of severe liver injury and advise patients to immediately seek medical attention if they experience symptoms of acute hepatitis such as nausea, vomiting, abdominal pain (especially RUQ abdominal pain), jaundice, dark urine, generalized pruritus, anorexia, etc. [see Warnings and Precautions (5.1)].
•Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swellin
