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, swelling of the ankles/legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Warnings and Precautions (5.2)].
 •Advise pregnant women and females of reproductive potential that KADCYLA exposure can result in fetal harm, including embryo-fetal death or birth defects [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8