The safety of YONDELIS^® was evaluated in 755 patients

YONDELIS^® was studied in 6 open-label, single-arm trials, in which 377 patients received YONDELIS^®, and 1 open-label, randomized, active-controlled clinical trial, in which 378 patients received YONDELIS^®. In these trials, 26% (197) of patients were treated with YONDELIS^® for 6 months or longer, and 8% (57) were treated with YONDELIS^® for 1 year or longer.¹

Incidence of selected treatment-emergent laboratory abnormalities in a pivotal trial*¹

CHEMISTRY

LABORATORY ABNORMALITIES:

Increased ALT

Increased AST

Increased ALP

Hypoalbuminemia

Increased creatinine

Increased CPK

Hyperbilirubinemia

YONDELIS^®

All Grades (%)

Grades 3-4 (%)

90

84

70

63

46

33

13

31

17

1.6

3.7

4.2

6.4

1.9

LABORATORY ABNORMALITIES:

Increased ALT

Increased AST

Increased ALP

Hypoalbuminemia

Increased creatinine

Increased CPK

Hyperbilirubinemia

Dacarbazine

All Grades (%)

Grades 3-4 (%)

33

32

60

51

29

9

5

0.6

1.2

0.6

3.0

1.2

0.6

0.6

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine phosphokinase.

HEMATOLOGY

LABORATORY ABNORMALITIES:

Anemia

Neutropenia

Thrombocytopenia

YONDELIS^®

All Grades (%)

Grades 3-4 (%)

96

66

59

19

43

21

LABORATORY ABNORMALITIES:

Anemia

Neutropenia

Thrombocytopenia

Dacarbazine

All Grades (%)

Grades 3-4 (%)

79

47

57

12

26

20

*Treatment-emergent laboratory abnormalities included those higher in the YONDELIS^® arm compared with the dacarbazine arm by ≥5% (all grades) or by ≥2% (Grades 3-4). Incidence based on number of patients who had both baseline and at least 1 on-study laboratory measurement.

YONDELIS^® group (range: 373 to 377 patients) and dacarbazine group (range: 166 to 168 patients).

Adverse reactions reported in the pivotal trial

Selected adverse reactions^† occurring in ≥10% of patients receiving YONDELIS^® and at a higher incidence than in the control arm in the pivotal trial^‡1

SYSTEM ORGAN CLASS

Gastrointestinal disorders

Adverse Reaction

Nausea

Vomiting

Constipation

Diarrhea

YONDELIS^® (N=378)

All Grades (%)

Grades 3-4 (%)

75

46

37

35

7

6

0.8

1.6

Adverse Reaction

Nausea

Vomiting

Constipation

Diarrhea

Dacarbazine (N=172)

All Grades (%)

Grades 3-4 (%)

50

22

31

23

1.7

1.2

0.6

0

SYSTEM ORGAN CLASS

General disorders and administration-site conditions

Adverse Reaction

Fatigue^§

Peripheral edema

YONDELIS^® (N=378)

All Grades (%)

Grades 3-4 (%)

69

28

8

0.8

Adverse Reaction

Fatigue^§

Peripheral edema

Dacarbazine (N=172)

All Grades (%)

Grades 3-4 (%)

52

13

1.7

0.6

SYSTEM ORGAN CLASS

Metabolism and nutrition disorders

Adverse Reaction

Decreased appetite

YONDELIS^® (N=378)

All Grades (%)

Grades 3-4 (%)

37

1.9

Adverse Reaction

Decreased appetite

Dacarbazine (N=172)

All Grades (%)

Grades 3-4 (%)

21

0.6

SYSTEM ORGAN CLASS

Respiratory, thoracic, and mediastinal disorders

Adverse Reaction

Dyspnea

YONDELIS^® (N=378)

All Grades (%)

Grades 3-4 (%)

25

4.2

Adverse Reaction

Dyspnea

Dacarbazine (N=172)

All Grades (%)

Grades 3-4 (%)

20

1.2

SYSTEM ORGAN CLASS

Nervous system disorders

Adverse Reaction

Headache

YONDELIS^® (N=378)

All Grades (%)

Grades 3-4 (%)

25

0.3

Adverse Reaction

Headache

Dacarbazine (N=172)

All Grades (%)

Grades 3-4 (%)

19

0

SYSTEM ORGAN CLASS

Musculoskeletal And connective tissue disorders

Adverse Reaction

Arthralgia

Myalgia

YONDELIS^® (N=378)

All Grades (%)

Grades 3-4 (%)

15

12

0

0

Adverse Reaction

Arthralgia

Myalgia

Dacarbazine (N=172)

All Grades (%)

Grades 3-4 (%)

8

6

1.2

0

SYSTEM ORGAN CLASS

Psychiatric disorders

Adverse Reaction

Insomnia

YONDELIS^® (N=378)

All Grades (%)

Grades 3-4 (%)

15

0.3

Adverse Reaction

Insomnia

Dacarbazine (N=172)

All Grades (%)

Grades 3-4 (%)

9

0

Treatment exposure

Approximately one-third of patients were able to stay on YONDELIS^® 6 cycles or longer

1 out of 3 (34%) patients in the YONDELIS^® group received 6 or more cycles of treatment, and 1 out of 10 (10%) received 12 or more cycles.²

REFERENCES:

1. YONDELIS^® (trabectedin) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
2. Demetri GD, von Mehren M, Jones RL, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016;34(8):786-793.
3. Demetri GD, von Mehren M, Jones RL, et al. Patient-reported outcomes from randomized, phase 3 study of trabectedin (T) vs dacarbazine (D) in advanced leiomyosarcoma or liposarcoma. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2016; Chicago, IL.