ASH Clinical News Advances in Hematology Research & Patient Care: Hi | Page 19

TABLE 4. Efficacy Results Among Evaluable Patient
Brentuximab vedotin
monotherapy (n=26)

Brentuximab vedotin +
dacarbazine (n=21)

Brentuximab vedotin +
bendamustine (n=9)*

ORR, n (%)

24 (92)

21 (100)

9 (100)

CR rate, n (%)

19 (73)

13 (62)

7 (78)

Median PFS, months (range)

10.5 (2.6-22.3)

Not reached (4.2-14.3)

Not reached (1.2-6.2)

Median observation time, months (range)

20.4 (4.6-30.4)

9.8 (4.9-14.3)

3.6 (2.3-7.0)

Patients with progression or death, n (%)

16 (62)

3 (14)

1 (11)

*Enrollment ongoing: ORR=overall response rate; CR=complete response; PFS=progression-free survival

• Brentuximab vedotin 1.8 mg/kg administered every 3 weeks for
up to 12 cycles plus dacarbazine 375 mg/m2 (n=20)
• Brentuximab vedotin 1.8 mg/kg administered every 3 weeks for
up to 12 cycles plus bendamustine 70 mg/m2 or 90 mg/m2 for up
to 6 cycles (n=20)
Patients were included in the study if they had an Eastern Cooperative Oncology Group performance status <3 and were ineligible for or
had declined conventional treatment.
The median age was 76 years (range = 62-92 years), 55 percent
were male, and 65 percent had stage 3-4 disease. The majority (70%)
were ineligible for conventional chemotherapy, while 30 percent had
declined conventional treatment.
At the time of data presentation, 60 patients had been treated:
27 with brentuximab vedotin monotherapy, 22 with brentuximab
vedotin plus dacarbazine, and 11 with brentuximab vedotin plus
bendamustine. Of these, 24, 21, and 9 patients, respectively, were
evaluable for efficacy.
A total of 45 patients have discontinued therapy due to adverse
events (AEs), progressive disease after complete or partial remission,
or other reasons. Fifteen patients are still receiving treatment, Dr.
Yasenchak noted.
Treatment-related grade ≥3 AEs were reported in 43 percent of
all patients receiving treatment in the study; 22 percent of these AEs
were serious and no patient had died within 30 days of last dose.
Grade ≥3 AEs occurred with the following frequencies:
• Brentuximab vedotin: 13 (48%)
• Brentuximab vedotin + dacarbazine: 8 (36%)
• Brentuximab vedotin + bendamustine: 5 (45%)
Patients in the dacarbazine group received a median of 11.5 treatment
cycles, those in the monotherapy group had received a median of
eight cycles, and the median duration of treatment had not yet been
defined for the brentuximab vedotin plus bendamustine cohort.
As seen in TABLE 4, for patients treated with brentuximab vedotin
plus dacarbazine, the overall response rate (ORR; the study’s primary
endpoint) was 100 percent, with 62 percent of patients achieving
complete remission (CR). The median PFS in this cohort had not
been reach Y