Table 1.

Efficacy of brentuximab vedotin in prospective, noncomparative, multicentre, phase 2 trials in patients with relapsed or refractory CD-30 positive Hodgkin lymphoma after high-dose chemotherapy, and after [24–26] and/or before [26, 27] autologous stem cell transplant

Study	Observation period [reference]	No. of pts	Overall ORa rate (%)	Median duration (months)		Median PFSb (months)	Median OSb (months)
				OR	CRc
NCT00848926	Median 18.5 months [24]	102	75d	6.7	20.5	5.6	22.4
(pivotal trial)	Median 33.3 months [28]		73	11.2	NYR	9.3	40.5
NCT01393717	After 4 cycles [27]	37	68d
NCT00947856	Final cut-off date January 2013 [25]	20e	60	9.2	9.4	9.9	NYR
JapicCTI-111650	At cut-off date May 2013 [26]	9f	67	NYR		11.1

All pts received a 30-min intravenous infusion of BV 1.8 mg/kg (or BV 1.2 mg/kg if this was the dose in the previous study [25]) once every 3 weeks for up to 4 [27] or 16 [24, 26] cycles, or until disease progression, unacceptable toxicity or study closure [25]

BV brentuximab vedotin, CR complete remission, HL Hodgkin lymphoma, NYR not yet reached, PFS progression-free survival, pts patients, OR objective response (CR + partial remission), OS overall survival, sALCL anaplastic large-cell lymphoma

^aAssessed using Revised Response Criteria for Malignant Lymphoma [21]

^bEstimated using Kaplan–Meier methods

^cIn pts who had a CR as a best OR response

^dPrimary endpoint

^ePts had responded to BV (CR or partial remission) during NCT00848926 (for HL pts), discontinued treatment while in remission and then experienced disease progression or relapse; data are for evaluable pts with HL (trial also included pts with sALCL)

^fData are for the phase 2 part of this phase 1/2 study in pts with HL (trial also included pts with sALCL)