THE PINNACLE TRIAL
THE LARGEST STUDY IN PATIENTS WITH MCL WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
|
|
Trial design and population: a prospective, phase 2, open-label, single-arm, multicenter
clinical trial in patients with previously treated MCL who progressed following their last prior
therapy (N = 155)
|
|
|
Key endpoints: response rates (CR, CRu, PR); TTP, DOR, OS, safety*
|
|
|
Eligibility criteria included: documented relapse or progression following 1 or 2 prior lines of
antineoplastic therapy of which at least 1 must have included an anthracycline or mitoxantrone
and at least 1 must have included rituximab (greater than or equal to 4 weeks prior to study entry)
|
|
|
The median number of cycles administered: 4 across all patients;
8 in responding patients (CR+CRu+PR)
|
| PINNACLE PATIENT PROFILE | N = 155 |
| Median age in years (range) | 65 (42,89) |
| Gender: male/female | 81%/19% |
| Karnofsky Performance Status score less than 90 | 29% |
| Greater than or equal to 1 extranodal sites involved with MCL | 75% |
| Stage 4 disease | 77% |
| Bone marrow positive for MCL | 55% |
| Refractory to prior therapy | 37% |
| Number of prior lines of therapy: 1/2-3 | 54%/46% |
Treatment with anthracyclines/mitoxantrone,
alkylating agents, and rituximab | 91% |
* TTP = Time to progression: time from first dose to disease progression in all patients.
DOR = Duration of response: time from initial documentation of first response to first disease progression in responding patients.
OS = Overall survival.
† SD = Stable disease.
PINNACLE trial response rates
VELCADE® DELIVERS 31% ORR WITH 8% CR*
*ORR = Overall response rate (CR + CRu + PR); CR = Complete response (CR + CRu)
† In PINNACLE, response rates to VELCADE were determined according to the International Workshop Response Criteria (IWRC) based on independent radiologic review of CT
scans. Complete response (CR) required complete disappearance of all detectable clinical and radiographic evidence of disease; normalization of biochemical
abnormalities; bone marrow clear of lymphoma, and resolution of all symptoms. CR/unconfirmed (CRu) required that all CR criteria were met except that
residual lymph node masses greater than 1.5 cm permitted if they have regressed at least 75%, and indeterminate bone marrow aspirate or biopsy permitted.
Partial response (PR) required greater than or equal to 50% decrease in the sum of the products of the longest perpendicular dimensions of all dominant lymph node masses and all other measurable sites
of disease; no evidence of relapse or progressive disease (PD). Stable disease (SD) required response less than that required for PR, but the criteria for relapse
or progressive disease were not met.
VELCADE demonstrates durable responses
IN PINNACLE, VELCADE PROVIDES DURABLE RESPONSE
|
|
Results demonstrate delayed onset of disease progression and need for
subsequent therapies
|
|
|
Median time to progression (TTP): 6.2 months (95% CI, 4.0,6.9)
|
Please
click here to view additional important safety information.
For full Prescribing Information
click here. (pdf) (74KB)
For further information about VELCADE® (bortezomib) for Injection, call 1-866-VELCADE (U.S. clinicians only).
