Press Releases
Epizyme Presents Updates from SYMPHONY-1 Tazemetostat + R² Combination Study in Relapsed/Refractory Follicular Lymphoma at the 2021 ASH Annual Meeting
Updated data from the Phase 1b portion of the study reported today included 40 FL patients who had received treatment with tazemetostat and R2 (400 mg [n=4], 600 mg [n=18], or 800 mg [n=18]) as of the
“The data presented today on the combination of rituximab, lenalidomide and tazemetostat, known as R2 + tazemetostat, have shown promising responses in the second-line FL setting and the side effects observed to date have been consistent with lenalidomide-based combinations,” said Connie Lee Batlevi, MD PhD, medical oncologist with
SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R2 in patients with relapsed or refractory FL after at least one prior line of therapy. The Phase 1b portion of the study is designed to determine the recommended Phase 3 dose, activity, and safety of tazemetostat and R2. In addition to the safety run-in analysis, the study also assessed the pharmacokinetics and continues to assess clinical activity of tazemetostat when administered in combination with R2.
The Phase 1b safety run-in component evaluated tazemetostat at three dose levels (400 mg, 600 mg, and 800 mg orally twice daily) in 28-day cycles with standard-dose R2 using a 3 + 3 design. Rituximab was administered at 375 mg/m2 intravenously on days 1, 8, 15 and 22 of cycle 1, then on day 1 of cycles 2 to 5. Lenalidomide was administered at 20 mg (creatinine clearance ≥60 mL/min) or 10 mg (if creatinine clearance <60 mL/min) orally once daily on days 1 to 21 every 28 days for 12 cycles. In the Phase 3 component, approximately 500 patients will be randomly assigned to receive the RP3D of tazemetostat + R2 or placebo + R2. The study will also include a maintenance arm with tazemetostat or placebo following the first year of treatment with tazemetostat + R2 or placebo + R2.
Treatment with tazemetostat and R2 was generally well tolerated. Grade 3/4 TEAEs were observed in 17 (42.5%) patients; the most common grade 3/4 TEAE (≥10%) was neutrophil count decrease/neutropenia (15.0.%) Ten patients (25.0%) reported a total of 16 SAEs (serious adverse events). The only SAE reported in >1 patient was COVID-19, reported in 2 patients; all other SAEs were reported in 1 patient each.
A table of the activity findings as of the data cut off are below:
Best Overall Response (BOR) Ratea, n (%) |
Tazemetostat + R2 (n = 35) |
Objective Response Rate (ORR) |
32 (91.4) |
Complete Responseb (CR) |
13 (37.1) |
Partial Response (PR) |
19 (54.3) |
Stable Disease (SD) |
3 (8.6) |
Progressive Disease (PD) |
0 |
a For BOR, there were 27 PET-CT-based responses and 8 CT-based responses. b For CR, 12 were PET-CT-based responses and 1 was a CT-based response. |
“We are encouraged to share progress of our tazemetostat program in follicular lymphoma with the cancer community, as we believe these data support the potential tazemetostat may play as a backbone of therapy in combination with current standards of care for patients living with the disease. We will continue to monitor these patients and we look forward to sharing follow-up data as they mature over time,” said Dr.
In addition to the SYMPHONY-1 presentation (Abstract #2207), two additional tazemetostat studies are being presented during the ASH Annual Meeting. The first is a trial-in-progress/study design presentation for SYMPHONY-2 (Abstract #3541), a multi-center, open-label, single-arm, Phase 2 study of tazemetostat in combination with rituximab for the treatment of relapsed or refractory FL. The trial is actively enrolling patients across 18 sites in
About TAZVERIK® (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:
- Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
- Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
- Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
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Revlimid + Rituximab (R2) is a registered trademark of Celgene Corporation, a Bristol Myers Squibb company.
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