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TAZVERIK® EFFICACY DATA1,2,a

CLINICAL TRIAL OVERVIEW

TAZVERIK® efficacy and safety were evaluated in an open-label, single-arm cohort (Cohort 5) of a multicenter study in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma (n=62). The primary efficacy endpoint was the overall response rate (ORR) and a secondary efficacy endpoint was duration of response (DOR).1,2

See Full Study Design See Full Study Design

TAZVERIK DEMONSTRATED EFFICACY IN EPITHELIOID SARCOMA TRIAL

15% of all
patients studied
achieved an ORR
(95% CI: 7-26% n=9/62)1,2,*

67% of all
responders (complete or partial)
achieved a DOR ≥6 months
(range=3.7-24.5+ months)1

*The ORR included 1.6% (n=1/62) of patients with a complete response and 13% (n=8/62) with a partial response.1,2

Time to response ranged from 1.4 to 18.4 months.1

Exploratory Subgroup Analysis Based on Investigator Assessment†

95months-icon

TAZVERIK as first-line systemic therapy2

  • ORR was 25% (95% CI: 10-47; n=6/24)
later-lines-icon

TAZVERIK in later lines2

  • ORR was 8% (95% CI: 2-21; n=3/38)
9.5 month.png

TAZVERIK as first-line systemic therapy2

  • Median DOR was 9.5 months (95% CI: 7.9 months-NE)
calendor.png

TAZVERIK in later lines2

  • Median DOR was not yet reached at follow-up of 2 years (95% CI: 9.2 months-NE)

†Based on investigator assessment; patients with no prior systemic therapy ("first-line") and those who had received at least 1 prior systemic therapy (“later lines”).

 

LIMITATIONS: These additional data from the phase 2, single-arm study represent subgroup analyses of overall response rate and duration of response. No conclusions of statistical significance can be drawn from these subgroup analyses.

NCCN Clinical Practice NCCN Clinical Practice

Tazemetostat (TAZVERIK®) is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcomas with a category 2A recommendation as the only preferred regimen for appropriate patients with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection*

*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 5, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

aStudy design: TAZVERIK was studied in the largest prospective, open-label, single-arm, multicenter phase 2 study in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients received 800 mg of TAZVERIK orally twice daily until confirmed disease progression or unacceptable toxicity. The major efficacy endpoints included confirmed overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR) and duration of response. The median duration of follow-up at the time of the efficacy analysis was 14 months (range 0.4 to 31). Among the 62 patients who received TAZVERIK, all had INI1 loss; median age was 34 years (range 16 to 79); 63% were male, 76% were White, 11% were Asian, 44% had proximal disease, 92% had an ECOG PS of 0 or 1, and 8% had an ECOG PS of 2. Prior surgery occurred in 77% of patients; 61% received prior systemic chemotherapy.1,3

CI=confidence interval; DOR=Duration of response; ECOG PS=Eastern Cooperative Oncology Group Performance Status; NE=not estimable; ORR=overall response rate.

References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., December 2023. 2. Gounder M, Schöffski P, Jones RL, et al. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study. Lancet Onc. 2020;21(11):1423-1432. doi: 10.1016/S1470-2045(20)30451-4. 3. Data on file.

 

Learn more about how

TAZVERIK works.

MECHANISM OF ACTION

Learn more about how safety and

tolerability were evaluated in the clinical trial.

SAFETY & TOLERABILITY

IMPORTANT SAFETY INFORMATION AND INDICATION

Warnings and Precautions

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 758 adults who received TAZVERIK 800 mg twice daily as monotherapy, myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or B-cell acute lymphoblastic leukemia (B-ALL) occurred in 1.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T-LBL). Monitor patients long-term for the development of secondary malignancies.

  • Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0‑45h]) at the 800 mg twice daily dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

Adverse Reactions

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).

Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.

Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

TAZVERIK is 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.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information.