On October 7, 2020 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that The Lancet Oncology published results of the company’s Phase 2 trial cohorts evaluating TAZVERIK (tazemetostat) for the treatment of epithelioid sarcoma and relapsed/refractory follicular lymphoma (Press release, Epizyme, OCT 7, 2020, View Source [SID1234568197]). Data included in these publications supported the accelerated approval of TAZVERIK by the U.S. Food and Drug Administration (FDA) for the treatment of epithelioid sarcoma in January 2020, and the accelerated approval of TAZVERIK by the FDA for the treatment of relapsed/refractory follicular lymphoma in June 2020.

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"The two publications in such a highly regarded, peer-reviewed journal as the Lancet are the culmination of years of hard work by our team, and the significant contributions by the patients and physicians who participated in our clinical trials," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "In our Phase 2 trials, TAZVERIK demonstrated durable clinical responses in both patient populations, including in patients with advanced disease who had previously received multiple therapeutic regimens. In addition, we observed consistently favorable safety with TAZVERIK, which we view as one of its most attractive features. These publications provide important support for TAZVERIK’s novel epigenetic approach, and I am very proud that we are able to offer it as an approved therapy for both patient populations."

"Based on its compelling clinical data and first-in-class mechanism, we believe TAZVERIK has a pipeline in-a-product opportunity that we hope may offer benefit to patients with a wide range of cancers," said Robert Bazemore, president and chief executive officer of Epizyme. "The two FDA accelerated approvals this year highlight the therapeutic impact TAZVERIK could have for patients, and we look forward to continuing to explore its potential in additional tumor types and combinations to reach as many patients as possible."

The publications can be accessed at the following link:
https://www.thelancet.com/journals/lanonc/onlinefirst

About TAZVERIK

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 2 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 a confirmatory trial(s).

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.

Dosage and Administration

The recommended dosage of TAZVERIK is 800 mg taken orally twice daily with or without food.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% 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

Epithelioid Sarcoma

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%).
Relapsed or Refractory Follicular Lymphoma

In 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).
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.