Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
The company's ongoing, global, randomized, controlled confirmatory trial assessing the combination of Tazverik plus doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES is underway.
In addition, Epizyme will conduct certain post-marketing activities, including clinical pharmacology evaluations to assess the effect of Tazverik on liver function and the effect of CYP3A inhibitors and inducers on Tazverik to inform aspects of the prescribing information.
The company will also expand enrollment in Cohort 6 of its Phase 2 study, which has enrolled 44 patients to date, for a total of at least 60 epithelioid sarcoma patients. This expansion is intended to provide more patient experience for potential future inclusion in the label.
The efficacy of Tazverik was evaluated in an open-label, single-arm cohort (Cohort 5) of a multi-center study (Study EZH-202, NCT02601950) in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients were required to have INI1 loss, detected using local tests, and an Eastern Cooperative Oncology Group performance status of 0-2.
Patients received Tazverik 800 mg orally twice daily until disease progression or unacceptable toxicity. Tumor response assessments were performed every eight weeks.
The major efficacy outcome measures were confirmed overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review and duration of response. Median duration of follow-up was 14 months (range 0.4 to 31).
Among the 62 patients who received Tazverik, 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.
In the total 62 patients treated, the ORR (95% confidence interval) was 15% (7%, 26%), with 1.6% of patients achieving a complete response and 13% achieving a partial response.
Among responders in the trial, 67% had a duration of response of six months or longer.
Serious adverse reactions occurred in 37% of patients receiving Tazverik. Serious adverse reactions in ≥3% of patients who received Tazverik were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress.
One patient permanently discontinued Tazverik due to an adverse reaction of altered mood.
Dosage interruptions due to an adverse reaction occurred in 34% of patients who received Tazverik.
The most frequent adverse reactions requiring dosage interruptions in ≥3% were hemorrhage, increased alanine aminotransferase, and increased aspartate aminotransferase.
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.
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).
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