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EZH-202 cohort 5

Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study

Phase 2N = 62NCT02601950

Population
62 eligible patients in the epithelioid sarcoma cohort (cohort 5), all included in the modified intention-to-treat analysis
Design
International open-label phase 2 basket study at 32 sites (seven cohorts of INI1-negative solid tumours or synovial sarcoma); cohort 5 enrolled patients aged 16 years or older with locally advanced or metastatic epithelioid sarcoma with INI1 loss or biallelic SMARCB1 alteration, 22 December 2015 to 7 July 2017; data cutoff 17 September 2018. Tazemetostat 800 mg orally twice daily in continuous 28-day cycles.
Primary endpoint
ORR
Arms
  • Tazemetostat (experimental, n = 62): Tazemetostat 800 mg orally twice daily in continuous 28-day cycles until progression, unacceptable toxicity or withdrawal
People
Gounder M
Show the numbers
Results reported for EZH-202 cohort 5
EndpointAnalysisTazemetostatControlEffect
ORRModified intention-to-treat population (all 62 patients who received at least one dose)primarymedian follow-up 13.8 monthsGounder 202015% (7–26%)—Nine of 62 patients had an objective response (investigator-assessed, RECIST 1.1). Median duration of response not reached (95% CI 9.2 to not estimable).
PFSModified intention-to-treat population (62)primaryGounder 2020median 5.5 months (3.4–5.9)—Single-arm result; no comparator.
OSModified intention-to-treat population (62)primaryGounder 2020median 19 months—Single-arm result; no comparator. The 95% CI printed is 11.0 to not estimable.
Results reported for EZH-202 cohort 5
EndpointAnalysisTazemetostatControlEffect
ORRModified intention-to-treat population (all 62 patients who received at least one dose)primarymedian follow-up 13.8 monthsGounder 202015% (7–26%)—Nine of 62 patients had an objective response (investigator-assessed, RECIST 1.1). Median duration of response not reached (95% CI 9.2 to not estimable).
PFSModified intention-to-treat population (62)primaryGounder 2020median 5.5 months (3.4–5.9)—Single-arm result; no comparator.
OSModified intention-to-treat population (62)primaryGounder 2020median 19 months—Single-arm result; no comparator. The 95% CI printed is 11.0 to not estimable.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Tazemetostat (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTazemetostat
0100.0%
368.5%
741.4%
1028.4%
1417.1%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Tazemetostat (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTazemetostat
0100.0%
1264.5%
2441.7%
3626.9%
4817.4%
Primary publication: Gounder M, Schöffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, et al. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study. Lancet Oncol. 2020;21(11):1423-1432. PubMedDOI

Appears in

Sources

  1. Gounder M, Schöffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, et al. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study. Lancet Oncol. 2020;21(11):1423-1432.

    PubMedDOI