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#ASCO17: Epizyme will hunt a quick OK for tazemetostat, despite disappointing analysts with new data

Robert Bazemore, CEO Epizyme

As the dust began to settle from the ASCO abstract drop last night, several analysts weighed in noting their cautious lack of optimism for Epizyme’s latest look at the data for tazemetostat, its EZH2 inhibitor now in Phase II for epithelioid sarcoma.

RBC’s Matthew Eckler noted the latest data were “below our expectations.”

For Geoffrey Porges at Leerink: “These results squeaked over the trial’s hurdle for proceeding to cohort expansion and the 13% ORR is below our mental threshold of a 20-30% response rate.”

But early Thursday Epizyme $EPZM was up and running with an enthusiastic assessment of its chances for gaining an accelerated FDA OK after filing for an approval next year on the Phase II.

The biotech’s shares were down 4% in pre-market trading Thursday.

Noted the Cambridge, MA-based biotech:

Based on discussions with the FDA, the Company has identified a path to submission for accelerated approval of tazemetostat based on the 60-patient cohort from its Phase II study, and will target a New Drug Application submission in 2018.

The analysts aren’t ruling out a success here. But several are plainly disappointed with where Epizyme appears to be right now.

“We had previously written that we were positive into this data release, with the expectation that the objective response rate would exceed 20% in this cohort,” Eckler wrote. “Barring improvements in future data presentations, we were obviously wrong. Tazemetostat showed a 13% ORR (0 CRs, 4 PRs) in 31 patients enrolled in the epithelioid sarcoma cohort (abstract # 11058), below previously reported Phase I data….”

Where analysts were seeing issues, though, Epizyme deciphered new opportunities.

“Epithelioid sarcoma is a difficult cancer for sarcoma oncologists like me to treat due to there being few available therapeutic options, which are associated with limited benefit and challenging side effects for patients,” said Dr. Mrinal M. Gounder, lead investigator, in a prepared statement. “INI1 loss is a defining feature of epithelioid sarcoma and the mechanism of tazemetostat makes this a compelling agent. These data show encouraging activity of tazemetostat as characterized by objective responses, duration of responses and prolonged disease stabilization, and I look forward to its continued development.”

“Bringing tazemetostat to patients is our number one priority,” said Robert Bazemore, president and chief executive officer of Epizyme.


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RAPS Regulatory Convergence 2017