Shares of Epizyme Inc. (EPZM - Free Report) rose almost 10% after the company announced the publication of tazemetostat phase I clinical data in The Lancet Oncology. The study demonstrated favorable safety findings and anti-tumor activity and established recommended dose for the phase II expansion study.
The phase I study was designed to evaluate the maximally tolerated dose and supported defining the recommended phase II dose (RP2D) of tazemetostat-a first-in-class selective inhibitor of EZH2.
Over a year, shares of Epizyme have returned 4.2%, as against the industry’s decline of 7.7%.
The phase I dose-escalation portion of the study evaluated the safety and tolerability of orally dosed tazemetostat. Tazemetostat was dosed twice daily as a single agent in patients with relapsed or refractory B-cell NHL (n=21) or with advanced solid tumors (n=43) including molecularly defined INI1- or SMARCA4-negative tumors.
Additional studies evaluated the adverse events, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of the agent. The results from these studies helped in determining the RP2D of 800 mg twice daily.
Anti-tumor activity was seen across several tumor types. In B-cell NHL, durable objective responses were observed in eight patients. Three patients had a complete response, one with diffuse large B-cell lymphoma (“DLBCL”) and two with follicular lymphoma (“FL”).
We note that, Epizyme is developing its lead product candidate, tazemetostat for a wide range of hematological malignancies. Tazemetostat, is being evaluated for both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease.
It is currently being studied as a monotherapy in ongoing phase II programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; both FL and DLBCL forms of non-Hodgkin lymphoma; mesothelioma; and combination studies in DLBCL and NSCLC.
A potential approval of the candidate will be significant boost for the company.
Zacks Ranks and Stocks to Consider
Epizyme carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the same space worth considering are Ligand Pharmaceuticals (LGND - Free Report) , Protagonist Therapeutics (PTGX - Free Report) and Catabasis Pharmaceuticals (CATB - Free Report) . Whlle Ligand and Protagonist sport a Zacks Rank #1 (Strong Buy), Catabasis carries a Zacks Rank#2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 54.6% over a year.
Protagonist’s loss estimates narrowed from $1.30 to 66 cents for 2018 and from $1.99 to $1.26 for 2019, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.95%.
Catabasis’ loss estimates narrowed from $1.09 to 92 cents for 2018 and from $1.76 to $1.48 for 2019, in the last 30 days. The company came up with a positive earnings surprise in all the preceding four quarters, with an average beat of 14.56%. The stock has rallied 22.2% so far this year.
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