Epizyme Inc.'s (EPZM:NASDAQ) new SYMPHONY-1 study data suggest "patients are experiencing deepening responses" to the company's approved cancer drug, tazemetostat, in combination with lenalidomide and rituximab, reported Wedbush analyst David Nierengarten in a June 2 research note.
Updated efficacy data from the Phase 1b study in relapsed/refractory follicular lymphoma are better than those reported in December 2021 from the same trial, Nierengarten highlighted.
"We believe these data continue to build a case for using tazemetostat in earlier lines of therapy with the standard lenalidomide and rituximab combination," the analyst commented.
Specifically, out of 38 evaluable patients, 36 (94.7%) responded to treatment as of Jan. 22, 2022. Nineteen (50%) patients experienced a complete response, and 17 (44.7%), had a partial response. Two patients had stable diseases. Percentages from the previous data release, in comparison, were 37.1% and 54.3%, respectively,
In the recent data readout, none of the patients had reached median progression-free survival or median duration of response at a median follow-up of 5.8 months.
The updated results also compare favorably to the historical range of overall response rate of 73–78% in patients with relapsed/refractory follicular lymphoma treated with lenalidomide and rituximab, Nierengarten pointed out.
As for the safety of tazemetostat plus lenalidomide and rituximab, patients tolerated the combination treatment well. Adverse events were consistent with the labels of both tazemetostat alone and of combination lenalidomide plus rituximab.
Out of 44 patients, 14 (32%) experienced serious treatment-emergent adverse events, and in 25 (57%) patients these were grades three to four. A decrease in neutrophil count was the most common one.
"The updated safety data were consistent with prior data, with no clear dose-response for treatment-emergent adverse events or dose modifications," wrote Nierengarten.
Regarding the next steps, enrollment is in progress for the Phase 3 study. In that, patients will be given either tazemetostat 800 milligrams twice a day plus lenalidomide and rituximab or placebo plus lenalidomide and rituximab.
As for Epizyme, it will be catalyst rich in H2/22, Nierengarten noted, and he suggested investors buy shares of the biopharma beforehand. These near-term events include interim Phase 2 results from the LYSA and CELLO-1 trials.
Wedbush has an Outperform rating and a $7 per share price target on Epizyme, the current share price of which is around $0.52.
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Disclosures for Wedbush Securities, Epizyme Inc., June 2, 2022
We, David Nierengarten and Dennis Pak, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.
1. WS makes a market in the securities of Epizyme.
3. WS co-managed a public offering of securities for Epizyme within the last 12 months.
4. WS has received compensation for investment banking services from Epizyme within the last 12 months.
5. WS provided Epizyme with investment banking services within the last 12 months.
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