Epizyme’s Next EPIsode: Vision for Rewriting Oncology Treatment with Epigenetics Showcased New Five-Year Corporate Strategy
Preliminary Safety and Activity Data from Ongoing Clinical Trials for TAZVERIK® Combinations in Follicular Lymphoma and Prostate Cancer Support Advancement
Basket Trials Evaluating Tazemetostat Combinations for Multiple New Heme and Solid Tumor Cancers to be Initiated in Second Half 2021
Investigational New Drug (IND) Submission Planned in Mid-2021 for Novel SETD2 Inhibitor Program
Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, hosted a call today outlining the Company’s strategic vision and focus on oncology treatment with the Company’s epigenetic pipeline. A link to the presentation and slideshow can be found here.
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"The recent accelerated approvals of TAZVERIK in Epithelioid Sarcoma and Relapsed / Refractory Follicular Lymphoma are, of course, the critical foundation on which we will continue to expand Epizyme’s mission of rewriting treatments for cancer through novel epigenetic medicines," said Robert Bazemore, President and Chief Executive Officer of Epizyme. "We believe TAZVERIK has the potential to become a backbone of treatment across lines of ES and FL therapy. Beyond that, we are focused on developing the pipeline-in-a-drug potential we see in TAZVERIK, while expanding our portfolio and bringing novel oncology therapeutics into clinical development. We aspire to change the standard of care for patients and physicians by developing targeted medicines with fundamentally new mechanisms of action directed at specific causes of cancers."
"I am really excited about Epizyme’s comprehensive and innovative clinical development plan both for tazemetostat and our pipeline, for which we anticipate a steady stream of data," said Dr. Shefali Agarwal, Epizyme’s, EVP, Chief Medical and Development Officer. "Our aim is to demonstrate the benefits of tazemetostat to patients in earlier lines of treatment for ES and FL by exploring various combinations with standard of care therapies. We also plan to further explore tazemetostat as both monotherapy and in combinations across multiple new hematologic and solid tumor cancers. Our experience and platform have led to an incredibly rich pipeline of both clinical and discovery programs targeting several classes of epigenetic modulators and we expect that many these programs will be entering clinical trials in the next several years."
Highlights from the Next EPIsode call included:
Preliminary Data from Confirmatory Phase 1b/3 Study EZH-302 in Follicular Lymphoma
The combination of TAZVERIK + R2 (Lenalidomide and Rituximab) is being evaluated in the Phase 1b safety run-in portion of the EZH-302 trial, which enrolled a total of 13 patients. Among the 13 patients evaluated in this standard dose escalation design, no Dose Limiting Toxicities (DLTs) were observed during the first cycle of treatment up to the highest dose of 800mg of TAZVERIK twice daily. As of mid-February, initial data from the trial also showed:
All but one of the 13 patients enrolled remain on therapy, and, to date, seven of the patients were also considered evaluable for efficacy based on the availability of tumor scans from investigators.
All seven evaluable patients demonstrated a response to treatment with TAZVERIK+R2 with three complete responses (CR) and four partial responses (PR).
The safety profile of TAZVERIK + R2 observed in these patients to date is consistent with that previously described with the respective drugs; no patients have discontinued due to an adverse event.
Based on these early safety and activity findings, Epizyme is preparing to commence the Phase 3 randomization portion of the trial. The Company plans to present further data from the Phase 1b portion of the study at a medical meeting in 2021.
Preliminary Data from Phase 1b/2 Study EZH-1101 In Prostate Cancer
The combination of tazemetostat with standard of care treatments, enzalutamide or abiraterone, is being evaluated in the Phase 1b safety run-in portion of the EZH-1101 trial, which enrolled a total of 21 men with metastatic prostate cancer. Among the 21 patients enrolled in a standard dose escalation design, no DLTs were observed at any dose of tazemetostat up to a maximum dose of 1600mg twice daily. As of mid-February, initial data from the trial also showed:
Seven out of 21 patients had a PSA response of ≥50%; one additional patient had a PSA response of ≥35%.
Six of the PSA50 responses were in the tazemetostat + enzalutamide cohort and one was in the tazemetostat + abiraterone/prednisone cohort.
The Company also observed a 47% disease control rate to-date and presented an example of radiographic response in a patient achieving a partial response (PR) in the trial.
The Company highlighted that all responses were in ARV7 negative patients using the EPIC platform, considered more rigorous in detecting ARV7 status. Only one ARV7 positive patient was enrolled in the safety run-in portion of the trial.
Based on these early safety and activity findings, Epizyme recently initiated enrollment in the Phase 2 efficacy portion of the trial. The Company plans to present further data from the Phase 1b portion of the study at a medical meeting in 2021.
Initiation of Basket Trials in Additional Heme and Solid Tumors Planned in Second Half 2021
Epizyme will initiate two signal finding basket studies to evaluate tazemetostat safety and efficacy across multiple new types of heme and solid tumors. With this approach, the Company will study multiple combinations with standard of care therapies and novel mechanisms of action to expand the potential of TAZVERIK to patients and the physicians who treat them. Epizyme announced on today’s call that it plans to initiate both basket studies in the second half of 2021.
Advancing Epizyme’s Novel SETD2 Inhibitor Program into the Clinic in 2021
SETD2 is a histone methyltransferase, similar to EZH2, which plays multiple important roles in oncogenesis. Based on the promise of SETD2 inhibition in multiple settings, including high risk t(4;14) multiple myeloma and in other B-cell malignancies such as large-cell lymphoma, as well as in combination with existing and emerging therapies including tazemetostat, Epizyme is planning to submit an IND (Investigational New Drug) application with the FDA in mid-2021.
"We are extremely excited about the potential for our SETD2 program and breadth of our growing discovery pipeline. Our ambition is to deliver at least five of these programs to the clinic in the next five years," said Jeffery Kutok, M.D., Ph.D, Epizyme’s Chief Scientific Officer. "We look forward to continuing to update you on the considerable number of promising compounds against important oncology targets in our pipeline as they move toward clinical development, furthering Epizyme’s mission of delivering medicines that can make meaningful differences in the lives of patients with cancer."
On the call today, the company reiterated its financial strength, with cash expected to be sufficient to fund these initiatives into 2023. Additionally, Epizyme plans to continue to evaluate collaborations with companies with an established commercial presence outside the United States, as well as potential clinical trial collaborations involving drugs where a tazemetostat combination makes sense. The scientific advice process with the European Medicines Evaluation Agency (EMEA) for tazemetostat in follicular lymphoma has begun and Epizyme will provide more details from these interactions and the path ahead later this year.
"As we consider the next five years, we expect to be the preferred partner of choice for accessing innovation in epigenetics. We have established a deep biological understanding of how best to evaluate novel, best in class epigenetic targets and, importantly, ensuring the right translational insights are captured early," said Matthew Ros, EVP, Chief Strategy and Business Officer. "We plan to leverage clinical and research collaborations to expand our ability to interrogate multiple investigative therapies with partners with like-minded scientific interests and expertise."
Next EPIsode Presentation and Slideshow
A replay of today’s webcast and the full slideshow presentation can be accessed and downloaded by visiting the Investor section of the Company's website at www.epizyme.com.
About Epizyme, Inc.
Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. The Company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.
About TAZVERIK® (tazemetostat)
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.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
View the U.S. Full Prescribing Information here: www.epizyme.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether commercial sales of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications will be successful; whether tazemetostat will receive marketing approval for epithelioid sarcoma or follicular lymphoma in other jurisdictions, full approval in the United States or approval in any other indication; whether preliminary results from clinical trials, such as the results reported in this release, will be indicative of the final results of such trials; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory trials; whether results from preclinical studies will warrant advancement into clinical trials on a timely basis or at all; whether results from clinical studies will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process; whether the company will receive regulatory approvals, including accelerated approval, to conduct trials or to market products; the impact of the COVID-19 pandemic on the company’s business, results of operations and financial condition; whether the company's cash resources will be sufficient to fund the company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements for the period anticipated; other matters that could affect the availability or commercial success of tazemetostat; and other factors discussed in the "Risk Factors" section of the company’s most recent Form 10-K or Form 10-Q filed with the SEC and in the company's other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
TAZVERIK® is a registered trademark of Epizyme, Inc.
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Erin Graves, Epizyme, Inc.
Bill Slattery, Jr., W2O Group