Epizyme, Inc. hosted a call 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. 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. 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.