Epithelioid sarcoma

HUTCHMED Initiates a Bridging Study of Tazemetostat in Patients with Relapsed/Refractory Follicular Lymphoma in China

Retrieved on: 
Monday, August 1, 2022
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HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a bridging study of tazemetostat in China.

Key Points: 
  • HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a bridging study of tazemetostat in China.
  • The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma (R/R FL).
  • The primary objective is to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have mutations in EZH21 (Cohort 1).
  • The most common (20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

HUTCHMED Announces TAZVERIK® Approved to be Used in Hainan Pilot Zone in China

Retrieved on: 
Wednesday, June 1, 2022
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TAZVERIK is a methyltransferase inhibitor of EZH21 developed by Epizyme, Inc. (Epizyme).

Key Points: 
  • TAZVERIK is a methyltransferase inhibitor of EZH21 developed by Epizyme, Inc. (Epizyme).
  • In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize TAZVERIK in China, Hong Kong, Macau and Taiwan.
  • These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response.
  • HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizymes SYMPHONY-1 study.

Epizyme Presents Updates from SYMPHONY-1 Tazemetostat + R2 Combination Study in Relapsed/Refractory Follicular Lymphoma at the 2022 ASCO Annual Meeting

Retrieved on: 
Thursday, June 2, 2022
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In addition to the SYMPHONY-1 presentation (Abstract # 7572 ), the Company has one additional tazemetostat study being presented during the ASCO Annual Meeting.

Key Points: 
  • In addition to the SYMPHONY-1 presentation (Abstract # 7572 ), the Company has one additional tazemetostat study being presented during the ASCO Annual Meeting.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
  • The most common (20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
  • Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer through novel epigenetic medicines.

C4 Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating CFT8634, an Orally Bioavailable BiDAC™ Degrader for the Treatment of Synovial Sarcoma and SMARCB1-null Tumors

Retrieved on: 
Monday, May 16, 2022
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The Phase 1 portion of the study will evaluate CFT8634 as an oral, single agent therapy for patients with synovial sarcoma and SMARCB1-null tumors to identify a recommended Phase 2 dose.

Key Points: 
  • The Phase 1 portion of the study will evaluate CFT8634 as an oral, single agent therapy for patients with synovial sarcoma and SMARCB1-null tumors to identify a recommended Phase 2 dose.
  • Following identification of recommended dosage, the Phase 2 portion of the trial is expected to expand to the following investigational arms: one in synovial sarcoma, and one in SMARCB1-null tumors.
  • CFT8634 is a BiDAC degrader targeting BRD9 for the treatment of cancers that are dependent on BRD9, including synovial sarcoma and SMARCB1-null cancers.
  • Both synovial sarcoma and SMARCB1-null tumors are believed to be dependent on BRD9 and, as a result, CFT8634 may be an effective treatment.

Epizyme Reports First Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 10, 2022
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Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, today reported first quarter 2022 financial results and provided a business update.

Key Points: 
  • Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, today reported first quarter 2022 financial results and provided a business update.
  • Commercial demand increased 16% in the first quarter of 2022 versus the fourth quarter of 2021 levels while total demand (commercial demand and free goods supplied through the patient assistance program) in the first quarter of 2022 was similar to fourth quarter 2021 levels.
  • Epizyme, in collaboration with LYSA, anticipates presenting top-line results from the Phase 2 portion of the study in the second half of 2022.
  • Non-GAAP adjusted R&D expenses were $27.8 million for the first quarter of 2022, compared to $30.3 million for the first quarter of 2021.

 Epizyme Announces Executive Appointment and Provides Tazemetostat Clinical Update

Retrieved on: 
Tuesday, March 15, 2022
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We are excited to welcome Jerald to Epizyme at a pivotal time for the organization, said Mr. Bogle.

Key Points: 
  • We are excited to welcome Jerald to Epizyme at a pivotal time for the organization, said Mr. Bogle.
  • I am thrilled to be joining Epizyme at such an important time for the company, said Mr. Korn.
  • Dosing the first patient in the Phase 3 portion of the SYMPHONY-1 study is an important milestone for Epizyme and our clinical development of tazemetostat in R/R FL, said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme.
  • TAZVERIK is a registered trademark of Epizyme, Inc.
    Revlimid + Rituximab (R2) is a registered trademark of Celgene Corporation, a Bristol Myers Squibb company.

Epizyme Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 1, 2022
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TAZVERIK commercial net sales in the fourth quarter of 2021 were $7.4 million, representing an increase of approximately 42% when compared to $5.2 million in the third quarter of 2021.

Key Points: 
  • TAZVERIK commercial net sales in the fourth quarter of 2021 were $7.4 million, representing an increase of approximately 42% when compared to $5.2 million in the third quarter of 2021.
  • Total end user demand in the fourth quarter of 2021 represented a 14% increase over third quarter 2021 levels.
  • Fourth Quarter and Full Year 2021 Financial Results:
    Cash Position: Cash, cash equivalents and marketable securities were $176.8 million as of December 31, 2021.
  • Revenue: Total revenue for the fourth quarter of 2021 was $11.6 million, compared to $4.5 million for the fourth quarter of 2020.

Epizyme Provides Business Highlights, Preliminary Fourth Quarter and Full Year 2021 Financials and Clinical Trial Updates

Retrieved on: 
Monday, January 10, 2022
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For Epizyme, 2021 was defined by key organizational changes that reduced our overall operating expenses while we accelerated TAZVERIK commercial adoption.

Key Points: 
  • For Epizyme, 2021 was defined by key organizational changes that reduced our overall operating expenses while we accelerated TAZVERIK commercial adoption.
  • TAZVERIK commercial net sales in the fourth quarter of 2021 are expected to be between $7.0-7.5 million, representing an increase of approximately 35% when compared to $5.2 million in the third quarter of 2021.
  • Total end user demand in the fourth quarter of 2021 is expected to represent at least a 14% increase over third quarter 2021 levels.
  • Epizyme also shared preclinical data on EZM0414 along with the SET-101 Phase 1/1b clinical trial design at the 2021 ASH conference.

Epizyme Presents Updates from SYMPHONY-1 Tazemetostat + R2 Combination Study in Relapsed/Refractory Follicular Lymphoma at the 2021 ASH Annual Meeting

Retrieved on: 
Sunday, December 12, 2021
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At Epizyme, we are committed to advancing the follicular lymphoma treatment landscape for patients, the healthcare teams who treat them, and the families who support them.

Key Points: 
  • At Epizyme, we are committed to advancing the follicular lymphoma treatment landscape for patients, the healthcare teams who treat them, and the families who support them.
  • In addition to the SYMPHONY-1 presentation (Abstract # 2207 ), two additional tazemetostat studies are being presented during the ASH Annual Meeting.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
  • The most common (20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Epithelioid Sarcoma Collaborative Publishes White Paper Outlining Challenges and Proposing Solutions to Improve Outcomes of Patients Facing Rare Cancer

Retrieved on: 
Tuesday, October 12, 2021
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There is very little information available about Epithelioid Sarcoma (ES).

Key Points: 
  • There is very little information available about Epithelioid Sarcoma (ES).
  • "Recommendations from the Epithelioid Sarcoma Collaborative: A White Paper" has now been published in the Journal of Oncology Navigation and Survivorship.
  • This white paper is the result of a partnership between the Epithelioid Sarcoma Collaborative and SARC (Sarcoma Alliance for Research Through Collaboration).
  • Epithelioid sarcoma (ES) is an uncommon soft tissue sarcoma (STS).