Tazemetostat Setbacks Hit Epizyme

As drug fails in DLBCL, firm focuses on lifting partial clinical hold on other trials. A first filing in a rare sarcoma has also been pushed back.

Overcoming challenges and crisis . Mixed media
Epizyme faces clinical trial headwinds • Source: Shutterstock

Epigenetic cancer therapy specialist Epizyme Inc. has ended development of its lead product tazemetostat as a monotherapy or in combination with prednisolone for diffuse large B-cell lymphoma, or DLBCL. The company has also pushed back the expected timeline for submitting its US NDA for the drug's first indication of epithelioid sarcoma. And it disappointed investors in offering no clear timeline for the resolution of a partial clinical hold on trials of the drug during its second-quarter investor call.

The termination came after an evaluation of the level of clinical activity in the three DLBCL cohorts of a Phase...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Nanobiotix/J&J Early Melanoma Data Show Potential For Future Indication

 
• By 

Radiotherapy enhancer JNJ-1900 (NBTXR3) generated a 47% ORR and 78.9% DCR in melanoma patients after multiple prior rounds of treatment. Discussions about development in additional cancers are ongoing with partner J&J.

EADV: Leo Makes A Big Leap With Eczema Drug Temtokibart Set For Phase III

 
• By 

CSO Jacob Thyssen tells Scrip that the monoclonal antibody which blocks the IL-22RA1 receptor subunit is a very safe and effective option to treat the chronic inflammatory skin disease.

Incyte’s Povorcitinib Wins Stack Up, Will It Be Enough To Hedge Jakafi Loss?

 
• By 

With patent expiry for its blockbuster blood cancer drug Jakafi on the horizon, Incyte will need to translate these povorcitinib wins from clinic to market.

Regeneron’s Garetosmab May Become Second Drug For Rare Bone Disease FOP

 

The company announced positive Phase III data for the drug in fibrodysplasia ossificans progressiva, as well as Phase II combination data among patients with obesity.

More from R&D

Regeneron’s Garetosmab May Become Second Drug For Rare Bone Disease FOP

 

The company announced positive Phase III data for the drug in fibrodysplasia ossificans progressiva, as well as Phase II combination data among patients with obesity.

Roivant Sets The Stage For Commercial Return With Brepocitinib Data

 

Positive Phase III data positions Roivant to launch the oral TYK2/JAK1 inhibitor for dermatomyositis, with an NDA filing planned in early 2026.

AstraZeneca’s Fasenra RESOLUTE Failure Highlights The Limits Of Biologics In COPD

 

AstraZeneca’s IL-5 blocker has again missed in COPD, adding to a number of disappointments for biologics in this disease. Complex biology and overlapping inflammatory pathways seem to be at the heart of the problem.