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Tuesday, March 21, 2023

Gilead CAR T-cell Therapy Improved Overall Survival In Pretreated Lymphoma

 

  • Kite, a Gilead Science Inc  company, announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study. 
  • The results showed a statistically significant improvement for Yescarta in OS versus historical treatment, which was the standard of care (SOC) in a curative setting for nearly 30 years, for initial treatment of adult patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy. 
  • Historical SOC is a multi-step process involving a platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy (HDT) and a stem cell transplant (ASCT) in those who respond to salvage chemotherapy. 
  • ZUMA-7 was conducted under a Special Protocol Assessment (SPA) with the FDA, whereby the trial design, clinical endpoints, and statistical analysis were agreed upon in advance with the Agency. Other health authorities also agreed with this pre-specified analysis.
  • ZUMA-7 is considered a landmark trial as the first and largest Phase 3 study of any CAR T-cell therapy, with the longest follow-up, which has demonstrated event-free survival (EFS), the primary endpoint, that is superior to historical SOC treatment. 
  • Data from the ZUMA-7 pivotal trial led to the U.S. approval for the initial treatment of R/R LBCL in April 2022 and European Union approval in October 2022.

Coya Has Proof-of-Concept Data From Small Study With ALS Patients

 

  • Coya Therapeutics Inc  reported 48-week clinical data for its proof-of-concept open-label study in 4 Amyotrophic Lateral Sclerosis (ALS) patients indicating that treatment with COYA 302 appeared to ameliorate disease progression.
  • During the 48-week treatment period, COYA 302 appeared to be well tolerated. 
  • Preliminary efficacy of COYA 302 was measured by the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in ALS patients.
  • The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of COYA 302 treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), indicating significant amelioration in the progression of the disease over the 48-week treatment period.
  • Treg suppressive function, expressed as a percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. 
  • The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. 
  • The available data up to 16 weeks suggest a decrease of these biomarker levels, which is consistent with the observed enhancement of Treg function. 
  • The evaluation of the complete biomarker data is ongoing.
  • The company said it plans to file an IND with the FDA in the second half of 2023 and initiate a clinical study soon after.

Yellen Tries To Reassure World That "The US Banking System Remains Sound"

 Watch Treasury Secretary Janet Yellen will address bank leaders from across the country at the American Bankers Association's annual Washington Summit (due to start at 1000ET): 

Read Yellen's prepared remarks below: (emphasis ours)