Update for January 12, 2021

Regulatory Update
 
The FDA designated tiragolumab in combination with atezolizumab, a Breakthrough Therapy for the treatment of metastatic non-small cell lung cancer with high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. 
 
Announced Research Updates
 
Sarepta announced interim data from 20 patients enrolled in a 48-week, 41 patient, Phase II trial, where SRP-9001 resulted in micro-dystrophin expression of 28.1% at 12-weeks. At 48-weeks, treatment with SRP-9001 improved the NSAA score by 1.7 points in the 20 treated patients, but the improvement was not statistically significant compared to a 0.9 point improvement in 21 placebo patients. The 41 patients enrolled in the study were between the ages of 4 to 7 at enrollment.
 
Loncastuximab tesirine is available through an expanded access program (EAP) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Information on the EAP on be accessed at: https://adctherapeutics.com/expanded-access-program/
 
Loxo announced that in the 323 patient, Phase I/II, open-label, dose-ranging, BRUIN trial, treatment with LOXO-305 resulted in an overall response of 52% for mantle cell lymphoma (MCL), 68% for MCL and Waldenström macroglobulinemia, 75% for Richter transformation, 50% for follicular lymphoma, 24% for diffuse large B-cell lymphoma, and 22% for marginal zone lymphoma.
 
Published Research Updates
 
In a 42-day, 281 patient, Phase III trial, 53.9% of patients treated with sofpironium improved their Hyperhidrosis Disease Severity Scale to two or less and had a 50% or more reduction in gravimetric sweat production compared to 36.4% that received placebo in Japanese patients with axillary hyperhidrosis.