Update for December 14, 2021

Regulatory Update
 
Merck is pausing enrollment in the Phase III IMPOWER 22 and 24 trials, which are evaluating once-monthly islatravir for pre-exposure prophylaxis in high risk patients, due to a decrease in total lymphocyte and CD4+ T-cell counts.
 
The EMA approved abrocitinib for the treatment of moderate-to-severe atopic dermatitis.
 
The EMA has accepted the MAA for olipudase alfa or the treatment of Niemann-Pick disease type A and type B.
 
Announced Research Updates
 
GSK announced that in the 28-week, 614 patient, Phase III, ASCEND-NHQ trial, 77% of patients treated with daprodustat achieved at least a 1 g/dL increase in hemoglobin compared to 18% who received placebo in non-dialysis dependent CKD patients with anemia.
 
Syndax announced that in a 354 patient, Phase III trial, adding entinostat to exemestane increased PFA to 6.32 months compared to 3.72 months with exemestane alone in Chinese patients with advanced HR+, HER2-, breast cancer.
 
UniQure announced that at 18-months, FIX activity was 36.9% of normal with an ABR requiring treatment of 0.83, after treatment with etranacogene dezaparvovec, in Hemophilia B patients enrolled in the 12-month, Phase III, HOPE-B trial.
 
Jiangsu HengRui announced that at two-years treatment with pyrotinib plus capecitabine resulted in a 66.6% overall survival compared to 58.8%% with lapatinib plus capecitabine in the PHOEBE trial
 
Roche announced that in a 2.5 year follow-up of the Phase II, CITYSCAPE trial, the combination of tiragolumab plus atezolizumab maintained an improvement in ORR (38.8% vs 20.6%) and PFS (5.6 months vs 3.9 months).
 
Moderna announced 29-day results from a 180 patient, Phase I trial, where immunization with mRNA-1010 elicited antibody titers that neutralized all H1N1 and H3N2 influenza strains tested.
 
BeiGene announced that in the 263 patient, Chinese Phase III, RATIONALE 309 trial, patients treated with tislelizumab plus gemcitabine and cisplatin achieved progression free survival of 9.2 months compared to 7.4 months with gemcitabine and cisplatin alone in patients with recurrent or metastatic nasopharyngeal cancer.
 
Vifor and Angion announced that in the 12-month, 253 patient, Phase II, GUARD trial, treatment with ANG-3777 did not reduce the increase in serum creatinine compared to placebo (8.4% vs 7.3%) in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury.
 
Roche announced that in a 62 patient, open-label, Phase I/Ib trial, treatment with mosunetuzumab induced a complete response in 60% and progression-free survival of 17.9 months in patients with relapsed or refractory follicular lymphoma. Roche announced that in a 262 patient, open-label, Phase I/Ib trial, treatment with mosunetuzumab plus polatuzumab induced an objective response rate (ORR) of 65% and a CR rate of 48.3% in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.
 
UCB announced that in the 43-day, 200 patient, Phase III, MycarinG trial, treatment with rozanolixizumab resulted in an improvement in the MG-ADL score compared to placebo in patients with myasthenia gravis.
 
Published Research Updates
 
In the 52-week, 714 patient, Phase III, open-label, TIMES 2 trial, HbA1c was reduced 0.46% with imeglimin alone, 0.56% to 0.92% when combined with oral therapy, 0.12% with a GLP receptor agonist and 0.92% with a DPP-4 inhibitor in Japanese patients with type 2 diabetes. 
 
In the 53 patient, open label Phase I, EXPLORER trial, treatment with avapritinib resulted in an ORR of 75% in patients with advanced systemic mastocytosis. Interim data from 32 patients enrolled in the 103 patient, open label Phase II, PATHFINDER trial, suggested that treatment with avapritinib resulted in an ORR of 75% in patients with advanced systemic mastocytosis. 
 
In the 12-week, 510 patient, Phase III, PSOARING 1 trial, treatment with tapinarof 1% daily resulted in achievement of the Physician Assessment (PGA) score of clear or almost clear and at least a 2-point improvement in the PGA score in 35.4% of patients compared to 6% with placebo in patients with plaque psoriasis. In the 12-week, 515 patient, Phase III, PSOARING 2 trial, treatment with tapinarof 1% daily resulted in achievement of the PGA score of clear or almost clear and at least a 2-point improvement in the PGA score in 40.2% of patients compared to 6.3% with placebo in patients with plaque psoriasis. 
 
In a 26-week, 157 patient, open-label extension of the 4-week, Phase II trial, treatment with ulotaront decreased the PANSS total score by 22.6 points.
 
In a 141 patient, open-label, Phase II trial, adding andecaliximab to nivolumab did not improve the objective response rate compared to nivolumab alone (10% vs 7%) in patients with pretreated metastatic gastric or gastroesophageal junction adenocarcinoma.