Update for September 14, 2021

Regulatory Update
 
The FDA accepted the BLA for tislelizumab to treat unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma and set a PDUFA date for 7/12/22.
 
Announced Research Updates
 
Sanofi announced that in the 37 week, 131 patient, Phase III, PEGASUS trial, treatment with rilzabrutinib did not increase the remission rate compared to placebo in patients with moderate-to-severe pemphigus.
 
AstraZeneca announced that in the 1,013 patient, Phase III, open-label, POSEIDON trial, patients treated with durvalumab, tremelimumab and platinum-based chemotherapy achieved OS of 14 months and PFS of 6.2 months compared to 11.7 months and 4.8 months with platinum-based chemotherapy alone in patients with metastatic non-squamous or squamous non-small cell lung cancer without epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions. 
 
Lilly announced that in the BRUIN trial, treatment with pirtobrutinib resulted in an overall response rate of 52% in 61 MCL patients and 63% in 139 chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients.
 
AB Science announced that in the 60-month, 712 patient, Phase III, AB12003 trial, treatment with masitinib plus docetaxel did not improve progression free survival (PFS) compared to docetaxel alone in the overall population of patients with metastatic Castrate Refractory Prostate Cancer. PFS was increased with masitinib plus docetaxel in patients with an ALP of 250 IU/mL or <.
 
Published Research Updates
 
In a three-year, 6,861 patient, Phase III trial, three doses of RTS,S/AS01 in the first year, followed by a booster dose in year two and three resulted in 278 cases of malaria per 1000 person-years compared to 305 cases per 1000 person-years with sulphadoxine/pyrimethamine plus amodiaquine chemoprevention and 113 cases per 1000 person-years with the combination of vaccine and chemoprevention in children 5 to 17 months of age in sub-Saharan Africa.
 
J&J is discontinuing the 2,637 patient, Phase IIb, Imbokodo trial, when the primary analysis failed to find a reduction in the incidence of HIV infection with the J&J HIV vaccine in a population of young women in sub-Saharan Africa at high risk of acquiring HIV.