Update for the Week Ending May 23, 2020

Regulatory Update
 
The FDA approved artesunate (Amivas LLC), on 5/26/2020, for the treatment of severe malaria in adult and pediatric patients. Until Amivas transitions artesunate's distribution through wholesalers, healthcare providers treating patients with severe malaria should call CDC to obtain IV artesunate. The CDC Malaria Hotline (770-488-7788) is available Monday–Friday, 9 am–5 pm EST. Outside these hours, providers should call 770-488-7100 and ask to speak with a CDC Malaria Branch clinician.
 
The FDA accepted the NDA for Eiger BioPharmaceuticals/Merck’s lonafarnib for treatment of Progeria and Progeroid Laminopathies and set a PDUFA date of 11/20/20.
 
The EMA accepted the MAA for AstraZeneca/FibroGen’s roxadustat for the treatment of anemia in adult patients with chronic kidney disease.
 
The EMA accepted the MAA for Incyte/MorphoSys’ tafasitamab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
 
The EMA accepted the MAA for bluebird bio/Celgene/Bristol-Myers Squibb’s idecabtagene vicleucel for the treatment of adult patients with multiple myeloma who have received at least three prior therapies.
 
Announced Research Updates
 
Viiv announced data from an interim analysis of a 4,600 patient, Phase IIb/III, HIV prophylaxis trial, where 0.38% of patients that received long-acting, injectable cabotegravir every eight weeks developed HIV compared to 1.21% with daily oral emtricitabine/tenofovir disoproxil fumarate in men who have sex with men and transgender women who have sex with men.
 
Kadmon announced that in the 6-month, 126 patient, Phase II, open-label, ROCKstar trial, treatment with belumosudil resulted in an overall response rate of 73% with 200 mg QD and 74% with 200 mg BID in patients with chronic graft-versus-host disease who have received at least two prior lines of systemic therapy.
 
Gilead and Galapagos announced results from the 58-week, 1,348 patient, Phase IIb/III, SELECTION trial. During the first 10 weeks of the trial patients received filgotinib 100 mg, 200 mg or placebo. Patients treated with filgotinib 100 mg did not achieve remission more than placebo, while the 200 mg dose did provide an improvement in the number of patients achieving remission. The 558 patients that achieved remission were re-randomized to filgotinib or placebo for an additional 48 weeks. In the maintenance part of the trial, 37.2% of patients treated with filgotinib 200 mg achieved clinical remission compared to 11.2% with placebo and 23.8% treated with filgotinib 100 mg achieved clinical remission compared to 13.5% with placebo in patients with ulcerative colitis.
 
Syndax announced that in a 608 patient, Phase III trial, entinostat plus exemestane did not improve overall survival in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer that had progressed on a non-steroidal aromatase inhibitor. Due to the lack of efficacy in the Phase III metastatic cancer trial, Syndax will not file an NDA for that indication.
 
Published Research Updates
 
In a 180 patient, Phase II trial, treatment with tremelimumab plus durvalumab resulted in overall survival of 6.6 months compared to 4.1 months with best supportive care in patients with urothelial cancer (note this trial defined statistical significance as a 2-sided p < 0.10 and the achieved difference was a p = 0.7).
 
In an 8-week, 204 patient, Phase II trial, 33.3% of patients treated with serlopitant reduced their Worst Itch Numeric Rating Scale (WI-NRS) score by at least 4 points compared to 21.1% with placebo in patients with mild to moderate psoriasis.
 
In a 50-patient, Phase II trial, treatment with camrelizumab plus apatinib resulted in an overall response rate of 43.3% of 40 patients that received continuously dosed apatinib, but 0% in 10 patients that received intermittent apatinib in patients with triple-negative breast cancer.
 
In a 48 patient, Phase II study, P2Y12 reaction units < 100 was achieved by 91% of patients that received a single 8 mg subcutaneous dose of selatogrel and 96% that received a 16 mg dose in patients that were experiencing an acute myocardial infarction.
 
In the 34-patient, Phase II, open-label, EVOLVE trial, treatment with cediranib plus olaparib resulted in objective responses and PFS of 0%/55% in platinum-sensitive patients, 20%/50% in platinum-resistant patients, and 8%/39% in highly resistant disease in patients with PARP inhibitor resistance ovarian cancer.