Update for April 27, 2021
The FDA approved loncastuximab tesirine (Zynlonta, ADC Therapeutics), on 4/21/2021, for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
The FDA approved dostarlimab (Jemperli, GlaxoSmithKline), on 4/22/2021, for the treatment of recurrent or advanced endometrial cancer with deficient mismatch repair. WAC for dostarlimab has been set at $10,000 per 500 mg vial for an estimated monthly cost of $15,000.
Agenus submitted a BLA for balstilimab for the treatment of recurrent/metastatic cervical cancer.
The FDA lifted the hold on uniQure’s hemophilia B gene therapy, etranacogene dezaparvovec, clinical trials after extensive tissue analysis found it unlikely the gene therapy vector contributed to the development of hepatocellular carcinoma.
Announced Research Updates
Sunovion announced that in a six-week, 39 patient, Phase II trial, treatment with SEP-363856 did not differ from placebo in the decrease of the Scale for Assessment of Positive Symptoms–Parkinson’s Disease (SAPS-PD), with a nonsignificant decrease (2.5 points vs 1.4 point decrease), in patients with Parkinson’s psychosis.
Coherus BioSciences and Junshi Biosciences announced interim results from the 514 patient, Phase III JUPITER-06 trial, where treatment with toripalimab in combination with paclitaxel/cisplatin achieved the progression free survival (PFS) and overall survival (OS) primary endpoints in patients with advanced esophageal squamous cell carcinoma.
LEO Pharma announced 56-week results from 513 patients participating in the 268-week, Phase III ECZTEND trial, a long term extension of patients with moderate-to-severe atopic dermatitis that completed the ECZTRA 1 to 8 trials, where continued treatment with tralokinumab resulted in 49.7% achieving IGA 0/1 and 82.8% achieved EASI-75.
Sanofi announced that in a 24-week, Phase II trial, treatment with rilzabrutinib reduced the severity of lesions and corticosteroid use in patients with pemphigus vulgaris.
BMS announced that in the 16-week, 666 patient, Phase III, POETYK PSO-1 trial, 58.7% of patients treated with deucravacitinib achieved PASI 75 and 53.6% achieved a Physician's Global Assessment (sPGA) score of 0 to 1 compared to 35.1% and 32.1% with apremilast and 12.7% and 7.2% with placebo in patients with moderate to severe psoriasis. BMS announced that in the 16-week, 1,020 patient, Phase III, POETYK PSO-2 trial, 53.6% of patients treated with deucravacitinib achieved PASI 75 and 50.3% achieved an sPGA score of 0 to 1 compared to 40.2% and 34.3% with apremilast and 9.4% and 8.6% with placebo in patients with moderate to severe psoriasis. Sanofi announced that in the 150 day, 1,500 patient, Phase III, MEDLEY trial, treatment with nirsevimab reduced the development of RSV-associated lower respiratory tract infection compared to placebo in healthy late preterm and term infants of 35 weeks or greater gestational age.
Published Research Updates
In a 54 patient, open-label, dose-ranging, Phase IIa trial, the overall response rate was 65% with belumosudil 200 mg once daily, 69% with 200 mg twice daily and 62% with 400 mg once daily in patients with chronic graft-versus-host disease.
In the 52-week, 20 patient, open-label, Phase II, ASCEND-Peds trial, treatment with olipudase resulted in a 40% improvement in splenomegaly and hepatomegaly, 32.9% improvement in predicted DLco, 0.56 point improvement in Z-scores and normalization of lipid profiles and liver transaminase in pediatric patients with acid sphingomyelinase deficiency.
In the 59 patient, Phase II, PASSION trial, 47 patients received treatment daily with camrelizumab plus apatinib, which resulted in an objective response rate of 34% in patients with small cell lung cancer.
In the 16-week, 743 patient, Phase IIIB, BE RADIANT trial, 61.7% of patients treated with bimekizumab achieved 100% reduction from baseline in their PASI score compared to 48.9% that received secukinumab in patients with moderate-to-severe chronic plaque psoriasis.
In the 16-week, 478 patient, Phase III, BE SURE trial, 86.2% of patients treated with bimekizumab achieved PASI 90 and 85.3% achieved an IGA score of clear or almost clear compared to 47.2% and 57.2% with adalimumab in patients with moderate-to-severe chronic plaque psoriasis.
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