The FDA approved sacituzumab govitecan (Trodelvy, Immunomedics) on 4/22/2020 to treat resistant metastatic triple-negative breast cancer. Trodelvy has a boxed warning about the potential risks for severe diarrhea and neutropenia.
Biogen has delayed plans to file a BLA for aducanumab (for the treatment of Alzheimer’s disease) from early 2020 to 3Q20.
Announced Research Updates
Scynexis announced that in the 188 patient, Phase III, VANISH-306 trial, treatment with ibrexafungerp resulted in clinical cure at day 10 in 68.3% of patients compared to an unknown percentage that received placebo in female patients with vulvovaginal candidiasis. Scynexis plans to submit an NDA for ibrexafungerp in second half of 2020.
Cara announced that in the 12-week, 473 patient, Phase III, KALM-2 trial, 54% of patients treated with difelikefalin had a 3-point or > improvement in the weekly mean WI-NRS compared to 42% with placebo in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus. Cara plans to submit an NDA for difelikefalin by the end of 2020.
Myovant announced that in the 24-week, 600 patient, Phase III, SPIRIT 2 trial, treatment with relugolix plus estradiol and norethindrone reduced dysmenorrhea (75.2% vs 30.4%) and non-menstrual pelvic pain (66.0% vs 42.6%) compared to placebo in patients with with pain associated with endometriosis. Myovant submitted an NDA for relugolix for the treatment of prostate cancer in April 2020 and plans to submit an NDA for use of the drug in the treatment of uterine fibroids in May 2020.
GSK announced that interim data from 70 patients enrolled in the Phase III GARNET trial, suggested a 43% objective response rate with treatment with dostarlimab in patients with previously treated recurrent or advanced mismatch repair (MMR)-deficient endometrial cancer.
Published Research Updates
In a 12-week, 708 patient, Phase III trial, 18.4% of patients treated with clascoterone 1% cream achieved an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement, compared to 9% with placebo in patients with moderate or severe facial acne. In a 12-week, 732 patient, Phase III trial, 20.3% of patients treated with clascoterone 1% cream achieved an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement, compared to 6.5% with placebo in patients with moderate or severe facial acne.
In the 18-month, 95 patient, Phase III, SAkuraStar trial, 70% of patients treated with satralizumab were relapse-free compared to 50% with placebo in patients with neuromyelitis optica spectrum disorder.
In a 28-day, 29 patient, Phase I, open-label trial, 78.6% of patients treated with itacitinib 200 mg plus corticosteroids and 66.7% of patients receiving 300 mg plus corticosteroids achieved an overall response in patients who developed acute graft-versus-host disease following allogeneic hematopoietic cell transplantation.
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