Announced Research Updates
Aprea Therapeutics announced that in a 12-month, 33 patient, Phase II trial, treatment with eprenetapopt plus azacitidine resulted in relapse free survival of 12.1 months and overall survival of 19.3 months in post-transplant patients with TP53 mutant MDS and AML.
NewAmsterdam Pharma (NAP) announced that in the 8-week, 120 patient, Phase II, ROSE trial, patients treated with obicetrapib 10 mg plus a high-intensity statin regimen achieved an LDL reduction of 51% in patients with an LDL-C > 70 mg/dL and triglycerides < 400 mg/dL, who are already being treated with a high-intensity statin. Results have not been announced for obicetrapib 5 mg nor placebo.
Published Research Updates
In a separate analysis of the 9-month, 1,222 patient, Phase III, SOLOIST-WHF trial, patients treated with sotagliflozin had 2.9 more days alive and out of the hospital. Sotagliflozin patients had a similar number of hospitalizations compared to the placebo group (38.5% vs. 41.4%), but fewer patients required multiple rehospitalizations (16.3% vs 22%).
Interim results after 19-months from the 1,101 patient, Phase II, IPATential150 trial, suggested that ipatasertib, added to abiraterone and prednisone/prednisolone, improved radiographic progression-free survival compared to abiraterone plus prednisone/prednisolone alone (18.5 months vs 16.5 months) in patients with metastatic castration-resistant prostate cancer (mCRPC) with PTEN loss, but not in all mCRPC patients regardless of PTEN status.
In the 283 patient, Phase III, EVIDENCE trial, treatment with icotinib resulted in a disease-free survival of 47 months compared to 22.1 months with vinorelbine/cisplatin for adenocarcinoma and squamous carcinoma or pemetrexed/cisplatin for non-squamous carcinoma in Chinese patients with advanced, epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer.
In a 28-day, 188 patient, Phase II trial, patients treated with oral insulin had a 1.7 mg/dL increase in their mean night-time continuous glucose monitoring (CGM) levels compared to a 13.7 mg/dL increase with placebo in type 2 diabetics receiving metformin.
In a 52-week, 741 patient, open-label, Phase III trial, patients treated with roxadustat increased hemoglobin by 0.39 g/dL compared to a 0.09 g/dL decrease with epoetin alfa in dialysis-dependent CKD patients with anemia, who were receiving erythropoiesis-stimulating agents. In a 24-week, 334 Japanese patient, open-label, Phase III trial, the change in average hemoglobin with roxadustat was non-inferior to darbepoetin alfa (-0.07 g/dl difference) in non-dialysis-dependent CKD patients with anemia, who were receiving erythropoiesis-stimulating agents.
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