By Scot Walker on 10/1/2019
Announced Research Updates
1. Helixmith announced that in a 3-month, 500 patient, Phase III trial, VM202 did not improve the verage pain score compared to placebo in patients with painful diabetic peripheral neuropathy.
2. GenSight announced that in the 96-week, 36 patient, Phase III, RESCUE trial, the eyes treated with lenadogen nolparvovec had an improvement in visual acuity of 24.9 letters in the ETDRS scale compared to a gain of 22.3 letters in the eyes that received sham injection in patients with LHON who had suffered vision loss of less than 6 months. Patients acted as their own controls with one eye injected with lenadogen nolparvovec and the other eye receiving a sham injection.
3. BeiGene announced interim data from a 54 patient, Phase II, open label, Chinese trial, where treatment with tislelizumab resulted in an overall response rate of 66.7% in patients with advanced lung cancer.
4. Urovant announced that in a 40-week blinded extension of the EMPWUR trial that followed 506 patients from the original trial population, treatment with vibegron continued to reduce micturitions per 24 hours and urge urinary incontinence episodes per 24 hours.
5. Pfizer announced that in a 12-week, 391 patient, Phase III, JADE MONO-2 trial, more patients treated with abrocitinib 100 mg and 200 mg achieved an Investigator Global Assessment (IGA) score of clear or almost clear skin, had a 2 point or > improvement in the IGA score and had more patients achieve at least a 75% or greater improvement in their Eczema Area and Severity Index (EASI) score compared to placebo in patients with moderate to severe atopic dermatitis.
6. Daiichi Sankyo and AstraZeneca announced that interim results from 23 patients from the Phase II, open-label, MOUNTAINEER trial, treatment with tucatinib in combination with trastuzumab resulted in an objective response rate of 52.2% in patients with HER2-positive (HER2+), RAS wild-type metastatic colorectal cancer (mCRC) after treatment with first- and second-line standard-of-care therapies.
7. Astellas and Seattle Genetics announced interim results from 45 patients in a Phase I, open label trial, where treatment with enfortumab vedotin plus pembrolizumab resulted in a 71% objective response rate in patients with locally advanced or metastatic urothelial cancer who progressed after receiving platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
8. Avanir announced that in a 12-week, 522 patient, Phase III trial, treatment with deudextromethorphan/quinidine did not improve the Cohen-Mansfield Agitation Inventory score compared to placebo in patients with agitation associated with dementia of Alzheimer's disease.
9. Lilly announced interim data from the 55 patients in the Phase I/II LIBRETTO-001, open-label trial with RET-mutant medullary thyroid cancer patients who had previously received cabozantinib and/or vandetanib, where treatment with selpercatinib resulted in a 56% objective response rate.
10. Immunomedics announced interim data from 35 patients in the Phase II, open label, TROPHY-U-O1 trial found that treatment with sacituzumab govitecan resulted in an ORR of 29% in patients with metastatic urothelial carcinoma who progressed after treatment with platinum-based therapy and checkpoint inhibitors.
11. ImmunoGen announced that in the 366 patient, Phase III, FORWARD I trial, mirvetuximab soravtansine did not improve progression-free survival compared to standard chemotherapy in patients with folate receptor alpha-positive, platinum-resistant ovarian cancer and had received up to three prior lines of therapy.
Published Research Updates
In the 12-month, 501 patient, dose ranging, Phase II, ORION-1 trial, the reduction in LDL with inclisiran was 29.5% to 38.7% with a single dose of the drug and 29.9% to 46.4% with a second dose at 3-months in patients with elevated LDL-C despite maximally tolerated statin therapy.
In a 52-week, 368 patient, Phase III, open-label trial, treatment with esaxerenone decreased systolic blood pressure by 23.1 mm Hg, diastolic blood pressure by 12.5 mm Hg and 66% of patients were maintained on monotherapy in Japanese patients with essential hypertension.
In a 1,140 patient, Phase III trial, veliparib added to carboplatin and paclitaxel followed by veliparib maintenance therapy improved progression-free survival compared to carboplatin plus paclitaxel induction therapy alone (34.7 months vs 22.0 months) in patients with previously untreated stage III or IV high-grade serous ovarian carcinoma.