Genentech announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ plus chemotherapy (carboplatin and ABRAXANE) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial treatment of people with advanced squamous non-small cell lung cancer (NSCLC). The study enrolled 1,021 people who were randomized equally (1:1:1) IMpower131 is a Phase III, open-label, multicenter, randomized study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and nab-paclitaxel or TECENTRIQ in combination with carboplatin and paclitaxel versus chemotherapy alone in people with stage IV squamous NSCLC. During the treatment-induction phase, people in Arm A received four or six cycles of TECENTRIQ plus carboplatin and paclitaxel, given on day one of each 21-day cycle. During the treatment-induction phase, people in Arm B received four or six cycles of TECENTRIQ, carboplatin and nab-paclitaxel. During the treatment-induction phase, people in Arm C received four or six cycles of carboplatin and nab-paclitaxel. IMpower131 met its PFS co-primary endpoint per study protocol.
Cidara Therapeutics reported that the randomized, controlled Phase II RADIANT clinical trial in acute vulvovaginal candidiasis (VVC) did not show sufficient efficacy to justify further development of the tested topical formulations. RADIANT was designed to evaluate gel and ointment topical formulations of the novel echinocandin antifungal CD101 in women with moderate-to-severe acute VVC. RADIANT was a multicenter, randomized, open-label, active-controlled, dose-ranging trial that enrolled 125 patients into three treatment cohorts. In the first cohort, 50 patients were treated with CD101 Gel; a second cohort of 50 patients was treated with CD101 Ointment. The third cohort comprised 25 patients treated with oral fluconazole. The trial included women with and without a history of recurrent VVC (RVVC). The study found that the gel and ointment topical formulations of CD101 evaluated in RADIANT were similar in efficacy to each other but lower in clinical and mycological cure rates compared to oral fluconazole.
Alexion Pharmaceuticals announced that the pivotal Phase III study of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, demonstrated non-inferiority to Soliris in complement inhibitor treatment-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH). This Phase III, randomized, open-label, active-controlled, multinational, and multicenter study evaluated the efficacy and safety of ALXN1210 compared to Soliris administered by intravenous (IV) infusion to adult patients (? 18 years of age) with PNH. The study enrolled 246 adult patients with a confirmed diagnosis of PNH. The study demonstrated non-inferiority on all four key secondary endpoints: percentage change from baseline in LDH levels, change from baseline in quality of life, proportion of patients with breakthrough hemolysis and proportion of patients with stabilized hemoglobin levels. In addition, numeric results for all six endpoints favored ALXN1210. Although ALXN1210 did not achieve superiority, a numeric trend in favor of ALXN1210 was observed for breakthrough hemolysis (4.0 percent [0.6 percent, 7.4 percent] vs. 10.7 percent [5.2 percent,16.3 percent] for Soliris) with a p-value of 0.074. The study also confirmed that ALXN1210 provides immediate and complete (>99 percent) inhibition of the complement C5 protein that is sustained over the entire 8 week dosing interval.
Array BioPharma announced results of its multicenter, open-label, randomized Phase III COLUMBUS trial for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. In the analysis of the primary endpoint, the median progression-free survival (mPFS) for patients treated with the combination of encorafenib, 450 mg daily, plus binimetinib, 45 mg twice daily (COMBO450) was 14.9 months versus 7.3 months for patients treated with vemurafenib, 960 mg twice daily [hazard ratio (HR) 0.54, 95 percent CI 0.41-0.71; p<0.0001]. The combination of encorafenib and binimetinib was generally well-tolerated. The median duration of treatment was 51.2 weeks (27.1-79.7) for encorafenib and 50.6 weeks (26.1-79.7) for binimetinib. The median dose intensity was 100 percent (93-100) of planned doses of encorafenib and 99.6 percent (80-100) of planned doses of binimetinib.
AOBiome Therapeutics announced clinical findings from Part 1 of a Phase Ib/IIa clinical trial of the company’s first-in-class Ammonia Oxidizing Bacteria (AOB) product candidate for intranasal delivery. AOBiome’s candidate is a single strain of beneficial AOB, Nitrosomonas eutropha, that converts naturally occurring ammonia to nitric oxide, a signaling molecule well known to regulate inflammation and vasodilation. In Part 1 of the double-blind, multi-dose, vehicle-controlled Phase Ib/IIa trial, AOBiome’s candidate demonstrated promising safety and tolerability when delivered intranasally to healthy volunteers (N=24, randomized 1:1:1 high dose AOB, low dose, and vehicle) over a period of two week. Based on these promising results, AOBiome announced that it has initiated Part 2 of its Phase Ib/IIa trial to assess preliminary efficacy in subjects with seasonal allergic rhinitis (SAR).
AstraZeneca announced the results of DERIVE, a Phase III study that evaluated the efficacy and safety of FARXIGA® (dapagliflozin 10 mg), in patients with type 2 diabetes (T2D) with moderate renal impairment (chronic kidney disease [CKD] stage 3A with eGFR of 45-59 mL /min /1 .73m2). The DERIVE trial randomized 321 patients with T2D (hemoglobin A1C [HbA1C] between 7-11 percent; mean 8.2 percent) and stage 3A CKD (mean estimated glomerular filtration rate [eGFR] 53 mL/min/1.73m2) from eight countries and treated them with either dapagliflozin 10 mg or placebo over 24 weeks. Dapagliflozin 10 mg significantly decreased mean HbA1C (-0.37 percent) vs placebo (-0.03 percent) from baseline to week 24 (difference -0.34 percent, p < 0.001). The study met its primary and secondary efficacy endpoints.
Heron Therapeutics announced positive topline results from its completed Phase III studies of the investigational agent HTX-011 in subjects undergoing bunionectomy (Study 301/EPOCH1) and hernia repair (Study 302/EPOCH2). EPOCH1 was a randomized, placebo- and active-controlled, double-blind, Phase III clinical study evaluating the efficacy and safety of locally administered HTX-011 at 60 mg compared to the standard dose of bupivacaine solution (50 mg) and placebo for post-operative pain control following bunionectomy surgery in 412 subjects. HTX-011 achieved all primary and key secondary endpoints in both Phase III trials, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications through 72 hours following surgery. The primary endpoint was pain intensity as measured by the Area Under the Curve (AUC) score from 0 to 72 hours post-surgery (AUC 0-72) compared to placebo. HTX-011 was well tolerated in both studies, with a safety profile comparable to placebo and bupivacaine solution. There were no drug-related serious adverse events or discontinuations due to drug-related adverse events in HTX-011-treated patients, and there were fewer opioid-related adverse events in HTX-011-treated patients.
Gastrointestinal Safety Study Antibe Therapeutics announced that its lead drug, ATB-346, met its primary endpoint in the Phase IIB gastrointestinal (“GI”) safety study. The double-blind study was conducted in 244 healthy volunteers and was designed to demonstrate the superiority of ATB-346 in GI safety compared to naproxen, the most prescribed nonsteroidal anti-inflammatory drug (“NSAID”) in the USA. Subjects on ATB-346 exhibited an ulceration rate of 2.5 percent versus an ulceration rate of 42.1 percent for subjects on naproxen at the end of the 2-week treatment period, with a very high degree of statistical significance (p<0.001). Subjects received either 250 mg of ATB-346 once-daily, a dose previously shown to be very effective in reducing osteoarthritis-associated pain, or 500 mg of naproxen twice-daily. The primary endpoint for the study was the incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth, considered the gold standard in assessing the GI safety of NSAIDs.
Arena Pharmaceuticals announced positive topline Phase II results from the OASIS trial for etrasimod, an investigational, once-daily, orally administered, selective sphingosine 1- phosphate (S1P) receptor modulator in development for the treatment of ulcerative colitis (UC). Patients receiving the 2 mg dose of etrasimod achieved statistically significant improvements versus placebo in the primary, all secondary, and clinical remission endpoints. OASIS was a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to assess safety and efficacy of two orally administered doses (1 mg and 2 mg) of etrasimod in patients with ulcerative colitis (UC) across 71 sites in 16 countries. Relative to placebo, there was a statistically significant (p = 0.009) 0.99 point improvement in a 3-component (stool frequency, rectal bleeding and findings on endoscopy) Mayo Clinic Score (ranging from 0 to 9) with etrasimod 2 mg at week 12. In the 1 mg group, there was a 0.43 point improvement in 3-component Mayo Clinic Score at week 12 relative to placebo, which was not statistically significant (p = 0.146). More patients in the etrasimod 2 mg group achieved endoscopic improvement compared with placebo (41.8 percent vs. 17.8 percent, p = 0.003).