Davy James

2 months ago | appliedclinicaltrialsonline.com | Davy James

The latest findings released from the Phase III EV-302/KEYNOTE-A39 (NCT04223856) trial show that the combination of Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced sustained benefits in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).1,2 The FDA approved the combination for la/mUC in December 2023 based on results from the EV-302 trial.3...

2 months ago | appliedclinicaltrialsonline.com | Davy James

Updated results from the Phase III REGENCY trial (NCT04221477) show that patients with lupus nephritis administered Gazyva/Gazyvaro (obinutuzumab) plus standard therapy achieved a statistically significant and clinically meaningful improvement in complete renal response (CRR) compared to standard therapy alone.1,2 The trial data, also published by The New England Journal of Medicine, bolster prior findings suggesting deep B-cell depletion with Gazyva/Gazyvaro is an effective therapeutic...

2 months ago | appliedclinicaltrialsonline.com | Davy James

The addition of the immune checkpoint inhibitor Tecentriq (atezolizumab) to postoperative chemotherapy was not found to improve treatment outcomes for patients with high-risk early-stage triple-negative breast cancer (TNBC), according to results from the Phase III ALEXANDRA/IMpassion030 trial (NCT03498716) published by JAMA Network Open.1,2 These findings reinforce the use of preoperative chemoimmunotherapy followed by surgery in the treatment of these patients, according to the study authors.

2 months ago | appliedclinicaltrialsonline.com | Davy James

Updated topline data from the Phase III BREAKWATER trial (NCT0460742) show the combination of Braftovi (encorafenib) plus Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy with or without bevacizumab in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.1,2 These data follow...

2 months ago | appliedclinicaltrialsonline.com | Davy James

Findings from a 12-month open-label extension (OLE) of the Phase Ib/IIa PACIFIC trial demonstrated patients with developmental and epileptic encephalopathies (DEEs) treated with bexicaserin experienced a significant reduction in seizure frequency with a tolerable safety profile.1 Bexicaserin, a 5-HT2C receptor agonist, was originally developed by Longboard Pharmaceuticals, which was acquired by H.