August's top stories: Pfizer’s cancer trial, Jardiance diabetes study results
Pfizer, Alliance Foundation Trials (AFT) and Austrian Breast & Colorectal Cancer Study Group (ABCSG) have launched Ibrance’s trial for receptor-positive early breast cancer, AstraZeneca and Peregrine partner for combination clinical trial in solid tumours and Boehringer and Eli Lilly present Jardiance study results for type 2 diabetes. Drugdevelopment-technology.com wraps up key headlines from August.
US-based drugmaker Pfizer, Alliance Foundation Trials (AFT) and Austrian Breast & Colorectal Cancer Study Group (ABCSG) launched Phase III trial of Ibrance (palbociclib) for patients with hormone receptor-positive early breast cancer.
The Palbociclib Collaborative Adjuvant Study (PALLAS) will assess whether the addition of Ibrance, developed by Pfizer, to standard therapy will improve disease-free survival and prevent the disease from recurring.
The study for patients with early-stage breast cancer is being carried out in conjunction with Breast International Group (BIG), German Breast Group (GBG), National Surgical Adjuvant Breast and Bowel Project (NSABP), and PrECOG.
UK-Swedish drugmaker AstraZeneca established a clinical trial collaboration with Peregrine Pharmaceuticals to assess the safety and efficacy of bavituximab in combination with durvalumab (MEDI4736) in multiple solid tumours.
The Phase I / Ib trial has been designed to assess the safety and efficacy of Peregrine's investigational phosphatidylserine (PS) signalling pathway inhibitor bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor durvalumab.
Bavituximab and durvalumab are investigational immunotherapies with different mechanisms, which will help the body's immune system to fight against cancer.
Bavituximab is said to target and modulate the activity of phosphatidylserine, while durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1).
Boehringer Ingelheim and Eli Lilly presented positive top-line results of Jardiance (empagliflozin) from the EMPA-REG OUTCOME study in type 2 diabetes patients at high risk of cardiovascular (CV) events.
According to the firm, the study met its primary endpoint and showed superiority of Jardiance, when added to standard of care in CV reduction.
The primary endpoint was defined as time to first occurrence of either CV death or non-fatal myocardial infarction or non-fatal stroke.
Jardiance is claimed to be the only glucose-lowering agent that has demonstrated CV risk reduction in a dedicated cardiovascular outcomes trial.
Roche reported positive results from the Phase II M13-982 study, which is designed to assess the efficacy and safety of venetoclax in people with relapsed or refractory chronic lymphocytic leukaemia (CLL) harbouring the 17p deletion.
Venetoclax is an investigational medicine being developed in collaboration with AbbVie. It is designed to selectively bind and inhibit the BCL-2 protein that plays a crucial role in a process known as apoptosis (programmed cell death).
According to Roche, the trial reached its primary endpoint demonstrating that venetoclax monotherapy resulted in a clinically meaningful reduction in the number of cancer cells in a pre-defined proportion of people with previously treated CLL harbouring the 17p deletion.
Clinical-stage immunotherapy firm Immune Design partnered with the subsidiaries of Merck to assess the safety and efficacy of its oncology investigative agents, G100 and LV305, with Merck's Keytruda (pembrolizumab) for non-Hodgkin's lymphoma (NHL) and melanoma.
The Phase I trials will evaluate the safety and efficacy of both investigative agents separately combined with an anti-PD-1 therapy Keytruda for NHL and melanoma.
Keytruda is a humanised monoclonal antibody, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Immune Design president and CEO Dr Carlos Paya said: "There is great potential to expand the potential of immunotherapy through combination approaches that will stimulate and enhance the immune system in order to mount the strongest response against cancer."
Eisai and Halozyme Therapeutics signed clinical collaboration agreement, under which the firms will assess Eisai's agent eribulin mesylate in combination with Halozyme's investigational drug PEGPH20 to treat metastatic breast cancer.
The Phase Ib / II study will assess eribulin mesylate (Halaven) in combination with PEGPH20 (PEGylated recombinant human hyaluronidase) in first-line HER2-negative metastatic breast cancer.
Halozyme Therapeutics president and CEO Dr Helen Torley said: "This agreement marks the first clinical collaboration agreement for Halozyme and extends the study of PEGPH20 to a substantially wider population of patients with a partner that is a clear leader in the treatment of metastatic breast cancer."
Clinical-stage biopharmaceutical firm Cellceutix started the Phase II trial of Prurisol for the treatment of plaque psoriasis.
The multi-centre trial has been designed to evaluate the efficacy and safety of Prurisol given orally compared to placebo in a randomised and double-blind setting in patients with mild to moderate chronic plaque psoriasis.
The company plans to enrol around 100 subjects in the study.
According to the firm, the primary efficacy endpoint of the trial will be the percentage of subjects with greater than or equal to a two-point improvement in investigator's global assessment (IGA) rating as defined by visual inspections of patient lesions.
Symbiomix Therapeutics presented the first pivotal trial results of its drug candidate SYM-1219 for the treatment of bacterial vaginosis (BV).
SYM-1219 is a single-dose and novel oral product that includes secnidazole, an antibiotic with favourable pharmacokinetics (PK) allowing for single-dose oral therapy to treat BV.
According to the firm, the trial results demonstrated that a single oral dose of SYM-1219 met the primary endpoint of clinical outcome responder (COR) and was well tolerated to treat BV.