publication date: Jul. 31, 2014
20140731 - Jul. 31, 2014
July 2014PDF

Colorectal Cancer 
Trifluridine and Tipiracil Hydrochloride Increase OS, PFS in Phase III Trial

A phase III trial of trifluridine and tipiracil hydrochloride significantly improved both overall and progression-free survival in refractory metastatic colorectal cancer that had progressed after standard therapies. 

Data from the trial of the oral anticancer combination, also known as TAS-102, were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer in Barcelona, Spain.

The global, randomized, double-blind trial, named RECOURSE, met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR=0.68, p < 0.0001). TAS-102 reduced the risk of mortality by 32 percent when compared to placebo. 


IDMC Halts Mekinist-Tafinlar Trial Early Due to OS Benefit; Recommends Crossover

An independent data monitoring committee recommended an early stop a phase III trial of Mekinist and Tafinlar in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma, following a demonstrated overall survival benefit.

The randomized, open-label study, named COMBI-v, compared the combination of Mekinist (trametinib) and Tafinlar (dabrafenib) to vemurafenib in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. 

Gastroenteropancreatic Neuroendocrine Tumors
Somatuline Demonstrates 65.1 Percent Of Patients Progression-Free at 96 Weeks

By priming pancreatic ductal adenocarcinomas with a therapeutic vaccine and a low-dose chemotherapy combination prior to surgery, researchers converted PDACs into cancers that may respond to immunotherapy.

Researchers pretreated PDAC patients with the vaccine GVAX and low doses of the chemotherapy cyclophosphamide, which caused the aggregation of immune cells inside the patients’ tumors, and many of these immune cells expressed proteins that may make these cancers amenable to immunotherapies such as PD-1 inhibitors.

The trial was published in Cancer Immunology Research, a journal of the American Association for Cancer Research, produced in collaboration with the Cancer Research Institute).

Acute Myeloid Leukemia
Volasertib and LDAC Doubled Response in Older Patients
Cervical Cancer
Study: Negative HPV Test More Accurate than Negative Pap Test In Predicting Cancer Risk
Proton Therapy
Phase II Study: Proton Therapy Can Have Similar Success Rate, Smaller Level of Risk in Treatment of Hodgkin Lymphoma
NCI CTEP-Approved Trials for the Month of July
FDA Approvals

  • Zydelig tablets approved for three blood cancers

  • Imbruvica approved in chronic lymphocytic leukemia

  • Avastin granted priority review in metastatic cervical cancer

  • Blinatumomab granted breakthrough therapy designation in acute lymphoblastic leukemia

  • CTL019 granted breakthrough therapy designation in adult and pedtiatric ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Mylan Inc. launches generic carboplatin injection in multi-dose vials

  • FDA approves IBA Cone Beam Computed Tomography proton therapy solution

  • FDA issues drug safety communication regarding docetaxel

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