Genentech said the phase III KATHERINE study met its primary endpoint, showing Kadcyla (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival) by 50 percent (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant treatment.
Novartis announced additional analysis from the global phase III SOLAR-1 trial investigating the alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant in men and postmenopausal women with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.
Novartis announced data from subgroup analyses of the three pivotal phase III MONALEESA trials showing that Kisqali (ribociclib) plus endocrine therapy extended progression-free survival compared to endocrine therapy alone, regardless of the presence of visceral metastases in pre-, peri- and postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer.
Insight Genetics Inc. announced the launch of its proprietary Insight TNBCtype, a new test for categorizing triple negative breast cancer tumors into distinct molecular subtypes through its wholly owned CLIA- and CAP-accredited lab, Insight Molecular Labs.
Biotheranostics Inc. presented data evaluating the impact of the Breast Cancer Index in early stage hormone receptor positive breast cancer patients classified as intermediate risk for distant recurrence by previous genomic testing.
First line immunotherapy with Imfinzi (durvalumab) or the combination of durvalumab and tremelimumab does not improve overall survival in unselected patients with lung cancer, according to late breaking results from the MYSTIC trial presented at the ESMO Immuno-Oncology Congress.
Cumberland Pharmaceuticals Inc., a U.S. specialty pharmaceutical company and Clinigen Group, the global pharmaceutical and services company, announce a new publication in Lung Cancer: Targets and Therapy of a contemporary retrospective series showing that subcutaneous amifostine administered before radiotherapy postponed the onset of acute esophagitis in stage III small cell lung cancer patients treated with concomitant doublet chemotherapy and hyperfractionated radiotherapy.
Kite, a Gilead company, announced two-year efficacy and safety data from the pivotal ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of two years after a single infusion of Yescarta (median follow up of 27.1 months), 39 percent of patients were in an ongoing response.
Kite, a Gilead company, announced updated results from ZUMA-3, a single-arm phase I/II study evaluating KTE-X19 (formerly KTE-C19), an investigational CD19 chimeric antigen receptor T cell therapy, in adult patients with relapsed or refractory acute lymphoblastic leukemia.
An interim analysis of a large phase III clinical trial found that the combination of ibrutinib plus rituximab was superior to standard treatment for patients age 70 and younger with previously untreated chronic lymphocytic leukemia.
