publication date: Sep. 22, 2016
CCL 39-08 - Sep. 22, 2016
August/September 2016PDF

 

 

Non-Small Cell Lung Cancer

Tecentriq Demonstrates Increase In Overall NSCLC Survival in Phase III Study

Genentech announced positive results for Tecentriq (atezolizumab) from the Phase III study OAK. The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer whose disease progressed on or after treatment with platinum-based chemotherapy.

Adverse events were consistent with what has been previously observed for Tecentriq. Genentech, a member of the Roche Group, will present full results at an upcoming medical meeting in 2016.

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Lymphoma

Adcetris Improves ORR4 in Phase III Trial

Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. said that the phase III ALCANZA clinical trial evaluating Adcetris (brentuximab vedotin) in cutaneous T-cell lymphoma met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4).

This randomized trial, which received a Special Protocol Assessment from FDA and scientific advice from the European Medicines Agency, compared the use of single-agent Adcetris to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.

 

Breast Cancer

Abemaciclib Phase III Trial Continues After Interim Efficacy Criteria Not Met

Eli Lilly and Co. said that following a pre-planned interim analysis of the MONARCH 2 trial, an independent data monitoring committee provided the recommendation to continue the study without modification as the interim efficacy criteria were not met.

The phase III trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

 

Prostate Cancer

Custirsen Trial Fails to Show Improvement in Survival

 

Melanoma

Two-drug Immunotherapy May Produce Better Survival in Advanced Melanoma

 

Hepatocellular Carcinoma

Study Confirms Association Between RFA Burn Time, OS In Patients Receiving ThermoDox

 

Kidney Cancer

Study Finds HIF-2 Inhibitors More Effective Than Sunitinib

 

Regulatory Actions

Novartis, MEI Pharma. Receive Breakthrough Therapy Designations

 

NCI CTEP-Approved Trials for the Months of August and September

 

Screening

FDA Warns Against Ovarian Cancer Screening

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