Tagrisso Demonstrates Superiority over Chemotherapy in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca today presented data from the AURA3 trial that data is supportive of Tagrisso (osimertinib) potentially becoming the new standard of care for 2nd-line treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive locally-advanced or metastatic non-small cell lung cancer (NSCLC). The first randomised Phase III data showed that Tagrisso 2nd-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3). The results were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the International Association for the Study of Lung Cancer, and published simultaneously online in The New England Journal of Medicine.”

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Nivolumab Combos Explored in First-Line NSCLC Trial

Excerpt:

“Although nivolumab (Opdivo) has demonstrated a clear survival advantage compared with chemotherapy in patients with progressive non–small cell lung cancer (NSCLC) who express PD-L1 in their tumor cells, the same cannot be said for those who are PD-L1–negative.

“As a result, researchers are seeking to elicit antitumor activity in a broader range of patients, notably through a multiarm trial evaluating the PD-1 inhibitor along with combinatorial approaches.

“CheckMate-227 (NCT02477826) is a phase III, open-label, randomized trial for patients with chemotherapy-naïve stage IV or recurrent NSCLC. The trial will enroll patients into separate groups according to PD-L1 expression status (≥1% or <1%).”

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Entinostat Anchors New Combo in HR+ Breast Cancer Study

Excerpt:

“A dual approach to overcoming resistance to endocrine therapy in patients with advanced hormone receptor (HR)–positive breast cancer is under investigation in a phase III trial that adds the novel drug entinostat to standard exemestane therapy after disease progression.

“The combination has generated excitement in the oncology drug development field after demonstrating an 8-month overall survival (OS) benefit over exemestane alone in the phase II ENCORE 301 study. Those positive results prompted the FDA to grant a breakthrough therapy designation to entinostat in this setting.”

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Fulvestrant Bests Anastrozole in Phase III Breast Cancer Study

Excerpt:

“First-line treatment with fulvestrant (Faslodex) led to significantly better progression-free survival (PFS) compared with anastrozole for patients with hormone receptor (HR)-positive advanced breast cancer, according to findings from the phase III FALCON trial reported at the 2016 ESMO Congress.

“Confirming results of an earlier phase II study, the FALCON trial yielded a median PFS of 16.6 months with fulvestrant versus 13.8 months with anastrozole. Moreover, a consistent advantage favoring fulvestrant emerged from a subgroup analysis. The overall advantage appeared to be driven by a substantial difference in PFS among patients without visceral metastases treated with fulvestrant.”

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Study Finds Ribociclib Improves Progression-Free Survival for Women with Metastatic Breast Cancer

Excerpt:

“In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, ribociclib, in combination with the aromatase inhibitor letrozole, dramatically improved progression-free survival (PFS) of post-menopausal women with hormone receptor-positive metastatic breast cancer, compared to the hormone therapy alone.

“The study found a 44 percent improvement in PFS with ribociclib, a CDK4/6 inhibitor, and letrozole as a front line therapy. Gabriel Hortobagyi, M.D., professor of Breast Medical Oncology, presented the findings at ESMO 2016 Congress, and is the corresponding author of the New England Journal of Medicine paper.”

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Significant Survival Gains with Atezolizumab vs Docetaxel for Non-Small-Cell Lung Cancer

Excerpt:

“The first phase III study of PD-L1 inhibitor atezolizumab in previously-treated non-small-cell lung cancer has seen significant improvements in survival compared to standard chemotherapy, researchers reported at the ESMO 2016 Congress in Copenhagen.

“PD-L1 inhibitors are of a class of cancer immunotherapies called checkpoint inhibitors, and work by inhibiting one of the mechanisms of resistance developed by cancer cells in order to evade the immune system.”

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Pembrolizumab New Option for First Line Treatment of Patients with Advanced Lung Cancer and High PD-L1 Expression

Excerpt:
“Pembrolizumab is set to become a new option for first line treatment of patients with advanced lung cancer and high PD-L1 expression, according to the results of the phase III KEYNOTE-024 trial presented at the ESMO 2016 Congress in Copenhagen and published in the New England Journal of Medicine.

“‘Pembrolizumab is a PD-1 antibody approved for second line treatment of patients with advanced non-small-cell lung cancer (NSCLC) and PD-L1 expression in their tumour cells,’ said lead author Professor Martin Reck, chief oncology physician, Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany. ‘KEYNOTE-024 is the first phase III trial of pembrolizumab as first line treatment in patients with high PD-L1 expression, who represent 27-30% of those with advanced NSCLC.’ ”

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NET Oncogene Patterns Don’t Fit the Classic Mold

Excerpt:

“Matthew H. Kulke, MD, MMSc, has been a leader in the development of new therapies and clinical management strategies for patients with neuroendocrine tumors (NETs).

“In a recent milestone, Kulke presented phase III clinical trial data at the 2015 European Cancer Congress indicating that telotristat etiprate, a novel tryptophan hydroxylase inhibitor, improves diarrhea control in combination with a somatostatin analog for patients with metastatic NETs and inadequately controlled carcinoid syndrome. In the clinical arena, Kulke serves as co-chair for the National Comprehensive Cancer Network guidelines panel on NETs and also is an active member of medical society advisory boards and task forces related to NETs.”

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Custirsen Combo Falls Short in Phase III mCRPC Trial

Excerpt:

“Adding custirsen to cabazitaxel (Jevtana) and prednisone in the second-line setting failed to improve overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC) in the phase III AFFINITY trial, according to OncoGenex, the company developing the drug.

“The open-label AFFINITY trial included 634 men with mCRPC who progressed on docetaxel. Patients were randomized to cabazitaxel plus prednisone with or without weekly custirsen. Treatment was administered until progression, unacceptable toxicity, or the completion of 10 cycles. The study was conducted at 95 locations in North America, Europe, Russia, and Australia.”

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