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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Pivotal ARMOR 3-SV Prostate Cancer Trial Discontinued After PFS Rates Miss the Mark

Excerpt:

“The pivotal phase III prostate cancer trial ARMOR 3-SV will be discontinued based on recommendations made by the trial’s independent data monitoring committee (DMC), according to the manufacturer Tokai Pharmaceuticals. The DMC concluded that ARMOR 3-SV would unlikely meet its primary endpoint of demonstrating improved radiographic progression-free survival (PFS) based on its review of all safety and efficacy data. Top-line data from the trial is not expected until next year.

“It’s a big setback for the company, which was seeking the right niche for the agent in a crowded prostate cancer treatment market. ARMOR 3-SV compared galeterone with enzalutamide (Xtandi) in patients with treatment-naïve metastatic castration-resistant prostate cancer (mCRPC), particularly in patients whose prostate tumors expressed AR-V7. These truncated ARs are missing the C-terminal end of the AR that contains the ligand-binding domain, which is known as C-terminal loss. AR-V7 is the most common form of C-terminal loss of androgen receptors (ARs), a key target in resistance. This form of AR-V7 is also thought to make patients unlikely to respond to either enzalutamide or abiraterone acetate (Zytiga).”

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Final OS Analysis Confirms Cobimetinib/Vemurafenib Benefit in Melanoma

Excerpt:

“Combination therapy with cobimetinib (Cotellic) and vemurafenib (Zelboraf) reduced the risk of death by 30% compared with vemurafenib alone in patients with BRAF-positive advanced melanoma, according to the final survival analysis of the phase III coBRIM study that has now been published in The Lancet Oncology.

“The targeted combination improved median overall survival (OS) by 4.9 months versus single-agent vemurafenib (HR, 0.70; 95% CI, 0.55-0.90; P = .005). The OS rates for the combination at 1 and 2 years were 74.5% and 48.3%, respectively.

“ ‘Melanoma is one of the few cancers that has increased in incidence over the past 30 years, and until recently, people with advanced forms of the disease have had few treatment options. Five years ago, the survival of people with advanced melanoma was measured in months, and now we have medicines that are helping people live years,’ Josina Reddy, MD, PhD, senior group medical director at Genentech, the company that manufactures the combination, said in an interview with OncLive.”

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AstraZeneca Provides Update on Phase III Trial of Selumetinib in Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca today announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC).

“The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.”

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Marine Drug Goes to Phase III Trials to Treat Lung Cancer

Excerpt:

“PharmaMar is starting a new Phase III trial, with patients suffering from small cell lung cancer (SCLC). It’ll test the efficacy of its third candidate obtained from marine organisms (PM1183) as a SCLC treatment.

“PharmaMar is one of the hot Biotechs in Spain, which just saw its second drug finish Phase III trials with good results (and is already in trials for other indications, as we’ve seen at ASCO).

“Now, PM1183 is under the spotlight. This cancer drug will be used in a second Phase III trial (after ovarian cancer). It’ll enrol 600 patients with small cell lung cancer (SCLC), for whom platinum-based treatments have failed before.”

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