Advanced Lung Cancer Knocked Out in Clinical Trial

Excerpt:

“A leading-edge immunotherapy clinical trial at UConn Health’s Carole and Ray Neag Comprehensive Cancer Center has packed a one-two punch, successfully controlling a patient’s advanced lung cancer using the combined power of two immunotherapy drugs.

“For 50 years Michel Gueret, 67, of Canton was a heavy smoker. That is until May 2012, when he received the devastating news that he had advanced lung cancer while hospitalized for a collapsed lung at UConn John Dempsey Hospital.”

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Case for Liquid Biopsies Builds in Advanced Lung Cancer

Excerpt:

“For patients with advanced lung cancer, a non-invasive liquid biopsy may be a more effective and suitable alternative to the gold standard tissue biopsy to detect clinically relevant mutations and help guide their course of treatment, suggests a new study published this week in the journal Clinical Cancer Research from researchers at the Abramson Cancer Center at the University of Pennsylvania(ACC).

“In patients with advanced non-small cell lung cancer (NSCLC) treated at Penn’s ACC, mutations detected from liquid biopsies (cell-free circulating tumor DNA (ctDNA) captured from blood) closely paralleled the mutations from tissue biopsies identified in next generation sequencing tests: EGRF, TP53, and ALK, to name a few. What’s more, in several cases, liquid biopsies captured clinically relevant mutations not found in tissue biopsies as patients’ disease progressed.”

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Bristol-Myers' Opdivo Fails Lung Cancer Trial; Shares Plunge

Excerpt:

“Bristol-Myers Squibb Co said its blockbuster Opdivo immunotherapy failed to slow progression of symptoms in previously untreated patients with advanced lung cancer, a major setback expected to benefit Merck & Co’s rival medicine.

“Shares of Bristol-Myers fell almost 16 percent to $63.54 on Friday after the company announced failure of the late-stage trial. Shares of Merck gained 8.7 percent to $62.89.

” ‘This is the worst-case scenario’ for Opdivo and Bristol-Myers, Leerink analyst Seamus Fernandez said in a research note. ‘There appears to be no silver lining.’ ”

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Novel Entrectinib Trial Focuses on Gene Rearrangements Across Many Tumor Types

Excerpt:

“A decade ago, researchers believed molecular alterations occurred in only one or two cancer types. That way of thinking has changed, however, with the understanding that the same alterations, especially gene fusions, can occur across many different tumor types.

“As a result, researchers have designed a recently launched clinical study into entrectinib, a first-inclass inhibitor of tropomyosin receptor kinases (Trk), as a basket trial in which the drug can be evaluated simultaneously for activity against three gene alterations and multiple tumor types.

“STARTRK-2 (NCT02568267) is an open-label, phase II study in which patients with locally advanced or metastatic solid tumors are assigned to different baskets according to whether their tumors harbor rearrangements in one of three key genes—NTRK1/2/3, ROS1, or ALK.”

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NivoPlus Clinical Trial Currently Recruiting Patients With Advanced Cancer

“The Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center in Arizona recently started a Phase Ib/II clinical trial called NivoPlus (NCT02423954) to test a new investigational immunotherapeutic treatment for several advanced cancers. This novel immunotherapeutic approach is based on the combination of an immunotherapy drug (nivolumab) with chemotherapy drugs (irinotecan, temsirolimus and a combination of irinotecan and capecitabine) which have been approved by the U.S. Food and Drug Administration (FDA).

“Cancer immunotherapy is defined as the use of the body’s own immune system to help fight cancer. In 2013, the renowned Science magazine established that cancer immunotherapy had been the scientific breakthrough of the year, and recent advances in the field have yielded promising results for cancer patients.

“Nivolumab is an antibody against the programmed death 1 (PD-1) receptor, an immune checkpoint that if inhibited results in the stimulation of the body’s antitumor immunity. Nivolumab has been approved by the FDA for the treatment of advanced melanoma in December 2014 and metastatic squamous non-small cell lung cancer in March 2015. Its combination with chemotherapeutic drugs is expected to activate the body’s immune system and improve the response to cancer.”


OncoGenex and Sarah Cannon Announce Completion of Patient Enrollment in the Spruce™ Clinical Trial Evaluating Apatorsen in Combination with Carboplatin and Pemetrexed in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

“OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) and Sarah Cannon announced today that patient enrollment has been completed in the Spruce™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer (NSCLC). Spruce is sponsored and led by Sarah Cannon Research Institute (SCRI), the research arm of Sarah Cannon, Hospital Corporation of America’s (HCA) global cancer enterprise, and is being conducted at 16 sites across the United States.

“In the Spruce trial, approximately 155 patients were randomized to receive either apatorsen or placebo in combination with carboplatin and pemetrexed therapy. The primary objective of the trial is progression-free survival (PFS), with additional analyses to evaluate overall survival, tumor response rates, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.

” ‘Despite advances in targeted therapies to treat lung cancer, the majority of patients lack specific biomarkers and chemotherapy remains a mainstay of treatment for these patients,’ stated David Spigel MD, Director of the Lung Cancer Research Program at Sarah Cannon Research Institute and trial study chair. ‘The Spruce trial will enable us to better understand the role of apatorsen in treating NSCLC and its potential to delay or prevent treatment resistance and improve survival outcomes for these patients who urgently need more effective treatment options.’ “


Study Finds No Reason for Cancer Survivors to Be Excluded in Advanced Stage Lung Cancer Trials

“The common practice of excluding patients with a prior cancer diagnosis from lung cancer clinical trials may not be justified, according to a study by researchers from UT Southwestern Medical Center.

“Having previously had cancer did not impact clinical outcomes in advanced lung cancer patients and these patients therefore should be considered for inclusion in clinical trials seeking new therapies, according to the study, appearing in the Journal of the National Cancer Institute.

” ‘When it comes to clinical trial eligibility, a history of prior cancer should not count against you,’ said senior author Dr. David Gerber, Associate Professor of Internal Medicine in the Division of Hematology and Oncology in the Harold C. Simmons Comprehensive Cancer Center. ‘For patients with advanced lung cancer, previous cancer does not adversely affect survival, regardless of the type, stage, or timing of the prior cancer.’ “


Pfizer's Xalkori Shows First-Line Benefit in ALK-Positive NSCLC

The gist: The drug Xalkori (aka crizotinib) has shown promise for treating people with a certain type of non-small cell lung cancer (NSCLC) who have not yet taken any other treatment. A clinical trial tested Xalkori in untreated NSCLC patients whose tumors had mutations of the ALK gene (“ALK-positive”). People who took Xalkori in the trial had almost 4 more months before their cancer worsened than people who took only chemotherapy.

“Pfizer’s targeted cancer therapy Xalkori (crizotinib) significantly extended progression-free survival in previously-untreated patients with a particular form of non-small cell lung cancer taking part in a late-stage trial compared to chemotherapy alone.

“Data from the Phase III PROFILE 1014 study, published in The New England Journal of Medicine, showed that patients with ALK-positive advanced NSCLC given Pfizer’s kinase inhibitor had a median PFS of 10.9 months compared to 7 months for those in the chemotherapy arm. Also, the objective response rate was much higher at 74% versus 45%, the firm noted.

“On the safety side, no unexpected issues arose in the trial, with the most commonly reported adverse events observed in the Xalkori being vision disorder (71%), diarrohea (61%), nausea (56%) and oedema (49%), and with chemotherapy, nausea (59%), fatigue (38%), vomiting (36%) and decreased appetite (34%).

“ALK gene rearrangements are present in about 5% of NSCLC cancers typically occurring in younger patients who don’t smoke. By identifying and enrolling only those patients whose advanced NSCLC tumours are ALK-positive, “this trial was able to demonstrate the superiority of Xalkori over an intravenous platinum-based chemotherapy regimen that has been a standard first-line treatment for more than a decade,” said Mace Rothenberg, chief medical officer for Pfizer Oncology.”


FDA Accepts AZ' Filing for First-Line Iressa

The gist: A drug called gefitinib (Iressa) may soon be available in the U.S. as an initial treatment choice for people with advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for an EGFR mutation. The drug is already approved in many other countries. But in the U.S., only people who have already taken it successfully as part of a clinical trial or expanded access program currently have access to it. The company that makes gefitinib has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The FDA will decide whether or not to approve gefitinib as a first-line treatment in late 2015.

“US regulators have accepted AstraZeneca’s New Drug Application for Iressa (gefitinib) as a targeted monotherapy for the first-line treatment of certain lung cancer patients.

“The drug giant is seeking approval to market Iressa for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who test positive for an epidermal growth factor receptor mutation (EGFRm).

“AZ is working with Qiagen in the US to develop a companion diagnostic test to guide the use of Iressa in this setting; In Europe, their collaboration resulted in the drug becoming the first EGFR tyrosine kinase inhibitor to have a European label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.”