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Cyramza Yields a Modest Survival Benefit in Second-line NSCLC

"Cyramza™ (ramucirumab, IMC-1121B; Eli Lilly) is a human IgG1 monoclonal antibody directed against the extracellular domain of VEGFR-2. It was recently approved by the Food and Drug Administration (FDA) for advanced gastric cancer or gastroesophageal junction adenocarcinoma. On February 19, 2014, Lilly announced via press release that the REVEL trial was positive for both overall survival (OS) and progression-free survival (PFS) benefit. Results from the randomized, double-blind, placebo-controlled Phase III REVEL trial (NCT01168973) were reported at the 2014 annual meeting of the American Society of Clinical Oncology (ASCO). The trial evaluated docetaxel with or without Cyramza in squamous or non-squamous Stage IV non-small cell lung cancer (NSCLC) patients following disease progression after one prior platinum-based therapy."


Editor's note: A new targeted drug called Cyramza (aka ramucirumab) shows promise as a potential treatment for people with advanced non-small cell lung cancer (NSCLC). In a clinical trial, scientists tested the drug on volunteer patients with stage IV NSCLC. Compared to standard chemotherapy alone, patients who were treated with chemo plus Cyramza lived longer and had more time pass before their cancer worsened.

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OBR  |  Jun 3, 2014

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Proteomic Signature for EGFR Inhibitor Therapy Predicts Survival Benefit of Second-Line Chemotherapy vs Erlotinib in NSCLC

Proteomic Signature for EGFR Inhibitor Therapy Predicts Survival Benefit of Second-Line Chemotherapy vs Erlotinib in NSCLC | Lung Cancer Dispatch | Scoop.it

"There are conflicting data on whether epidermal growth factor receptor (EGFR) inhibitor therapy is beneficial in second-line treatment of lung cancer patients with unknown or wild-type EGFR status. In a phase III trial (PROSE) reported in The Lancet Oncology, Gregorc et al assessed the predictive value of a proteomic signature serum protein test for likely outcome of EGFR inhibitor therapy in non–small cell lung cancer (NSCLC) patients receiving second-line therapy with the EGFR inhibitor erlotinib (Tarceva) vs chemotherapy. They found that the test was predictive of differential survival benefit for erlotinib vs chemotherapy, with patients classified by the test as likely to have poor outcome on EGFR inhibitor therapy having better outcome on chemotherapy."

"Overall survival was significantly better with chemotherapy among patients with a proteomic classification of poor, whereas there was no difference between chemotherapy and erlotinib in patients with a classification of good."

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The ASCO Post  |  May 22, 2014

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Synta Announces Results from Final Analysis of the GALAXY-1 Trial of Ganetespib in NSCLC

Synta Announces Results from Final Analysis of the GALAXY-1 Trial of Ganetespib in NSCLC | Lung Cancer Dispatch | Scoop.it

"Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced final results from the GALAXY-1 trial, a global, randomized, multi-center study designed to identify the patients with advanced non-small cell lung cancer (NSCLC) with adenocarcinoma histology most likely to benefit from second-line treatment with the Company’s lead drug candidate, the Hsp90 inhibitor ganetespib, in combination with docetaxel versus docetaxel alone. Ganetespib is a next-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 1000 patients to date."


Editor's note: This story is about clinical trials designed to test the drug ganetespib in people with non-small cell lung cancer (NSCLC). The drug manufacturer (Synta) recently reported updated results for one of the trials, GALAXY-1. The results confirm that the researchers were able to identify patients who were most likely to benefit from a treatment that combines ganetespib with the chemotherapy drug docetaxel.

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Synta  |  May 8, 2014

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Interim Results from Lung Cancer Clinical Trial of Tivantinib Remain Ambiguous

Interim Results from Lung Cancer Clinical Trial of Tivantinib Remain Ambiguous | Lung Cancer Dispatch | Scoop.it

An ongoing clinical trial is evaluating the effects of cancer drug tivantinib in non-small cell lung cancer (NSCLC). The trial studies patients with advanced non-squamous NSCLC who do not have any mutations in the EGFR gene. Patients receive erlotinib (Tarceva) either by itself or in combination with tivantinib. Enrollment in the trial was stopped because rates of interstitial lung disease (ILD), which can cause lung scarring, may be higher in patients receiving tivantinib. (No such increased levels of ILD were seen in a different trial using tivantinib.) For the patients already enrolled, overall survival, time without cancer worsening, and percentage of patients experiencing tumor shrinkage all seem increased in tivantinib-treated patients. However, it is not yet clear whether these effects are indeed caused by tivantinib or are due to chance.

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MarketWatch  |  Jan 16, 2014

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Xalkori More Effective than Chemotherapy As Second-Line Treatment in ALK+ Lung Cancer

Xalkori More Effective than Chemotherapy As Second-Line Treatment in ALK+ Lung Cancer | Lung Cancer Dispatch | Scoop.it

The ALK inhibitor crizotinib (Xalkori) has shown effectiveness in patients with non-small cell lung cancer (NSCLC) who have changes in the ALK gene that make the gene overactive (so-called 'ALK-positive' patients). A recent clinical trial compared Xalkori to chemotherapy as a second-line treatment in these patients. Over 300 patients with ALK-positive advanced NSCLC who had undergone one previous round of chemotherapy were treated either with Xalkori or one of the chemotherapy drugs pemetrexed (Alimta) or docetaxel (Taxotere). Tumors shrank in 65% of Xalkori-treated patients, compared to 20% of those receiving chemotherapy. The Xalkori-treated patients also went longer without their cancer worsening, experienced fewer symptoms, and reported higher quality of life.

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Medical Xpress  |  Jan 13, 2014

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Positive Results For Vargatef in Lung Cancer Study

Positive Results For Vargatef in Lung Cancer Study | Lung Cancer Dispatch | Scoop.it

New clinical trial results suggest that adding the drug nintedanib (Vargatef) to second-line chemotherapy can improve survival for some patients with non-small cell lung cancer (NSCLC). Patients with advanced NSCLC whose cancer had progressed after first-line chemotherapy received either Vargatef and the chemotherapy drug docetaxel (Taxotere) or Taxotere alone. On the whole, Vargatef was associated with slightly longer times without worsening of the cancer (3.4 months vs 2.7 in the Taxotere-only group), but no improvement in overall survival. However, in patients with lung adenocarcinoma, a subtype of NSCLC, the addition of Vargatef improved overall survival by over 2 months (12.6 months vs 10.3 with Taxotere alone). Vargatef disrupts the formation of new blood vessels that feed growing tumors.

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Clinical Oncology News  |  Oct, 2013

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Trial Results for New Lung Cancer Drug Ganetespib Leave Some Skeptical

Trial Results for New Lung Cancer Drug Ganetespib Leave Some Skeptical | Lung Cancer Dispatch | Scoop.it

The GALAXY-1 clinical trial examines patients with advanced lung adenocarcinoma, a type of non-small cell lung cancer (NSCLC), receiving either ganetespib (a new cancer drug) and docetaxel (Taxotere, a chemotherapy drug) or Taxotere alone as second-line treatment. Recent interim results show ganetespib-treated patients surviving 10.4 months on average (vs 8.4 months in the Taxotere-only group) and experiencing a 10% reduction in the risk of death. This is a smaller difference than was seen in preliminary results in September, 2012 and June, 2013 (31% and 18% reduction in risk of death, respectively). It is also unclear whether the effect is indeed caused by ganetespib or due to chance. However, the drug’s makers emphasize that ganetespib may be more effective in certain patient subgroups.

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The Street | Oct 27, 2013

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Second-Line Chemotherapy More Effective Than Tarceva in Lung Cancer without EGFR Mutations

Second-Line Chemotherapy More Effective Than Tarceva in Lung Cancer without EGFR Mutations | Lung Cancer Dispatch | Scoop.it

EGFR inhibitors like erlotinib (Tarceva) are highly effective for most patients with non-small cell lung cancer (NSCLC) who have mutations in the EGFR gene. However, results from the TAILOR clinical trial suggest that, in patients without EGFR mutations (who have so-called EGFR wild-type NSCLC), EGFR inhibitors may be less effective than chemotherapy as second-line treatment. Patients with advanced wild-type NSCLC who had previously been treated with platinum-based chemotherapy were given either Tarceva or the chemotherapy agent docetaxel (Taxotere). Average survival in the Taxotere-treated group (8.2 months) was longer than in the Tarceva group (5.4 months).

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Healio | Aug 21, 2013

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New Clinical Trial Investigates Novel Lung Cancer 'Nanomedicine'

New Clinical Trial Investigates Novel Lung Cancer 'Nanomedicine' | Lung Cancer Dispatch | Scoop.it

A new phase II clinical trial is investigating the new cancer drug BIND-014 as a second-line treatment for non-small cell lung cancer (NSCLC). BIND-014 is part of a group of 'nanoengineered' drugs called Accurins, which consist of: 1) targeting particles that direct them preferentially to the disease site–in the case of BIND-014, these particles bind to PSMA, a protein expressed on cancer cells; 2) a 'stealth layer' protecting them from the body's immune system; 3) a controlled-release structure ensuring that the 'payload' is released at the optimal rate; and 4) the drug's actual payload–in the case of BIND-014, the chemotherapy agent docetaxel (Taxotere). Accurins are designed to maximize the drug concentration delivered to the tumor, while minimizing toxicity to healthy tissues.

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Boston.com | Jul 29, 2013

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New Cancer Drug Vargatef Extends Progression-Free Period in Lung Cancer

Patients treated with the new cancer drug nintedanib (Vargatef), in addition to second-line chemotherapy, experienced a longer delay before their lung cancer worsened, a recent phase III clinical trial showed. The study focused on patients with advanced non-small cell lung cancer (NSCLC) whose cancer had progressed after a first round of chemotherapy. Trial participants received the chemotherapy agent docetaxel (Taxotere) either with or without Vargatef. Those treated with Vargatef went an average of 3.4 months before their cancer started to grow again, compared to 2.7 in patients who were given Taxotere alone. There was also evidence that Vargatef may increase overall survival, especially in patients with lung adenocarcinoma, a subtype of NSCLC.

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PR Newswire | June 3, 2013

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Phase II Study Shows New Drug is Effective against NSCLC

Phase II Study Shows New Drug is Effective against NSCLC | Lung Cancer Dispatch | Scoop.it

Preliminary results from an ongoing phase II clinical trial of new lung cancer drug AXL1717 suggest that the drug is effective against non-small cell lung cancer (NSCLC). Patients with advanced NSCLC received either AXL1717 or chemotherapy with docetaxel (Taxotere) as a second-line treatment. AXL1717, which acts by inhibiting a protein called IGF1R, appeared to be as effective as Taxotere at delaying cancer progression. AXL1717 may be a treatment option for patients who do not respond or become resistant to Taxotere or other second-line treatments. AXL1717 is manufactured by drug company Axelar. More information about the clinical trial can be found here: http://clinicaltrials.gov/show/NCT01561456

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News-Medical.Net | Apr 2, 2013

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Lung Cancer Drug Bavituximab May Move Forward into Phase III Trial

Despite problems with vial labeling that weakened the findings of a recent phase II clinical trial, Peregrine Pharmaceuticals plans to move its new cancer drug bavituximab forward into a phase III trial. A second analysis of the phase II results, which adjusted for the labeling inconsistencies, still found that adding bavituximab to chemotherapy as a second-line treatment for non-small cell lung cancer (NSCLC) increased patients’ survival time, even though the difference may merely be due to chance. Bavituximab targets phosphatidylserine, a protein found on the surface of tumor blood vessels that suppresses the body’s immune response. By blocking phosphatidylserine, bavituximab allows the immune system to attack the cancer.

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Cancer Network | Mar 2, 2013

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Taxotere-Afinitor Combination Only Modestly Effective in Advanced NSCLC

Taxotere-Afinitor Combination Only Modestly Effective in Advanced NSCLC | Lung Cancer Dispatch | Scoop.it

A phase II clinical trial examined the use of the chemotherapy drug docetaxel (Taxotere) combined with everolimus (Afinitor), a member of a family of drugs called mTOR inhibitors, as second- or third-line treatment in advanced non-small cell lung cancer (NSCLC). The treatment was well tolerated, but only modestly effective compared to standard therapy in similar patients. The patients in the study had not been selected for any specific biomarkers; better effectiveness may be achieved in patients with relevant biomarkers.

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Journal of Thoracic Oncology | Feb 14, 2013

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Studies Reveal Potential New Targeted Therapies for Common, Hard-to-Treat Cancers

Studies Reveal Potential New Targeted Therapies for Common, Hard-to-Treat Cancers | Lung Cancer Dispatch | Scoop.it

"Positive results from four clinical trials of investigational targeted drugs for advanced ovarian, lung, and thyroid cancers, and chronic lymphocytic leukemia were highlighted today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO). Findings from the mid- and late-stage trials suggest new ways to slow disease progression and improve survival for patients who experience relapses or resistance to available treatments...


"Second-line treatment with ramucirumab plus standard docetaxel extends survival for patients with advanced non-small cell lung cancer: This phase III clinical trial marks the first time in a decade that a survival benefit has been achieved in second-line therapy for patients with advanced non-small cell lung cancer – findings that could impact the care of 60,000 patients each year in the United States."


Editor's note: Learn more about targeted therapy drugs for lung cancer.

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Medical Xpress  |  Jun 2, 2014

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Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686
for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer
(NSCLC) in Patients with the T790M Mutation

Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686 <br/>      for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer <br/>      (NSCLC) in Patients with the T790M Mutation | Lung Cancer Dispatch | Scoop.it

"Clovis Oncology, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent CO-1686 as monotherapy for the treatment of second-line EGFR mutant NSCLC in patients with the T790M mutation. The Breakthrough Therapy designation was granted based on interim efficacy and safety results from an ongoing Phase 1/2 study of CO-1686. CO-1686 is the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M."


Editor's note: CO-1686 is a targeted therapy drug that is meant to treat patients whose tumors have mutations in the EGFR gene, as detected by molecular testing. Some tumors with EGFR mutations become resistant to first-line treatment and develop a new mutation called T790M. Evidence shows that non-small cell lung cancer (NSCLC) patients with T790M may benefit from second-line treatment with CO-1686.The drug has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). This means that the FDA finds CO-1686 to be very promising compared to currently available treatments for T790M-mutated NSCLC, and will accelerate the approval process that would ultimately permit oncologists to prescribe the drug outside of a clinical trial.

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MarketWatch  |  May 19, 2014

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NICE to Bar Second-Line Use of Tarceva

NICE to Bar Second-Line Use of Tarceva | Lung Cancer Dispatch | Scoop.it

"A proposal by (National Health Service) NHS cost regulators to no longer back the second-line use of Tarceva (erlotinib) to treat relapsed non-small cell lung cancer (NSCLC) has angered the drug's manufacturer Roche and will no doubt come as a shock to patients.


"Following a review of existing guidance, the National Institute for Health and Care Excellence (NICE) has decided that treatment with Tarceva after first-line therapy has failed is no longer a cost-effective option for the NHS.

 

"According to Roche, the move means that more than 1,000 patients in England and Wales every year will be at risk from being left without an active second-line treatment option."

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PharmaTimes  |  Feb 4, 2014

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Cancer Drug Tafinlar Receives Breakthrough Therapy Designation for Lung Cancer

Cancer Drug Tafinlar Receives Breakthrough Therapy Designation for Lung Cancer | Lung Cancer Dispatch | Scoop.it

The application for dabrafenib (Tafinlar) as a treatment for certain lung cancer cases has been given a boost with the U.S. Food and Drug Administration (FDA) designating it a breakthrough therapy. Tafinlar is being investigated as a therapy for patients with non-small cell lung cancer (NSCLC) who have a mutation called BRAF V600E in the BRAF gene and have received at least one previous round of chemotherapy. In a recent clinical trial, Tafinlar exhibited antitumor activity in such patients. The breakthrough therapy designation provides increased drug development guidance from the FDA and accelerated approval for drugs that treat serious or life-threatening conditions and that provide a substantial improvement over currently available treatments. Tafinlar is already approved for use in certain types of skin cancer.

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ASCO Post  |  Jan 13, 2014

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New Clinical Trial Examines Lung Cancer Drug Bavituximab

New Clinical Trial Examines Lung Cancer Drug Bavituximab | Lung Cancer Dispatch | Scoop.it

The makers of the cancer drug bavituximab are initiating the SUNRISE trial, a phase III clinical trial investigating the efficacy of the drug against non-small cell lung cancer (NSCLC). Patients with advanced non-squamous NSCLC whose cancer has progressed after first-line treatment will receive either bavituximab plus docetaxel (Taxotere) or Taxotere by itself. Bavituximab inhibits phosphatidylserine, a protein found on the surface of tumors and tumor-associated cells that acts to suppress the body’s immune reponse. By blocking phosphatidylserine’s action, bavituximab allows the immune system to continue attacking the cancer. To find out more, patients can go to www.sunrisetrial.com.

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Yahoo! Finance  |  Dec 30, 2013

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New Clinical Trial Will Study Novel Lung Cancer Drug Vantictumab

New Clinical Trial Will Study Novel Lung Cancer Drug Vantictumab | Lung Cancer Dispatch | Scoop.it

A new clinical trial will investigate the safety of vantictumab (OMP-18R5), a new lung cancer drug targeting cancer stem cells (CSCs). CSCs, the actively multiplying cells responsible for generating tumors, are thought to be central in cancer relapse by 'repopulating' tumors, even if the bulk of the tumors cells are destroyed during treatment. Vantictumab blocks the Wnt pathway, a key molecular signaling pathway used by CSCs. Patients with previously treated advanced non-small cell lung cancer (NSCLC) will receive vantictumab in combination with the chemotherapy agent docetaxel (Taxotere). In addition to the safety of the drug combination, the trial will also investigate how effective it is and whether any biomarkers predict how well patients respond.

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MarketWatch  |  Nov 15, 2013

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UK Health Authority Issues Final Rejection for Cancer Drug Xalkori

UK Health Authority Issues Final Rejection for Cancer Drug Xalkori | Lung Cancer Dispatch | Scoop.it

The UK’s National Institute for Health and Clinical Excellence (NICE) confirmed its decision to reject using National Health Service funding to provide crizotinib (Xalkori) to patients. Xalkori is used for patients with previously treated non-small cell lung cancer (NSCLC) who have mutations in the ALK gene. While NICE acknowledges that Xalkori is effective in these patients, they do not consider its benefit substantial enough to warrant its high cost. Xalkori has been found to extend the time without cancer progression by an average of 5.1 months compared to standard chemotherapy; it is unclear whether it increases overall survival. UK patients can still take Xalkori, but would have to pay the full cost themselves (£37,512 - £51,579 for a complete treatment course).

Cancer Commons's insight:

PharmaTimes | Sep 25, 2013

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Raja Mudad's curator insight, September 27, 2013 6:31 AM

We are very lucky in this country (so far!!) to be able to use cutting edge, science-based treatments for cancers.  Xalkori (crizotinib) for ALK + patients with lung cancer will not be covered in the UK.

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VeriStrat Test Can Predict Lesser Response to Tarceva

VeriStrat Test Can Predict Lesser Response to Tarceva | Lung Cancer Dispatch | Scoop.it

EGFR inhibitors like erlotinib (Tarceva) can greatly benefit non-small cell lung cancer (NSCLC) patients with mutations in the EGFR gene, but their effectiveness in patients without such mutations is less clear. VeriStrat is a blood test meant to predict how well patients would respond to EGFR-inhibitor treatment. A study designed to evaluate VeriStrat examined patients with advanced NSCLC without EGFR mutations in whom platinum-based chemotherapy had stopped working and who received either different chemotherapy or Tarceva as their second-line treatment. Patients with a VeriStrat result of 'poor' survived longer when treated with chemotherapy than with Tarceva. In contrast, chemotherapy and Tarceva worked equally well for those with a 'good' test result. Good VeriStrat results also predicted longer survival in general.

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ASCO Post | Aug 21, 2013

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Colorado Medicare Will Cover VeriStrat Test for Guiding Lung Cancer Treatment

Colorado’s Medicare provider has announced that it will cover VeriStrat, a test designed to guide decisions about second-line therapies for advanced non-small cell lung cancer (NSCLC). The main second-line therapy options in NSCLC include chemotherapy or the drug erlotinib (Tarceva). While Tarceva can significantly improve outcomes in patients with mutations in the EGFR gene, it also benefits some patients without these mutations. VeriStrat, a rapid blood test, helps predict which of these patients would be more likely to respond to Tarceva and which would be better served by other treatments. Medicare coverage will allow many more patients in Colorado to access this useful tool.

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Fort Mill Times | June 20, 2013

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Xalkori More Successful than Chemotherapy in Lung Cancer Patients with ALK Mutations

Xalkori More Successful than Chemotherapy in Lung Cancer Patients with ALK Mutations | Lung Cancer Dispatch | Scoop.it

Crizotinib (Xalkori) may be more beneficial than chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the ALK gene, a phase III clinical trial found. The patients had previously been treated with chemotherapy, after which their cancer had started to progress again. During the trial, they received either a different chemotherapy agent or Xalkori. Xalkori-treated patients went on average 7.7 months without a worsening of their cancer, compared to 3.0 months in the chemotherapy-treated patients. Patients on Xalkori also experienced better quality of life. This study demonstrates the importance of genetic testing for biomarkers, such as ALK mutation, and prescription of targeted therapies based on these biomarkers.

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ScienceDaily | June 1, 2013

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New Drug Shrinks NSCLC Tumors, But Does Not Improve Survival, Early Results Say

New Drug Shrinks NSCLC Tumors, But Does Not Improve Survival, Early Results Say | Lung Cancer Dispatch | Scoop.it

Results from a phase II clinical trial show that Cerulean Pharma’s anticancer drug, CRLX101, did not increase survival for patients with previously treated non-small cell lung cancer (NSCLC). However, CRLX101 did shrink tumor size. Cerulean took a risk by focusing on overall survival; early clinical trials often measure drug effectiveness by looking at less-challenging measures, such as treatment response rate or time to cancer worsening. Several other clinical trials of CRLX101 in different cancers, including small cell lung cancer (SCLC), are still ongoing. More details about the drug and the trial can be found at: http://www.xconomy.com/boston/2013/03/06/cerulean-pharma-arrives-at-moment-of-truth-with-cancer-drug/.

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PR Newswire | Mar 22, 2013

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Bavituximab Looks Less Promising in Revised Clinical Trial Results

In revised results from a phase II clinical trial, Peregrine Pharmaceuticals’ experimental cancer drug bavituximab appeared less effective than in previous reports. While patients with advanced non-small cell lung cancer (NSCLC) receiving a higher dose of bavituximab plus chemotherapy as a second-line treatment survived longer than patients receiving chemotherapy alone or with a lower bavituximab dose, the difference was not statistically significant. In September, preliminary results from the same trial had reported that the higher bavituximab dose doubled patients’ survival time. Since then, an internal review revealed problems with drug vial labeling, which distorted initial results.

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Reuters | Feb 19, 2013

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