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Helix BioPharma Corp. Receives U.S. Food and Drug Administration Approval to Initiate a Clinical Trial of L-DOS47 in Combination With Pemetrexed and Carboplatin

Helix BioPharma Corp. Receives U.S. Food and Drug Administration Approval to Initiate a Clinical Trial of L-DOS47 in Combination With Pemetrexed and Carboplatin | Lung Cancer Dispatch | Scoop.it

"Helix BioPharma Corp. (frankfurt:HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced that it has received approval from the U.S. Food and Drug Administration ("FDA"), to initiate a Phase I clinical trial with L-DOS47.


"The study is entitled "A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer"."


Editor's note: Clinical trials can be a way for some lung cancer patients to access certain treatments they would not otherwise be able to have. Learn more.

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MarketWatch  |  Apr 22, 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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Alimta Offers Only Limited Advantage in Lung Cancer Study

The recent PointBreak clinical trial compared two treatment regimens for non-squamous non-small cell lung cancer (NSCLC). Previously untreated patients with advanced non-squamous NSCLC received initial treatment with carboplatin (Paraplatin), bevacizumab (Avastin), and either pemetrexed (Alimta) or paclitaxel (Taxol/Abraxane). The Alimta-treated group was then given maintenance treatment with Alimta and Avastin, while the other patients received Avastin only. Alimta treatment was associated with slightly longer times until the cancer progressed again (average 6.0 months, compared to 5.6 in the Alimta-free regimen). However, overall survival did not differ between the groups. The two regimens differed in what specific side effect were most common, but had similar overall toxicities and were generally tolerable.

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MedPage Today | Oct 21, 2013

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Trial of New Lung Cancer Drug OGX-427 Now Enrolling Participants

Trial of New Lung Cancer Drug OGX-427 Now Enrolling Participants | Lung Cancer Dispatch | Scoop.it

The Spruce trial, a phase II clinical trial examining the effectiveness of the cancer drug OGX-427 in non-small cell lung cancer (NSCLC), is now open for enrollment. The trial will study patients with previously untreated, advanced non-squamous NSCLC. They will receive the chemotherapy agents carboplatin (Paraplatin) and pemetrexed (Alimta) in combination with either OGX-427 or a placebo. The sponsors also plan to add the Cedar trial, which will investigate the use of OGX-427 in squamous cell NSCLC. OGX-427 inhibits Hsp27, a protein that is highly expressed in many tumor cells. The drug may be especially promising for patients without mutations that make them eligible for currently available targeted therapies.


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MarketWatch | Aug 1, 2013

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Diagnostics Company Ready to Patent Test for Squamous Cell Lung Cancer

Diagnostics Company Ready to Patent Test for Squamous Cell Lung Cancer | Lung Cancer Dispatch | Scoop.it

The molecular diagnostics company Rosetta Genomics has received permission to patent their Rosetta Lung Cancer Test. The test analyzes lung tumor tissue and distinguishes squamous cell carcinoma (SCC) from other types of non-small cell lung cancer (NSCLC). Clearly identifying a patient's cancer subtype is becoming increasingly important for choosing an optimal treatment plan, thanks to the increasing role of targeted therapies and the growing understanding of how drug effects can differ among various cancer subtypes. For example, pemetrexed (Alimta) and bevacizumab (Avastin) benefit many NSCLC patients, but are not recommended for those with SCC. The patent allowance will permit Rosetta to develop their test for use in patients.

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Yahoo! Finance | Jul 25, 2013

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Afatinib May Be Candidate for First-Line Treatment in Certain Lung Cancers

Results from the LUX-Lung 3 clinical trial show that afatinib appears to be well tolerated and more effective than chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Afatinib produced higher response rates and longer periods without cancer progression than cisplatin (Platinol) plus pemetrexed (Alimta), suggesting that it could be considered as a first-line therapy in advanced EGFR-mutant NSCLC. Afatinib, which is under priority review for approval by the FDA, may be effective in patients resistant to other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa). However, no trials so far have directly compared afatinib with Tarceva or Iressa.

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Medscape | Jul 9, 2013

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Comparison of Combination Chemotherapy Regimens Shows No Significant Differences

Both pemetrexed (Alimta) plus carboplatin (Paraplatin) and Paraplatin plus paclitaxel (Taxol/Abraxane) plus bevacizumab (Avastin) are effective chemotherapy regimens against non-small cell lung cancer (NSCLC). However, until recently, the safety and efficacy of the two regimens had not been directly compared. To evaluate whether one regimen was superior, a phase III clinical trial determined how long patients with advanced non-squamous NSCLC remained free of either cancer progression or severe toxic side effects when treated with either of the two regimens. While patients receiving the Alimta plus Paraplatin regimen tended to have slightly longer relapse- and toxicity-free periods than those given Paraplatin plus Taxol/Abraxane plus Avastin, the difference was not very pronounced and could have happened by chance. The two regimens also did not differ regarding overall time until cancer progression, response rate and overall survival time.

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CancerNetwork | June 6, 2013

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Alimta-Paraplatin Combination Appears to Be Effective Treatment for Elderly Lung Cancer Patients

Alimta-Paraplatin Combination Appears to Be Effective Treatment for Elderly Lung Cancer Patients | Lung Cancer Dispatch | Scoop.it

Most elderly patients with advanced non-small cell lung cancer (NSCLC) do not receive chemotherapy and no age-specific guidelines for choosing chemotherapy agents exist. A phase II clinical trial investigated treatment with pemetrexed (Alimta) and carboplatin (Paraplatin) for elderly (aged 70+ years) patients with advanced NSCLC and little functional impairment. The combination treatment was as effective in these patients as it had been in younger populations in previous studies and more effective than single-agent chemotherapy. While some patients experienced serious side effects, especially blood-related complications, overall toxicity was acceptable, suggesting that combined Alimta and Paraplatin may be a viable treatment option for similar patients.

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Lung Cancer | Feb 25, 2013

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Trial Supports the Use of Pemetrexed for Chinese NSCLC Patients

Trial Supports the Use of Pemetrexed for Chinese NSCLC Patients | Lung Cancer Dispatch | Scoop.it

A recent study compared the drug docetaxel with pemetrexed in Chinese patients with advanced, non-squamous, non-small cell lung cancer (NSCLC). The results show that both treatments are similarly effective. Patients who took pemetrexed also experienced fewer adverse effects.

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Lung Cancer | Nov 21, 2012

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Hint of Survival Benefit with Bevacizumab-Pemetrexed Maintenance for NSCLC

Hint of Survival Benefit with Bevacizumab-Pemetrexed Maintenance for NSCLC | Lung Cancer Dispatch | Scoop.it

"Updated data from the phase III AVAPERL trial hint that there might be an overall survival (OS) benefit of using bevacizumab in combination with pemetrexed as maintenance therapy in patients with advanced nonsmall cell lung cancer (NSCLC).

“ 'The AVAPERL study was not powered to detect differences in OS between treatment arms', Fabrice Barlesi, of Aix Marseille University in France, and colleagues observe in the Annals of Oncology.

“ 'The analysis revealed, however, that OS was numerically increased by nearly 4 months in patients treated with maintenance bevacizumab-pemetrexed as compared with bevacizumab alone', the international team of researchers reports."


Editor's Note: Maintenance therapy is "treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy. It may include treatment with drugs, vaccines, or antibodies that kill cancer cells, and it may be given for a long time," according to the National Cancer Institute. Patients in this study were found to have longer survival times when taking a combination of the drugs bevacizumab and pemetrexed as a maintenance therapy than when taking bevacizumab alone.

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News-Medical.Net  |  Mar 19, 2014

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FDA Grants Regular Approval to Xalkori for Treatment of ALK-Mutant Lung Cancer

FDA Grants Regular Approval to Xalkori for Treatment of ALK-Mutant Lung Cancer | Lung Cancer Dispatch | Scoop.it

The U.S Food and Drug Administration (FDA) has granted regular approval to the drug crizotinib (Xalkori) for the treatment of advanced non-small cell lung cancer (NSCLC) in patients who have mutations in the ALK gene. Xalkori received accelerated approval for this application in August 2011. Regular approval was awarded based on the results of a study examining patients with advanced NSCLC whose cancer had progressed despite first-line chemotherapy. Patients treated with Xalkori went an average of 7.7 months without further cancer worsening, compared to 3.0 months in those receiving the chemotherapy agents pemetrexed (Alimta) or docetaxel (Taxotere). Tumors shrank in 65% of the Xalkori-treated patients, compared to 20% with Alimta or Taxotere. However, overall survival did not differ between the Xalkori group and the chemotherapy group.

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ASCO Post  |  Nov 21, 2013

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Personalized Treatment Yields Results for Cancer Patients

Personalized Treatment Yields Results for Cancer Patients | Lung Cancer Dispatch | Scoop.it

Personalized cancer medicine uses genetic testing of patients’ tumors to guide individually tailored treatment decisions. Such tests can determine which chemotherapies would likely be most effective and whether the patient may benefit from novel drugs targeting specific mutations. One example is the case of Elizabeth Lacasia, who has advanced bronchioalveolar carcinoma, a type of non-small cell lung cancer (NSCLC). Testing revealed that she does not have any of the mutations targeted by the new drugs. Based on her test results, she was treated with a combination of Tarceva (erlotinib) and Alimta (pemetrexed) following an alternating schedule that has been proven effective for people with her cancer type. Her cancer has been in remission for 2 years.

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Newswise | Sep 10, 2013

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Maintenance Therapy with Avastin-Alimta Combination Appears Effective in Advanced NSCLC

Maintenance Therapy with Avastin-Alimta Combination Appears Effective in Advanced NSCLC | Lung Cancer Dispatch | Scoop.it

Maintenance therapy with bevacizumab (Avastin) and pemetrexed (Alimta) showed promising effects in the AVAPERL phase III clinical trial. Patients with advanced non-small cell lung cancer (NSCLC) were first treated with Avastin, Alimta, and cisplatin (Platinol). Those who responded to the treatment were either continued on both Avastin and Alimta or on Avastin only. Patients maintained on both drugs experienced more serious side effects, but went for longer without their cancer progressing (7.4 months on average, compared to 3.7 months for Avastin-only patients). While the study did not examine the benefits of Alimta-only maintenance treatment, the results suggest that the Avastin-Alimta combination is preferable to maintenance on Avastin only.

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Healio | Jul 26, 2013

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Maintenance Therapy with Alimta Improves Outcomes in Lung Cancer

Patients whose advanced nonsquamous, non-small cell lung cancer (NSCLC) responds to chemotherapy with pemetrexed (Alimta) and cisplatin (Platinol) appear to benefit from continuing Alimta treatment after they have achieved remission (continuation maintenance therapy). Results from the PARAMOUNT clinical trial showed that maintenance treatment with Alimta prolonged time without cancer worsening and increased survival times compared to treatment with a placebo. Continuation maintenance therapy with Alimta may be the preferable treatment choice for patients who do not experience significant toxicity from Alimta.

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Medscape | Jul 11, 2013

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Adding Paraplatin to Alimta Increases Survival in Lung Cancer Study

Adding Paraplatin to Alimta Increases Survival in Lung Cancer Study | Lung Cancer Dispatch | Scoop.it

Results from a phase III clinical trial suggest that adding carboplatin (Paraplatin) to pemetrexed (Alimta) can improve outcomes in non-small cell lung cancer (NSCLC). Over 200 patients with advanced NSCLC received first-line treatment with Alimta either by itself or in combination with Paraplatin. The combination of the two chemotherapy agents extended the time before the cancer started growing again, and prolonged survival compared to Alimta alone. However, the combination treatment group had a higher incidence of serious side effects and four treatment-associated deaths.

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Healio | June 24, 2013

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New Clinical Trial of Drug OGX-427 Aims to Help Patients Ineligible for Targeted Therapies

OncoGenex Pharmaceuticals announced that it will begin the Spruce clinical trial, a phase II study investigating the use of their cancer drug OGX-427 in non-small cell lung cancer (NSCLC). Patients with advanced non-squamous NSCLC will receive first-line treatment with chemotherapy using carboplatin (Paraplatin) and pemetrexed (Alimta), either with or without the addition of OGX-427. OGX-427 inhibits a protein called Hsp27, which is elevated in many cancers. The study investigators suggest that OGX-427 may be especially helpful for patients whose cancers lack certain mutations that would make them eligible for currently available targeted therapies.

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Pharmaceutical Business Review | Apr 12, 2013

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Combined Calsed and S-1 May be Effective Second-Line Treatment for Lung Cancer without EGFR Mutations

While new treatments for non-small cell lung cancer (NSCLC) such as tyrosine kinase inhibitors (TKIs) and Alimta (pemetrexed) are effective second-line treatments for patients whose tumors carry mutations in the EGFR gene, they are less effective for patients without such mutations. Twenty-six patients with inoperable, previously treated NSCLC received treatment with amrubicin (Calsed) and S-1 and experienced higher treatment response rates, longer periods without cancer progression, and longer overall survival than has been reported with single-agent chemotherapy. The beneficial effects were independent of cancer subtype, suggesting that combined Calsed and S-1 may be an effective second-line treatment for NSCLC without EGFR mutation.


Research paper: http://link.springer.com/article/10.1007/s00280-012-2061-1/fulltext.html

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Cancer Chemotherapy and Pharmacology | Jan 18, 2013

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Non-squamous NSCLC Study Results Disappoint Drug-Maker Eli Lilly

Non-squamous NSCLC Study Results Disappoint Drug-Maker Eli Lilly | Lung Cancer Dispatch | Scoop.it

Alimta manufacturer Eli Lilly had high hopes for the PointBreak study, which compared an Alimta-based, first-line, non-squamous, non-small cell lung cancer (NSCLC) treatment with a well-established, Taxol-based standard. Initial results were promising, but the 939 patient study ultimately did not show significantly improved patient survival for the Alimta regimen.

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Ground Report | Nov 10, 2012

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