A drug called erlotinib or Tarceva can extend life for women with advanced lung cancer, experts say.

Early trial results show the drug can reduce the chances of dying by a quarter.

An American cancer conference heard how it could offer new hope to those patients too sick for chemotherapy.

In trials, 15% of women were alive and had no progression of their cancer 12 months after taking the drug compared with only 5% of those on a placebo.

The study involved 670 men and women with advanced non-small cell lung cancer, of whom more than half were over the age of 77.

According to Cancer Research UK, which ran the trial, almost half of the 39,750 lung cancer patients in the UK fall into the category of being too ill for chemotherapy.

Erlotinib works by interfering with how cancer cells multiply.

Dr Siow Ming Lee, trial leader and senior lecturer at the University College London Cancer Institute, said: “These results are a real step forward in the search for an effective treatment for patients with advanced lung cancer.

“We are not yet sure why it was most effective in women but this is positive news for this large group who have few other treatment options.

“Erlotinib should be recommended for women with non-small cell lung cancer who are unsuitable for first-line chemotherapy.”

The drug is licensed in the UK to be used as a second-line treatment after chemotherapy.

Kate Law, Cancer Research UK’s director of clinical trials, said: “This important trial demonstrates which patients are most likely to benefit from this new treatment.

“It is encouraging to see advances being made in lung cancer treatment, especially for those patients who have few alternatives.”

Source: BBC News

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Pfizer Inc. announced the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). An independent Data Safety Monitoring Committee (DSMC) recommended A4021018 be stopped after concluding that the addition of figitumumab to erlotinib is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to erlotinib alone in the study population.

“As a pioneer in the IGF-1R field, we are committed to a thorough evaluation of figitumumab. We will carefully review our extensive clinical database and use this information to refine the figitumumab clinical program with the goal of identifying the right patient population in which to evaluate this compound.”

“This outcome is disappointing to us and to patients with NSCLC. Pfizer is working to thoroughly analyze all available data from the figitumumab program to better understand the compound and the IGF-1R (insulin growth factor-1 receptor) pathway,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. “As a pioneer in the IGF-1R field, we are committed to a thorough evaluation of figitumumab. We will carefully review our extensive clinical database and use this information to refine the figitumumab clinical program with the goal of identifying the right patient population in which to evaluate this compound.”

The Company has notified A4021018 clinical investigators and has initiated the notification procedure for all involved regulatory agencies of the discontinuation of A4021018. Investigators have been instructed to work with all of their patients in the A4021018 study on an individual basis to determine an appropriate course of action.

In December 2009, Pfizer announced the stop of A4021016 (ADVIGO 1016), a Phase 3 study examining the effects of figitumumab as first-line treatment in patients with advanced non-adenocarcinoma NSCLC, after an analysis by the DSMC showed that addition of figitumumab to carboplatin plus paclitaxel would be unlikely to meet the primary endpoint of improved overall survival compared to paclitaxel plus carboplatin alone.

Pfizer is continuing to study figitumumab in clinical trials for the potential treatment of prostate, breast and lung cancers, and Ewing’s sarcoma.

About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide. NSCLC accounts for about 85 percent of lung cancer cases and 25 to 30 percent are of squamous histology. Nearly 60 percent of NSCLC patients are diagnosed late with Stage IIIB/IV advanced disease. Despite recent advances, NSCLC remains difficult to treat, particularly in the metastatic setting.

About Figitumumab (CP-751,871)
Figitumumab, an investigational fully human monoclonal antibody, is a highly specific inhibitor of the insulin growth factor-1 receptor (IGF-1R) pathway. The IGF-1R pathway is thought to be one of the fundamental signaling pathways that leads to uncontrolled growth and survival of tumor cells, and may represent a resistance mechanism against EGFR inhibitors and other anti-cancer therapies.

About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers, including breast, lung, prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer Oncology has biologics and small molecules in clinical development and more than 200 clinical trials underway.

By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for the right patient at the right time.

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Aggressive childhood brain tumours could be treatable with a novel combination of two existing cancer drugs, a study suggests.

Researchers led by the Institute of Cancer Research (ICR) examined 90 tumours from children and found two new genetic abnormalities in nine of them.

They were then able to kill these abnormal tumours, in laboratory tests, by combining the two existing drugs.

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But one expert says the findings remain “far off being applicable to patients”.

In the UK, about 400 children are diagnosed with brain tumours every year.

The research, published in the journal Clinical Cancer Research, brought together scientists from the UK, France, Portugal, Brazil and America.

The abnormal tumours – known as glioblastomas, aggressive and often fatal cancers of the brain’s glial cells – contained too many copies of the EGFR gene and mutations of the gene the scientists say have never before been found in children.

They tried to block the EGFR gene with a drug, erlotinib (Tarceva), used in clinical trials to treat adult glioblastomas, but identified a molecule specific to the children’s cells – platelet-derived growth factor receptor (PGFR) – that was making it ineffective.

But when they combined erlotinib with a drug, imatinib (Glivec), they hoped would block the PGFR molecules, they killed a significant number of the cancer cells.

Dr Chris Jones, who led the research, said it proved “that cancers may look the same, but it is only when you get down to the genetic level that you can truly understand them and devise treatments”.

Professor Geoff Pilkington, of the Brainstrust charity, said the research, though fascinating, was at too early a stage to turn into a treatment for patients.

“This sort of twin therapy is a good thing to consider for the future,” he said.

Bur he added: “The cells of the brain seem to be unusually resistant to anything thrown at them.”

Source: BBC NEWS

Popularity: 4% [?]

Roche announced new data on Monday from the Phase III SATURN study, which showed that patients with advanced non-small-cell lung cancer who received Tarceva (erlotinib) immediately after initial chemotherapy had a significant improvement in overall survival, compared with those who received placebo. “Treating patients immediately following first-line chemotherapy versus waiting for the cancer to grow or spread before giving additional treatment represents a new approach in advanced NSCLC,” the company said.

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Principal investigator Federico Cappuzzo remarked: “This study has now not only confirmed that immediate treatment with Tarceva after initial chemotherapy delayed the progression of disease, but also importantly helped patients in the study live longer,” which was a secondary endpoint of the 889-patient trial. Full results will be presented later this summer at a conference.

OSI, which co-markets Tarceva in the US with Roche’s Genentech unit, previously reported results for the primary endpoint of the SATURN study that showed that Tarceva extended progression-free survival as a first-line maintenance therapy in patients with advanced NSCLC, compared with placebo. The overall survival data will be used to support European and US applications that were filed in March for this indication.

Currently, the drug is approved in the US and EU as a second-line treatment for patients with locally advanced or metastatic NSCLC.

Source: FirstWord

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New Phase III data for AstraZeneca’s Zactima (vandetanib) presented at ASCO showed that the drug reduced the risk of disease progression by 21 percent in patients with advanced non-small-cell lung cancer when combined with sanofi-aventis’ Taxotere (docetaxel), compared with Taxotere therapy alone. The company indicated that it would file Zactima for FDA approval by the end of the month.

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In the ZODIAC study, 1391 patients who were previously treated with one anti-cancer therapy for advanced NSCLC were randomised to treatment with either Zactima plus Taxotere, or Taxotere alone. Findings showed that median progression free survival (PFS) was 17.3 weeks for the group that received the combination therapy, compared with 14 weeks for the Taxotere-only arm.

AstraZeneca’s medical science director Peter Langmuir stated that “for the first time, we are actually improving efficacy…For patients in second-line treatment, there are three agents approved; none of them has been shown to be any better than docetaxel,” he explained. Lead researcher Roy Herbst added that he believes “this study will have immediate clinical implications,” and he said that more research should be undertaken to determine which patients are most likely to respond to the combination treatment.

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The drugmaker also presented details from two other previously reported studies, one of which involved Roche’s and OSI’s Tarceva (erlotinib), and the other Eli Lilly’s Alimta (pemexetred). Neither study met its primary endpoint in PFS. Langmuir stated that Zactima’s advantage would be as a proven combination therapy.

Source: FirstWord

Popularity: 6% [?]

OSI Pharmaceuticals on Thursday released results from a Phase III trial of Tarceva (erlotinib) in patients with advanced non-small-cell lung cancer, which showed positive results for the drug when used to treat the disease earlier than currently indicated. OSI noted that the study evaluated Tarceva as a single agent, first-line maintenance therapy for patients with advanced NSCLC who did not progress following first-line chemotherapy treatment.

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The SATURN trial enrolled 889 patients with advanced NSCLC who were treated with four cycles of standard first-line chemotherapy, followed by treatment with either Tarceva or placebo if their cancer did not progress. For the primary endpoint of progression-free survival in the overall population, data showed that patients who took Tarceva lived a median of 12.3 weeks without their disease worsening, compared with 11.1 weeks for those who received placebo. OSI also said the study met a second co-primary endpoint of PFS in patients with EGFR-positive tumours.

Regarding the result for Tarceva PFS in the overall population, OSI stated that the figures were not representative of patient benefit because of data distribution. CEO Colin Goddard remarked that the average benefit in patients who took Tarceva was 22 weeks, compared with 16 weeks for those who took placebo. The results were released ahead of a presentation of the data scheduled for later this month at ASCO.

Goddard estimated that use of Tarceva as maintenance therapy in NSCLC would add more than $500 million to the product’s annual US sales within one to three years of approval for this indication, which the company expects could be granted in 2010. Sales of Tarceva in the US, where it is co-marketed with Genentech, were $457 million in 2008. The drug has already been filed for expanded approval with the FDA, and with the European Medicines Agency by OSI’s international partner Roche.

Source: FirstWord

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The FDA, Genentech and OSI Pharmaceuticals reported that new safety warnings have been added to the prescribing information of Tarceva (erlotinib), which advise of serious health complications, including death, that have been revealed through routine monitoring of clinical study and post-marketing reports.

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The adverse events now noted on the drug’s label include gastrointestinal perforation, which the FDA noted has resulted in some deaths, as well as “bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders.”

Tarceva is indicated in the US as a monotherapy for patients with locally advanced or metastatic non-small-cell lung cancer in whom prior chemotherapy has failed, as well as for the first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer, in combination with Eli Lilly’s Gemzar (gemcitabine).

Source: FirstWord

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Roche announced that the company will commence a late-stage trial investigating whether Tarceva (erlotinib) is superior to chemotherapy as a first-line treatment in patients with non-small-cell lung cancer (NSCLC) who have genetic mutations in their epidermal growth factor receptor (EGFR).

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News of the upcoming study comes after AstraZeneca said an EU committee adopted a positive opinion for Iressa (gefitinib) in adults with NSCLC with the same gene mutation. Commenting on the potential competition between the products, analyst Michael Leuchten of Deutsche Bank suggested that “we don’t doubt that Iressa will find its place in the treatment of non-small-cell lung cancer, but see little risk to the Tarceva franchise,” adding that “the two treatments are remarkably similar and entering a carved-up market without knock-out data is challenging.”

Deutsche Bank analysts said Iressa, which garnered sales of $250 million in 2008, will likely be a niche product, potentially generating $474 million in revenue in 2014.

Source: FirstWord

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OSI announced that it filed two lawsuits in a US district court, against Teva and Mylan, alleging that the companies’ applications to the FDA to sell generic versions of Tarceva (erlotinib) would infringe on three patents associated with the cancer drug.

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The filing of the lawsuits restricts the FDA from approving the generic drugmakers’ applications until as late as May 2012, OSI stated. Tarceva is marketed in a partnership between OSI and Genentech in the US, where the drug is approved to treat pancreatic cancer and non-small-cell lung cancer.

Source: FirstWord

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Roche announced that it submitted Tarceva (erlotinib) to EU regulators for expanded approval for the drug as a first-line maintenance therapy in patients with advanced non-small-cell lung cancer who have not progressed in their disease after first-line treatment with chemotherapy. In addition, Genentech and OSI Pharmaceuticals stated that OSI filed a parallel application for Tarceva with the FDA. OSI’s CEO, Colin Goddard, noted that “if approved, Tarceva will be the first EGFR targeted and oral therapy available as a first-line maintenance treatment for people with NSCLC.”

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Both submissions were based on data from the late-stage SATURN trial, which demonstrated that Tarceva met the study’s primary endpoint of significantly extending progression-free survival, compared with placebo, in patients with advanced NSCLC when administered immediately after initial treatment with chemotherapy, the drugmakers said.

Genentech and OSI indicated that overall survival data for Tarceva are expected in the second half of this year and will be included in the FDA review.

Source: FirstWord

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