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Apr-21-2008Avastin study fails to show improved lung cancer survival(topic overview)
CONTENTS:
- ZURICH, Apr. 21, 2008 (Thomson Financial delivered by Newstex) -- Genentech (NYSE:DNA) Inc. said fresh data from a previously reported Phase III clinical study of Avastin in combination with gemcitabine and cisplatin chemotherapy, in patients with advanced, non-squamous, non-small cell lung cancer confirmed positive results. (More...)
- Avastin is indicated for the first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy, and for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. (More...)
- Avastin, which is vital to the future prospects of both Genentech and its associate Roche Holding, is already approved in NSCLC in the United States and Europe. (More...)
- Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com. (More...)
- The company's full year profit amounted to $39.6 million, up 22% from $32.4 million reported last year. (More...)
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ZURICH, Apr. 21, 2008 (Thomson Financial delivered by Newstex) -- Genentech (NYSE:DNA) Inc. said fresh data from a previously reported Phase III clinical study of Avastin in combination with gemcitabine and cisplatin chemotherapy, in patients with advanced, non-squamous, non-small cell lung cancer confirmed positive results. The update confirmed the clinically and statistically significant improvement in the primary endpoint of progression free survival for both the 15 mg and the 7.5 mg doses of Avastin compared to chemotherapy alone. [1] According to Genentech, the study failed to demonstrate a statistically significant prolongation of overall survival, a secondary endpoint, for either dose in combination with gemcitabine and cisplatin chemotherapy compared to chemotherapy alone. Median survival of patients in all arms of the study exceeded one year, longer than formerly reported survival times in this indication. The company stated that its pivotal Phase III U.S. study of Avastin plus carboplatin and paclitaxel chemotherapy proved a statistically significant improvement in overall survival for patients with advanced lung cancer, compared to chemotherapy alone.[2]
Importantly, the Genentech pivotal Phase III U.S. study (E4599) of Avastin plus carboplatin and paclitaxel chemotherapy showed a statistically significant improvement in overall survival for patients with advanced lung cancer compared to chemotherapy alone (25 percent improvement, hazard ratio 0.80).[3]
The AVAIL study tested two doses of Avastin in combination with the chemotherapy drugs gemcitabine and cisplatin compared to chemotherapy alone in patients with newly diagnosed non-small cell lung cancer. Last year, results from the study's primary endpoint showed that both the low-dose and high-dose arms of Avastin plus chemo resulted in a statistically significant improvement in progression-free survival compared to chemo alone.[4] Monday, Genentech confirmed that neither doses of Avastin plus chemo resulted in a statistically significant improvement in overall survival compared to chemo alone. Patients in all three arms of the study reported a median survival of more than 12 months, which is longer than typically seen in these patients. Given the strong survival benefit reported for Avastin in the U.S. study, it's highly unlikely that the new AVAIL data will prompt doctors to stop using Avastin to treat lung cancer. It could compel some doctors to switch to a lower dose of Avastin, which could pinch revenue. This was the fear that surfaced last year when the first AVAIL results were released.[4] The updated data could prompt negative sentiment toward Avastin, said Goldman Sachs analyst May-Kin Ho, in a note to investors. She pointed out that a prior late-stage study on the drug showed an improvement in overall survival rates for patients on Avastin and chemotherapy. "The lack of overall survival benefit in Avail (recent study data) may be due to a lack of statistical power," she said, adding that the result is from a secondary goal and there were different chemotherapy backgrounds for the patients involved. Avastin is sold in an already tightly competitive market and faces the possibility of more competition from New York-based ImClone Systems Inc. That company's drug Erbitux is being studied as a lung cancer treatment and in September study data showed that it improved the overall survival rate for patients.[5] The new European data comes from a study called AVAIL that was conducted by Swiss drugmaker Roche, which sells Avastin in Europe. While the lack of a survival benefit in the AVAIL study does not put Avastin lung cancer revenue at risk entirely, some doctors may re-evaluate how they use the drug when treating lung cancer patients. This is especially true as Avastin is expected to get some new competition in the lung cancer market from Erbitux, the cancer drug owned by ImClone Systems IMCL.[4]
In June, ImClone and its European partner Merck KGaA will present results from a phase III study of Erbitux in non-small cell lung cancer patients. The companies have previously reported that Erbitux successfully prolonged survival in these patients, but the precise extent of that benefit is being kept under wraps until the American Society of Clinical Oncology annual meeting. It's expected that Erbitux will improve survival in lung cancer patients by at least four to five weeks. This would make Erbitux a significant player in the lung cancer treatment market, especially for patients who, for various reasons, are not eligible to receive, or cannot to, Avastin.[4] The brokerage said it had learnt from "a reliable public source" that ImClone's medicine had demonstrated an unexpected survival benefit in a second Phase III trial -- the so-called BMS-099 trial for first line metastatic lung cancer. The revelation came as Genentech announced fresh findings from a clinical trial called Avail showing that Avastin improved progression-free survival in patients with non-small cell lung cancer (NSCLC) but did not prolong their overall survival.[6] SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, Inc. (NYSE:DNA) today announced an update for the previously reported Roche-sponsored international Phase III clinical study (AVAiL) of Avastin (bevacizumab) in combination with gemcitabine and cisplatin chemotherapy, in patients with advanced, non-squamous, non-small cell lung cancer (NSCLC).[3]
" The statistically significant improvement in overall survival observed in E4599, as well as the safety and improvement in progression-free survival in AVAiL and E4599, give us confidence in Avastin ' s safety and efficacy for patients with advanced, non-squamous, non-small cell lung cancer. These studies reinforce our belief that Avastin is an important treatment option for patients with this most common form of lung cancer, " said Hal Barron, M.D., senior vice president, Development and chief medical officer.[3]
Genentech's most important cancer drug, Avastin is already approved as a treatment for non-small cell lung cancer based on a separate study conducted in the U.S., which showed that Avastin, used in combination with chemotherapy, prolonged patient survival by about two months, or 25%.[4] Genentech's DNA cancer drug Avastin failed to prolong survival in patients with non-small cell lung cancer, according to updated results from a European clinical trial released Monday.[4]
The results mean Erbitux has two Phase III trials with proven survival benefit compared with only one for Avastin, increasing the chances that Erbitux could pose a serious threat to Avastin in the lung cancer treatment market in future. Avastin, which is vital to the future prospects of both Genentech and its associate Roche Holding AG (ROG.VX: Quote, Profile, Research ), is already approved in NSCLC in the United States and Europe. Erbitux was initially developed for colon cancer but its sponsors now want to use it in a wider range of tumour types. It is sold in Europe by Germany's Merck KGaA (MRCG.DE: Quote, Profile, Research ) and in the United States by Bristol-Myers Squibb Co (BMY.N: Quote, Profile, Research ).[6]
NEW YORK, Apr. 21, 2008 (Thomson Financial delivered by Newstex) -- Shares of Genentech (NYSE:DNA) Inc. fell in premarket trading Monday after the biotechnology company said a Phase III trial for Avastin did not meet its secondary endpoint of a statistically significant porlongation of overall survival.[7]
The update confirmed the clinically and statistically significant improvement in the primary endpoint of progression free survival (PFS) for the two different doses of Avastin studied in the trial (15 mg/kg and 7.5 mg/kg) compared to chemotherapy alone.[3] The company said that the study, in combination with gemcitabine and cisplatin chemotherapy in patients with advanced non-small cell lunch cancer, met the primary endpoint of progression free survival for 2 different doses compared with chemotherapy alone.[7] The study did not demonstrate a statistically significant prolongation of overall survival, a secondary endpoint, for either dose in combination with gemcitabine and cisplatin chemotherapy compared to chemotherapy alone. Median survival of patients in all arms of the study exceeded one year, longer than previously reported survival times in this indication.[3]
No new safety signals for Avastin were observed in the study, and there were no clinically meaningful differences in safety between the two doses of Avastin. AVAiL is an international study, conducted outside of the U.S., that enrolled 1,043 patients with previously untreated, advanced, non-squamous, NSCLC. The study met its primary endpoint of progression-free survival, defined as the time from randomization to the first event of progression or death, and was presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2007.[3]
Biotechnology company Genentech Inc. said Monday updated results from a late-stage study show Avastin increased progression-free survival for lung cancer patients, but failed to improve overall survival rates.[5] LONDON, April 21 (Reuters) - Genentech Inc's (DNA.N: Quote, Profile, Research ) blockbuster cancer drug Avastin faces a big challenge from ImClone Systems Inc's (IMCL.O: Quote, Profile, Research ) Erbitux in lung cancer, Morgan Stanley analysts said on Monday, citing unpublished data.[6] Monday, Morgan Stanley's European drug analyst issued a note to clients stating that an update from a previous study of Erbitux in lung cancer also showed a survival benefit in favor of the drug.[4]
Neither ImClone nor Merck KGaA would confirm the report to the Morgan Stanley analyst, but if confirmed, the data could provide more evidence to support Erbitux's role as a lung cancer treatment.[4] Erbitux in lung cancer, Morgan Stanley analysts said on Monday, citing unpublished data.[8]
Avastin is indicated for the first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy, and for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. [3] In 2006, the Food and Drug Administration (FDA) approved Avastin for the first-line treatment of unresectable, locally advanced, recurrent metastatic, non-squamous, NSCLC on the basis of E4599.[3]
E4599 was a randomized, controlled, multi-center trial that enrolled 878 patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC. Patients with mixed histology were excluded if the predominant cell type was squamous.[3]
The most common severe adverse reactions (NCI-CTC Grade 3-5) across clinical trials in metastatic colorectal cancer, NSCLC, and metastatic breast cancer that occurred at a higher incidence (greater than or equal to 2 percent higher rate v. controls) were hypertension, proteinuria, and headache.[3] Morgan Stanley said the companies had declined to confirm the Erbitux clinical trial news, but shares in Germany's Merck KGaA were likely to rally strongly, ahead of the big ASCO cancer meeting at the end of May.[6]
Avastin, which is vital to the future prospects of both Genentech and its associate Roche Holding, is already approved in NSCLC in the United States and Europe. Erbitux was initially developed for colon cancer but its sponsors now want to use it in a wider range of tumour types. [8] Avastin is also approved as a colon cancer treatment and recently gained approval as a breast cancer treatment. It is Genentech's key revenue driver, with sales of just under $2.3 billion in 2007.[5]
Genentech added that it did not notice any new safety signals for Avastin in the study and that there were no clinically significant differences in safety between the two doses of Avastin.[2] Genentech said it didn't observe any new safety signals for Avastin, and there were no meaningful differences between the 2 doses.[7]
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com. Such statements are predictions and involve risks and uncertainties such that actual results may differ materially. [3] Actual results may be affected by a number of factors including, but not limited to, unexpected safety, efficacy or manufacturing issues, the need for additional data, data analysis or clinical studies, FDA actions or delays, failure to maintain FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals and new product approvals and launches, and intellectual property or contract rights.[3]
Secondary endpoints included overall survival, response rate, time to treatment failure and safety.[3] The study had a principal endpoint of overall survival and tested 15 mg/kg of Avastin with a different chemotherapy regimen than the AVAiL study.[2] Concerns about the lack of a survival benefit in the AVAIL study first surfaced April 14, sending Genentech shares lower.[4]
The company's full year profit amounted to $39.6 million, up 22% from $32.4 million reported last year. [2]
SOURCES
1. Genentech says phase III trials of Avstin for lung cancer meet primary endpoint
2. RTTNews - Breaking News, financial breaking News, Positive EPS Surprises, Stock research .
3. Genentech Provides Update on ''AVAiL'' Phase III Study of Avastin Plus Chemotherapy in First-Line, Advanced, Non-Squamous, Non-Small Cell Lung Cancer
4. European Trial Slows Genentechs Avastin | Biotech | DNA IMCL - TheStreet.com
5. Avastin study fails to show improved lung cancer survival
6. UPDATE 2-Erbitux seen challenging Avastin in lung cancer | Markets | Markets News | Reuters
7. Genentech down in premarket after Avastin trial fails to meet secondary endpoint
8. Genentech Faces ImClone Pressure on Cancer Drug - Pharmaceuticals * US * News * Story - MSNBC.com
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