Healthcare Industry News: Enzastaurin
News Release - June 4, 2006
Updated Analysis in Second-Line Treatment of Lung Cancer Trial Confirms Similar Survival for Alimta(R) and DocetaxelAlimta Also Shows Tolerability as Triplet Combination Treatment in First-Line Lung Cancer
ATLANTA, June 4 (HSMN NewsFeed) -- Data presented today at the 42nd American Society of Clinical Oncology (ASCO) annual meeting in Atlanta, Ga., affirms that ALIMTA® (pemetrexed), manufactured and marketed by Eli Lilly and Company, offers patients with advanced non-small cell lung cancer (NSCLC) similar overall survival as docetaxel (Taxotere®).
The survival data were part of a large (n=571), randomized Phase III study to evaluate the efficacy and safety profile of Alimta as second-line therapy in NSCLC. First reported in 2003(i), the study found that patients in the Alimta arm achieved 8.3 months of median survival, whereas those in the docetaxel arm obtained 7.9 months. This updated analysis of data tracked patients from the same study nearly two years beyond the conclusion of the original study and found similar results. The updated data showed that patients who received Alimta experienced 8.3 months of median survival compared to 8.0 months for those in the docetaxel arm.
"The data mirror previously reported results and confirm the efficacy of Alimta versus docetaxel," said Filippo de Marinis, M.D., director of the Pulmonary-Oncology Unit at San Camillo-Forlanini High Specialization Hospitals in Rome, Italy, and one of the study's principal investigators. "Based on these data, and on its safety advantage, Alimta should be regarded as a standard of care for non-small cell lung cancer patients in the second-line setting."
Patients in both arms of the trial were given standard doses of therapy for NSCLC. On day one of a 21-day cycle, patients in the Alimta arm of the trial received Alimta (500 mg/m squared), which was supplemented with vitamin B12 and folic acid as per label instructions. A team of researchers led by Lilly discovered that this vitamin supplementation given with Alimta significantly reduces the frequency and severity of the drug's side effects without compromising its ability to kill cancer cells. Patients in the docetaxel arm were given a 75 mg/m squared infusion.
As previously reported, the incidence of severe neutropenia, a decrease in the number of white blood cells that increases the risk of infection, was five percent in the Alimta arm and 40 percent in the docetaxel arm, an eight-fold difference that was statistically significant (p= <0.001). The difference in the incidence of neutropenic fever and subsequent hospitalizations between the Alimta and docetaxel arms was also statistically significant: two percent for the Alimta patients compared to 13 percent for the docetaxel patients (p= <0.001).
In a third finding that reached statistical significance, the incidence of drug-related serious adverse events -- which include side effects that could lead to a life-threatening outcome, death or hospitalization -- was 10 percent for Alimta patients and 24 percent for docetaxel patients (p= <0.001).
The incidence of grades 3/4 Alanine Transaminase (ALT) -- a laboratory measurement of liver function -- was 1.9 percent in the Alimta arm, a rate that was significantly greater than in the docetaxel arm (p=0.028). According to findings, the incidence of grades 3/4 ALT in the Alimta arm was transient.
Alimta Data in First-Line NSCLC
In addition to its role in the second-line treatment of NSCLC, Alimta is also being investigated as a potential option for the treatment of first-line and earlier stages of NSCLC. Data disseminated on an additional study presented at the ASCO meeting reported on a single cohort Phase II clinical study which evaluated the safety and efficacy of a triplet therapy in which bevacizumab (Avastin®) was added to the combination of Alimta plus carboplatin, a regimen which has been reported upon in published articles.(ii,iii) Preliminary findings of this study suggest that this triplet therapy can be delivered at full doses of each drug with limited toxicity for the first-line treatment of NSCLC.
"Alimta is a very valuable component of the Lilly Oncology franchise," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Lilly. "We are extremely pleased that data continue to demonstrate the ability of the combination of Alimta and a platinum agent like carboplatin to serve as a reliable chemotherapeutic foundation for the treatment of non-small cell lung cancer. We are confident that Alimta will continue to provide notable benefits for patients with thoracic cancers and have great hopes for its potential in other tumor types."
Alimta is currently being studied in combination with eleven targeted agents in NSCLC, including bevacizumab (Avastin®), erlotinib (Tarceva®), cetuximab (Erbitux®), bortezomib (Velcade®), Matuzumab, as well as Enzastaurin, Lilly's own novel investigational compound.
Alimta is an antifolate, which interferes with a crucial process that allows cancer cells to reproduce and spread. Alimta was first approved by the U.S. Food and Drug Administration in 2004 for malignant pleural mesothelioma, a tumor of the linings of the lungs often associated with exposure to asbestos, and also for second-line treatment of NSCLC. In the two years since its first approval for marketing, Alimta has been approved in 71 countries for either NSCLC or mesothelioma, and has become the leader for these indications in most markets. The most common side effects when Alimta is used as monotherapy are disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, rash and desquamation.
About Non-Small Cell Lung Cancer
The most common type of lung cancer, non-small cell lung cancer (NSCLC) represents 75-80 percent of all lung cancers. NSCLC has five-tier staging, starting at 0 and rising to the severity of stage IV. NSCLC can spread through the lymphatic system, penetrating the chest lining, ribs, and the nerves and blood vessels that lead to the arm. The liver, bones and brain are potential targets if the cancerous cells enter the blood stream.
Alimta was first approved by the US Food and Drug Administration in 2004 for second-line treatment of non-small cell lung cancer (NSCLC), and for malignant pleural mesothelioma. In the two years since its first approval for marketing, Alimta has been approved in 71 countries for either NSCLC or mesothelioma and has become the leader for these indications in most markets. Delivered via a 10-minute infusion, Alimta is an antifolate, which interferes with a crucial process that allows cancer cells to reproduce and spread.
Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology has been collaborating with cancer researchers to deliver innovative treatment choices and valuable programs to patients and their physicians. Inspired by courageous patients living with cancer, Lilly Oncology is providing treatments that are considered global standards of care and developing a broad portfolio of novel targeted therapies to accelerate the pace and progress of cancer care. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.
Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.
ALIMTA® (pemetrexed), Lilly
Avastin® (bevacizumab), Genentech
Tarceva® (erlotinib), Genentech
Taxotere® (docetaxel), Aventis Pharmaceuticals
Erbitux® (cetuximab), ImClone Systems, Bristol-Myers Squibb
Velcade® (bortezomib), Millennium Pharmaceuticals, Johnson & Johnson Pharmaceutical Research & Development
This press release contains forward-looking statements about the potential of Alimta for the treatment of non-small cell lung cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
(i) Hanna N, Shepherd FA, Fossella FV, et al. Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients with Non-Small Cell Lung Cancer Previously Treated with Chemotherapy. Journal Clinical Oncology, Vol. 22, pp. 1589-1597; May 1, 2004.
(ii) Scagliotti GV, Kortsik C, Dark GG, et al. Pemetrexed combined with oxaliplatin or carboplatin as first-line treatment in advanced non-small cell lung cancer: a multicenter, randomized, phase II trial. Clin Cancer Res. 2005 Jan 15;11 (2 Pt 1):690-6.
(iii) Zinner RG, Fossella FV, Gladish GW, et al. Phase II study of pemetrexed in combination with carboplatin in the first-line treatment of advanced nonsmall cell lung cancer. Cancer. 2005 Dec 1;104(11):2449-56.
Source: Eli Lilly
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