Patients with breast, lung and kidney cancer lived longer or saw symptoms reduced in clinical trials that were released this weekend at the American Society of Clinical Oncology meeting in Atlanta.
The annual gathering featured strong showings from the big pharma trio of
- Pfizer drug Sutent almost doubled progression-free survival time in patients who took the drug as a first-choice treatment instead of a standard treatment, according to trial results. The trial involved 750 patients with a type of kidney cancer called advanced clear-cell carcinoma, who hadn't had chemotherapy, though most of the patients had their cancerous tumor and diseased kidney removed. Patients either received Sutent, also known as sunitinib, or interferon-alpha, a standard kidney cancer treatment. Sutent is already approved to treat kidney cancer patients.
- Wyeth said temsirolimus, used alone and as a first treatment, significantly increased the overall survival of patients with advanced renal-cell carcinoma compared with interferon-alpha. The preliminary findings came from an interim analysis of a continuing phase III clinical trial of the experimental drug. Patients who were treated with temsirolimus by itself experienced a 3.6-month increase in median overall survival time compared with those treated with interferon-alpha alone, or 10.9 months vs. 7.3 months. In late 2004, temsirolimus was granted fast-track status by the Food and Drug Administration for the treatment of kidney cancer patients with poor prognoses.
- Pfizer's Sutent also produced positive results in lung cancer. The phase II safety and efficacy trial involved 63 patients who had received between one and four prior treatments for nonsmall-cell lung cancer and were still getting worse. The patients underwent six-week cycles in which they received 50 milligrams of the drug per day for four weeks followed by a two-week break. According to the trial results, tumors shrank by 50% or more in 9.5% of patients who received the drug, and stopped growing in an additional 43% of trial patients, researchers said. The presentation marked the first time Sutent was proven effective when used alone in nonsmall-cell lung cancer patients whose disease got worse even after prior treatments.
- Eli Lilly (LLY) - Get Eli Lilly and Company Report said data affirm that its Alimta offers patients with advanced nonsmall-cell lung cancer similar overall survival benefits as Taxotere, a type of chemotherapy made by Sanofi-Aventis (SNY) - Get Sanofi Report. The survival data were part of a 571-patient phase III study designed to evaluate the effectiveness and safety profile of Alimta as a second-line therapy in nonsmall-cell lung cancer. First reported in 2003, the study found that patients in the Alimta arm achieved 8.3 months of median survival, whereas those in the Taxotere group saw 7.9 months. Alimta was first approved by the Food and Drug Administration in 2004 as a second-line treatment of nonsmall-cell lung cancer and for malignant pleural mesothelioma.
- Abraxis BioScience (ABBI) reported the results from a number of clinical studies of Abraxane as a treatment for late-stage nonsmall-cell lung cancer. One of the phase II studies involved giving patients with stage three and four cancer, who hadn't received chemotherapy, weekly Abraxane and carboplatin, a type of chemo sold under the brand name Paraplatin by Bristol-Myers Squibb (BMY) - Get Bristol-Myers Squibb Company Report. Abraxis said 50% of the patients had either a complete or partial response, and an additional 36% had stable disease for at least 12 weeks. The median time until the disease worsened was 28 weeks. The FDA has cleared Abraxane for treating breast cancer.
- Breast cancer patients given GlaxoSmithKline's Tykerb plus the oral chemotherapy drug capecitabine, known by the brand name Xeloda, saw their cancer more effectively controlled than with Xeloda alone. While patients receiving Xeloda alone went 19.7 weeks before their disease got worse, patients on the combination of drugs went 36.9 weeks before their cancer progressed. And while 11 out of 161 patients on Xeloda alone saw their cancer spread to the brain, just four out of 160 patients on the combination saw brain metastases, a condition with significant unmet medical need. Doctors believe that Tykerb, unlike some other breast cancer drugs like Genentech's Herceptin, has the ability to cross the blood-brain barrier to reach brain tumors.
- Switching breast cancer patients from standard treatment to the Pfizer drug Aromasin reduces their risk of death, according to another trial. The study found that patients who made the switch after two to three years on tamoxifen, a commonly used breast cancer treatment, had a 15% lower risk of dying than those who didn't. Researchers also reported a 17% reduction in the risk of cancer spreading to other parts of the body, a 44% lower incidence of cancer developing in the opposite breast and a 24% lower risk of patients experiencing other events like new breast cancer, recurrence of breast cancer or death from something other than breast cancer.
- Millennium Pharmaceuticals (MLNM) said clinical data show the potential benefit of using Velcade upfront to treat multiple myeloma in newly diagnosed patients. The data indicated an overall response rate of 40% when Velcade was used as a single agent, including a complete response rate of 10%. Millennium said the results provide further rationale for several phase II studies of Velcade in combination with other therapies that have had some of the highest-recorded response rates, including complete responses, in treating multiple myeloma, a blood cancer.
- Cell Genesys (CEGE) reported "encouraging" long-term follow-up data from a mid-stage trial of Gvax immunotherapy for chronic myelogenous leukemia. The company said adding Gvax to Novartis' (NVS) - Get Novartis AG Report Gleevec reduced persistent leukemic disease in 10 of 19 patients in a study. "We continue to be encouraged by the results of this phase II trial in CML, in particular by the achievement of sustained molecular responses when Gvax is added to ongoing Gleevec therapy," said Joseph Vallner, the president and chief operating officer of Cell Genesys. "Gvax immunotherapy, in our view, may represent an important new treatment strategy for CML."
- Genzyme (GENZ) said a late-stage clinical trial showed that Campath exhibited significantly higher overall and complete response rates over chlorambucil in previously untreated patients with progressive B-cell chronic lymphocytic leukemia. Genzyme said 83% of patients on Campath responded to the drug, compared with 56% of those on chlorambucil. The company said 24% of the study participants getting Campath had a complete response, vs. 2% of the chlorambucil patients. Chlorambucil is considered by many to offer the most tolerable safety profile for previously untreated patients. Genzyme made the announcement along with a unit of Berlex Laboratories, a U.S. affiliate of Germany's Schering AG (SHR) . Chlorambucil is marketed as Leukeran by GlaxoSmithKline.
- New data from 4,000 patients show that Avastin enables patients with advanced colorectal cancer to live longer without their disease worsening, Switzerland's Roche said. Roche markets the drug with Genentech (DNA) , in which it owns a majority stake. The data represent the largest data set on Avastin ever available. An international study and its U.S. counterpart investigated the use of Avastin in advanced colorectal cancer in combination with standard chemotherapies. The U.S. arm of the study found the median length of time without the cancer growing was 10.2 months, regardless of the chemo used.
- Amgen (AMGN) - Get Amgen Inc. Report reported interim results from a safety and efficacy study of its experimental drug panitumumab, which was found to be effective in stopping tumor growth in patients with metastatic colorectal cancer. According to early results, 13% of patients whose condition did not improve with standard chemotherapy saw their tumors shrink thanks to the drug, and 30% of patients' tumors stopped growing. However, as of the interim analysis, 88 patients had enrolled in the trail and only 23 patients met the criteria for evaluation. Researchers are looking to enroll at total of 150 patients in the trial.
- Millennium Pharmaceuticals reported the results of a clinical study on the effectiveness of Velcade in the treatment of relapsed or refractory mantle-cell lymphoma. The phase II data revealed an overall response rate, including complete responses, of 33%. The median duration of the study participants' response was 9.2 months. The company said it expects the data to be the basis for a supplemental new drug application in the near future. Velcade is currently approved for multiple myeloma patients who have received at least one prior therapy.