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Kidney Drugs Take Stage

Althea Chang

Positive data was released in trials targeting kidney and lung cancer Sunday at the American Society of Clinical Oncology's annual meeting in Atlanta.

Pfizer(PFE Quote) kidney cancer 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, thought 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.

According to the results, patients on Sutent survived 47.3 weeks without their disease getting worse, while people on the standard treatment went 24.9 weeks without progression.

"As a result of this trial we believe sunitinib will become the new standard of care for advanced renal cell cancer," said Dr. Robert Motzer of Memorial Sloan Kettering Cancer Center in New York. "There were some side effects, including fatigue and reduced blood cell counts, but because of the overwhelming superiority and efficacy of this drug, and the fact that the side effects were very well tolerated, the benefits clearly outweigh the costs," Motzer said.

Sutent is already approved to treat kidney cancer patients.

Wyeth (WYE Quote) 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.

"Until just a few years ago there were no promising drugs for kidney cancer," said Dr. Gary Hudes of Fox Chase Cancer Center in Philadelphia. "Now there are two that have recently been approved by the FDA and several more that are looking very good in clinical trials," he said.

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. Fast track designation is granted by the FDA for drugs with the potential to treat conditions with significant unmet medical need. The status allows an expedited review of the drug application but does not guarantee expedited approval.

Millennium Pharmaceuticals (MLNM Quote) said new 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%.

The company 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.

Separately, Millennium 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.

Eli Lilly (LLY Quote) said data presented at ASCO affirm that Alimta offers patients with advanced nonsmall-cell lung cancer similar overall survival benefits as Taxotere, a type of chemotherapy made by Sanofi-Aventis (SNY Quote).

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.

The updated analysis tracked patients from the same study for nearly two more years and found 8.3 months of median survival for the Alimta group and 8.0 months for patients getting Taxotere.

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.

The incidence of drug-related serious adverse events, including those that could lead to death or hospitalization, was 10% for Alimta patients and 24% for those on Taxotere, Lilly said. As Lilly previously reported, the occurence of severe neutropenia, a low white blood cell count that increases the risk of infection, was 5% in patients on Alimta and 40% in the Taxotere group.

"Based on these data, and on its safety advantage, Alimta should be regarded as a standard of care for nonsmall-cell lung cancer patients in the second-line setting," said trial investigator Dr. Filippo de Marinis of the San Camillo-Forlanini High Specialization Hospitals in Rome.

"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," said Dr. Richard Gaynor, Lilly's vice president of cancer research.

Alimta is also being studied as a first-choice treatment for nonsmall-cell lung cancer in advanced and early-stage patients and is being investigated as part of a combination treatment with other drugs.

Abraxis BioScience (ABBI Quote) 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 Quote). 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.

Also among lung cancer findings presented at ASCO, Cell Therapeutics (CTIC Quote) said its treatment's effectiveness could be affected by the female sex hormone estrogen.

In a trial involving Cell Therapeutics' lung cancer drug Xyotax, there was a significant survival difference between female patients who were on the drug compared with those who weren't. Meanwhile, among male trial patients, there was little difference in overall survival among patients who received the drug and those who didn't.

Preclinical and clinical studies have indicated that Xyotax's metabolism by lung cancer cells may be influenced by estrogen, according to Cell Therapeutics.