Big pharmaceutical companies were in the spotlight Saturday at the American Society of Clinical Oncology meeting in Atlanta.
presented positive results for its experimental lung cancer drug Sutent.
The phase II safety and efficacy trial involved 63 patients who had received between one and four prior treatments for non-small 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.
This presentation marked the first time Sutent was proven effective when used alone in non-small cell lung cancer patients whose disease got worse even after prior treatments.
"We feel it looks as good as anything out there in terms of what's already been approved," said Dr. Mark Socinski of the University of North Carolina at Chapel Hill, the lead investigator in the trial.
The results are preliminary and this is only the first step, Socinski warned in an interview. More studies need to be conducted to "see where it fits in with standard treatments and how to optimize it."
For example, the trial's four-week-on, two-week-off dosing schedule may not be the best way to give the drug, Socinski says. It's currently being testing using a continuous dosing schedule at a lower dose, 37.5 milligrams a day, with roughly the same amount of drug being administered in the same amount of time.
Still, Socinski has high hopes for Sutent. Cancer drugs are often studied first in patients who've run out of other treatment options.
"Its potential benefit may be greater in the first-line setting than the refractory setting," Socinski says. He believes Sutent should be studied in combined with standard first-choice treatments to see whether it can improve the effects of those standard drugs.
Pfizer's shares were at $24.19 at the market close on Friday.
Last year at ASCO, biotech giant
stole the show with impressive data on its proposed lung cancer drug Avastin.
Avastin, which is currently approved to treat colon cancer, is being tested in phase III clinical trials to treat kidney, breast, pancreatic, non-small cell lung, prostate and ovarian cancers, according to Genentech's Web site.
Also on Saturday,
released new data on its experimental breast cancer drug Tykerb.
According to trial results, breast cancer patients given 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.
The phase III study involved patients whose cancer had progressed despite prior treatments with Herceptin, which was also highly touted at last year's ASCO meeting. Phase III is the stage of trials conducted immediately before a drug is submitted for Food and Drug Administration marketing approval.
"Trastuzumab is a very effective drug that has substantially improved the available treatments for women with metastatic breast cancer that produces large amounts of the HER2/neu protein," said Dr. Charles Geyer Jr. of the Allegheny General Hospital in Pittsburgh, the lead investigator. "However, because
Herceptin eventually stops controlling these cancers, there is a need for effective alternative treatments that block the function of HER2/neu in another way," he said.
HER2-positive breast cancer breast cancer is a more aggressive form of the cancer caused by a genetic mutation in tumor cells. It affects 20% to 30% of breast cancer patients and has a higher likelihood or reappearing after treatment.
GlaxoSmithKline shares closed at $55.99 Friday.
While big pharma companies made headlines Saturday morning at ASCO, big biotechs like
also featured prominently.
The world's biggest biotech 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.
In addition, Amgen reported results from an early trial involving its drug AMG 706 as a monotherapy for advanced thyroid cancer. The phase I trial, which was designed to determine the appropriate dosing for the drug, suggests that the drug has "promising anti-tumor activity," according to an Amgen press release. Phase I is the first stage of clinical drug trials in humans.
Amgen's shares closed at $69.18 Friday.