News

A key clinical trial for cancer patients that Canada could not take part in because one drug company would not support it is going ahead in this country after all.

In an unusual move, a drug company will buy a rival's product, Avastin, so that hundreds of colorectal cancer patients across Canada can participate in the study run by the National Cancer Institute in the United States.

The study will answer two burning questions among oncologists who treat colorectal cancer: What drug works most effectively with chemotherapy: Avastin or Erbitux? Or do they work best together?

U.S.-based ImClone Systems Inc., which manufactures Erbitux, will provide not only its drug to patients participating in the study, but also Avastin, which is distributed in Canada by Roche Canada, holder of the Canadian licence.

Provincial governments have been eager to see the outcome of the trial, because several of them will fund drugs only if they are found to be cost-effective. However, most refuse to fund Avastin, which typically costs $36,000 for a course of treatment.

Avastin is available in Newfoundland and Labrador, British Columbia (which permits some compassionate access to it) and in at least one Quebec hospital.

As for Erbitux, Bristol-Myers Squibb Canada decided not to launch the drug it distributes and licenses after it failed to agree on a price with the federal Patented Medicine Prices Review Board. The Cancer Advocacy Coalition of Canada estimates Erbitux costs $56,000 for a standard course of therapy.

About 300 patients with advanced colorectal cancer will be able to get access to the new drugs as early as September as part of the trial. Last year, about 20,000 people in Canada were diagnosed with the disease, and about 8,500 died of it.

A Globe and Mail cancer series in November revealed that Canada could not be part of the trial because many metastatic colorectal cancer patients were not getting what is considered the standard of care in most of the world: Fluorouracil, a chemotherapy drug also known as 5FU, in combination with Oxaliplatin and Avastin.

Alan Venook is principal investigator of the trial and professor of clinical medicine at the University of California.

He called it marvellous that ImClone is buying Avastin, but said: "I think it's distressing that this is what it takes."

ImClone's vice-president of medical affairs, Dvorit Samid, said the total amount has not been tallied, but Roche Canada is selling the drug to them at cost.

"The trial is a very important question for patients," said Dr. Samid. "... Everybody hopes, all of us hope for the sake of patients, that when you take the two biological [drugs] and add to chemo[therapy], we will further improve the outcome."

In the fall, Sabrina Paiva, manager of communications and stakeholder relations for Roche Canada, said the company could not sanction a trial in which some patients would not receive Avastin. One group is getting only Erbitux and chemotherapy.

This week, she provided a written statement, saying: "We are currently in discussion with ImClone. In light of the fact that public funding is not available in most provinces, this study will provide another avenue for patients to get access to Avastin."

If the trial succeeds, Erbitux stands to become a substitute for Avastin or be added to the regimen of Avastin and chemotherapy.

Ralph Meyer, director of the National Cancer Institute of Canada's Clinical Trials Group, stressed there is still an approval process to go through, with a decision expected by the end of the month. After that, hospital research and ethics boards will decide whether to participate.

The trial will enroll 2,300 patients, most from the United States.

One hundred of the Canadian patients will receive chemotherapy plus Avastin, 100 will receive chemotherapy and Erbitux and 100 will receive chemotherapy, Avastin and Erbitux.

"Two out of three patients in this study will get access to Avastin, which we know improves survival, so, yes, this trial will be an important means to get treatment," said Derek Jonker, co-chair of the colorectal cancer working group for the National Cancer Institute of Canada.

As for Erbitux, while no provincial government funds that drug, in large part because it has not been marketed, some patients are still obtaining it.

The Ontario government has approved 172 patients to receive Erbitux in U.S. hospitals.

What the drugs do

Avastin, the trade name for bevacizumab, is a monoclonal antibody that prevents the growth of new blood vessels, helping to starve tumours and making it harder for cancers to grow. It offers a median of 4.7 months more of survival to patients with an incurable form of colorectal cancer. Specifically, clinical trials have shown that patients getting Avastin along with chemotherapy survived a median of 20.3 months, compared with 15.6 months for those receiving chemotherapy alone.

Erbitux, the trade name for cetuximab, is a monoclonal antibody that shrinks tumours in some patients and delays tumour growth, especially when used as a combination treatment. Late last month, the drug was found to prolong the lives of patients with incurable cancer. According to study results, the survival time of participants -- for whom other therapies had failed -- was, on average, six months for those patients given cetuximab, versus 4½ months for patients who received the best supportive care alone. Supportive care was defined as treatments to improve symptoms and quality of life.

Lisa Priest