Novartis's Afinitor shows promise in breast cancer

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By Kate Kelland

STOCKHOLM | Sun Sep 25, 2011 6:03pm EDT

STOCKHOLM (Reuters) - C ombining two drugs from Novartis and Pfizer to treat post-menopausal women with a certain type of advanced breast cancer more than doubled the time they lived without their disease getting worse, study data showed on Monday.

Investigators conducting a clinical trial found that women treated with a combination of Novartis' Afinitor or everolimus, and Pfizer's oestrogen-blocker Aromasin, known generically as xemestane, had progression-free survival (PFS) of as much as seven months more than women treated with the Pfizer drug alone.

"This is a highly significant improvement in the time to disease progression. It's quite remarkable," said Jose Baselga of Massachusetts General Hospital and Harvard Medical School, who led the trial and presented the data at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm.

He said side effects were consistent with those previously reported in trials of Afinitor and did not lead to a worse quality of life for patients on the drug.

Baselga's analysis of the data showed that PFS for women in the Afinitor group was 6.9 months versus 2.8 months for those not taking the Novartis drug -- a 57 percent improvement.

The trial was stopped early after a separate independent analysis by a central review committee showed that Afinitor extended PFS to 10.6 months compared to 4.1 months -- a 64 percent improvement.

"These results are impressive and, potentially, could represent a new therapeutic option," Baselga said.

Afinitor targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism. Novartis says there are around 220,000 newly diagnosed cases worldwide each year of the type of advanced breast cancer that could benefit from Afinitor.

Novartis has been upbeat about the prospects for the drug, which is already approved for other types of cancer, such as kidney and a rare type of pancreatic cancer.

The Swiss firm's CEO Joe Jimenez told Reuters in a recent interview it could generate an extra $1 billion or more in annual sales from its new use in breast cancer. [ID:nL5E7K227N]

Herve Hoppenot, president of Novartis's oncology division, said the magnitude of benefit seen in this trial showed that Afinitor is "a potential important new treatment approach".

The Swiss drugmaker is planning to file for regulatory approval of Afinitor in breast cancer by the end of this year.

Novartis reported Afinitor sales for cancer of $243 million in 2010 but analysts expect that number to balloon if the drug is licensed in breast cancer. Thomson Reuters Pharma data show analysts on average forecast sales of $1.53 billion by 2016.

The hormone oestrogen promotes the growth of about two thirds of breast cancers, and hormonal therapies such as Aromasin which block the effect of oestrogen or reduce its levels are used to treat these so-called hormone receptor-positive breast cancers.

But many breast cancer patients, and nearly all those with advanced forms of the disease where it has spread to other parts of the body, become resistant to hormonal therapy.

"When patients stop responding to hormonal therapy, the benefits from any secondary therapy are limited," Baselga said.

The Phase III clinical trial, known as BOLERO 2, was designed to test the efficacy of Afinitor in patients resistant to aromatase inhibitors - drugs that cut the amount of oestrogen produced and help to slow or reverse the growth of the cancer.

It was as conducted in 24 countries in 724 patients with an average age of 62. All patients had already been treated with the aromatase inhibitors anastrozole, sold by AstraZeneca as Arimidex, or the generic drug letrozole. Some had also been treated with tamoxifen, fulvestrant and chemotherapy.

Pfizer's Aromasin lost its patent in April and is now available in a cheaper generic version.

(Editing by Greg Mahlich)

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Breast cancer study shows benefits of double therapy

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A woman undergoes a mammography exam, a special type of X-ray of the breasts, which is used to detect tumours as part of a regular cancer prevention medical check-up at a clinic in Nice, south eastern France January 4, 2008.

Credit: Reuters/Eric Gaillard

By Kate Kelland

STOCKHOLM | Sat Sep 24, 2011 6:04pm EDT

STOCKHOLM (Reuters) - Giving breast cancer patients radiotherapy and chemotherapy at the same time significantly cuts the risk their tumors will come back and should be considered as a new treatment approach across the world, cancer experts said on Sunday.

The double treatment, known as synchronous chemoradiation, could also save lives among people with breast cancer, a disease that currently kills 425,000 women a year worldwide, according to the British experts who conducted a major scientific study.

They said the synchronous treatment, which the study showed has limited side effects and does not harm patients' quality of life, should be considered for use by all breast cancer doctors.

"The results have implications worldwide," Indrajit Fernando, a consultant clinical oncologist at the University Hospitals Birmingham Trust, told reporters at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm.

"Clinical practice needs to be reviewed."

Breast cancer is the most common cancer among women. A recent study by the Institute for Health Metrics and Evaluation in the United States found that in 2010 it killed around 425,000 people and was newly diagnosed in 1.6 million.

Radiotherapy and chemotherapy are usually given after breast cancer surgery to kill any remaining cancer cells in the breast, chest wall or underarm area, and to try to reduce the risk of a local cancer recurrence. The standard approach is to give chemotherapy first, followed by radiotherapy.

But the best timings for radiotherapy and chemotherapy have long been debated among cancer experts, so Fernando's team decided to study various schedules of radiotherapy with a type of chemotherapy called anthracycline-CMF chemotherapy in patients with early-stage breast cancer.

The study involved almost 2,300 women in Britain who had already undergone surgery to remove their tumors.

The results showed that compared with the standard approach, giving both treatments at the same time "reduces the risk of local cancer recurrence by 35 percent in women with early breast cancer," Fernando said.

After a follow-up of over eight years, the study found that only 41 patients in the synchronous chemoradiation group had suffered recurrence, compared with 63 patients in the group who had standard chemotherapy followed by radiation treatment.

At five years, tumors had recurred in only 2.8 percent of those who got both treatments at the same time, compared with 5.1 percent among those who received the therapies separately.

Although there were no differences in overall survival rates between the two groups after five years, Fernando said he would expect to see survival rates rise in larger groups of patients over a longer time period.

"Even a 2.3 percent reduction in local recurrence rates will have an impact worldwide when we consider that this is a very common cancer," he said, citing data showing that for every four local recurrences of the disease prevented, one death from breast cancer death can be avoided.

Fernando said he has already changed practice in his own clinic and will send his data to Britain's National Institute of Clinical Excellence, which advises on treatment guidelines.

Michael Baumann, president of the European Cancer Organization, said more follow up would be needed to assess potential longer-term side effects. "I am convinced this trial will spur a lot of discussion," he said.

(Editing by Ruth Pitchford)

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Sangamo gene therapy shows promise in reducing HIV

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By Deena Beasley

Sun Sep 18, 2011 1:18pm EDT

n">(Reuters) - An early stage trial of Sangamo BioSciences Inc's HIV treatment found that the gene therapy reduced levels of the virus and even eliminated it in one patient with a naturally occurring gene mutation.

The very small Phase 1 trial tested the SB-728-T gene therapy, which is designed to disrupt the CCR5 gene used by HIV to infect cells of the immune system.

If shown to be safe and effective, the treatment could end the need for the antiretroviral drugs now used to keep the virus that causes AIDS in check by suppressing viral replication in the blood.

Trial results presented in Chicago on Sunday at the Interscience Conference on Antimicrobial Agents and Chemotherapy show a "statistically significant relationship between estimated modification of both copies of the CCR5 gene and viral load," said Dr. Carl June, trial investigator and director of translational research at the University of Pennsylvania's cancer research institute.

In a statement, June said the results suggest the need to increase the frequency of the modified cells in HIV-infected patients, which could lead to a "functional cure" for AIDS, but the means of achieving this have not been clarified.

Sangamo said earlier this year that a single infusion of the treatment improved immune system damage in nearly all of the subjects analyzed in the first trial of the therapy in humans.

The 10 patients in the trial were on antiretroviral therapy when the study began. After four weeks, six of them went on a "treatment interruption," during which they stopped taking antiviral medication for 12 weeks.

Viral load decreased in three of the six subjects, with one patient's viral load reduced to undetectable levels. That patient carried a naturally occurring mutation in one copy of his CCR5 gene.

Humans contain two copies of each gene, one from the father and one from the mother, which sometimes are referred to as the alleles of a gene.

"Since one copy of his gene was already disrupted naturally, twice as many of his cells were 'biallelically' modified," Sangamo Chief Executive Officer Edward Lanphier said in a telephone interview, meaning that both members of the CCR5 gene pair were knocked out.

He estimated that between 5 percent and 10 percent of HIV patients carry the genetic mutation.

Around 33 million people worldwide have the human immunodeficiency virus (HIV) that causes AIDS. Major producers of current HIV drugs include Gilead Sciences and GlaxoSmithKline.

Lanphier said Sangamo will move ahead with a strategy to maximize the number of cells that can be "biallelically" modified by SB-728-T. Options include targeting only the small segment of patients with mutated CCR5 genes or using "strategies that boost the amount of engraftment of modified cells."

The CEO said he plans to unveil details of Sangamo's plans at an investment banking conference in New York on Wednesday.

Lanphier emphasized that the company intends to take the HIV treatment into mid-stage trials without a partner.

"We have more than sufficient cash to push forward into Phase 2 trials," he said, reaffirming that Sangamo expects to have cash holdings of at least $85 million at year-end.

(Reporting by Deena Beasley in Los Angeles)

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