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Roche Breast-Cancer Treatment Advances: targeted therapy
 
 
  "Roche's Genentech unit has 25 such agents under development for different cancers, including eight in human studies....Roche said it expects to file an application with the US Food and Drug Administration and other regulators for T-DM1 by the end of the year.....The study involved a drug currently dubbed T-DM1, or trastuzumab emtansine, which combines Roche's cancer drug Herceptin with a chemotherapy drug in a medicine designed to be delivered directly to the cancer cell. Traditional chemotherapy drugs are designed to kill cancer, but they also affect healthy cells in the body.......T-DM1 is an elegantly crafted weapon that relies on technology in-licensed from ImmunoGen, which stands to gain mid-single digit royalties on the product. An antibody linked to a highly toxic drug delivers the payload right in the target. That may sound simple, but it's taken 30 years to get the technology right. And now it's a must-have approach for every big pharma company in oncology.......Genentech has eight other ADCs in the clinic, says Dietmar Berger, vice president in product development oncology at Genentech. And it has a total of 25 ADCs in the pipeline, with a number of programs built with technology provided by Seattle Genetics, a pioneer in the field. "Genentech is a company which is really built on the program," Berger tells FierceBiotech. "Personally, I believe it's going to revolutionize therapy." And a combo study of pertuzumab and T-DM1 is in the works."

T-DM1 results push Genentech's armed antibody tech into ASCO's center stage

June 3, 2012
FierceBiotech

CHICAGO - T-DM1 lived up to its star billing at ASCO. The "armed antibody" from Roche's Genentech subsidiary was in the center ring at ASCO as the wraps came off Phase III data, delaying disease progression in metastatic breast cancer patients by several months while reducing the risk of adverse events. And in the process investigators highlighted antibody-drug conjugates as the hot new technology in cancer drug development.

T-DM1 delayed tumor progression by an average of 3.2 months. Median progression-free survival was 9.6 months for the T-DM1 arm while standard therapy delivered a median PFS rate of 6.4 months. Close to two thirds of the patients taking T-DM1--which was designed with ADC technology provided by ImmunoGen--were alive after two years, while slightly fewer than half of the patients receiving a Tykerb/Xeloda combo survived the same period.

The interim overall survival data fell short of statistical significance, but Duke investigator Kimberley Blackwell said that the data clearly demonstrated that using an antibody to guide a highly toxic dose of chemo right to the tumor target works as expected. Final overall survival rates will be determined in 2014. Blackwell also highlighted that the targeted treatment delivered a better quality of life for patients, saving them from the toxic effects of broadly delivered chemotherapy. Patients take T-DM1, for example, didn't lose their hair.

T-DM1 is an elegantly crafted weapon that relies on technology in-licensed from ImmunoGen, which stands to gain mid-single digit royalties on the product. An antibody linked to a highly toxic drug delivers the payload right in the target. That may sound simple, but it's taken 30 years to get the technology right. And now it's a must-have approach for every big pharma company in oncology.

Roche ($RHHBY) has already been rebuffed once by the FDA, which handed back its new drug application for the treatment after refusing to consider an approval based on promising mid-stage data. And there's still some question whether regulators will insist on a final set of survival data before approving the drug. Given the targeted design of the drug--which zeroes in on HER2-positive patients--and the agency's insistence that it is becoming more flexible on its review of life-saving therapies, though, Roche is given good odds that it can now win a regulatory OK. The pharma giant plans to file for an approval later in the year.

Roche is already bumping up against the PDUFA date for pertuzumab, which is likely to be given to breast cancer patients in combination with Herceptin. If approved, T-DM1 could enter into that therapeutic regimen, offering advanced-stage patients another option and raising the possibility that it may eventually help dramatically change the prognosis for earlier-stage patients.

"I think it is the first of many antibody drug conjugates to follow," Blackwell told a big audience of reporters in Chicago. And Roche is investing a considerable amount of time and money to find out.

Genentech has eight other ADCs in the clinic, says Dietmar Berger, vice president in product development oncology at Genentech. And it has a total of 25 ADCs in the pipeline, with a number of programs built with technology provided by Seattle Genetics, a pioneer in the field.

"Genentech is a company which is really built on the program," Berger tells FierceBiotech. "Personally, I believe it's going to revolutionize therapy." And a combo study of pertuzumab and T-DM1 is in the works.

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Roche press release

Roche's targeted investigational breast cancer medicine, trastuzumab emtansine (T-DM1), reduced the risk of cancer worsening or death by 35 percent in pivotal phase III trial

Roche's targeted investigational breast cancer medicine, trastuzumab emtansine (T-DM1), reduced the risk of cancer worsening or death by 35 percent in pivotal phase III trial

Basel, 3 June 2012

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III EMILIA study of trastuzumab emtansine (T-DM1) met its co-primary endpoint, of a significant improvement in the time patients with HER2-positive metastatic breast cancer (mBC) lived without their disease getting worse (progression-free survival; PFS). The study showed that the risk of disease worsening or death was reduced by 35 percent for people who received trastuzumab emtansine compared to those who received lapatinib plus Xeloda® (capecitabine) chemotherapy (HR=0.65, p-value <.0001). The EMILIA study is the first randomised Phase III trial of trastuzumab emtansine in patients with HER2-positive mBC who had previously received Herceptin® (trastuzumab) and a taxane chemotherapy.

There was also a trend for patients who received trastuzumab emtansine to live longer (overall survival, or OS, the other co-primary endpoint of the study) than those who received lapatinib plus Xeloda, but these data are currently not mature. The safety profile of trastuzumab emtansine was consistent with that seen in previous studies, with fewer patients who received trastuzumab emtansine experiencing Grade 3 or higher (severe) adverse events (AEs) than those who received lapatinib plus Xeloda (40.8 percent compared to 57 percent).

The EMILIA data will be presented in the plenary session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Kim Blackwell, M.D., Duke University School of Medicine (Abstract #LBA1, Sunday 3 June at 1:45 pm CDT). The EMILIA data were also featured in the official ASCO press programme on Saturday 2 June.

"The encouraging efficacy, safety profile and quality of life results from the EMILIA study support our belief that trastuzumab emtansine may have an important role for patients with HER2-positive metastatic breast cancer," said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. "We are working with global regulatory authorities to submit these data as quickly as possible and hope that trastuzumab emtansine will soon be available to patients with this aggressive type of breast cancer."

Based on the EMILIA findings, Roche and Genentech plan to submit applications for trastuzumab emtansine in HER2-positive mBC this year to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).

Trastuzumab emtansine is an investigational medicine known as an antibody-drug conjugate (ADC). It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. Trastuzumab emtansine is designed to target and inhibit HER2 signalling and deliver the chemotherapy directly inside HER2-positive cancer cells.

Study results

The results presented at ASCO represent the final analysis of PFS and the first interim analysis of OS.

There was a significant improvement in the time patients receiving trastuzumab emtansine (n=495) lived without their disease getting worse compared to those who received lapatinib plus Xeloda (n=496), as assessed by an independent review committee: median PFS was 9.6 months versus 6.4 months, respectively.

The first interim OS analysis demonstrated a trend towards improved OS in patients receiving trastuzumab emtansine versus those who received lapatinib plus Xeloda: median OS was 23.3 months for patients who received lapatinib plus Xeloda but had not been reached for patients receiving trastuzumab emtansine and requires longer follow-up (HR=0.62; P=0.0005).

As the hazard ratio for OS did not cross the pre-specified stopping boundary for the study, the OS analysis is not considered statistically significant at this time. The final analysis is expected to take place by 2014.

One-year survival in patients who received trastuzumab emtansine was 84.7 percent versus 77.0 percent for patients who received lapatinib plus Xeloda. Two-year survival was 65.4 percent versus 47.5 percent, respectively.

The response rate (the percentage of patients with tumour shrinkage) was 43.6 percent for those who received trastuzumab emtansine versus 30.8 percent of patients who received lapatinib plus Xeloda.

The time-to-symptom progression, a patient-reported measure of quality of life, was also improved in patients who received trastuzumab emtansine: 7.1 months in patients who received trastuzumab emtansine versus 4.6 months in patients who received lapatinib plus Xeloda.

Fewer patients who received trastuzumab emtansine experienced Grade 3 or higher (severe) AEs than those who received lapatinib plus Xeloda, at 40.8 percent versus 57 percent, respectively. For people receiving trastuzumab emtansine, compared to those receiving lapatinib plus Xeloda, the most common (occurring in more than 2 percent of patients) Grade 3 or higher AEs were low platelet count (12.9 percent versus 0.2 percent), increased levels of enzymes released by the liver and other organs (in most patients these levels had returned to normal by the time of the next dose of trastuzumab emtansine; aspartate aminotransferase: 4.3 percent versus 0.8 percent; alanine aminotransferase: 2.9 percent versus 1.4 percent) and anaemia (2.7 percent versus 1.6 percent).

For those patients receiving lapatinib plus Xeloda compared to those receiving trastuzumab emtansine, the most common Grade 3 or higher AEs were diarrhoea (20.7 percent versus 1.6 percent), hand-foot syndrome (16.4 percent versus 0) and vomiting (4.5 percent versus 0.8 percent).

About the EMILIA study

EMILIA (TDM4370g/BO21977) is an international, Phase III, randomised, open-label study comparing trastuzumab emtansine alone to lapatinib in combination with Xeloda in 991 patients with HER2-positive locally advanced or metastatic breast cancer whose disease progressed after initial treatment with Herceptin and a taxane-based chemotherapy.

Participants in the trastuzumab emtansine arm received:

Trastuzumab emtansine 3.6 mg/kg dose every three weeks

Participants in the lapatinib plus Xeloda arm received:

Lapatinib 1250 mg dose daily, every three weeks. Xeloda 1000 mg/m2 dose, twice daily, days 1-14, every three weeks.

The co-primary efficacy endpoints of the study are PFS (as assessed by an independent review committee) and OS. Safety is also a primary endpoint of the study. Other study endpoints include and one-year and two-year survival rates, safety profile, PFS as assessed by investigator, objective response rate, duration of response and quality of life. About trastuzumab emtansine

Trastuzumab emtansine is an ADC being studied in HER2-positive cancers. It is comprised of the antibody trastuzumab and the chemotherapy agent DM1 attached together using a stable linker. Trastuzumab emtansine is designed to target and inhibit HER2 signalling and deliver the chemotherapy agent DM1 directly inside HER2-positive cancer cells. Trastuzumab emtansine binds to the HER2-positive cancer cells, and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once trastuzumab emtansine is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1.

In addition to EMILIA, there are two ongoing Phase III studies of trastuzumab emtansine:

MARIANNE is comparing three different regimens (trastuzumab emtansine alone, trastuzumab emtansine plus pertuzumab, and Herceptin plus a taxane chemotherapy) in patients with HER2-positive mBC who have not been previously treated for their metastatic disease. TH3RESA is comparing trastuzumab emtansine to physician's choice of treatment in people with HER2-positive mBC who have already received both Herceptin and lapatinib.

Genentech, a member of the Roche Group, licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.

Building on the results of trastuzumab emtansine studies to date, Roche/Genentech have approximately 25ADCs in the pipeline. About breast cancer

Breast cancer is the most common cancer among women worldwide. Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually.1 In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as "HER2 positivity" and affects approximately 15-20 percent of women with breast cancer.2 HER2-positive cancer is a particularly aggressive form of breast cancer.3

About metastatic Colorectal Cancer (mCRC)

Colorectal cancer is one of the most common cancers in the world, with over 1.2 million new cases diagnosed each year; it is the second most common cancer in women and the third most common cancer in men.1

Despite improvements in screening for early diagnosis, colorectal cancer remains one of the biggest cancer killers in the world and is responsible for over 600,000 deaths each year.1,2

In general the current treatment options for colorectal cancer are surgery, chemotherapy, and biological therapies. Early-stage (localised) cancer has the potential to be cured if the tumour can be successfully surgically removed. Patients with advanced (metastatic) disease are usually treated with chemotherapy after surgery, known as 'first-line' treatment. Many people initially respond to chemotherapy, but unfortunately, in the majority of cases the disease eventually progresses after first-line treatment and patients may require a further round of treatment ('second-line'). There is therefore a real need for effective, tolerable treatments for long-term disease control in metastatic colorectal cancer.

About Avastin: Over 7 Years of Transforming Cancer Care

With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the US and over 30 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer and breast cancer. Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today - over one million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

About Avastin: Mode of Action

An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasise) to other parts of the body. Tumours develop their own blood supply in a process called angiogenesis by releasing vascular endothelial growth factor (VEGF) - a key driver for tumour growth. Avastin is an antibody that precisely targets and inhibits VEGF for continuous tumour control. Avastin's precise VEGF inhibition allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References 1. Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr. 2. Wolff A.C et al. American Society of Clinical Oncology/ College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med - Vol 131, January 2007. 3. Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-83.

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Fox

A study involving an experimental cancer drug being developed by Roche Holding showed it delayed disease progression in women with a specific type of breast cancer compared to conventional therapy.

The study involved a drug currently dubbed T-DM1, or trastuzumab emtansine, which combines Roche's cancer drug Herceptin with a chemotherapy drug in a medicine designed to be delivered directly to the cancer cell. Traditional chemotherapy drugs are designed to kill cancer, but they also affect healthy cells in the body.

Details from the study were scheduled to be presented Sunday at the American Society of Clinical Oncology's annual meeting.

The study involved about 1,000 women with HER2-positive breast cancer, a type believed to account for 20 percent to 25 percent of all breast cancer cases.

The study was designed to measure progression-free survival, which is a measurement of the time from the start of treatment until the disease gets worse or the patient dies, and overall survival, which is a measurement of time from the start of treatment until death. So far patients in the study have been followed for about two years.

The median progression-free survival for patients receiving T-DM1 was 9.6 months, compared to 6.4 months in the group receiving the alternative treatment of Xeloda, another Roche drug, and GlaxoSmithKline's Tykerb. The difference is considered statistically significant.

The median overall survival two years after starting treatment was 23.3 months for Xeloda and Tykerb and had not been reached for patients in the T-DM1 group. At the two-year mark, 65.4 percent of T-DM1 patients were alive, compared to 47.5 percent of patients receiving Xeloda and Tykerb, researchers said.

Roche said it expects to file an application with the US Food and Drug Administration and other regulators for T-DM1 by the end of the year.

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CHICAGO-An experimental drug being developed by Roche Holding AG delayed progression of disease and appeared to improve survival in women with a specific type of breast cancer in a study that illustrates the potential of an emerging new strategy for treating cancer.

The study involved a drug known as T-DM1, which combines Roche's cancer drug Herceptin with a potent chemotherapy agent in a treatment designed to be delivered directly to the cancer cell. The intent is to hit the tumor with a double punch that is more powerful than Herceptin alone and that limits the side effects associated with chemotherapy.

Herceptin targets a protein called HER2 found on tumors in about 20%-25% of breast-cancer patients. The two other components of T-DM1, both developed by ImmunoGen Inc., a Waltham, Mass., biotechnology company, are a chemotherapy agent called emtansine that is too potent to be delivered as a conventional medicine, and a linker that connects the two drugs. Herceptin then delivers the package to the tumor cell, where it releases the toxic cargo to kill the cancer.

"This is a completely new way of treating HER2-positive breast cancer," said Kimberly Blackwell, the study's lead researcher and a professor of medicine at Duke University. She presented the results Sunday at the annual meeting of the American Society of Clinical Oncology.

Agents such T-DM1 are called antibody-drug conjugates and they are the focus of intense interest in the pharmaceutical industry. Roche's Genentech unit has 25 such agents under development for different cancers, including eight in human studies.

ImmunoGen is working with other companies including Bayer AG, Eli Lilly & Co., Novartis AG, and Sanofi SA to develop similar cancer drugs. ImmunoGen said T-DM1 is the most advanced drug candidate that uses its technology.

The first such agent to gain U.S. Food and Drug Administration approval was Seattle Genetics Inc.'s Adcetris, indicated for Hodgkin's Lymphoma and another rare cancer. The company is also collaborating with such companies as Abbott Laboratories, Celldex Therapeutics Inc. GlaxoSmith Kline Plc and Pfizer Inc.

"Every major pharmaceutical company is exploring this," said Louis Weiner, director of Georgetown University's Lombardi Comprehensive Cancer Center.

The new study, called Emilia, involved about 1,000 women with HER2-positive breast cancer who had been previously treated with Herceptin and a traditional chemotherapy drug. About half of the women were then treated with T-DM1 and the other half were treated with a combination of Xeloda, another Roche drug, and GlaxoSmithKline PLC's Tykerb. The drugs were administered every three weeks until the disease progressed or patients experienced unmanageable side effects.

The study was designed to measure progression-free survival, which is a measurement of the time from the start of treatment until the disease gets worse or the patient dies, and overall survival, which is a measurement of time from the start of treatment until death. So far patients in the study have been followed for about two years.

The median progression-free survival for patients receiving T-DM1 was 9.6 months, compared to 6.4 months in the group receiving Xeloda and Tykerb, a difference considered statistically significant.

The median overall survival two years after starting treatment was 23.3 months for Xeloda and Tykerb and had not been reached for patients in the T-DM1 group. Patients in the study are still being followed. At the two-year mark, 65.4% of T-DM1 patients were alive, compared to 47.5% of patients receiving Xeloda and Tykerb, researchers said.

"It looks like it is a useful regimen and looks like it will have powerful impacts on survival," said Georgetown's Dr. Weiner, who wasn't involved with the study.

The study showed more patients in the T-DM1 group had elevations in liver function tests and a blood disorder known as thrombocytopenia. More patients in the Xeloda and Tykerb group had dose reductions, diarrhea, vomiting and a condition called hand-foot syndrome which is redness, swelling and pain on the hands or feet.

Roche said it plans to file for FDA approval of T-DM1 by the end of this year.

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Roche Smart-Bomb Cancer Drug Delays Breast-Tumor Growth

Bloomberg/Businessweek

By Naomi Kresge and Robert Langreth on June 03, 2012

An experimental breast cancer drug from Roche Holding AG (ROG) that carries chemotherapy directly into malignant cells while bypassing healthy ones delayed tumors longer and with fewer side effects than an established therapy.

The treatment, combining Roche's Herceptin with an older chemotherapy medicine, delayed progression of tumors 3.2 months longer than GlaxoSmithKline Plc (GSK)'s Tykerb with chemotherapy in women with advanced disease. The data is being reported today at the American Society of Clinical Oncology meeting in Chicago.

More patients on the drug, dubbed T-DM1, were alive after two years, though the difference fell short of statistical significance. Still, the results "are the first proof" that using an antibody to precisely target a toxic chemotherapy dose into a solid tumor can work, said Kimberly Blackwell, a study author and professor of medicine at Duke University.

"It is fantastic data," said Shanu Modi, a breast cancer oncologist at Memorial Sloan-Kettering Cancer Center in New York, who was not involved in the current trial. If approved, "it is going to be rapidly taken up by the oncology community. For sure, I will be using a lot of it."

Roche, based in Basel, Switzerland, is in talks with the U.S. Food and Drug Administration and plans to file for marketing approval in the U.S. and Europe by the end of the year, said Sandra Horning, head of oncology research for Roche. A final review of survival data is due in 2014, she said.

ImmunoGen Technology

The Swiss drugmaker used technology from ImmunoGen Inc. (IMGN) (IMGN), a Waltham, Massachusetts-based biotechnology company, to strap Herceptin together with a compound derived from a chemotherapy drug that proved too toxic for patients two decades ago. The combination delivers the powerful treatment straight to the tumor -- avoiding healthy cells and releasing its payload only once it gets to the cancer cells.

Cancer researchers have dreamed for decades of developing "smart bombs that can deliver cancer-killing agents directly to the tumor," Blackwell said in the interview at the conference.

The study looked at women whose disease had progressed after previous treatment with Herceptin and chemotherapy. The experimental treatment delayed progression of the disease for 9.6 months, versus 6.4 months for the standard therapy. About 65 percent of patients who got T-DM1 were still alive after two years, compared with 47.5 percent of patients who got Tykerb and chemotherapy.

Modi and Blackwell predicted in interviews that a survival benefit will be proven with longer patient follow-up. Blackwell said the survival difference may turn out to be more than a year.

'Significantly Better'

"The drug worked," Blackwell, at Duke's Durham, North Carolina campus, said in a statement. "It was significantly better than a very effective approved therapy."

The data may be a "coming of age" for antibody-drug conjugates like T-DM1, Howard Liang, a Boston-based analyst for Leerink Swann & Co., wrote in a note to investors before the conference.

The study is "good news for women" because it shows T-DM1 can deliver a potent poison to cancer cells without many of the side effects suffered by the patients who got Tykerb, Roche's Horning said. Diarrhea, vomiting and swollen, painful hands and feet were all less common in patients who took T-DM1.

"What we're trying to do is deliver chemotherapy in a smarter way," she said. "We feel like we're moving to the next generation."

Less Toxic

Fewer toxic side-effects could be "a major selling point" for the T-DM1 drug, said Jennifer Litton, a breast cancer specialist at MD Anderson Cancer Center in Houston, who was not involved in the trial. "I have patients calling me asking for this drug."

Roche is testing the armed antibody technology in eight molecules in early patient trials for prostate, ovarian, breast, non-Hodgkin's lymphoma and other cancers, Stefan Frings, head of medical affairs oncology, said in a telephone interview. Also due for completion in 2014 is a trial combining T-DM1 with another new Roche breast cancer therapy, pertuzumab.

"This may really represent a transformational event in cancer therapies," ImmunoGen Chief Executive Officer Dan Junius said in a telephone interview. Numerous antibody-drug conjugates like T-DM1 may be available within four years, he said.

The FDA rejected a request in 2010 to speed up the approval process for T-DM1 based on data from preliminary trials. It said that patients those trials had not exhausted all available options, said Charlotte Arnold, a Roche spokeswoman, in an e- mail.

Cancer Killer

About 1.4 million women are newly diagnosed with breast cancer every year and almost 460,000 die, making it the biggest cancer killer among women, according to the International Agency for Research on Cancer in Lyon, France.

About 25 percent of cases are distinguished by a protein called HER2 on the surface of the cancer cells that causes them to multiply more quickly. Herceptin latches onto HER2, blocking it without killing the cell.

Herceptin, approved in 1998 as one of the first targeted therapies against breast cancer, had 5.3 billion Swiss francs in sales last year, making it the drugmaker's third-biggest-selling cancer drug after therapies Rituxan and Avastin.

 
 
 
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