In Study, Drug Delays Worsening of Breast Cancer, With Fewer Side Effects - NYTimes.... Page 1 of 3
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`In Study, Drug Delays Worsening of Breast Cancer, With
`
`chcr Side Effects
`
`
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`
`
`CHICAGO — A drug that delivers a powerful poison to tumors
`without some of the side effects of traditional treatments can delay
`
`a
`,
`,
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`the worsening of breast cancer and also appears to submantially
`prolong lives, accordlng to results of a study presented here Saturday.
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`Besides representing an advance in
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`su es
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`is now being pursued. by numerous
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`pharmaceutical companies to treat meagre
`various types of cancer in a way that
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`delivers drugs to cancerous cells while
`sparing healthy ones.
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`“We’ve envisioned a world where cancer treatment would
`kill the cancer and not hurt the patient," Dr. Kimberly L.
`Blackwell, a professor of medicine at the Duke Cancer
`Institute and the lead investigator in the trial, said in an
`lntchiCW~ “And this drug does that"
`The drug, known as T-DMi, was developed by Gencutcch,
`which sponsored the trial. The company, a unit of Roche,
`plans to file for approval later this year. That could mean
`the drug will reach the market next year.
`
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`.
`
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`T-DMl and similar drugs under development consist of
`
`. The antibodies latch onto cancer cells
`and deliver the toxic payload directly into those cells. Since the toxin is not active until it
`reaches the tumor, side effects are reduced.
`
`Such treatments, known as antibody-drug conjugates, have been pursued for decades, but
`2 only now is success being achieved.
`
`One such drug, Adcetris, was approved last year to treat two rare types of lymphoma.
`5 T—DM1 could be the first approved for a common cancer, Over all, about 25 such drugs are
`
`“I think it really represents the first broad demonstration of the potential of antibody-drug
`conjugates in cancer treatment,” said Dr. Louis M. Weiner, director of the Lombardi
`Comprehensive Cancer Center at Georgetown University. Dr. Weiner was not involved in
`the study but is scheduled to present a commentary on it after the results are formally
`presented Sunday at the American Society of Clinical Oncology meeting here.
`
` The late-stage clinical trial involved 991 women with metastatic breast cancer whose
`
`cancer was worsening despite previous treatment with the drug Herceptin and a
`: chemotherapy drug called a taxane. Half the women got T-DM1 and the other half received
`
`two drugs that are now commonly used torsuch patients v Tykerb, also known as
`lapatmib, and Xeloda, also known as capecrtabme.
`
`in clinical trials, according to Alain Beck, a French pharmaceutical researcher.
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`T-DMi delayedtheworseningofdiseasebyaboutthree months. Forthosewho received fi
`T-DM], the median time before the disease progressed was 9.6 months, compared with 6.4
`months for those getting the two other drugs.
`t
`"a a
`It is still too early to say definitively that T—DMi also prolonged lives, because not enough
`id‘s
`time has elapsed since the trial began. While the survival data, strictly speaking, did not
`meet the trial’s statistical goal, researchers said they were confident it would end up doing
`: so.
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`gr
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`http://www.nytimes.com/2O l2/06/03/health/research/in-study-drug-delays—worsening-of—hr. .. 1/21/2015
`
`IMMUNOGEN 2116, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`IMMUNOGEN 2116, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`In Study, Drug Delays Worsening of Breast Cancer, With Fewer Side Effects — NYTimes.... Page 2 of 3
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`About 84.7 percent of patients getting T—DM1 were alive after one year, compared to 77.0
`percent of those in the control group By another commonly used measure called the
`. hazard ratio, T-DMI reduced the risk of death by 38 percent.
`:
`. The median survival for those getting T-DM1 is not yet known. But Dr. Blackwell said it
`would likely be at least a year longer that: the 23.3-montl. median survival for the women
`in the control group.
`
`“This will be the largest survival benefit that we’ve ever seen in HER2-positive breast
`.
`.
`‘ cancer,” shesaid.
`
`
`
`About one in five cases of breast cancer are HERa-positive, meaning that the tumors have
`high levels of a protein called HER2. T—DM1 is designed to treat only such cases of breast
`cancer, and all the women in the trial had that type. That is because the antibody in T-DMi
`is Hereeptin, also known as trastuzumab, a Genentech drug designed to treat HER2—
`positive ttnnors.
`
`To make T-DMi, trastuzumab, the T in the name, is attached to DMl, a toxin far more
`potent than the typical chemotherapy drug.
`
`The trastuzurnab latches onto cells with the HER2 protein protruding from their surface
`and is taken inside the cells. Inside the cell, the antibody is degraded, setting the toxin free.
`Although the toxin is still connected to the linker, it is still able to kill the cells.
`Both DM1 and the method oflinking it to the antibodywere developed by InimunoGen of
`Waltham, Mass. The company was founded in 1981, and T—DMi could be the first drug
`using ImmunoGen’s technology to make it to market.
`
`Investigators and some outside experts said a key advantage of T—DMI, which is also
`known as trastuzumab emtansine, was its relative safety. About 40.8 percent of the women
`: get-ting T<DM1 suffered a serious side effect compared to 57.0 percent of those getting the
`two other drugs.
`
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`About 12.9 percent of the patients getting T-DMi had substantially lowered blood platelet
`counts, which can increase the risk of bleeding. But investigators said that actual cases of
`'
`FUD
`g bleeding were rare.
`I"
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`“it’s less toxicthan its comparator and also more effective,” said Dr. Clifford A. Hudis, a
`
`' breast cancer specialist at the Memorial Sloan-Kettering Cancer Center who was not @i
` iA‘.»
`involved in the trial. “How often do we get that?”
`
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`The Food and Drug Administration turned down the application, however, saying that all
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`treatment options had not been exhausted, according to a statement issued by the
`company at the time. The F.D.A. decision spurred criticism from some patient advocates.
`Asked Saturday if he regretted that decision in light of the new data, Dr. Richard Pazdur,
`who is in charge of cancer drugs at the F.D.A., said, “I don’t go backwards. This is a
`different data set we’re looking at.”
`
`
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`Genentech tried to win approval for T-DMi in 2010 as a treatment for women who had run
`5 out of options. The application was based on a single trial with no control group in which
`: one third of the patients experienced tumor shrinkage.
`
`'
`5
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`éew Yer k ecli‘io:
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`Drugs [Pharmaceuticalsl
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`lierceptin (Drug)
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`Breast Cancer
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`Research
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`http ://www.nytirnes.com/2O l 2/06/03/health/research/in—study-drug-delays-worsening-of—br. . . 1/21/2015
`
`IMMUNOGEN 2116, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`IMMUNOGEN 2116, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`In Study, Drug Delays Worsening of Breast Cancer, With Fewer Side Effects - NYTirnes.... Page 3 of 3
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`http ://Www.nytimes.com/20 1 2/06/03/health/research/in-study-drug-delays—worsening-of—br... 1/21/2015
`
`IMMUNOGEN 2116, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`IMMUNOGEN 2116, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`