Roche / Genentech's "Magic Bullet" in HER2+ Breast Cancer
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`Roche I Genentech'ss"Magic Bullet'"m HER2+ Breast
`Cancer
`
`3 ion 2012, by Gordon Goclionauer
`HEM-targeted therapy was the star of the show at today’s plenary session at the
`2012 ASCO meeting. 'i'soMl (trastuzumah emtansine) is Genentech ,/ Roche’s
`antibodyvclrug conjugate, consisting of a potent rnicrotubule polymerization
`inhibitor conjugated to the trastuzumah monoclonal antibody via a highly stable
`linker. T-DM: is designed to take advantage of the targeted nature of the antibody
`to selectively deliver the cytotoxic agent to HER2+ breast cancer cells. Roche is
`hoping that'T-DMI will further expand their franchise in HER2+ breast cancer.
`Roche‘s other product, Herceptin (trastuzumab), currently dominates the HER2+
`market, with about 70% utilization in fronHine HER2+ metastatic breast cancer
`
`patients.‘ Although Tykerh® (lapatinih, GiaxoSmithKiine) is approved in the
`second~line in combination with Xelodaflii (capecitabine, Roche), about half of lJ.S.
`physicians choose to rechallenge with Herceptin plus chemotherapy, leaving
`Tykerb for later-lines of therapy.’
`
`in today’s presentation (Lam), Roche / Genentech wowed the audience with the
`impressive results from the EMILIA study, which evaluated "l"DM*1 monotherapy
`versus Xeloda plus Tykerb (XT) in relapsed HER2+ metastatic breast cancer
`patients. TDM »1 showed a progression-tree survival (PPS) benefit of 9.6 months
`versus 5.4 months with XT (HRintSSO, p<0.0001) and improved overall survrval ~
`although the median was not yet reached in the TOM-1 arm, the OS was 23.3
`months in the XTi-arm (HR=0.621, p=0.00l)5). Adding to the excitement was the
`improved toxicity profile of TOM»), showing lower rates of Grade 3 Adverse Events
`(41% versus 57%), very little gastrointestinal toxicity, and only liver toxicity was
`increased compared to Xi'. it would appear that the Worm underperformed in
`EMMA compared to the Phase III registrationvenabling trial for Tykerb, il'l which
`XT showed a 8.4 month PFS. Hopefully more detailed future analyses will shed
`some light on reasons for the apparent discrepancy in XT performance. A cursory
`analysis of the presented patient demographics does not afford an explanation as
`the demographics were coiriparable and discontinuation rates were similar
`between the two studies,
`
`Based on this impressive data, it will be interesting to see exactly where TOM-‘1
`fits into the treatment paradigm once it is approved. With the success of the
`CLEOPATRA trial and Perjeta's (pertuzumab, Roche / Generitech) impending
`approval in combination with first-line Herceptin, this raises the question of
`whether TDM—l will occupy the second~line after Herceptin/pcrtuzumab, or will
`Herceptin “rechallenge” remain the second-line treatment of choice, followed by
`third—line TDM~1? Where will 'i'ykerb fit in? The treatment paradigm in fir-spline
`may change again soon, as Roche is studying i’DM~l with or without Perjeta and
`compared to Herceptin plus Peijeta and taxane in the MARIANNE study.
`Whichever scenario comes to fruition, it is evrdent that Roche r’ Genentech have
`been successful in muscling out most competitors ll’l this tumor subtype, and
`TOM->1. gives the company some protection from potential future biosimilar
`competition that they face for Herceptin.
`
`7' Unfi'zation data from the 2011 Kantar Herr/m Orifice/Miami? {1.5.
`Arch/rectum.
`
`'i’rearmen.’
`
`SHARE ...;
`
`TAGS
`
`oncology, CancerMPact, Treatment Architecture, Genentoch, T—DMl, safety
`profile, linker technology, microtubuie polymerization inhibitor, Herceptin,
`Cancer, THBRESA, EMILIA, treatment paradigm, HER2+, ASCO 2012, breast
`cancer, trastuzumab emtansine, MARIANNE, antibody drug conjugate,
`Roche, maytansine (DMi), conjugated cytotoxic
`
`BACK TO PREVIOUS PAGE ._,
`
`IMMUNOGEN 2019. pg. 1
`Phigenix v. Immunogen
`|PR2014-00676
`http://www.kantarhealth.com/blog/oncology/gordon-gochenauer/2012/06/03/Roche_Gene...
`
`7/30/2014
`
`IMMUNOGEN 2019, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Page 1 of 2
`
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`
`i Reset password E Help
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`Search
`
`Sub
`
`About us
`
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`
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`
`Slog
`
`Careers
`
`Contact
`
`You are here: Home.)
`
`Blog. Oncology
`
`SUBSCRIBE TO BLOG --)
`
`r"...
`
`~ 3"
`may. as“;
`“£955; *
`
`Non-Small Cell Lung
`Cancer ~ a global View
`on standards of care
`and patient outcomes.
`>1:
`l~'
`
`Market Access
`
`Emerging Markets
`
`Additional Marketing Insights &
`Consultancy
`
`Blogger Profiles
`
`VIEW ARCHIVE w)
`
`Roche I Genentech'ss"Magic Bullet'"m HER2+ Breast
`Cancer
`
`3 ion 2012, by Gordon Goclionauer
`HEM-targeted therapy was the star of the show at today’s plenary session at the
`2012 ASCO meeting. 'i'soMl (trastuzumah emtansine) is Genentech ,/ Roche’s
`antibodyvclrug conjugate, consisting of a potent rnicrotubule polymerization
`inhibitor conjugated to the trastuzumah monoclonal antibody via a highly stable
`linker. T-DM: is designed to take advantage of the targeted nature of the antibody
`to selectively deliver the cytotoxic agent to HER2+ breast cancer cells. Roche is
`hoping that'T-DMI will further expand their franchise in HER2+ breast cancer.
`Roche‘s other product, Herceptin (trastuzumab), currently dominates the HER2+
`market, with about 70% utilization in fronHine HER2+ metastatic breast cancer
`
`patients.‘ Although Tykerh® (lapatinih, GiaxoSmithKiine) is approved in the
`second~line in combination with Xelodaflii (capecitabine, Roche), about half of lJ.S.
`physicians choose to rechallenge with Herceptin plus chemotherapy, leaving
`Tykerb for later-lines of therapy.’
`
`in today’s presentation (Lam), Roche / Genentech wowed the audience with the
`impressive results from the EMILIA study, which evaluated "l"DM*1 monotherapy
`versus Xeloda plus Tykerb (XT) in relapsed HER2+ metastatic breast cancer
`patients. TDM »1 showed a progression-tree survival (PPS) benefit of 9.6 months
`versus 5.4 months with XT (HRintSSO, p<0.0001) and improved overall survrval ~
`although the median was not yet reached in the TOM-1 arm, the OS was 23.3
`months in the XTi-arm (HR=0.621, p=0.00l)5). Adding to the excitement was the
`improved toxicity profile of TOM»), showing lower rates of Grade 3 Adverse Events
`(41% versus 57%), very little gastrointestinal toxicity, and only liver toxicity was
`increased compared to Xi'. it would appear that the Worm underperformed in
`EMMA compared to the Phase III registrationvenabling trial for Tykerb, il'l which
`XT showed a 8.4 month PFS. Hopefully more detailed future analyses will shed
`some light on reasons for the apparent discrepancy in XT performance. A cursory
`analysis of the presented patient demographics does not afford an explanation as
`the demographics were coiriparable and discontinuation rates were similar
`between the two studies,
`
`Based on this impressive data, it will be interesting to see exactly where TOM-‘1
`fits into the treatment paradigm once it is approved. With the success of the
`CLEOPATRA trial and Perjeta's (pertuzumab, Roche / Generitech) impending
`approval in combination with first-line Herceptin, this raises the question of
`whether TDM—l will occupy the second~line after Herceptin/pcrtuzumab, or will
`Herceptin “rechallenge” remain the second-line treatment of choice, followed by
`third—line TDM~1? Where will 'i'ykerb fit in? The treatment paradigm in fir-spline
`may change again soon, as Roche is studying i’DM~l with or without Perjeta and
`compared to Herceptin plus Peijeta and taxane in the MARIANNE study.
`Whichever scenario comes to fruition, it is evrdent that Roche r’ Genentech have
`been successful in muscling out most competitors ll’l this tumor subtype, and
`TOM->1. gives the company some protection from potential future biosimilar
`competition that they face for Herceptin.
`
`7' Unfi'zation data from the 2011 Kantar Herr/m Orifice/Miami? {1.5.
`Arch/rectum.
`
`'i’rearmen.’
`
`SHARE ...;
`
`TAGS
`
`oncology, CancerMPact, Treatment Architecture, Genentoch, T—DMl, safety
`profile, linker technology, microtubuie polymerization inhibitor, Herceptin,
`Cancer, THBRESA, EMILIA, treatment paradigm, HER2+, ASCO 2012, breast
`cancer, trastuzumab emtansine, MARIANNE, antibody drug conjugate,
`Roche, maytansine (DMi), conjugated cytotoxic
`
`BACK TO PREVIOUS PAGE ._,
`
`IMMUNOGEN 2019. pg. 1
`Phigenix v. Immunogen
`|PR2014-00676
`http://www.kantarhealth.com/blog/oncology/gordon-gochenauer/2012/06/03/Roche_Gene...
`
`7/30/2014
`
`IMMUNOGEN 2019, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Roche / Genentech‘s "Magic Bullet" in HER2+ Breast Cancer
`
`Page 2 of 2
`
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`http://www.kantarhealth.com/blog/oncology!gordon-gochenauer/20 1 2/06/03/Roche_Gene. ..
`
`7/3 0/2014
`
`IMMUNOGEN 2019. pg. 2
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2019, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`
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