Larotaxel (L) in combination with trastuzumab in patients with HER2 + ...
`
`http://meeting.ascopubs.org/cgi/content/short/26/15_suppl/1070
`
`Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
`Vol 26, No 15S (May 20 Supplement), 2008: 1070
`© 2008 American Society of Clinical Oncology
`
`Abstract
`Larotaxel (L) in combination with trastuzumab in patients
`with HER2 + metastatic breast cancer (MBC): Interim
`analysis of an open phase II label study
`V. Dieras, P. Viens, C. Veyret, G. Romieu, A. Awada, E. Lidbrink, H. Bonnefoi, D.
`Mery-Mignard, F. Dalenc and H. Roché
`
`Institut Curie, Paris, France; Institut Paoli Calmettes, Marseille, France; Centre Henri
`Becquerel, Rouen, France; Centre Val d'Aurelle, Montpellier, France; Institut Jules Bordet,
`Bruxelles, Belgium; Karolinska University Hospital, Stockholm, Sweden; Institut Bergonié,
`Bordeaux, France; sanofi-aventis, Antony, France; Institut Claudius Regaud, Toulouse,
`France
`
`1070
`
`Background: Larotaxel (L), a semi-synthetic taxoid, has shown preclinical and clinical
`activity against taxane-resistant BC, and it presents the ability to cross the blood brain
`barrier. In HER2 + BC, trastuzumab (H) combined with taxanes is highly active, particularly
`in early stage BC. However, there is a need to develop new combinations for HER2+ pts
`who develop metastatis (mets), especially brain mets. Methods: MBC pts, < 1 prior
`chemotherapy (Ct) for metastatic disease, measurable disease, HER2 + (IHC 3+ and/or
`FISH +), baseline LVEF 50%, were eligible to receive 90 mg/m2 L, 1-hour infusion and 6
`mg/kg (8 mg/kg loading dose) H, every 3 weeks(w). Inclusion of patients with asymptomatic
`brain mets (mandatory baseline CTscan ) was allowed. Main objectives: activity of LH
`combination (ORR as per RECIST), progression free-survival, CNS outcome or
`occurrence, overall survival, safety and pharmacokinetic (PK) profiles. Tumor assessments
`and LVEF were done every 2 cycles(cy). Results: As of Dec. 2007, 41/50 pts were treated.
`The first 26 evaluable pts are presented in this per-protocol interim analysis: median age of
`55.5 y (30–78), 19 pts (73%) with > 2 organs involved (including 4 with brain mets), 17pts
`with prior Ct for metastatic disease (prior taxane: 13 and prior H:15). The median number of
`cy was 6 (1–12). Most common gr 3–4 adverse events: febrile neutropenia/neutropenic
`infection (4), diarrhea (2), asthenia (6). Eleven (42.3%) confirmed partial responses (PR)
`were reported in 1st or in 2nd line with 1 PR and 3 stable disease (SD) lasting 18 w in pts
`with brain mets. Preliminary PK results: clearance of L at cy1 and 6 are similar to those
`
`1 of 2
`
`6/20/2014 6:17 PM
`
`AVENTIS EXHIBIT 2101
`Mylan v. Aventis, IPR2016-00712
`
`

`
`Larotaxel (L) in combination with trastuzumab in patients with HER2 + ...
`
`http://meeting.ascopubs.org/cgi/content/short/26/15_suppl/1070
`
`observed in monotherapy. Conclusions: L and H at full doses can be combined with a
`manageable toxicity. Preliminary data suggest good activity in pretreated pts with high
`tumor burden, including pts with brain mets. PK analysis will be presented on the whole
`population.
`
`Author Disclosure
`
`Employment
`or Leadership
`
`Consultant or
`Advisory
`Role
`
`sanofi-aventis
`
`Stock
`Ownership Honoraria Research
`
`Expert
`Testimony
`
`Other
`Remuneration
`
`Abstract presentation from the 2008 ASCO Annual Meeting
`
`2 of 2
`
`6/20/2014 6:17 PM