Vol
`
`No 168, Part I of H
`
`.LIQURNAL OF
`TM
`"CNCOLOGY
`
`
`
`415t Annual Meeting
`
`May 13-17,. 2005
`Orange County Convention Center
`
`Orlando, FL
`
`www.jco.org
`
`Official journalof the American Society of Clinical Oncology
`
`AS ( : ‘ if
`
`Par Pharm., Inc.
`
`Exhibit 1090
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`Par Pharm., Inc. v. Novartis AG
`Case lPR2016-01479
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`Ex. 1090-0001
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`Ex. 1090-0001
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`

`

`4lst
`
`Annual Meeting of the
`
`American Society of Clinical Oncology
`
`May 13—17, 2005
`
`Orlando, Florida
`
`2005 Annual Meeting Proceedings Part I
`
`(a supplement to the Journal of Clinical Oncology)
`
`ASC®
`
`Copyright 2005 American Society of Clinical Oncology
`
`Ex. 1090-0002
`
`Ex. 1090-0002
`
`

`

`Editor: Steven M. Grunberg, MD
`
`Publisher and Managing Editor: Lisa Greaves
`Editorial Assistant: Elissa Fuchs
`
`Administrative Associate: Adel] Cokley
`
`Director of Production: Victoria Vaughn
`
`Production Manager: Dana Monzi
`
`Executive Editor: Deborah Whippen
`
`Requests for permission to reprint abstracts should be directed to Intellectual Property
`Rights Manager, American Society of Clinical Oncology, 330 John Carlyle St., Suite 300,
`Alexandria, VA 22314. Tel: 703-299-0150; fax 703-518-8157; e-mail permissions®asco.org.
`Editorial correspondence and production questions should be addressed to Managing Editor,
`Annual Meeting Proceedings, American Society of Clinical Oncology, 330 John Carlyle St., Suite
`300, Alexandria, VA 22314. Tel: 703-519-1437; fax 703-518-8157; e-mail abstracts@asco.org.
`
`Copyright © 2005 American Society of Clinical Oncology. All rights reserved. No part of this
`publication may be reproduced or transmitted in any form or by any means, electronic or
`mechanical, including photocopy, recording, or any information storage and retrieval system,
`without written permission by the Society.
`
`The American Society of Clinical Oncology assumes no responsibility for errors or
`omissions in this document. The reader is advised to check the appropriate medical literature
`and the product information currently provided by the manufacturer of each drug to be
`administered to verify the dosage, the method and duration or administration, or
`contraindications. It is the responsibility of the treating physician or other health-care
`professional, relying on independent experience and knowledge of the patient, to determine
`drug, disease, and the best treatment for the patient.
`
`Abstract management and indexing provided by Database Publishing Group, Inc.,
`Cambridge, MA. Composition services and print production provided by Cadmus Professional
`Services, Linthicum, MD.
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`Ex. 1090-0003
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`Ex. 1090-0003
`
`

`

`
`
`SUPPLEMENT TO
`
`iJOURNAL OF- CLINICAL ONCOLOGY
`E'Official
`JOurnal of
`the American Society of‘ Clinicai Oncology
`
`
`
`
`V01. 23, N0. 168
`
`June 1, 2005
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`|
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`|
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`l
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`
`
`Plenary(Abstracts1—10).......................................................................................................................................................
`
`13
`
`4s
`41s
`
`1063
`1133
`
`Breast Cancer
`Scheduled presentations (Abstracts 500 — 674) ...........................................................................................................
`Published only (Abstracts 675 —
`Cancer Prevention
`Scheduled presentations (Abstracts 1000 —
`Published only (Abstracts 1030 — 1031
`Central Nervous System Tumors
`Scheduled presentations (Abstracts 1500 —1571 1145
`Published only (Abstracts 1572 -
`1325
`Developmental Therapeutics: Cytotoxic Chemotherapy
`135s
`Scheduled presentations (Abstracts 2000 —
`Published only (Abstracts 2085 —21 1555
`Developmental Therapeutics: Immunotherapy
`Scheduled presentations (Abstracts 2501 —
`Published only (Abstracts 2585 -
`
`Developmental Therapeutics: Molecular Therapeutics
`Scheduled presentations (Abstracts 3000 —
`Published only (Abstracts 3088 -
`Gastrointestinal (Colorectell Cancer
`Scheduled presentations (Abstracts LBA3500 — 3634)...
`Published only (Abstracts 3635 — LBA3747)
`Gastrointestinal (Noncolorectal) Cancer
`30113
`Scheduled presentations (Abstracts 4000 — 41 38)
`Published only (Abstracts 4139 —4280) 342:
`Genitourinary Cancer
`Scheduled presentations (Abstracts 4500 —
`Published only (Abstracts 4650 — 4804) .................... ..
`Gynecologic Cancer
`Scheduled presentations (Abstracts 5000 — 5094) ...................................................................................................... 4553
`Published only (Abstracts 5095 — LBA5183) .................................................................................................................. 4183
`Head and Neck Cancer
`Scheduled presentations (Abstracts LBA5500 — 5582) ............................................................................................. 500:
`
`Published only (Abstracts 5583 — 5610) ....................................................................................................................... 5208
`(continued on following page)
`
`166s
`.. 1813
`
`1925
`2133
`
`
`.. . .
`. ..
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`
`
`3111s
`. 4153
`
`
`
`Journal ofCiiniml Onmlogy ussn 0732-183X) ispublishcd Sfidnncsayar. directions monthly. byhmcrican Society ofClinical Oncology. 1900 Duke St. Suite 200. Alexandria.
`VA 22314. Periodicals postach plid at Alexandria, VA. and a: additionalmailing otficcs. Publication Mai] Agreement Number 953239.
`Editorial correspondence flaccid be addressed mo Daniel G. Heller, MD, Journal ofCiinr'ml Orwulogy. 33010hn Carlyle &. Suite 300. Alexandria. VA 22314. Telephone: (-703)
`797-1900; Fax: (703) 684-8720. E-mail; jco@asoo.org. interact: www.ioo.org.
`POSTMASTER: ASCO members send change ofaddress to American Socicqofciinical Oncology. 1900 Duke St. Suite 100. Alexandria. VA 223 H. Non-members lend change
`ofaddress tojournalofClinicalWWW Service, 33010hnCadyIcSt, SuitcSOO.Alcxand1-ia, VA 22314.
`2005 annual subscription rates, cfl’em'vc September I, 2004: United States and possessions: individual. 5421:31an issue, 535. International: individual. $587; single issue, 545.
`institutions: Tier 1: 5580 US. $820 int'i; Tier 2: 5675 US. $915 11191: Tier 3: $975 US. 31,215 1m”); Tier 4: $1,075 US. $1.315 lnr’l; Tier 5: sonnet ICU for a quote. Sea
`http:flwww.}co.orglsubscriptionsltieredpricing.shunl for descriptions ofeach tier. Student and resident: United State: Ind possessions $210; at] other countries. $293. To receive
`nudmtlresident rate. orders must be accompanied by name ofaffiliated institution, date of term, and the signature of programlresidancy coordinator on institution letterhead.
`Orders will be billed at individilal rate until proof of status is received. Current prices are in effect for back volumu and back issues. Bank ileum sold in maturation with a
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`'
`
`Ex. 1090-0004
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`Ex. 1090-0004
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`

`

`3
`Health Services Research
`Scheduled presentations (Abstracts 6000 - 6031).......................................................................................... at
`Published only (Abstractsecm — 6126) ................
`......................................mm..-......................... 540:
`Loam“, L1rn'phoma,MVeloma, and Transplantation (Adult)
`Scheduled presentations (Abstracts 8500 — 0677)....Wm..-............................................................... 560:
`Published only (Abstracts 6680 - 6746) .......................................................................................... Elle
`
`an:
`-
`presentations (Abstracts 7000 - 7227).........................-......._........._
`Published only (Abstracts 7228 —7354) ..............................................................-...... an:
`Melanoma
`Scheduled presentations (Abstracts 7500 - 7559)......................._...__.....___.....-.............. 710:
`Published only (Abstracts 7560 — 7573) .................................................................................. 725:
`Patient Care
`Scheduled presentations (Abstracts 8000 — 8132).....................................................................—... 12!:
`Published only (Abstracts 81 33 -— 8284) ............................................................................. 152:
`
`_
`Pediatric Oncology
`Scheduled presentations (Abstracts 8500 — 8561)..............................................-.... Ills
`Sarcoma
`Scheduled presentations (Abstracts 9000 - 9081) ............................................................... 016:
`Tumor Biology and Human Genetics
`Scheduled presentations (Abstracts 9500 - 961 1).................................................................................................... 031:
`Published only (Abstracts 9612 — 9708 ............................................................................................................................ file
`Indexes
`Disclosure Indax.-.............-...................................................................................,................................................................... use
`Author Index .................................................
`Subject Index.............................................................................................................
`
`. .
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`.. ..
`
`.
`
`..
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`Ex. 1090-0005
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`Ex. 1090-0005
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`

`

`American Society of Clinical Oncology
`
`4lst Annual Meeting
`
`2005 Abstracts
`
`Abstract Session Descriptions for Scheduled Presentations
`
`Oral Abstract Presentation Sessions
`
`Oral Abstract Presentation Sessions include didactic presentations of the abstracts determined by the Scientific
`Program Committee to be of the highest scientific merit. Experts in the field serve as Discussants to place the findings
`into perspective. The Plenary Sessions include the abstracts selected by the Scientific Program Committee as having
`significant findings.
`
`Integrated Education Sessions
`Integrated Education Sessions provide a forum for science in oncology, combining the presentation of selected
`abstracts on a specific topic with didactic lectures. Experts in the field place the studies in the appropriate
`context based on the strength of the evidence and critically discuss the conclusions in terms of their applicability to
`ciinical practice.
`
`Poster Discussion Sessions
`
`Poster Discussion Sessions highlight selected abstracts of clinical research in poster format. The posters are grouped
`by topic or by the questions posed as a result of the research findings. The posters are on display for a specified time,
`followed by a discussion session in which experts provide commentary on the research findings.
`
`General Poster Sessions include selected abstracts of clinical research in poster format. The posters are grouped by
`topic and are on display for a specified time.
`
`General Poster Sessions
`
`Publish only abstracts were selected to be published in conjunction with the Annual Meeting, but not to be presented
`at the Meeting.
`
`Publication Abstracts
`
`This publication contains abstracts selected by the ASCO Scientific Program Committee for presentation at the
`2005 Annual Meeting and for publication. The type of session, the day, and the session start/end times are
`located to the right of the abstract number for scheduled presentations. To determine the location of the
`abstract session, refer to the Pocket Program or ASCO.org.
`
`Dates and times are subject to change.
`All modifications will be posted on ASCO.org (www.asco.org).
`
`Ex. 1090-0006
`
`Ex. 1090-0006
`
`

`

`3285
`
`Gastrointestinal [NoncolorectoU Cancer
`
`General PosterSssslon, Sat. 2:00 PM - 5:00 PM
`4001
`Prospective non-randomized shitty of concurrent radiation and platinum plus
`5-H: based chemotherapy with or without paclituol with consecutive surgery
`in esophageal ricer patients. M. Zemariova. A. Pazdra, F. Novalr, G.
`Pazdrova, M. Smejlral, M. Haiuzilr, J. Krizova, L. Petruzelka; 131‘ Model
`Faculty VFN, Dive of Oncology, Surgery, & Internal Medan, Charles Univ.
`Prague, Czech Republic
`Background: Combined modality treatment in esophageal cancer is sug-
`gested to improve survival. Results of study with new chemoradiotherapy
`regimen and special interest on nutritional status are presented. Methods:
`80 patients (pts), 67men, median age of 58 (range 44—76 years). with
`operable esophageal cancer were enrolled. They received the following
`neoadjuvant therapy: carboplatin. AUG 6, N on days 1 and 22. fluorouracil,
`300mg/day. Cl on days 1 to 42, radiation therapy 45Gyl25frl5 weeks
`beginning on day 1. 41pts (51%) were non—randomly assigned to paclitaxe!
`200 mglm2l3hours IV on days 1 and 22. Nutritional supports since the
`beginning of the study was offered to all pts. Surgery was done within 4—8
`weeks after completion of CRT if feasible. Results: All pts were evaluated for
`toxicity with G3+4 Ieukopenia 30%. neutropenia 32%. anemia 7%,
`trombocytopenia 27%, febrile neutropenia 8%. esophagitis 22%. vomiting
`10%, pneumotoxicity 12%. 55 pts (69%) had surgery, 43 (54%) were
`completely resected with 20 (25%) achieving pathologic complete remis—
`sion (pCR) and additional 8 (10%) having microscopic residual disease.
`There were 9 surgery-related deaths, mostly due to pulmonary insuffi-
`ciency. 25 pts were not resected, 15 for early progression, 10 for medical
`reasons. After a median followup of 24 months 31i80 (39%) pts are still
`alive with median survival (MS) 17.5 months. Mean weight loss before
`treatment start was 8 kg and during CRT 2.25 kg. Patients with above-
`average weight loss had non-significantly shorter MS (p=0. 128). Paclitaxel
`didn’t influence treatment results in terms of MS or pCR. 12l20 patients
`having pCR are alive. median survival was not reached. Conclusions: This
`combined-modality approach for the treatment of localized esophageal
`cancer is feasible and the efficacy is encouraging, with 46% of completely
`resected patients having pCR as positive predictive factor for survival.
`Relatively increased postoperative mortality was observed in this group.
`Worse prognosis of patients with substantial weight loss is reason for
`intensive nutritional support during treatment. Supported by grant lGA M2
`CR 1530—3.
`
`General Poster Session. Sat, 2:00 PM - 6:00 PM
`4083
`Preliminary results of a phase II trial or gefittnih in progressive metastatic
`neumenttocrlne hnnors (NET): A Phase II Consortium (P20) study. Q
`Hobday, M. Mahoney, C. Erlichman, R. Lloyd, G. Kim, D. Mulkerin, J.
`Pious, T. Fitch, R. Donehawer; Mayo Clinic, Rochester, MN; Mayo Clinic.
`Jacksonville. FL; Univ of Wisconsin, Madison. WI; Washington Univ, 3:
`Louis, MO; Mayo Clinic. Scottsdale, AZ; Johs Hopkins Univ, Baltimore, MD
`Background: Metastatic NET (including islet cell carcinoma (ICC) and
`carcinoid tumors) are progressive in nature despite their indolent behavior.
`Systemic treatment options are limited. lmmunohistochemichal (IHC) data
`suggest these tumors frequently express the epidermal growth factor
`receptor (EGFR). This suggests that EGFR mediated signaling may contrib-
`ute to the growth of NET. Gefitinib is a small-molecule inhibitor of the
`EGFR tyrosine kinase domain. Methods: We evaluated 6 month progression-
`free survival (PFS) in two separate cohorts (ie, carcinoid and ICC) and using
`two separate Phase I]
`trial designs. PFS rates at 5 months of 30%
`(carcinoid) and 10% (ICC) were considered promising. Importantly. objec—
`tive radiologic progression by RECIST criteria was required for study entry.
`Other eligibility criteria included: ECOG PS 5 2, s 1 prior chemotherapy,
`and good organ function. Prior or concurrent octreotide and prior interferon
`were allowed. Results: 37 patients (pts) were enrolled: (22 carcinoid, 15
`ICC). There were 16. 20. and 1 patientswith P5 of 0. 1, and 2 respectively.
`Median age was 56 yrs (range 36 —79). 14 of 22 (64%) pts with carcinoid
`tumors and 2 of 15 (13%) pts with ICC were progression-free at 6 months.
`No objective responses have been observed. Grade 3—4 toxicity (Le. at least
`pOSSibly related to getinitib) was observed in 3 carcinoid pts including
`diarrhea (1). nausea (1). duodenal ulcer (l). anorexia (1), dehydration (1),
`fatigue (1), and rash (1);and 3 ICC pts including fatigue (1), hyperglycemia
`(1), and rash (1). (H0 markers of the EGFR pathway on tumor tissue will be
`presented. Conclusion: Gefitinib can produce prolonged disease stabiliza-
`tion in pts with prior documented objective progression of carcinoid tumors
`and ICC. Further accrual to this multicenter P20 trial is ongoing. Supported
`by NO) CM17104.
`
`
`This material may be protected by Copyright law (Title 17 us. Code)
`
`
`
`
`4-082
`
`General Poster Session, Sat. 2:00 PM - 5:00
`
`,
`
`
`A phase II study of weeth psclitairol and doxilluridine (an intern“
`
`i.
`metabolitoolcopecltahlne) combination chemotheraoytoradvanc --
`l
`
`lwazalii, .
`astrlc cancer.
`l. Take 0 hi F. Makita, Y. Tanahaslii, S.
`shikawa, T. Ohya, S. Kawate, Y. Morisliilsj-
`akamura. T. O wa.
`.
`
`aebaslii, Gunma. Japan; National Nishi—gunma H ",r
`Gunma Univ,
`Shibukawa, Japan; Shibulrawa Geri Hosp, Shibukawa, Japan,- Tateba
`‘1
`
`Kasai Hosp, Tarebayashi, Japan; National Takasalri Hosp, Takasalri, Jfrll'
`Maebasni Red Cross Hosp, Maebasi‘il. Japan; Fujhroshida City mg.
`Fujflroshida. Japan; Ojlya Geri Hosp, Ojrya, Japan
`,
`
`nd: Paciitaxel and doxifluridine (5’VDFUR: an intermediate metabor
`Bsc
`Iiteo capecitabine), which have distinct mechanismsof action and tox'
`'
`.‘:
`
`i
`profiles, each have considerable single-agent activity in gastric cancer,
`synergistic interaction between these two drugs was suggested from
`1
`
`taxane-induced upr
`ulation of thymidine phosphoryiase. which con
`5'-DFUR to 5-FU. T erefore, this stu
`evaluated the antitumor acti '
`
`l
`and toxicities of paclitaxel and 5'-DFU in combination in patients
`'
`advanced/recurrent gastric cancer (AGC). Medians: Patients with histologt'
`
`cally confirmed AGC, which was unresectable or metastatic. PS 0—2, and:
`
`ever 20 years old were eligible for this study. The treatment included.
`paclitaxe 80 mgi‘m2 i.v. on days 1. 8. and 15 every 4 weeks and
`doxifluridine 533 mglm2 p.o. on days 1—5lweeir until there was diseasg
`
`progression or the appearance of unacceptable toxicity. Results: Betwegfi
`April 2003 and October 2004. 59 patients were enrolled in this stu :
`
`Their median age was 67.0 ears (range: 36—79) and 48 patients wed.
`astric cancer and 26 had,
`male. Thirty-three patients
`ad advanced
`
`recurrent gastric cancer. After a median o ,2 (range: 1—17) cycles d‘
`chemotherapy. 59 patients were evaluated for toxicity and 45 patients were-r
`evaluated for response.
`In the intention—to—treat analysrs,
`the overall
`
`response rate was 33.3% (95% 0).. 19.6—47.1%), including 1 CR_. 14¢;
`
`PR5. 22 505, and 8 PBS. The first-line therapy involved 26 patients
`
`alone) in whom the response rate was 46.23;}
`(prima
`advanced or surge
`
`(95% .l.. 27.0~65.3%).
`he second-line therapy involved 16 patients-
`(70% T5-1 failure) in whom the response rate was 18.8% (95% C.I.;
`036—37990. The median overall survival was 259 days. The actual dose
`
`intensity was 83.0% (49l59) of the planned dose duringthe first two cycles
`drugs. Commonly observed grade 3/4 adverse events were
`for bot
`
`'
`Ieukopenia (11.9%), nausea and vomiting (8.5%). diarrhea (6.1%). a '
`fatigue (5.1%). There was no neutro enic ever or treatment-related 008111.;
`Conclusions: Paclitaxel and 5‘-DFU combination chemotherapy is at:th
`in A60 and well tolerated.
`
`
`
`
`General Poster Session. Sat. 2:00 PM - 6:00 PI
`4084
`Malignant carcinoid syndrome: Survival
`In the emotion LAlt on. L.
`:i
`Anthony. T. Kong, Y. Shyr; LSUHSC New Orleans, New Orleans,
`Vanderbilt Univ, Nashville, TN
`
`,
`
`Background: Somatostatin analogues (SMSA) (octreotide) are effective it?
`controlling excess hormonal symptoms in the majority of patients (pts) with
`is a de_
`carcinoid syndrome. Octreotide long acting release (LAR)
`
`(intramuscular) formulation introduced 10 years after the immedi
`release (subcutaneous (sclhntravenous) octreotide became commercial
`
`available in 1988. Monthly octreotide LAR provides continuous a -
`predictable blood levels. Immediate release octreotide results in wi '
`
`fluctuating blood levels and requires pts to comply with 2—4 dai
`injections for optimal control of symptoms. For carcinoid syndrome N
`
`(elevated SvHIAA). a median overall survival of 24 months (N=90) wall;
`
`reported by Z Davis. C Moertei. D Mcllrath (Surg. Gyn & Obst 137:637)
`in the preSMSA era. Octreotide LAR's effect on survival to
`1973)
`unknown. Methods: Consecutive carcinoid syndrome pts treated with SM
`
`SQ (N=90) between 1985—1995 were the control group. The investi
`tional group consisted of consecutive carcinoid syndrome pts treated w' i g),
`
`octreotide LAR (N=145) between 1996-2004. Entry criteria inclu 7-:
`elevated 5-HIAA andlor blood chromogranin A and biopsy proven Stage
`"
`carcinoid. Patient characteristics recorded were: age, race, gender. prim .i;
`
`and metastatic disease sites. disease duration, concomitant therapies a
`.‘
`
`SMSA or octreotide LAR dose. A Kaplan~Meier estimator and the
`
`rank~test were used to determine median survival and statistical signiflt,
`
`canoe. respectively. Results: The 2 groups were similar with regards to as!)
`race. gender, biochemical marker elevation. primary (majority were midgulf,
`
`and metastatic disease sites and concomitant therapies. The survhfli
`.
`curves for the 2 groups were significantly different. The estimated ove
`
`median survival, p values and Hazard Ratio with 95% confidence inte
`V‘
`(Ci) from the time of metastatic disease diagnosis are: Control group (SMSQ.
`
`80) = 143 months Investigational group (octreotide LAR) = 229 month '
`*p < 0.0001; Hazard Ratio: 0.34 (95% CI of ratio: 0.18 to 0.
`
`Conclusions: Carcinoid syndrome pts receiving treatment with octreotidgi
`LAR have a 66% (range 46—82%) lower risk of death than pts receivi
`.,
`intermittent SMSA SCI
`therapy.
`(Supported in part by NIH-GCR
`RR00095).
`
`iI
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`EX. 1090-0007
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`Ex. 1090-0007
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