2012 Engage Healthcare Communications, LLC
THE PEER-REVIEWED FORUM FOR EVIDENCE IN BENEFIT DESIGN
FOR PAYERS, PURCHASERS, POLICYMAKERS, AND OTHER HEALTHCARE STAKEHOLDERS
Chicago, ILPrecision medicine isthe new catch phrase in oncology,and examples of it were evidentacross the vast halls of McCormickPlace at the 2012 American Society ofClinical Oncology (ASCO) meeting.
Precision medicine is the next itera-tion of personalized medicine, amoniker perhaps meant to convey theincreasing refinement of the molecu-lar targets that underlie tumors. It hasbecome evident that mutations that
Molecular Profiling GuidingCancer TherapyPrecision Medicine Focus of ASCO 2012 By Caroline Helwick
Novel T-DM1 Prolongs Remissionin Metastatic Breast Cancer: ANew Smart BombBy Audrey Andrews
Chicago, ILThe media darling atASCO 2012 was a novel agent somecalled a smart bomb, because of itshighly targeted and potent effect thatspares surrounding healthy tissue.
Trastuzumab emtansine, betterknown as T-DM1, the antibody-drugconjugate linking trastuzumab to acytotoxic agent, delivers its punchdirectly into the tumor of patients withHER2-positive metastatic breast can-cer, and this agent is associated withlittle toxicity. T-DM1 is one of an
entirely new class of agents that couldhave a major impact on the disease.
Early results from EMILIA, an inter-national phase 3 clinical trial presentedat the meetings plenary session,showed an increase of approximately30% in progression-free survival (PFS)with T-DM1 compared with a stan-dard treatment regimen.
For patients facing metastaticbreast cancer, this is a breakthrough,said lead author Kimberly L.Blackwell, MD, of Duke Cancer
Courtesy of A
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PERSONALIZED MEDICINE . . . . . . . 6Patients willing to pay for genetictesting to assess cancer riskWhy hasnt genomic testingchanged the landscape?
HEALTH ECONOMICS . . . . . . . . . . . . . 8High OOP costs in MedicareCancer screening is cost-effective
GI CANCERS . . . . . . . . . . . . . . . . . . . . . . 11New therapies on the horizon
LUNG CANCER . . . . . . . . . . . . . . . . . . 16Afatinib boosts PFS in EGFRmutations
PROSTATE CANCER . . . . . . . . . . . . 17Abiraterone before chemotherapy a promising strategy
RENAL CANCER . . . . . . . . . . . . . . . . . 20Tivozanib outperforms sorafenib as first-line therapy
MULTIPLE MYELOMA . . . . . . . . . . . 23Pomalidomide shows strong activityin relapsed/refractory disease
DRUG PIPELINE . . . . . . . . . . . . . . . . . 25PAYERS PERSPECTIVES . . . . . . 26Payers collaborate with providers to adopt oncology pathways?
IN THIS ISSUE
AUGUST 2012 I VOL 5, NO 5 I SPECIAL ISSUE ASCO 2012: Payers Perspectives
Quality of Life Drives Patient Preference for Metastatic RCC DrugPazopanib winner in head-to-head QOL comparisonBy Wayne Kuznar
Chicago, ILThe surprising results ofthe head-to-head randomized clinicaltrial PISCES on patient preference forone cancer therapy over another showthat patient-reported quality-of-life(QOL) differences influence treatmentpreference far more than physicianshad imagined, suggested researchers atASCO 2012.
In a double-blind, crossover trial,168 patients with metastatic renal-cell
carcinoma (mRCC) were randomized1:1 to 10 weeks of 800 mg of pazopanibor 50 mg of sunitinib as first-line can-cer treatment; after a 2-week washoutperiod, patients received 10 weeks ofthe alternate treatment. The primaryend point was patient preference,measured at 22 weeks.
Because patients with mRCC re -ceive therapies for many months oreven years, the researchers assessed
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Patient Adherence Rises with Costof Oral Cancer Drugs A potential designer drug phenomenonBy Caroline Helwick
Chicago, ILCanadian researchersreported a finding at the 2012American Society of Clinical Oncol -ogy meeting that runs contrary towhat other researchers have ob servedin the majority of studies. In this
study, as oral drug costs increas ed, sodid the likelihood of patients adher-ing to a prescribed regimen.
Low adherence rates have beendocumented for many oral therapiesin various diseases, and medication
is a registered trademark of Incyte Corporation.
Indications and UsageJaka is indicated for treatment of patients with intermediate or high-risk myelo brosis, including primary myelo brosis, postpolycythemia vera myelo brosis and postessential thrombocythemia myelo brosis.
Important Safety Informationt5SFBUNFOUXJUI+BLBDBODBVTFIFNBUPMPHJDBEWFSTF
reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, withthe most frequent being thrombocytopenia and anemia.A complete blood count must be performed before initiating therapy with Jaka . Complete blood counts should be monitored as clinically indicated and dosingadjusted as requiredt5IFUISFFNPTUGSFRVFOUOPOIFNBUPMPHJDBEWFSTF
reactions were bruising, dizziness and headachet1BUJFOUTXJUIQMBUFMFUDPVOUT9/L at the start
of therapy are more likely to develop thrombocytopenia
during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jaka . If clinically indicated, platelet transfusions may be administeredt1BUJFOUTEFWFMPQJOHBOFNJBNBZSFRVJSFCMPPEUSBOTGVTJPOT
Dose modi cations of Jaka for patients developing anemia may also be consideredt/FVUSPQFOJB"/$9/L) was generally reversible
and was managed by temporarily withholding Jaka t1BUJFOUTTIPVMECFBTTFTTFEGPSUIFSJTLPGEFWFMPQJOH
serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before TUBSUJOH+BLB1IZTJDJBOTTIPVMEDBSFGVMMZPCTFSWFQBUJFOUTreceiving Jaka for signs and symptoms of infection JODMVEJOHIFSQFT[PTUFSBOEJOJUJBUFBQQSPQSJBUFtreatment promptlyt"EPTFNPEJDBUJPOJTSFDPNNFOEFEXIFOBENJOJTUFSJOH+BLBXJUITUSPOH$:1"JOIJCJUPSTPSJOQBUJFOUTXJUI
Prescribing Information. Incyte Corporation. November 2011. 1
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has shown that with the right process, manufacturers can successfully collaborate with regulatory agencies and
How PROs were successfully integrated into the Jaka (ruxolitinib) drug development program1
A novel approach to engage clinicians and FDA
130TBSFBOJNQPSUBOUNFBOTUPEFNPOTUSBUFUSFBUNFOUbene ts in clinical trials.6TFPGB130JOTUSVNFOUDBOevaluate symptoms best judged by the patient, whether caused by the disease or treatment toxicity. Assessment of symptom burden is important because it can be a major indicator of disease severity, progression or improvement. *ODPSQPSBUJOH130TJOUPBDMJOJDBMUSJBMQSPHSBNQSPWJEFTBmeans for evaluating the impact of therapy from the patients perspective and helps patients and clinicians make better-informed decisions.
TAILORING a PRO tool for myelo brosis
.ZFMPCSPTJT.'JTBMJGFUISFBUFOJOHQSPHSFTTJWFEJTFBTFcharacterized by splenomegaly, debilitating symptoms and cytopenias.5-7 Measures to assess both the splenomegalyand core symptoms of MF were incorporated into the phase III,EPVCMFCMJOEQMBDFCPDPOUSPMMFETUVEZ$0.'035*GPS+BLB4QMFFOSFEVDUJPOBTNFBTVSFECZJNBHJOH.3*PS$5
was the primary and biologic endpoint, and a reduction in total TZNQUPNTDPSF544
UIF130NFBTVSFXBTBLFZTFDPOEBSZendpoint.8,9 The TSS encompassed the following symptoms: abdominal discomfort, pain under left ribs, early satiety, pruritus,
night sweats and bone/muscle pain.9
5PJODMVEF130TJOUIFUSJBMBOPWFMJOTUSVNFOUIBEUPCFspeci cally developed. After patient interviews, advice fromclinical experts and extensive input from the FDA, the modi ed Myelo brosis Symptom Assessment Form, version NPEJFE.'4"'WXBTOBMJ[FEBTQBSUPGUIF4QFDJBM1SPUPDPM"TTFTTNFOUQSJPSUPUIFJOJUJBUJPOPG$0.'035*Ultimately, Jaka was approved by the FDA for the treatment of intermediate or high-risk MF.1,8 This became Incytes rst approved drug and also the rst oncology medicine approved with symptom data in its label since the FDA s draft guidance on 130TXBTOBMJ[FEJO
gresswith patient-reported outcomes
Placebo (n = 145)Jaka (n = 145)
COMFORT-I: Percent Change in TSS in Individual Patients From Baseline to Week 24 or Last Observation9,a,b
Upper 50th Percentile Upper 50th Percentile
Each bar represents an individual patients response. Worsening of TSS is truncated at 150%.
Placebo (n = 153)Jaka (n = 155)
COMFORT-I: Percent Change in Spleen Volume in Individual Patients From Baseline to Week 24 or Last Observation9,a
Upper 50th Percentile Upper 50th Percentile
Each bar represents an individual patients response.
Jaka is a registered trademark of Incyte Corporation. 2012, Incyte Corporation. All rights reserved.RUX-1130A 05/12
I is indicated for treatment of patients with intermediate
for patients developing anemia