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Berlin et al. ESMO 2006
Safety and Efficacy of Panitumumab Safety and Efficacy of Panitumumab Monotherapy in the Treatment of Metastatic Monotherapy in the Treatment of Metastatic
Colorectal Cancer (mCRC) – Summary of Colorectal Cancer (mCRC) – Summary of Results Across Clinical StudiesResults Across Clinical Studies
Jordan Berlin,Jordan Berlin,11 Eric Van Cutsem Eric Van Cutsem,,22 Marc Peeters, Marc Peeters,33
J. Randolph Hecht, J. Randolph Hecht,44 Michael Wolf, Michael Wolf,5 5 Rafael Amado,Rafael Amado,55 Neal J. MeropolNeal J. Meropol66
Abstract #326OAbstract #326O
11Vanderbilt University Medical Center, Nashville, TN; Vanderbilt University Medical Center, Nashville, TN; 22University Hospital University Hospital Gasthuisberg, Leuven, Belgium; Gasthuisberg, Leuven, Belgium; 33Ghent University Hospital, Ghent, Ghent University Hospital, Ghent, Belgium; Belgium; 44UCLA School of Medicine, Los Angeles, CA; UCLA School of Medicine, Los Angeles, CA; 55Amgen Inc., Amgen Inc., Thousand Oaks, CA; Thousand Oaks, CA; 66Fox Chase Cancer Center, Philadelphia, PAFox Chase Cancer Center, Philadelphia, PA
Berlin et al. ESMO 2006
IntroductionIntroduction
• Panitumumab is a high-affinity (KPanitumumab is a high-affinity (Kd d = 5 = 5 10 10−11−11 M), fully human IgG2 M), fully human IgG2
monoclonal antibody directed against EGFr.monoclonal antibody directed against EGFr.11
• Panitumumab inhibits EGFr-mediated activity, including EGFr Panitumumab inhibits EGFr-mediated activity, including EGFr tyrosine autophosphorylation, tumor cell growth, and tyrosine autophosphorylation, tumor cell growth, and metastases.metastases.1-41-4
• Panitumumab monotherapy shows clinical activity in patients Panitumumab monotherapy shows clinical activity in patients with late‑stage colorectal cancer whose disease progressed after with late‑stage colorectal cancer whose disease progressed after standard irinotecan- and/or oxaliplatin-containing chemotherapy standard irinotecan- and/or oxaliplatin-containing chemotherapy regimens.regimens.55
• This summary of five studies presents efficacy data for This summary of five studies presents efficacy data for panitumumab in a total of 732 patients with mCRC who were panitumumab in a total of 732 patients with mCRC who were refractory to prior therapy. Two studies are complete, three are refractory to prior therapy. Two studies are complete, three are interim.interim.
11Foon et al. Int J Radiat Oncol Biol Phys. 2004;58:984-990.Foon et al. Int J Radiat Oncol Biol Phys. 2004;58:984-990.22Freeman et al. Eur J Cancer Suppl. 2004;2:95-96. Abstract 313.Freeman et al. Eur J Cancer Suppl. 2004;2:95-96. Abstract 313.33Freeman et al. Proc Am Assoc Cancer Res. 2005;46:1062. Abstract 4494. Freeman et al. Proc Am Assoc Cancer Res. 2005;46:1062. Abstract 4494. 44Lynch and Yang. Semin Oncol. 2002;29(suppl 9):47-50.Lynch and Yang. Semin Oncol. 2002;29(suppl 9):47-50.55Peeters et al. Proc Am Assoc Cancer Res. 2006;47: Abstract CP-1.Peeters et al. Proc Am Assoc Cancer Res. 2006;47: Abstract CP-1.
Berlin et al. ESMO 2006
ObjectivesObjectives
• Assessment of the efficacy of panitumumab in patients with Assessment of the efficacy of panitumumab in patients with disease progression during or after prior fluoropyrimidine, disease progression during or after prior fluoropyrimidine, irinotecan, and/or oxaliplatin treatment for mCRCirinotecan, and/or oxaliplatin treatment for mCRC
• Key objectives of the studies included:Key objectives of the studies included:
–Objective tumor responseObjective tumor response
–Progression-free survivalProgression-free survival
–Duration of responseDuration of response
• Secondary objectives of the studies included:Secondary objectives of the studies included:
–Time to responseTime to response
–Survival timeSurvival time
–Safety (eg, adverse events, skin toxicities, human anti-human Safety (eg, adverse events, skin toxicities, human anti-human antibody responses)antibody responses)
Berlin et al. ESMO 2006
Peeters, et al. 2006Peeters, et al. 2006aa
Berlin, et al. Berlin, et al. 20062006bb
Hecht, et al. Hecht, et al. 20062006cc Malik, et al. 2005Malik, et al. 2005dd
PanitumumabPanitumumab(N=229)(N=229)
CrossoverCrossover(N=177)(N=177) (N=93)(N=93) (N=88)(N=88) (N=150)(N=150)
Phase Phase 33 3 (ES)3 (ES) 22 22 22
Dose Dose scheduleschedule
6 mg/kg Q2W6 mg/kg Q2W 6 mg/kg Q2W6 mg/kg Q2W 6 mg/kg Q2W6 mg/kg Q2W 6 mg/kg Q2W6 mg/kg Q2W 2.5 mg/kg QW2.5 mg/kg QW
Response Response assessmentassessment
RECISTRECISTCentral reviewCentral review
RECISTRECISTLocal reviewLocal review
WHOWHOCentral reviewCentral review
WHOWHOCentral reviewCentral review
RECISTRECISTCentral reviewCentral review
Assessment Assessment scheduleschedule
Wks 8-48 and Wks 8-48 and Q3M thereafter Q3M thereafter until PDuntil PD
Q8W and at Q8W and at investigator investigator discretiondiscretion
Wks 8-48 and Wks 8-48 and Q3M thereafter Q3M thereafter until PDuntil PD
Wks 8-48 and Wks 8-48 and Q3M thereafter Q3M thereafter until PDuntil PD
Q9W and at Q9W and at investigator investigator discretiondiscretion
EGFr EGFr staining by staining by IHC, central IHC, central reviewreview
≥ ≥ 1% of 1% of evaluatedevaluatedtumor cellstumor cells
≥ ≥ 1% of 1% of evaluatedevaluatedtumor cellstumor cells
≥ ≥ 10% of 10% of evaluated evaluated tumor cellstumor cells
<1% (negative) <1% (negative) or 1 to < 10% or 1 to < 10% of evaluated of evaluated tumor cellstumor cells
High EGFr: 2+ or High EGFr: 2+ or 3+ in ≥ 10% of 3+ in ≥ 10% of tumor cellstumor cells
Low EGFr: sum of Low EGFr: sum of 1+, 2+, and 3+ in ≥ 1+, 2+, and 3+ in ≥ 10%, but 2+ and 10%, but 2+ and 3+ in < 10% of 3+ in < 10% of evaluated tumor evaluated tumor cellscells
Design and MethodsDesign and Methods
aPeeters et al. Proc Am Assoc Cancer Res. 2006;47: Abstract CP-1bBerlin et al. J Clin Oncol. (Meeting Abstracts). 2006;24:3548cHecht et al. J Clin Oncol. (Meeting Abstracts). 2006;24:3547dMalik et al. J Clin Oncol. (Meeting Abstracts). 2005;23:3520
Berlin et al. ESMO 2006
Key Eligibility CriteriaKey Eligibility Criteria
• Age Age 18 years 18 years
• ECOG score of 0 – 2 (4 studies)ECOG score of 0 – 2 (4 studies)0 – 1 (1 study)0 – 1 (1 study)
• Pathologic diagnosis of CRCPathologic diagnosis of CRC
• Radiographic documentation of disease progression during or Radiographic documentation of disease progression during or within 6 months of most recent chemotherapy of within 6 months of most recent chemotherapy of fluoropyrimidine andfluoropyrimidine and
– Irinotecan Irinotecan 65 mg/m 65 mg/m22/week for 8 weeks and /week for 8 weeks and
– Oxaliplatin Oxaliplatin 30 mg/m 30 mg/m22/week for 6 weeks (4 studies)/week for 6 weeks (4 studies)
• Prior fluoropyrimidine and irinotecan Prior fluoropyrimidine and irinotecan oror oxaliplatin, oxaliplatin, or both, any or both, any exposure; no requirement for documentation of disease exposure; no requirement for documentation of disease progression progression (1 study: Malik, et al. 2005)(1 study: Malik, et al. 2005)
• Evaluation of tumor cell EGFr membrane staining (by IHC at Evaluation of tumor cell EGFr membrane staining (by IHC at central laboratory)central laboratory)
Berlin et al. ESMO 2006
Patient DispositionPatient Disposition
All PatientsAll Patients
Patients enrolled, n (%)Patients enrolled, n (%) 739 (100)739 (100)
Patients who received study drug,Patients who received study drug,aa n (%) n (%) 732 (99)732 (99)
Efficacy set, n (%)Efficacy set, n (%) 617 (84)617 (84)
Median (min, max) follow-up,Median (min, max) follow-up,bb weeks weeks
All-enrolled analysis setAll-enrolled analysis set
Efficacy analysis setEfficacy analysis set
56 (3, 151)56 (3, 151)64 (16, 151)64 (16, 151)
aSafety setbFollow-up time is calculated from the enrollment date to the date of the data cut-off
ResultsResults
Berlin et al. ESMO 2006
DemographicsDemographics
aECOG status 3 was reported in 1 panitumumab patient in the phase 3 study
Peeters, et al. 2006Peeters, et al. 2006Berlin, et Berlin, et al. 2006al. 2006
Hecht, et Hecht, et al. 2006al. 2006
Malik, et Malik, et al. 2005al. 2005
PanitumumabPanitumumab(N=231)(N=231)
CrossoverCrossover(N=176)(N=176) (N=93)(N=93) (N=88)(N=88) (N=148)(N=148)
Sex - n (%)Sex - n (%)
MenMen 146 (63)146 (63) 111 (63)111 (63) 51 (55)51 (55) 51 (58)51 (58) 83 (56)83 (56)
Median (min, max) Median (min, max) age - yearsage - years
62 (55, 68)62 (55, 68) 62 (32, 83)62 (32, 83) 59 (31, 82)59 (31, 82) 62 (26, 85)62 (26, 85) 60 (21, 88)60 (21, 88)
Race - n(%)Race - n(%)
WhiteWhite 229 (99)229 (99) 175 (99)175 (99) 74 (80)74 (80) 71 (81)71 (81) 120 (81)120 (81)
BlackBlack 1 (0)1 (0) 0 (0)0 (0) 8 (9)8 (9) 12 (14)12 (14) 14 (9)14 (9)
HispanicHispanic 1 (0)1 (0) 0 (0)0 (0) 7 (8)7 (8) 3 (3)3 (3) 5 (3)5 (3)
OtherOther 0 (0)0 (0) 1 (1)1 (1) 4 (4)4 (4) 2 (2)2 (2) 9 (6)9 (6)
ECOG status - n (%)ECOG status - n (%)aa
00 107 (46)107 (46) 53 (30)53 (30) 31 (33)31 (33) 41 (47)41 (47) 37 (25)37 (25)
11 94 (41)94 (41) 85 (48)85 (48) 55 (59)55 (59) 42 (48)42 (48) 111 (75)111 (75)
22 29 (13)29 (13) 38 (22)38 (22) 7 (8)7 (8) 5 (6)5 (6) 0 (0)0 (0)
Berlin et al. ESMO 2006
Disease CharacteristicsDisease Characteristics
Peeters, et al. 2006Peeters, et al. 2006Berlin, et Berlin, et al. 2006al. 2006
Hecht, et Hecht, et al. 2006al. 2006
Malik, et Malik, et al. 2005al. 2005
PanitumumabPanitumumab(N=231)(N=231)
CrossoverCrossover(N=176)(N=176) (N=93)(N=93) (N=88)(N=88) (N=148)(N=148)
Primary diagnosis,Primary diagnosis,n (%)n (%)
Colon cancerColon cancer 153 (66)153 (66) 113 (64)113 (64) 70 (75)70 (75) 61 (69)61 (69) 106 (72)106 (72)
Rectal cancerRectal cancer 78 (34)78 (34) 63 (36)63 (36) 23 (25)23 (25) 27 (31)27 (31) 42 (28)42 (28)
Number of prior lines of Number of prior lines of chemotherapy, n (%)chemotherapy, n (%)
231 (100)231 (100) 176 (100)176 (100) 93 (100)93 (100) 88 (100)88 (100) 6565aa (100) (100)
11 1 (0)1 (0) 0 (0)0 (0) 0 (0)0 (0) 0 (0)0 (0) 0 (0)0 (0)
22 146 (63)146 (63) 114 (66)114 (66) 2 (2)2 (2) 13 (15)13 (15) 24 (37)24 (37)
≥ ≥ 33 84 (36)84 (36) 62 (35)62 (35) 91 (98)91 (98) 75 (85)75 (85) 41 (63)41 (63)aPrior chemotherapy is based on a subset of patients who had received fluoropyrimidine, oxaliplatin and irinotecan.
Berlin et al. ESMO 2006
Best Objective ResponseBest Objective Response
aModified RECIST criteria; blinded central reviewbModified RECIST criteria; local reviewcModified WHO criteria; blinded central reviewAll responses were confirmed > 4 weeks after response criteria were first metDisease control rate is the sum of the objective response and stable disease rates
Peeters, et al. 2006Peeters, et al. 2006Berlin, et Berlin, et al. 2006al. 2006
Hecht, et al. Hecht, et al. 20062006
Malik, et Malik, et al. 2005al. 2005
PanitumumabPanitumumab(N=231)(N=231)
CrossoverCrossover(N=176)(N=176) (N=39)(N=39) (N=23)(N=23) (N=148)(N=148)
Analysis SetAnalysis Set All EnrolledAll Enrolled
Modified Modified Intent-to-Intent-to-
treattreat
AdjudAdjudPrior Prior
FailureFailure
AdjudAdjudPrior Prior
FailureFailureAll All
EnrolledEnrolled
Overall objective Overall objective response (CR or response (CR or PR), n (%)PR), n (%)
19 (8)19 (8)aa 20 (11)20 (11)bb 3 (8)3 (8)cc 3 (13)3 (13)cc 13 (9)13 (9)aa
Stable Disease, n (%)Stable Disease, n (%) 64 (28)64 (28) 58 (33)58 (33) 8 (21)8 (21) 7 (30)7 (30) 43 (29)43 (29)
Disease ControlDisease Control 83 (36)83 (36) 78 (44)78 (44) 11 (28)11 (28) 10 (43)10 (43) 55 (37)55 (37)
PD, n (%)PD, n (%) 113 (49)113 (49) 65 (37)65 (37) 20 (51)20 (51) 10 (43)10 (43) 59 (40)59 (40)
Berlin et al. ESMO 2006
Time and Duration of ResponseTime and Duration of Response
aObjective responses were assessed by blinded central review except for Peeters, et al (2006) crossover study, where the responses were assessed by local review.bNot estimable
Peeters, et al. 2006Peeters, et al. 2006Berlin, et al. Berlin, et al.
20062006Hecht, et al. Hecht, et al.
20062006Malik, et al. Malik, et al.
20052005
PanitumumabPanitumumab(N=231)(N=231)
CrossoverCrossover(N=176)(N=176) (N=39)(N=39) (N=23)(N=23) (N=148)(N=148)
Median (range) Median (range) time to time to response - response - weeksweeksaa 7.9 (7, 15)7.9 (7, 15) 7.7 (7, 25)7.7 (7, 25) 11.0 (8, 11)11.0 (8, 11) 11.0 (7, 12)11.0 (7, 12) 8.1 (7, 25)8.1 (7, 25)
Median (range) Median (range) duration of duration of response – response – weeksweeks95% CI95% CI
17.0 (8, 25)17.0 (8, 25)
16.4, 25.316.4, 25.3
16.4 (8, 35)16.4 (8, 35)
16.0, 23.916.0, 23.9
13.2 (12,14)13.2 (12,14)
12.4, 14.012.4, 14.0
16.1 (16, 16)16.1 (16, 16)
NE, NENE, NEbb
18.1 (8, 36)18.1 (8, 36)
17.9, 23.317.9, 23.3
Berlin et al. ESMO 2006
Progression-Free SurvivalProgression-Free Survival
Median (95% CI) in WeeksPeeters, et al. (2006): 8.0 (7.9, 8.4)
Berlin, et al (2006): 7.9 (7.4, 11.4)Hecht, et al (2006): 8.1 (7.1, 22.9)Malik, et al (2005) : 13.6 (8.3, 16.1)
Peeters, et al (2006) (ES): 8.1 (8.0, 12.4)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pro
po
rtio
nw
ith
Pro
gre
ssio
n-f
ree
Su
rviv
al
Weeks0 4 8 12 16 20 24 28 32 36 40 44
Peeters, et al (2006)
Berlin, et al (2006)Hecht, et al (2006)
Malik, et al (2005)
Peeters, et al (2006) (ES)231
5932
148
174209
5332
139
149118
2417
94
8376
1815
70
5649
128
68
3640
128
43
2231
51
41
1719
40
28
513
10
24
18
00
18
05
00
14
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00
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.
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Patients at risk:
Berlin et al. ESMO 2006
Progression-Free Survival by Objective Progression-Free Survival by Objective Response in the Phase 3 Trial Response in the Phase 3 Trial
Eve
nt-f
ree
Pro
babi
lity
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Weeks from Randomization0 8 16 24 32 40 48 56
CR/PRCR/PRSDSDOtherOther
CR/PR 8%CR/PR 8%SD 28%SD 28%
OtherOther64%64%
Other=Pts with progressive disease, unevaluable assessments, or no assessments; Groups not comparable due tolead-time bias and lack of randomization. By central review by modified RECIST; responses were confirmed at least 4 weeks after response criteria were first met
Berlin et al. ESMO 2006
Progression-Free Survival by Objective Progression-Free Survival by Objective Response in the Phase 3 Trial Response in the Phase 3 Trial
Eve
nt-f
ree
Pro
babi
lity
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Weeks from Randomization
0 8 16 24 32 40 48 56
BSC SDBSC SD
BSC OtherBSC Other
Panitumumab CR/PRPanitumumab CR/PR
Panitumumab SDPanitumumab SD
Panitumumab OtherPanitumumab Other
CR/PRCR/PRSDSD
OtherOther
Other=Pts with progressive disease, unevaluable assessments, or no assessments; Groups not comparable due to lead-time bias and lack of randomization. By central review by modified RECIST; responses were confirmed at least 4 weeks after response criteria were first met
28%28%10%10%
64%64%90%90%
8%8%
Berlin et al. ESMO 2006
Adverse Events of InterestAdverse Events of Interest
MedDRA v.8 preferred terms; graded using the NCI CTCAE v 2.0, with the exception of some dermatology/skin adverse events that were graded using the CTCAE v 3.0 with modificationsaSafety analysis setbCaptured as laboratory values above grade 0
AnyAny(N = 732)(N = 732)
Grade 3-4Grade 3-4(N = 732)(N = 732)
Subjects with any adverse eventSubjects with any adverse eventaa – n (%) – n (%)
Fatigue Fatigue
Nausea Nausea
DiarrheaDiarrhea
VomitingVomiting
Abdominal PainAbdominal Pain
Constipation Constipation
DyspneaDyspnea
CoughCough
Edema peripheralEdema peripheral
EdemaEdema
Pleural effusionPleural effusion
Deep vein thrombosisDeep vein thrombosis
Pulmonary embolismPulmonary embolism
HypomagnesemiaHypomagnesemia
239 (33)239 (33)
208 (28)208 (28)
185 (25)185 (25)
152 (21)152 (21)
147 (20)147 (20)
146 (20)146 (20)
106 (14)106 (14)
100 (14)100 (14)
83 (11)83 (11)
30 (4)30 (4)
16 (2)16 (2)
9 (1)9 (1)
7 (1)7 (1)
31 (4)31 (4)
41 (6)41 (6)
14 (2)14 (2)
15 (2)15 (2)
21 (3)21 (3)
37 (5)37 (5)
13 (2)13 (2)
28 (4)28 (4)
4 (1)4 (1)
9 (1)9 (1)
4 (1)4 (1)
7 (1)7 (1)
6 (1)6 (1)
4 (1)4 (1)
9 (1)9 (1)
Hypomagnesemia (Lab)Hypomagnesemia (Lab)bb 226 (31)226 (31) 32 (4)32 (4)
Berlin et al. ESMO 2006
Skin-Related Toxicities Occurring Skin-Related Toxicities Occurring in in 10% of Patients 10% of Patients
MedDRA v.8 preferred terms; graded using the NCI CTCAE v 2.0, with the exception of some dermatology/skin adverse events that were graded using the CTCAE v 3.0 with modificationsaSafety analysis set
AnyAny
(N = 732) (N = 732)
Grade 3-4Grade 3-4
(N = 732)(N = 732)
Subjects with any adverse eventSubjects with any adverse eventaa – n (%) – n (%)
Dermatitis acneiform Dermatitis acneiform
Pruritus Pruritus
Erythema Erythema
Rash Rash
Skin exfoliationSkin exfoliation
ParonychiaParonychia
Skin fissuresSkin fissures
Dry skinDry skin
669 (91)669 (91)
382 (52)382 (52)
379 (52)379 (52)
384 (52)384 (52)
263 (36)263 (36)
145 (20)145 (20)
142 (19)142 (19)
115 (16)115 (16)
99 (14)99 (14)
95 (13)95 (13)
36 (5)36 (5)
13 (2)13 (2)
33 (5)33 (5)
20 (3)20 (3)
10 (1)10 (1)
8 (1)8 (1)
5 (1)5 (1)
1 (0)1 (0)
Berlin et al. ESMO 2006
Infusion reactionsInfusion reactions
• Six of 732 (0.8%) patients had infusion reactions of any grade per Six of 732 (0.8%) patients had infusion reactions of any grade per investigatorinvestigator
• Two (0.3%) patients had a grade 3 infusion reaction per Two (0.3%) patients had a grade 3 infusion reaction per investigatorinvestigator
• One patient discontinued panitumumab per patient decisionOne patient discontinued panitumumab per patient decision
Berlin et al. ESMO 2006
Antibodies to PanitumumabAntibodies to Panitumumab
aaAcid dissociation ELISA assayAcid dissociation ELISA assay
Peeters, et al. 2006Peeters, et al. 2006Berlin, et Berlin, et al. 2006al. 2006
Hecht, et Hecht, et al. 2006al. 2006
Malik, et Malik, et al. 2005al. 2005 TotalTotal
PanitumumabPanitumumab(N=229)(N=229)
CrossoverCrossover(N=176)(N=176) (N=91)(N=91) (N=88)(N=88) (N=148)(N=148) (N=732)(N=732)
Samples Samples available for available for testing,testing,aa n n
224224 152152 9090 8888 145145 699699
Baseline Baseline samples, n (%)samples, n (%)
221 (99)221 (99) 150 (99)150 (99) 88 (97)88 (97) 87 (100)87 (100) 142 (98)142 (98) 688 (98)688 (98)
Post-dose Post-dose samples, n (%)samples, n (%)
185 (83)185 (83) 71 (47)71 (47) 66 (73)66 (73) 66 (76)66 (76) 107 (74)107 (74) 495 (71)495 (71)
Baseline Baseline positivepositive
3 (1)3 (1) 2 (1)2 (1) 0 (0)0 (0) 0 (0)0 (0) 0 (0)0 (0) 5 (<1)5 (<1)
Post-dose Post-dose positivepositive
0 (0)0 (0) 2 (1)2 (1) 0 (0)0 (0) 0 (0)0 (0) 0 (0)0 (0) 2 (<1)2 (<1)
Berlin et al. ESMO 2006
ConclusionsConclusions
• Across all studies, panitumumab had consistent antitumor activity Across all studies, panitumumab had consistent antitumor activity in patients with mCRC:in patients with mCRC:
– Objective response rates ranged from 8% to 13%Objective response rates ranged from 8% to 13%
– Disease control rates ranged from 28% to 44%Disease control rates ranged from 28% to 44%
– Progression-free survival ranged from 8 to 14 weeksProgression-free survival ranged from 8 to 14 weeks
• Panitumumab was well toleratedPanitumumab was well tolerated
– Of 732 patients, 0.3% had grade 4 skin-related toxicities, and Of 732 patients, 0.3% had grade 4 skin-related toxicities, and 13% had grade 3 skin-related toxicities13% had grade 3 skin-related toxicities
– The majority of patients (78%) had grade 1 or 2 skin-related The majority of patients (78%) had grade 1 or 2 skin-related toxicitiestoxicities
– Grade 3 infusion reaction rate was 0.3% (there were no grade 4 Grade 3 infusion reaction rate was 0.3% (there were no grade 4 infusion reactions); premedication was not requiredinfusion reactions); premedication was not required
– Less than 1% of patients had anti-panitumumab antibodies Less than 1% of patients had anti-panitumumab antibodies
Berlin et al. ESMO 2006
ConclusionsConclusions
• Across all studies, EGFr staining levels were not Across all studies, EGFr staining levels were not associated with panitumumab activityassociated with panitumumab activity
• There was an association of panitumumab activity with There was an association of panitumumab activity with the incidence of skin toxicity (data not shown)the incidence of skin toxicity (data not shown)
• Additional studies in mCRC with other agents are Additional studies in mCRC with other agents are ongoingongoing
Berlin et al. ESMO 2006
AcknowledgementsAcknowledgements
• We wish to thank the patients who participated in these We wish to thank the patients who participated in these studies and their familiesstudies and their families
• We also wish to acknowledge the investigators and We also wish to acknowledge the investigators and research teams who enrolled patientsresearch teams who enrolled patients
• We acknowledge the assistance of Mee Rhan Kim and We acknowledge the assistance of Mee Rhan Kim and Geoffrey Smith for slide productionGeoffrey Smith for slide production