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Panitumumab

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Cola

Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2) and 5-fluorouracil (5-FU) (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2), followed by 5-FU (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).

Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).

mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m\^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m\^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m\^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m\^2) via ambulatory pump administered for a period of 46 to 48 hours.

mFOLFOX6

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.

Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.

Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.

For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date.

Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.

For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator's review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.

The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.

Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.

Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.

Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.

Amgen

The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.

Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.

Panitumumab Plus mFOLFOX6

Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.

Bevacizumab Plus mFOLFOX6

Total

Age, Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Asian

Japanese

Race/Ethnicity, Customized

Prior Adjuvant Oxaliplatin Therapy

BRAF wild-type

RAS Wild-type

RAS/BRAF wild-type

Testing not performed

Sample acceptance failure

This analysis was performed on tumors from 136 and 137 participants in each treatment group respectively. BRAF = v-raf murine sarcoma viral oncogene homolog B1; RAS = rat sarcoma viral oncogene homolog, and includes Kirsten rat sarcoma-2 viral oncogene (KRAS) exons 2, 3 \& 4 and neuroblastoma RAS viral (v-ras) oncogene (NRAS) exons 2, 3, and 4. Participants may appear in more than one category.

RAS and BRAF Mutation Status

Study Director

Intent-to-treat (ITT) analysis set (all randomized participants)

Progression-free Survival (PFS)

Overall Survival

Evaluable for Local Tumor Response Analysis Set, defined as the subset of participants in the ITT Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.

Percentage of Participants With an Objective Response

Evaluable for Local Tumor Response Analysis Set: Responders

Duration of Response

Time to Disease Progression

Time to Initial Objective Response

Resection Rate

Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.

Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)

Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.

Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)

Overall Survival in Participants With Wild-type RAS

Overall Survival in Participants With Wild-type RAS / BRAF

Wild-type RAS Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.

Percentage of Participants With an Objective Response for Participants With Wild-type RAS

Wild-type RAS/BRAF Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS/BRAF Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.

Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF

Any adverse event (AE)

AE with worst grade of 3

AE with worst grade of 4

AE with worst grade of 5

Serious adverse event (SAE)

AE leading to discontinuation of study drug

Any treatment-related adverse event (TRAE)

Treatment-related AE with worst grade of 3

Treatment-related AE with worst grade of 4

Treatment-related AE with worst grade of 5

Serious treatment-related adverse event

TRAE leading to discontinuation of study drug

Safety analysis set, which included all randomized participants who received at least 1 dose of protocol treatment (ie, panitumumab, bevacizumab, or any component of mFOLFOX6).

Number of Participants With Adverse Events (AEs)

Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2) and 5-fluorouracil (5-FU; 2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors	NCT00819780	Colon Cancer Colorectal Canc... Rectal Cancer Metastatic Colo...	Panitumumab Bevacizumab mFOLFOX6	18 Years -	Amgen
PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors	NCT00819780	Colon Cancer Colorectal Canc... Rectal Cancer Metastatic Colo...	Panitumumab Bevacizumab mFOLFOX6	18 Years -	Amgen

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