Vectibix® is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC): Read More
Vectibix® is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC): Read More
20100007 study
Prospective evaluation of patients with
chemorefractory WT RAS* mCRC1
A phase 3, open-label, multicenter, randomized (1:1) study of 377 patients with chemorefractory WT KRAS† mCRC treated with Vectibix® Q2W + BSC or BSC alone. Eligible patients were required to have received prior therapy with irinotecan, oxaliplatin, and a thymidylate synthase inhibitor.1,2
Prespecified key secondary endpoints:1
*Defined as wild type in both KRAS and NRAS.1
†Exon 2 in codons 12 and 13.1
‡RAS mutation status was determined for 324 patients using Sanger bidirectional sequencing.2
§Response was evaluated by investigators per RECIST version 1.1 criteria.2
BSC = best supportive care; ECOG PS = Eastern Cooperative Oncology Group Performance Status; mCRC = metastatic colorectal cancer; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; Q2W = every 2 weeks; RECIST = Response Evaluation Criteria in Solid Tumors; WT = wild type.
SIGNIFICANT IMPROVEMENT IN OS WITH
VECTIBIX® + BSC IN PATIENTS WITH WT RAS* mCRC (P = 0.0135)1
WT RAS mCRC population (n = 270) |
Vectibix® + BSC (n = 142) |
BSC alone (n = 128) |
---|---|---|
OS median months (95% CI) | 10.0 (8.7-11.6) |
6.9 (5.2-7.9) |
HR (95% CI), P value | 0.70 (0.53-0.93) | P = 0.0135 |
PFS median months (95% CI) | 5.2 (3.5-5.3) |
1.7 (1.6-2.2) |
HR (95% CI), P value | 0.46 (0.35-0.59) | P < 0.0001 |
ORR† (95% CI) | 31% (23.5%-39.3%) |
2.3 (0.5%-6.7%) |
*Defined as wild type in both KRAS and NRAS.1
†Response was evaluated by investigators per RECIST version 1.12
BSC = best supportive care; CI = confidence interval; HR = hazard ratio; mCRC = metastatic colorectal cancer; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumors; WT = wild type.
*A hypothetical patient profile of treatment for a chemorefractive mCRC patient.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; CBC = complete blood count; CT = computed tomography; ECOG PS = Eastern Cooperative Oncology Group Performance Status; FOLFIRI = leucovorin calcium (folinic acid), fluorouracil, and irinotecan hydrochloride; FOLFOX = fluorouracil, leucovorin, and oxaliplatin; Hb = hemoglobin; mCRC = metastatic colorectal cancer; PLT = platelet; WBC = white blood count; WT = wild type.
Medical history
Presentation
Prior therapy
Performance status
Laboratory results
RAS status
Imaging results
Surgery consult on metastatic disease
*A hypothetical patient profile of treatment for a chemorefractive mCRC patient.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ASPECCT = A Study of Panitumumab efficacy and safety Compared to Cetuximab; CBC = complete blood count; CT = computed tomography; ECOG PS = Eastern Cooperative Oncology Group Performance Status; FOLFIRI = leucovorin calcium (folinic acid), fluorouracil, and irinotecan hydrochloride; FOLFOX = fluorouracil, leucovorin, and oxaliplatin; Hb = hemoglobin; mCRC = metastatic colorectal cancer; PLT = platelet; WBC = white blood count; WT = wild type.
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix® monotherapy
Vectibix® is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC):
Vectibix® is not indicated for the treatment of patients with RAS-mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix® is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
For information about the use of Vectibix® in combination with sotorasib, see Vectibix® Prescribing Information.
Please see Vectibix® full Prescribing Information, including Boxed WARNING.
Interstitial Lung Disease (ILD)/Pneumonitis
Most Common Adverse Reactions
Drug Interactions
LUMAKRAS® is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Please see accompanying LUMAKRAS® full Prescribing Information.
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix® monotherapy
References 1. Vectibix® (panitumumab) prescribing information, Amgen. 2. Kim TW, Elme A, Kusic Z, et al. Br J Cancer. 2016;115:1206-1214.