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RYBREVANT®

(amivantamab-vmjw)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

RYBREVANT® (amivantamab-vmjw)

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Use of RYBREVANT in Colorectal Cancer

Last Updated: 01/31/2025

SUMMARY

  • RYBREVANT (amivantamab-vmjw) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).1
  • OrigAMI-1 (NCT05379595) is an ongoing, phase 1b/2, open-label, multicenter, global study evaluating the efficacy and safety of RYBREVANT (administered intravenously in 28-day cycles) monotherapy and in combination with standard of care (SOC) chemotherapy (combination of modified leucovorin, 5-fluorouracil, and oxaliplatin [mFOLFOX6] or combination of leucovorin, 5-fluorouracil, and irinotecan [FOLFIRI]) in patients with advanced or metastatic colorectal cancer (mCRC). Enrollment is planned for approximately 225 patients.2-5
    • Median progression-free survival (PFS) was 5.7 months, not estimable (NE), 4.6 months, and 3.6 months, and overall response rates (ORRs) were 29%, 47%, 20%, and 13% in the RYBREVANT monotherapy cohorts A, A2, B, and C, respectively, as included in Table: Antitumor Activity in the RYBREVANT Monotherapy Cohorts.4 Median PFS was 7.5 months (95% confidence interval [CI], 7.4-NE) and ORR was 49% (95% CI, 33-65) in the RYBREVANT plus chemotherapy combination cohorts (cohorts D or E), as included in Table: Antitumor Activity in the RYBREVANT Plus Chemotherapy Combination Cohorts D or E.5
    • Preliminary data from cohort B suggest that RYBREVANT may be active in patients who have genetic alterations associated with EGFR monoclonal antibody (mAb) resistance. Further, its clinical activity was improved in patients whose tumors harbored TP53+APC co-mutations, as included in Table: Antitumor Activity in Cohort B by TP53+APC Co-Mutation Status. Patients who were rechallenged with RYBREVANT >2 mutational decay (MD) half-lives after prior anti-EGFR therapy had improved efficacy and PFS, as included in Table: Antitumor Activity in Cohort B by Time to RYBREVANT Rechallenge.4
    • The safety profile for RYBREVANT at both dose levels was consistent with previous reports, as included in Table: Safety Profile for the RYBREVANT Monotherapy Cohorts.4 The safety profile of RYBREVANT plus mFOLFOX6 or FOLFIRI was consistent with each individual component, without additive toxicity, as included in Table: Safety Profile for the RYBREVANT Plus Chemotherapy Combination Cohorts.5
    • The updated results on the antitumor activity of RYBREVANT as monotherapy or in combination with chemotherapy (mFOLFOX6 or FOLFIRI) in patients with right-sided (R-sided) RAS/BRAF wild-type (WT) mCRC are reported. Median PFS was 3.7 (95% CI, 3.4-5.5) and 7.4 (95% CI, 1.8-NE) months, and ORRs were 22% (95% CI, 8-44) and 43% (95% CI, 10-82) in the RYBREVANT monotherapy cohort C and RYBREVANT plus chemotherapy combination cohorts D and E, respectively, as included in Table: Antitumor Activity in the R-Sided mCRC Cohorts. In cohort C, 1 patient with R-sided mCRC achieved a complete response. The safety profile of RYBREVANT in patients with R-sided mCRC was consistent with previous reports, as included in Table: Safety Profile for the R-Sided mCRC Cohorts. The most common grade ≥3 treatment-emergent adverse events (TEAEs) related to EGFR and MET inhibition were rash (cohort C, 4%; cohorts D and E, 14%) and hypoalbuminemia (cohort C, 13%). No treatment-related discontinuations with RYBREVANT were reported in any cohort.6

ongoing clinical study

OrigAMI-1 Study

Study Design/Methods

  • Ongoing phase 1b/2, open-label, multicenter, global study designed to assess the efficacy and safety of RYBREVANT monotherapy and in combination with SOC chemotherapy (mFOLFOX6 or FOLFIRI) in patients with advanced or mCRC.2-5
  • The study design is shown in Figure: OrigAMI-1 Study Design.
  • In cohort B, a retrospective analysis also evaluated the effect of time from withdrawal of prior EGFR mAb treatment to subsequent RYBREVANT treatment.4
    • A previous study showed that the frequency of RAS and EGFR mutant clones declined after stopping prior anti-EGFR treatment (ie, cetuximab or panitumumab). The MD half-life of these clones was found to be 4.4 months.7
    • Patients were divided into 2 groups based the amount of time between prior anti-EGFR mAb withdrawal and the start of RYBREVANT treatment:
      • >2 MD half-lives (>8.8 months between anti-EGFR mAb withdrawal to the start of RYBREVANT treatment)
      • ≤2 MD half-lives (≤8.8 months between anti-EGFR mAb withdrawal to the start of RYBREVANT treatment)

OrigAMI-1 Study Design2-6

OrigAMI-1 (ClinicalTrials.gov Identifier: NCT05379595); data cutoff: October 31, 2024.
Abbreviations: 1L, first line; 2L, second line; 5-FU, 5-fluorouracil; AE, adverse event; AMI, amivantamab; CBR, clinical benefit rate; ctDNA, circulating tumor DNA; DCR, disease control rate; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; FOLFIRI, combination of leucovorin, 5-fluorouracil, and irinotecan; ILD, interstitial lung disease; IV, intravenous; mCRC, metastatic colorectal cancer; mFOLFOX6, modified combination of leucovorin, 5-fluorouracil, and oxaliplatin; ORR, overall response rate; PFS, progression-free survival; RP2D, recommended phase 2 dose; SOC, standard of care; VEGF, vascular endothelial growth factor.
aCentral ctDNA testing was performed at screening to identify KRAS/NRAS missense alterations (leading to G12X, G13X, Q61X, K117X, A59X, or A146X), BRAF missense alterations (leading to V600X change), or ERRB2/HER2 amplification, as detected by Guardant360 CDx.
bSOC chemotherapy is defined as fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
c1050 mg in patients weighing <80 kg and 1400 mg in patients weighing ≥80 kg.
d1750 mg in patients weighing <80 kg and 2100 mg in patients weighing ≥80 kg.
eDose escalation identified AMI dose (1050 mg IV [1400 mg if ≥80 kg] weekly for the first 4 weeks, then Q2W) in combination with standard mFOLFOX6 or FOLFIRI dosing as the RP2D.
fmFOLFOX6 includes oxaliplatin (85 mg/m2) IV, leucovorin 400 mg/m2 (or 200 mg/m2 if levoleucovorin) IV, 5-FU bolus (400 mg/m2) IV, and 5-FU (2400 mg/m2 or 1200 mg/m2/day for 2 days).
gFOLFIRI includes irinotecan (180 mg/m2) IV, leucovorin 400 mg/m2 (or 200 mg/m2 if levoleucovorin) IV, 5-FU bolus (400 mg/m2) IV, and 5-FU (2400 mg/m2 or 1200 mg/m2/day for 2 days).
hComplete/partial response or stable disease of duration of ≥11 weeks.

Results: RYBREVANT Monotherapy Cohorts (Cohorts A, B, and C)4

  • Results are reported as of the data cutoff date of November 27, 2023.
Patient Characteristics

Patient Characteristics in the RYBREVANT Monotherapy Cohorts4
Characteristic
Cohort A (n=17)
Cohort A2 (n=15)
Cohort B (n=54)
Cohort C (n=23)
Median (range) age, years
63 (45-80)
55 (34-76)
60.5 (36-79)
60 (34-79)
Male, n (%)
12 (71)
9 (60)
36 (67)
13 (57)
Race, n (%)
   Asian
14 (82)
14 (93)
34 (63)
13 (57)
   White
2 (12)
0
18 (33)
6 (26)
   Othera
1 (6)
1 (7)
2 (4)
4 (17)
ECOG PS, n (%)
   0
11 (65)
8 (53)
26 (48)
9 (39)
   1
6 (35)
7 (47)
28 (52)
14 (61)
Liver metastases, n (%)
13 (76)
9 (60)
39 (72)
18 (78)
Median (range) lines of prior therapy
2 (2-3)
2 (2-3)
2 (2-3)
2 (2-3)
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; NR, not reported.
aBlack/multiple/American Indian/Alaska Native/NR.
Note: One patient who received RYBREVANT monotherapy is enrolled in a separate cohort with a different dose and their results are not presented here.
Efficacy

Antitumor Activity in the RYBREVANT Monotherapy Cohorts4
Outcome
RYBREVANT Monotherapy Cohorts
Cohort A (n=17)
Cohort A2 (n=15)
Cohort B (n=54)a
Cohort C (n=22)b
Median duration of treatment, months
7.9
6
6.9
3.3
Median DOR, months
7.4
NE
7.4
NE
Median PFS, months
5.7
NE
4.6
3.6
ORR, n (%)
5 (29)
7 (47)
11 (20)
3 (13)
   PR, n
5
7
11
3
   uPR
-
1
-
-
   SD, n
10
4
27
14
   PD, n
2
1
13
4
DCR, %
88
93
74
78
Abbreviations: DCR, disease control rate; DOR, duration of response; NE, not estimable; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease; uPR, unconfirmed partial response.
Note: Data presents response evaluable analysis set, which includes patients who received ≥1 dose of study drug and either had ≥1 postbaseline efficacy disease assessments, or discontinued treatment for any reason, or had disease progression/death prior to the first postbaseline disease assessment.
aFor cohort B, n=51 for duration of treatment, DOR, and median PFS, assessments.
bFor cohort C, n=21 for duration of treatment, DOR, and median PFS, assessments.
  • Preliminary data from cohort B suggests that RYBREVANT may be active in patients who have genetic alterations associated with EGFR mAb resistance (eg, alterations in MAP2K1, EML4-ALK fusion).
  • In cohort B, the clinical activity of RYBREVANT was improved in patients whose tumors harbored TP53+APC co-mutations, as included in Table: Antitumor Activity in Cohort B by TP53+APC Co-Mutation Status.

Antitumor Activity in Cohort B by TP53+APC Co-Mutation Status4
Outcome
TP53+APC Co-Mutation Status
Co-Mutated (n=31)
Non-Co-Mutated (n=18)
Median PFS, months
6
4
ORR, n (%)
9 (29)
1 (6)
DCR, %
24 (77)
11 (61)
Abbreviations: DCR, disease control rate; ORR, overall response rate; PFS, progression-free survival.

Antitumor Activity in Cohort B by Time to RYBREVANT Rechallenge4
Outcome
Time From Prior Anti-EGFR to RYBREVANT Rechallenge
HR (95% CI); P-Value
≤2 MD Half-Lives (n=29)
>2 MD Half-Lives (n=25)
Median PFS, months (95% CI)
2.8 (1.8-3.8)
5.6 (4.6-9)
0.34 (0.17-0.68); log-rank P=0.0013a
CBR, %
28
80
-
   PR
10
33
-
   SD
45
58
-
   PD
45
8
-
Abbreviations: CBR, clinical benefit rate; CI, confidence interval; HR, hazard ratio; MD, mutational decay; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.
aFor median PFS: HR, 4.6 (95% CI, 3.5-5.6).
Safety

Safety Profile for the RYBREVANT Monotherapy Cohorts4
TEAEs (≥20%), n (%)
Cohorts A, B, and C (n=94)
Cohort A2 (n=15)
All Grades
Grade ≥3
All Grades
Grade ≥3
Infusion-related reaction
51 (54)
1 (1)
9 (60)
0
Dermatitis acneiform
35 (37)
3 (3)
6 (40)
1 (7)
Rash
27 (29)
7 (7)
7 (47)
0
Hypoalbuminemia
26 (28)
6 (6)
5 (33)
0
Paronychia
21 (22)
1 (1)
2 (13)
0
Fatigue
20 (21)
2 (2)
1 (7)
0
Peripheral edema
19 (20)
1 (1)
5 (33)
0
Abbreviations: TEAE, treatment-emergent adverse event.

Results: RYBREVANT Plus Chemotherapy Combination Cohorts (Cohorts D and E)5

  • Results are reported as of the data cutoff date of July 22, 2024.
    • Cohort D included 20 patients receiving RYBREVANT plus mFOLFOX6. Cohort E included 23 patients receiving RYBREVANT plus FOLFIRI.
Patient Characteristics

Patient Characteristics in the RYBREVANT Plus Chemotherapy Combination Cohorts5
Characteristic
Cohort D (n=20)
Cohort E (n=23)
Total (n=43)
Median (range) age, years
64 (39-79)
61 (36-69)
62 (36-79)
Male, n (%)
14 (70)
17 (74)
31 (72)
Race, n (%)
   Asian
10 (50)
15 (65)
25 (58)
   Black/African American
1 (5)
1 (4)
2 (5)
   White
9 (45)
7 (30)
16 (37)
ECOG PS, n (%)
   0
11 (55)
11 (48)
22 (51)
   1
9 (45)
12 (52)
21 (49)
Tumor side, n (%)
   Left-sided
15 (75)
20 (87)
35 (81)
   Right-sided
5 (25)
3 (13)
8 (19)
Prior lines of therapy in the metastatic setting, n (%)
   0
8 (40)
3 (13)
11 (26)
   1
12 (60)
20 (87)
32 (74)
Liver metastases, n (%)
14 (70)
17 (74)
31 (72)a
Abbreviation: ECOG PS, Eastern Cooperative Oncology Group performance status.
aOne patient had a non-target liver lesion.
Efficacy

Antitumor Activity in the RYBREVANT Plus Chemotherapy Combination Cohorts D or E5
Efficacy Outcome
Total (n=43)
Median follow-up, months (range)
7.3 (1.1-14.4)
Investigator-assessed response
   ORR, % (95% CI)a
49 (33-65)
      Median DOR,b months (95% CI)
7.4 (5.6-NE)
      Time to response,b weeks
8.3
      Cohort D, % (95% CI)
60 (36-81)
      Cohort E, % (95% CI)
39 (20-62)
      Patients receiving 1L therapy, %
64
      Patients receiving 2L therapy, %
44
   DCR, % (95% CI)
88 (75-96)
   Median PFS, months (95% CI)
7.5 (7.4-NE)
   Received curative intent surgery,c n (%)
7 (16)
      Completed, n
5
      Scheduled, n
2
Treatment ongoing,d n (%)
29 (67)
Abbreviations: 1L, first line; 2L, second line; CI, confidence interval; DCR, disease control rate (confirmed responders + patients with stable disease); DOR, duration of response; NE, not estimable; ORR, objective response rate; PFS, progression-free survival.
aORR was defined as the proportion of patients achieving partial response or complete response by investigator assessment at ≥2 consecutive disease assessments.
bAmong confirmed responders.
cPatients could undergo curative intent surgery and were censored upon procedure completion.
dOne patient discontinued due to an adverse event prior to the first disease assessment.

Intrahepatic Antitumor Activity in the RYBREVANT Plus Chemotherapy Combination Cohorts D or E5
Intrahepatic Tumor Response, (n/n) %
Total (n=43)
Measurable target liver lesions
 (30/43) 70
Intrahepatic outcome
   ORR
 (16/30) 53
   DCR
 (28/30) 93
Abbreviations: DCR, disease control rate (confirmed responders + patients with confirmed stable disease); ORR, objective response rate.
Safety

Safety Profile for the RYBREVANT Plus Chemotherapy Combination Cohorts5
TEAEs (≥25%) by Preferred Term, n (%)
Cohort D (n=20)
Cohort E (n=23)
All Grades
Grade ≥3
All Grades
Grade ≥3
Associated with EGFR inhibition
   Stomatitis
11 (55)
0
11 (48)
0
   Diarrheaa
11 (55)
1 (5)
14 (61)
2 (9)
   Rash
10 (50)
2 (10)
10 (43)
1 (4)
   Dermatitis acneiform
3 (15)
0
8 (35)
1 (4)
   Paronychia
7 (35)
0
10 (43)
0
Associated with MET inhibition
   Hypoalbuminemia
7 (35)
0
14 (61)
1 (4)
Associated with chemotherapy (mFOLFOX6 or FOLFIRI)
   Neutropenia
10 (50)
7 (35)
14 (61)
11 (48)
   Anemia
4 (20)
0
7 (30)
1 (4)
   Thrombocytopenia
6 (30)
3 (15)
2 (9)
0
Other
   Fatigue
10 (50)
0
7 (30)
2 (9)
   IRR
9 (45)
0
9 (39)
0
   Vomiting
8 (40)
1 (5)
7 (30)
0
   Hypokalemia
7 (35)
1 (5)
7 (30)
2 (9)
   ALT increased
3 (15)
0
7 (30)
0
   Nausea
6 (30)
1 (5)
13 (57)
0
   Hypoesthesia
6 (30)
0
1 (4)
0
   Peripheral sensory neuropathy
6 (30)
0
1 (4)
0
   Constipation
5 (25)
0
7 (30)
0
   Asthenia
5 (25)
0
4 (17)
1 (4)
Abbreviations: ALT, alanine aminotransferase; EGFR, epidermal growth factor receptor; FOLFIRI, combination of leucovorin, 5-fluorouracil, and irinotecan; IRR, infusion-related reaction; MET, mesenchymal-epithelial transition; mFOLFOX6, modified combination of leucovorin, 5-fluorouracil, and oxaliplatin; TEAE, treatment-emergent adverse event.
aDiarrhea was also associated with irinotecan, a component of the FOLFIRI regimen.

Results: RYBREVANT Monotherapy Cohort C and RYBREVANT Plus Chemotherapy Combination Cohorts D and E With R-Sided mCRC6 

  • Results are reported as of the data cutoff date of October 31, 2024.
  • The updated results on the antitumor activity of RYBREVANT as monotherapy and in combination with chemotherapy (mFOLFOX6 or FOLFIRI) in patients with R-sided RAS/BRAF WT mCRC are reported.
  • R-sided disease was defined as a primary tumor arising from the cecum, ascending colon, or transverse colon.
Patient Characteristics
  • Cohort C included 23 patients with R-sided disease who received RYBREVANT monotherapy. In cohort D, 4 of 20 patients receiving RYBREVANT plus mFOLFOX6 had R-sided disease. In cohort E, 3 of 23 patients receiving RYBREVANT plus FOLFIRI had R-sided disease.
  • Patient characteristics are included in Table: Patient Characteristics in the R-Sided mCRC Cohorts.

Patient Characteristics in the R-Sided mCRC Cohorts6
Characteristic
Cohort C (n=23)
Cohorts D and E (n=7)
Median (range) age, years
60 (34-79)
61 (36-74)
Male, n (%)
13 (57)
6 (86)
Race, n (%)
   Asian
13 (57)
5 (71)
   Black/African American
1 (4)
1 (14)
   White
6 (26)
1 (14)
   Othera
3 (13)
0
ECOG PS, n (%)
   0
9 (39)
2 (29)
   1
14 (61)
5 (71)
Median prior lines of therapy in the metastatic setting, n (range)
2 (1-3)
1 (1-1)
   Prior EGFRi, n (%)
10 (43)
0
Liver metastases,b n (%)
18 (78)
6 (86)
Primary tumor location, n (%)
   Cecum
0
1 (14)
   Ascending colon
9 (39)
4 (57)
   Hepatic flexure
7 (30)
1 (14)
   Transverse colon
7 (30)
1 (14)
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; EGFRi, epidermal growth factor receptor inhibitor; mCRC, metastatic colorectal cancer; R-sided, right-sided.
aIncludes patients who identified as American Indian or Alaska Native, those who identified as multiple races, and those who did not report a race.
bPatients could have metastases at >1 location.
Efficacy

Antitumor Activity in the R-Sided mCRC Cohorts6
Efficacy Outcome
Cohort C (n=23)a
Cohorts D and E (n=7)
Median follow-up, months (range)
8.1 (0.6-20.3)
8.2 (3.2-11.9)
ORR,b % (95% CI)
22 (8-44)
43 (10-82)
   Median DOR,c months (95% CI)
9.8 (3.7-NE)d
NE (5.8-NE)e
DCR, % (95% CI)
78 (56-93)
86 (42-100)
Median PFS, months (95% CI)
3.7 (3.4-5.5)
7.4 (1.8-NE)
Best response, n
   CR
1
0
   PR
4
3
   SD
13
3
   PD
4
1
Abbreviations: CI, confidence interval; CR, complete response; DCR, disease control rate (confirmed responders + patients with confirmed SD); DOR, duration of response; mCRC, metastatic colorectal cancer; NE, not estimable; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; R-sided, right-sided; SD, stable disease.
aOne patient discontinued due to an adverse event prior to the first disease assessment. The patient was response evaluable but did not have evaluable target lesion measurements in any postbaseline disease assessment.
bORR was defined as the proportion of patients achieving PR or CR by investigator assessment at ≥2 consecutive disease assessments.
cAmong confirmed responders.
dOf the 5 responders, 3 remain on treatment and have ongoing response.
eAll 3 responders remain on treatment, with 1 of 3 responders showing ongoing response.
Safety
  • Safety data are included in Table: Safety Profile for the R-Sided mCRC Cohorts.
    • The most common grade ≥3 TEAEs related to EGFR and MET inhibition were rash (cohort C, 4%; cohorts D and E, 14%) and hypoalbuminemia (cohort C, 13%), respectively.
  • No treatment-related discontinuations with RYBREVANT were reported in any cohort.

Safety Profile for the R-Sided mCRC Cohorts6
TEAEs (≥20%) by Preferred Term, n (%)
Cohort C (n=23)
Cohorts D and E (n=7)
All Grades
Grade ≥3
All Grades
Grade ≥3
Associated with EGFR inhibition
   Dermatitis acneiform
7 (30)
1 (4)
2 (29)
0
   Diarrheaa
6 (26)
0
5 (71)
1 (14)
   Rash
6 (26)
1 (4)
4 (57)
1 (14)
   Stomatitis
6 (26)
0
6 (86)
0
   Pruritus
5 (22)
0
1 (14)
0
   Paronychia
4 (17)
0
3 (43)
0
Associated with MET inhibition
   Hypoalbuminemia
8 (35)
3 (13)
1 (14)
0
   Peripheral edema
6 (26)
0
0
0
Other
   IRR
14 (61)
0
4 (57)
0
   Fatigue
7 (30)
0
2 (29)
0
   Nausea
6 (26)
0
3 (43)
0
   Constipation
6 (26)
0
2 (29)
0
   ALT increased
5 (22)
1 (4)
1 (14)
0
   Anemia
5 (22)
1 (4)
1 (14)
0
   AST increased
5 (22)
1 (4)
1 (14)
0
   Insomnia
5 (22)
0
1 (14)
0
   Vomiting
5 (22)
0
1 (14)
0
   Ascites
5 (22)
2 (9)
0
0
   Hypokalemia
3 (13)
2 (9)
2 (29)
1 (14)
   Weight decreased
2 (9)
0
3 (43)
0
   Asthenia
2 (9)
0
2 (29)
0
   Thrombocytopenia
1 (4)
0
4 (57)
1 (14)
   Neutropenia
0
0
5 (71)
3 (43)
   Leukopenia
0
0
3 (43)
0
   Dry Mouth
0
0
2 (29)
0
   Flatulence
0
0
2 (29)
0
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; EGFR, epidermal growth factor receptor; FOLFIRI, combination of leucovorin, 5-fluorouracil, and irinotecan; IRR, infusion-related reaction; mCRC, metastatic colorectal cancer; MET, mesenchymal-epithelial transition; mFOLFOX6, modified combination of leucovorin, 5-fluorouracil, and oxaliplatin; R-sided, right-sided; TEAE, treatment-emergent adverse event.
aDiarrhea was also associated with 5-fluorouracil, a component of the mFOLFOX6 regimen, and with irinotecan, a component of the FOLFIRI regimen.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 16 January 2025.

References

Show
1 Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953.  
2 Janssen Research & Development, LLC. A phase 1b/2, open-label study of amivantamab monotherapy and in addition to standard-of-care chemotherapy in participants with advanced or metastatic colorectal Cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 January 16]. Available from: https://www.clinicaltrials.gov/study/NCT05379595 NLM Identifier: NCT05379595.  
3 Oberstein PE, Eng C, Cutsem EV, et al. A phase 1b/2, open-label study of amivantamab monotherapy or in combination with standard-of-care chemotherapy in patients with advanced or metastatic colorectal cancer. Poster presented at: American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium; January 19-21, 2023; San Francisco, CA.  
4 Oberstein PE, Moreno V, Raghav K, et al. Amivantamab monotherapy in relapsed/refractory metastatic colorectal cancer: OrigAMI-1, an open-label, phase 1b/2 study. Poster presented at: American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium; January 18-20, 2024; San Francisco, CA.  
5 Pietrantonio F, Ho GF, Su Y-L, et al. Amivantamab plus FOLFOX or FOLFIRI in metastatic colorectal cancer: results from OrigAMI-1, a phase 1b/2 study. Oral Presentation presented at: European Society for Medical Oncology (ESMO) Congress; September 13-17, 2024; Barcelona, Spain.  
6 Raghav K, Cutsem EV, Arnold D, et al. Amivantamab with and without chemotherapy in right-sided advanced or metastatic colorectal cancer: updated results from OrigAMI-1, an open-label, phase 1b/2 study. Poster presented at: American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium; January 23-25, 2025; San Francisco, CA.  
7 Parseghian CM, Loree JM, Morris VK, et al. Anti-EGFR-resistant clones decay exponentially after progression: implications for anti-EGFR re-challenge. Ann Oncol. 2019;30(2):243-249.