
CYRAMZA® (ramucirumab) injection 10 mg/mL solution + erlotinib is the first and only FDA-approved 1L combination therapy for patients with EGFR mut+ mNSCLC1
RELAY: A global, multicenter, randomized, double-blind, placebo-controlled phase III trial of CYRAMZA + erlotinib vs placebo + erlotinib in previously untreated patients with EGFR mut+ mNSCLC1,2

*Stratification factors: Geographic region (East Asia vs other), gender, EGFR mutation (exon 21 substitution vs exon 19 deletion mutation), and local EGFR testing method (therascreen® and cobas® vs other PCR and sequencing-based methods).
ORR= CR + PR; ORR does not include SD.2
Prespecified analysis included, but was not limited to, evaluation of PFS outcomes by exon 21 and exon 19 mutations.2
SELECT IMPORTANT SAFETY INFORMATION
Impaired Wound Healing
- CYRAMZA has the potential to adversely affect wound healing. CYRAMZA has not been studied in patients with serious or non-healing wounds.
- Withhold CYRAMZA for 28 days prior to elective surgery. Do not administer CYRAMZA for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established.
Patient demographics and clinical characteristics of patients at baseline (ITT population)2

Parameter | CYRAMZA + erlotinib (n=224) | Placebo + erlotinib (n=225) | |
---|---|---|---|
Age | Median (IQR), years ≥65 years |
65 (57-71) 122 (54%) |
64 (56-70) 111 (49%) |
Sex | Female Male |
FEMALE 141 (63%)MALE 83 (37%) |
FEMALE 142 (63%)MALE 83 (37%) |
Race† | Asian White Other |
172 (77%) 52 (23%) 0 |
174 (77%) 48 (21%) 3 (1%) |
Smoking status | Ever Never Unknown or missing |
64 (29%) 134 (60%) 26 (12%) |
73 (32%) 139 (62%) 13 (6%) |
Geographical region‡ | East Asia Other |
166 (74%) 58 (26%) |
170 (76%) 55 (24%) |
ECOG PS | 0 1 |
116 (52%) 108 (48%) |
119 (53%) 106 (47%) |
Pathological diagnosis at study entry | Adenocarcinoma NSCLC not otherwise specified |
215 (96%) 9 (4%) |
218 (97%) 7 (3%) |
Disease stage at diagnosis§ | Stage IV Other |
195 (87%) 29 (13%) |
189 (84%) 36 (16%) |
EGFR mutation type at randomization (eCRF) | Exon 19 deletion Exon 21 (L858R) substitution Missing Other |
123 (55%) 99 (44%) 1 (<1%) 1 (<1%) |
120 (53%) 105 (47%) 0 0 |
EGFR testing method | therascreen® or cobas® Other PCR and sequencing-based methods |
96 (43%) 127 (57%) |
101 (45%) 124 (55%) |
†Other included American Indian or Alaska Native, black or African-American, or missing; data were missing for 1 patient in the placebo + erlotinib group.
‡East Asia includes South Korea, Hong Kong, Japan, and Taiwan; other includes Canada, France, Germany, Italy, Romania, Spain, Turkey, the United States, and the United Kingdom.
§All patients were required to have stage IV NSCLC at study entry; patients with recurrent metastatic disease were permitted as long as the adjuvant or neoadjuvant therapy was completed at least 12 months prior to development of metastatic disease; previous adjuvant or neoadjuvant therapy was not required; at study entry, all patients (as per inclusion criteria) had metastatic stage IV disease (195 [87%] of 224 in the CYRAMZA + erlotinib group vs 191 [85%] of 225 in the placebo + erlotinib group) or recurrent metastatic stage IV disease (29 [13%] vs 34 [15%]).
Ask your sales representative about RELAY
1L=first-line; CNS=central nervous system; DoR=duration of response; ECOG=Eastern Cooperative Oncology Group; eCRF=electronic case report form; EGFR=epidermal growth factor receptor; IQR=interquartile range; ITT=intent-to-treat; IV=intravenous; mNSCLC=metastatic non-small cell lung cancer; mut+=mutation-positive; NSCLC=non-small cell lung cancer; ORR=overall response rate; OS=overall survival; PCR=polymerase chain reaction; PFS=progression-free survival; PS=performance status; SD=stable disease; Q2W=every 2 weeks.
References: 1. CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Nakagawa K, Garon EB, Seto T, et al; for RELAY Study Investigators. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial [published online October 4, 2019]. Lancet Oncol. doi:10.1016/S1470-2045(19)30634-5.