
The overall safety profile of CYRAMZA® (ramucirumab) + erlotinib was consistent with that of its individual components1,2
Adverse reactions occurring in ≥5% of patients with a ≥2% difference between arms1

*Includes all preferred terms that are part of the System Organ Class Infections and Infestations. Most common (≥1%) Grade ≥3 infections and frequencies for CYRAMZA with erlotinib compared to placebo with erlotinib, respectively, include pneumonia (3% versus 0%), cellulitis (1% versus 0%), paronychia (4% versus 3%), skin infection (1% versus 0%), and urinary tract infection (1% versus 0%).1
†Includes 3 fatal events in the CYRAMZA arm.
‡Gastrointestinal hemorrhage, proteinuria, and pulmonary hemorrhage are consolidated terms.
§Grade ≥3 does not exist in CTCAE.
||Includes 1 fatal event in the CYRAMZA arm.
- The most common serious adverse reactions in patients who received CYRAMZA with erlotinib were pneumonia (3.2%), cellulitis (1.8%), and pneumothorax (1.8%).
- Treatment discontinuation of all study drugs due to adverse reactions occurred in 13% of CYRAMZA with erlotinib-treated patients, with increased alanine aminotransferase (1.4%) and paronychia (1.4%) being the most common. The most common adverse reactions leading to treatment discontinuation of CYRAMZA were proteinuria (8.6%) and hyperbilirubinemia (6%).
Laboratory abnormalities worsening from baseline in ≥20% (all grades) of patients receiving CYRAMZA + erlotinib with a difference between arms of ≥2%1

¶The denominator used to calculate the incidence varied, based on the number of patients with a baseline, and at least 1 on-study laboratory measurement: CYRAMZA-treated patients (range 215–218 patients) and placebo-treated patients (range 224–225 patients).
ECOG Performance Status
- In the RELAY trial of patients with EGFR mut+ mNSCLC, 92% (207/224) of patients maintained ECOG PS of 0 or 1 while on treatment with CYRAMZA + erlotinib vs 95% (214/225) of patients on placebo + erlotinib3
At baseline, approximately 52% of patients in the RELAY trial had an ECOG PS of 0 and approximately 48% of patients had an ECOG PS of 1.1,2
Time to deterioration in ECOG PS was a prespecified exploratory analysis. The RELAY trial was not powered to detect statistical differences between treatment groups in regard to time to deterioration in ECOG PS.
CNS Metastases
- 0.9% of patients in the CYRAMZA + erlotinib arm (n=2/224) and 3.6% of patients in the placebo + erlotinib arm (n=8/225) developed CNS metastases4
- This was a prespecified subgroup analysis. Due to the small subset of patients, no conclusion can be made. The RELAY trial was not powered for subgroup analyses, and treatment differences observed cannot be regarded as statistically significant
- Patients with CNS metastases were excluded from the RELAY trial1
The RELAY trial evaluated the efficacy and safety of CYRAMZA + erlotinib vs placebo + erlotinib in previously untreated patients with EGFR mut+ mNSCLC. Major outcome measure was PFS. Supportive outcome measures included OS, ORR, and DoR. Patients were stratified by EGFR mutation status (exon 21 (L858R) vs exon 19 deletion), geographic region (East Asia vs other), gender, and local EGFR testing method (therascreen® and cobas® vs other PCR and sequencing-based methods). All patients were required to have ECOG performance status 0 or 1. Patients were randomized 1:1 to receive CYRAMZA 10 mg/kg (n=224) or placebo (n=225) every 2 weeks + erlotinib 150 mg/day.1,2
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CNS=central nervous system; CTCAE=Common Toxicity Criteria for Adverse Events; DoR=duration of response; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; mNSCLC=metastatic non-small cell lung cancer; mut+=mutation-positive; N/A=not applicable; ORR=overall response rate; OS=overall survival; PCR=polymerase chain reaction; PFS=progression-free survival; PS=performance status.
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. 3. Data on File, Lilly USA, LLC, DOF-RB-US-0087. 4. Data on File, Lilly USA, LLC, DOF-RB-US-0086.