Clinical trial efficacy: REGARD
CYRAMZA as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
SELECT IMPORTANT SAFETY INFORMATION
Infusion-Related Reactions (IRR)
- IRR, including severe and life-threatening IRR, occurred in CYRAMZA clinical trials. Symptoms of IRR included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. In 2137 patients with various cancers treated with CYRAMZA in which premedication was recommended or required, the incidence of all Grade IRR ranged from <1- 9%. Grade 3-5 IRR incidence was <1%
- Premedicate prior to each CYRAMZA infusion. Monitor patients during the infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Reduce the infusion rate by 50% for Grade 1-2 IRR. Permanently discontinue CYRAMZA for Grade 3- 4 IRR.
REGARD trial: Efficacy
CYRAMZA monotherapy significantly extended OS1
REGARD OS: MEDIAN - MONTHS (95% CI)1
- The percentage of deaths at the time of analysis was 75% (179 patients) and 85% (99 patients) in the CYRAMZA and placebo arms, respectively1.
CYRAMZA monotherapy significantly improved PFS1
REGARD PFS: MEDIAN - MONTHS (95% CI)1
- The percentage of events at the time of analysis was 84% (199 patients) and 92% (108 patients) in the CYRAMZA and placebo arms, respectively1.
- 65 of 199 events in CYRAMZA-treated patients and 31 of 108 events in placebo-treated patients were deaths.1.
REGARD Trial Design (N=355)1 The phase III REGARD trial evaluated the efficacy and safety of CYRAMZA vs placebo in patients with locally advanced or metastatic gastric or GEJ adenocarcinoma with disease progression or after prior fluoropyrimidine- or platinum-containing chemotherapy. Major efficacy outcome measure was OS. Supportive efficacy outcome measure was PFS. All patients were ECOG PS 0 or 1. Prior to enrollment, 85% of patients had progressed during treatment or within 4 months after the last dose of first-line chemotherapy for metastatic disease, and 15% of patients progressed during treatment or within 6 months after the last dose of adjuvant chemotherapy. Patients were randomized 2:1 to CYRAMZA 8 mg/kg every 2 weeks plus BSC (n=238) or placebo plus BSC (n=117).1