Advanced or metastatic gastric or GEJ adenocarcinoma
Clinical trial efficacy: RAINBOW
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
- CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Across five clinical studies in 1916 patients with various cancers treated with CYRAMZA, the incidence of all Grade and Grade 3-5 gastrointestinal perforations ranged from <1-2%.
- Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.
RAINBOW trial: Efficacy overview
Adding CYRAMZA to paclitaxel increased median OS by 30%1
versus placebo + paclitaxel - that could mean more time for your patients
RAINBOW OS: MEDIAN –MONTHS (95% CI)1
- The percentage of deaths at the time of analysis was 78% (256 patients) and 78% (260 patients) in the CYRAMZA plus paclitaxel and placebo plus paclitaxel treatment arms, respectively.1
40% of patients on CYRAMZA + paclitaxel survived 1 year or longer2
What could more time mean to your patients?
Survival Rate % (95% CI)
Adding CYRAMZA to paclitaxel significantly increased PFS vs paclitaxel + placebo1
RAINBOW PFS: MEDIAN –MONTHS (95% CI)1,3
- The percentage of events at the time of analysis was 85% (279 patients) and 88% (296 patients) in the CYRAMZA plus paclitaxel and placebo treatment arms, respectively1.
- 56 of 279 events in CYRAMZA-treated patients and 55 of 296 events in placebo-treated patients were deaths.
22% of patients on CYRAMZA + paclitaxel were progression free for 9 months or longer4
PFS Rate % (95% CI)4
Adding CYRAMZA to paclitaxel nearly doubled the response vs paclitaxel alone1,3
RAINBOW ORR: PERCENT OF PATIENTS (95% CI)*1
*2 complete responses in CYRAMZA-treated patients and 1 complete response in placebo-treated patients.
*ORR was defined as complete plus partial response. Disease progression and tumor response were assessed by investigators in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.13
SELECT IMPORTANT SAFETY INFORMATION
IMPAIRED WOUND HEALING
- Impaired wound healing can occur in patients who receive drugs that inhibit the VEGF or VEGFR pathway. CYRAMZA, a VEGFR2 antagonist, 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 28 days following a major surgical procedure and until the wound is fully healed. Discontinue CYRAMZA in patients who develop wound healing complications that require medical intervention.
The phase III RAINBOW trial evaluated the efficacy and safety of CYRAMZA + paclitaxel vs placebo + paclitaxel in patients with locally advanced or metastatic gastric or GEJ adenocarcinoma with disease progression on or after prior fluoropyrimidine- and platinum-containing chemotherapy. Major efficacy outcome measure was OS. Supportive efficacy outcome measures were PFS and ORR. All patients were ECOG PS 0 or 1. Prior to enrollment, 97% of patients had progressed during treatment or within 4 months after the last dose of first-line chemotherapy for metastatic disease. Twenty-five percent of patients had received anthracycline in combination with platinum/fluoropyrimidine therapy, while 75% did not. Patients were randomized 1:1 to CYRAMZA 8 mg/kg (n=330) or placebo (n=335) every 2 weeks (on days 1 and 15) of each 28-day cycle. Patients in both arms received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle.1,5