Patients with metastatic colorectal cancer treated with Cyramza and standard FOLFIRI lived a median of 1.6 months longer than patients treated with FOLFIRI alone, according to results from the phase 3 RAISE trial.
Patients with metastatic colorectal cancer (mCRC) who were treated with Cyramza (ramucirumab) combined with standard FOLFIRI lived a median of 1.6 months longer than patients treated with FOLFIRI alone, according to results from the phase 3 RAISE trial. The data were presented at a presscast held ahead of the 2015 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.
“Ramucirumab is an effective new treatment option for second-line treatment [of mCRC], including patients with poor prognosis,” said lead study author Josep Tabernero, director of the Vall d’Hebron Institute of Oncology in Barcelona, Spain.
The RAISE trial included 1072 patients with mCRC who had progressed during or after receiving firstline combination therapy with Avastin (bevacizumab), oxaliplatin and a fluoropyrimidine. Patients were stratified by region, KRAS mutation status and time to progressive disease after starting firstline therapy. OS was the primary endpoint, with secondary endpoints including progression-free survival (PFS), objective response rate (ORR) and toxicity.
The median OS was 13.3 months with Cyramza plus chemotherapy versus 11.7 months with chemotherapy alone. Median PFS was 5.7 and 4.5 months, respectively. The OS and PFS results were comparable across patient subgroups.
“The RAISE trial clearly demonstrates that sustained inhibition of the angiogenesis from firstline to secondline mCRC therapy improves survival in a clinically representative mCRC population,” said Tabernero.
Tumor shrinkage rates were similar between the two arms. There was not a statistically significant difference in ORR at 13.4 percent with the Cyramza combination and 12.5 percent in the placebo arm. The most common severe adverse events in the Cyramza arm included neutropenia (38.4 percent), hypertension (11.2 percent), diarrhea (10.8 percent) and fatigue (11.5 percent). The rate of febrile neutropenia was comparable between the two arms.
“We know that when patients with advanced colorectal cancer have progression of their disease on firstline chemotherapy plus bevacizumab, we can either continue the bevacizumab with secondline chemotherapy or use a different angiogenesis inhibitor, ziv-aflibercept (Zaltrap), with chemotherapy. And now we know that ramucirumab can be given with chemotherapy in this setting, as well,” said Smitha S. Krishnamurthi, ASCO expert and presscast moderator.
“All of these approaches have had a similar increase in survival,” added Krishnamurthi. “It will now be interesting to see the effect of ramucirumab in other randomized studies and settings for colorectal cancer.” Cyramza has approved indications as a single agent and in combination with paclitaxel to treat patients with advanced gastric or gastroesophageal junction adenocarcinoma. It is also approved in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer. The agent has also been examined in HER2-negative metastatic breast cancer, but it failed to delay disease progression in a phase 3 trial.