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Key Trials Seek to Expand on Efficacy, Tolerability of Treatment Regimens in Refractory CRC

Caroline Seymour
Published: Friday, Mar 22, 2019

Iman Imanirad, MD

Iman Imanirad, MD

The CCTG CO.26, ReDOS, and IMblaze370 trials, although not all positive, are all trials that have shaped approaches to treating patients with advanced refractory colorectal cancer (CRC).

At the meeting, Imanirad, a medical oncologist at Moffitt Cancer Center, discussed these trials in depth and their impact on patients with refractory metastatic CRC.

CCTG CO.26

In the Canadian trial, investigators examined the combination of durvalumab (Imfinzi) and tremelimumab in patients with advanced refractory disease. This combination of CTLA-4 and PD-L1 inhibition resulted in benefit regardless of whether the patient had microsatellite instability-high (MSI-H)/mismatch repair-deficient tumors or microsatellite stability (MSS) disease, said Imanirad.

“Durvalumab and tremelimumab improved survival in the phase II study, and there was no adverse impact on QoL,” said Imanirad. “The toxicity profile was in line with previous immunotherapy regimens, and that should be a platform to launch a phase III clinical trial in the refractory setting.”

ReDOS

Due to the off-target effects of regorafenib (Stivarga), its toxicity is ill-tolerated by many patients, explained Imanirad. As such, this phase II trial was designed to assess regorafenib in a step-wise manner to see if it could be better tolerated. The proportion of patients who were able to complete 2 cycles of treatment and initiate a third cycle served as the primary endpoint of the trial, with secondary endpoints of OS, PFS, and time to progression.
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