Fruquintinib provides improvement in overall survival for refractory mCRC

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Published: 12 Sep 2022
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Dr Nageshwara Arvind Dasari - MD Anderson Cancer Center, Houston, USA

Dr Nageshwara Arvind Dasari speaks to ecancer on the FRESCO-2 trial, evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. 

FRESCO-2 was a randomised, double-blind, placebo-controlled, phase 3 MRCT conducted in the US, Europe, Japan & Australia, comparing fruquintinib + best supportive care with placebo + best supportive care.

The results concluded that fruquintinib has a significant and clinically meaningful improvement in overall survival in patients with refractory mCRC. FRESCO-2 results are consistent with FRESCO and should support a new treatment option in refractory mCRC.

The study that I’m going to talk about today is FRESCO-2, it’s a global, randomised, placebo-
controlled phase III study of fruquintinib in patients with metastatic colorectal cancer that have been
refractory to all available therapies. Fruquintinib is a very selective and potent inhibitor of VEGF
receptors 1, 2 and 3.

This is a global study and patients who were eligible for the study had progressed through all
available therapies, including cytotoxic therapies, any targeted therapies, as well as a VEGF inhibitor.
They should have also received TAS-102 and/or regorafenib, so all available therapies currently.
These patients were randomised 2:1 to fruquintinib versus placebo with overall survival being the
primary endpoint and progression free survival being the key secondary endpoint.
Really exciting results in that the study was positive and improved overall survival with a hazard ratio
of 0.66, so that is a 34% reduction in the risk of death. Similarly, the progression free survival was
also highly positive with a hazard ratio of 0.321. So, overall this represents a new treatment option for
these patients who desperately need new options. We’re hoping that this would add on to the
available options and improve survival of these patients.

What was really gratifying was that this drug was not just effective but also was very well tolerated
overall compared to other VEGF TKIs in the space. This appears to be better tolerated, of course
within the limitations of cross-trial comparison. In fact, the rates of discontinuation of fruquintinib and
placebo were about the same in this trial. So that is a very important factor in that these patients have
very advanced cancer, have undergone multiple lines of therapy so are very susceptible to side
effects. Again, it’s not just very effective but also very well tolerated.

So really exciting results, as we’ve just seen, and this would be addressing a huge unmet need for
these patients with refractory metastatic colorectal cancer who do not have any other options
currently. This drug is also very well tolerated. So the study was designed in collaboration with
regulatory agencies around the world and we’re hoping that this will be approved soon and to be
made available to all the patients.

Building on these successes that we’ve discussed today, we’re hoping that we can do additional trials
looking at combination therapies with fruquintinib, both in the refractory setting and perhaps even
moving into earlier lines of therapy.