Opdivo + Yervoy's FDA Win for Colorectal Cancer – What Pharma Needs to Know
Dr. Andrew Merron, Executive Director, DRG Oncology
In July 2018, Opdivo + Yervoy received FDA approval for colorectal cancer on the back of a Phase II study.
Dr. Andrew Merron, Executive Director, DRG Oncology, discusses:
- 2 reasons why this approval is significant
- The outlook for other checkpoint inhibitors in the pipeline for colorectal cancer
- Key issues pharma needs to consider while pursuing colorectal cancer drug development
Visit DRGOncology.com for more insights from Andrew and other oncology experts.
Earlier in July, the FDA approved Opdivo in combination with Yervoy for the treatment of metastatic colorectal cancer.
I think it's a really interesting event and the reason I wanted to talk about it is two-fold.
- The first is that it's another example of immune checkpoint inhibitors gaining approval in oncology and that the march continues in oncology.
- The second reason is that it's an example of the FDA approving drugs on the basis of Phase II trials.
What's the outlook for other checkpoint inhibitors in the pipeline for colorectal cancer?
On the surface, it looks like colorectal cancer is a good indication for checkpoint inhibitors but bear in mind that the current approvals are in a very narrow inpatient population so they don't have access to this very large, treatable pool.
This is because just 5% of colorectal cancer patients are MSI-high so the current approvals are in a very small sub-population. Future checkpoint inhibitors may gain approval. Infinity is one example which is mirroring the same sort of trial setup as Keytruda and Opdivo and Opdivo plus Yervoy now, so that could gain approval.
But it's also important to bear in mind that no every checkpoint inhibitor trial is successful. There was a high-profile failure of Tecentriq in combination with Cotellic, a Roche combo, which failed. And that failed in a much larger group of patients which would've opened up the opportunity even broader. So that's failed so it's important to think that we need to focus where these checkpoint inhibitors are relevant.
What are the key issues pharma needs to consider while pursuing colorectal cancer drug development?
Some of the key things that I think are important are:
- Immune checkpoint inhibitors are now available in colorectal cancer and it's what we've been discussing today but only for this small group of patients. As we've seen, they failed in larger groups of patients. So despite them entering, they're not really transforming the colorectal cancer market in the same way that they have done in melanoma and bladder for example.
- Other things that pharma needs to consider in colorectal cancer, well, there's clearly a big opportunity here so there's the patients outside of the MSI-high group who still need urgent, new treatments. And there is ongoing development of other drug classes. An example is BRAF/MEK inhibitors and we think that these will gain approval. But again, actually, these are going to be narrowed down to a small patient group as well, BRAF mutants.
- Unlike most other indications, colorectal cancer is one where we're probably going to see a decline in overall revenue. We know that oncology is transforming at an incredible rate and most indications are growing but colorectal cancer will actually probably decline based on the fact that it's dominated by Avastin and Cetuximab and other biologics and these will experience biosimilar erosion.