Keytruda is not seen as a first line treatment for newly diagnosed patients yet. 

Wouldn’t it be lovely if we could have immunotherapy for head and neck cancer right from the start? No surgery, no radiation, no Cisplatin, all of which can have awful long term consequences.

The truth is that Keytruda is not there yet. When we first present for treatment we have to have the cancer surgically removed or blasted with chemoradiation or variations on these three treatments: slash, burn and poison.

They work for the majority of us but headlines about a recent study and new approvals for Keytruda, have blurred the lines a bit. A lot of people now think Keytruda has been approved by the FDA and European Commission for all first line treatment when in fact the study refers to first line treatment for “metastatic and unresectable recurrent squamous cell carcinoma.”

It’s only a first line for people for whom conventional treatments have failed or have distant mets beyond the locoregional area, such as to the lungs. Not a first line for those with a new diagnosis.

So here’s what the medical dictionary says about first line treatment:

First-line therapy
The first treatment given for a disease. It is often part of a standard set of treatments, such as surgery followed by chemotherapy and radiation. When used by itself, first-line therapy is the one accepted as the best treatment. If it doesn’t cure the disease or it causes severe side effects, other treatment may be added or used instead. Also called induction therapy, primary therapy, and primary

However, in comparison to other treatments given for metastatic and unresectable squamous cell carcinoma of the head and neck up till now, it is a new treatment mode. Previously these patients had a pretty harsh cocktail of Erbitux and two other chemo drugs.

I think that Erbitux is approved in New Zealand but not yet funded. NZ patients currently receive a potent chemo combination to slow down the cancer if they are at this advanced stage.

I dont think Erbitux has lived up to its early promise.

The 882 patients in the study published in Lancet were divided into three groups with some getting Keytruda alone as a monotherapy, some getting Keyruda plus some standard chemo and the third group getting Erbitux and other chemo drugs.

The people who received Keyrtruda as a monotherapy, did so because they had the biomarker PD-L1. This indicates that the cancer is more likely to respond to it. See the other article linked to below, on how these biomarkers work.

The study showed significant improvement in overall survival in the patients who had Keyruda. It’s expressed statistically so the median overall survival improvement is only 13 months for Keytruda for the first group versus 10.7 for the third group but a median is only a middle figure and some people will live for years. The study looked at only 24 months.

Funnily enough, Keytruda has been approved in New Zealand for metastatic HNC for a couple of years now. I dont think patients have to jump though other treatment hoops to get it. The big bugbear in New Zealand is that it is not funded by Pharmac so people it’s indicated for can’t access it unless they have $70, 000 plus for the drug alone. I’m not sure how much private insurance pays; at any rate it is unaffordable for the average person.

Before this study was published, I heard that the chances of Keytruda working for you are 20%. I’ve heard recently that it is over 30%. This needs fact checking.

The main point of this post is to clarify the conclusions of the recent study. They do show stronger evidence for Keytruda and the data is getting a little bit closer to make an application to Pharmac more hopeful. Many misleading headlines gave the impression it was first line treatment for all head and neck cancer at all stages which is what motivated me to write this.

The next step will be for Merck to try it on newly diagnosed patients. Then the hopes and dreams of the first paragraph might be realised.

Here is a link to a summary I wrote on Keytruda in late 2018 (before this study) after hearing a talk by a drug company representative. I hope I summed up adequately how Keytruda and other immunotherapies work. 

https://hncsa.org.nz/keytruda-for-hnc-patients-2018/