Hold the line! Stay with me! If you find yourself alone, riding in the green fields with the sun on your face, do not be troubled. For you are in Elysium, and you're already dead!
Is PV-10 a first-line treatment for melanoma? Can it be a first-line treatment? Is it a second-line treatment for melanoma? What's the difference between first- and second-line? Or is PV-10 just another treatment for metastatic melanoma? Or is it just one tool in an oncologist's tool kit?
I'll discuss the addressable or target melanoma market for PV-10 in a subsequent blog post.
The first-line treatment for most skin cancers, especially melanoma, is surgery. So, when considering non-surgery or drug treatments, first-line treatment in this case is the first treatment after surgery has failed to stop the spread of the disease. Second-line treatment is the next treatment used when the first treatment [after surgery] has failed.
The contemplated MM Phase 3 trial is designed to include using PV-10 both as first- and second-line treatments (i.e., treatments after surgery). The comparator arm, whether DTIC or TMZ, would be the first-line treatment. After a couple or three months passess and the comparator arm fails, patients in this arm would then be treated with PV-10 (i.e., second-line). In the PV-10 arm, patients receive rose bengal out of the gate (i.e., first-line).
As you may recall from the MM Phase 2 study, PV-10 also was used as first- and second-line treatments. Surgery had failed. In some cases, patients first received PV-10 (i.e., first-line). In other cases, patients received PV-10 after, first, surgery, and second, another drug treatment (to some surprising and positive results!).
What about local/regional treatment versus systemic treatment. PV-10 is not a first-line systemic treatment. It is a second-line systemic treatment, which means PV-10 is used when systemic treatments have failed (but that is not the focus of the Phase 3 trial).
While there is clear evidence, through clinical trials and immunology studies of the remote bystander effect (i.e., systemic effects), management's primary focus with and claim to the FDA is using PV-10 as first- and second-line [after surgery] treatments for all local/regional and distant cutaneous/subcutaneous metastases of the disease.
PV-10's use, one might argue, based on the plethora of clinical results from the Phase 1 and 2 trials as well as the compassionate care program, could treat at least half of the melanoma market (not just the metastatic melanoma market) by itself or in combination with other drugs, as a first-line treatment in lieu of surgery and as a first-line treatment after surgery.
Wow! That's a claim!