If anyone did read the portions of the 2014 Lancet I posted on ORR for older dendritic therapy, it should be encouraging not only for future techs like DCVax-Direct, but it also might give some a bit more insight into how DCVax-L -- proven safer than any oncology therapy on the planet over the span of a decade -- might use CIs for potential synergy trials.
Recently we learned a couple things. Car-ts don't work in solid tumors. I've alluded to this previously in prior posts, and Yervoy (CTLA-4) + Opdivo is too toxic for many and fatal for 3%. Keytruda and Opdivo alone have barely enough ORR to obtain approval, and after that, their durability improvement appears modest.
DCVax-L is not just for Brian cancer. It is used right now in Israel on all types of cancers. With the new dosing schedule that includes booster shots, I'm speculating they are getting 20% or more ORR for tumor shrinkage (Opdivo was approved with a lower ORR!).
Of course the really impressive numbers for DCVax-L phase III should be related to Overall survival and Progression free survival, but ORR can be a faster route to approval in most cases.
Anyway, suspend your disbelief if you must, but lets imagine taking Opdivo or Keytruda and adding it to DCVax-L. I've discussed this before, more often with DCVax-Direct, but let's consider our therapy that has a ten year old safety track record.
I surmise, again, DCVax-L could be used both as pretreatment and concurrent treatment with said CIs.
Why? Because DCVax-L naturally recovers the immune system, increases t-cell proliferation, activity and efficacy, and, in cases where patients have high tumor burden, can safely stabilize a patient before they are subject to checkpoint inhibitors (which might otherwise induce cytokine storms.)
After pretreatment is complete and concurrent combinational therapy is started, less rescue medicine is likely necessary, the CIs actually have t-cells to "take the breaks off," and those t-cells are directed by DCVax-L to attack all the relevant antigens in the tumors.
Thus the potential advantages from using DCVax-L with CIs are:
1. Improving safety profile for CI by combining it with DCVax-L.
2. Potentially improve efficacy of both CI and DCVax-L.
3. Improving the approval speed for DCVax-L on other indications through ORR as the primary endpoint. Combinational effect on tumor response may be logarithmic.
4. Maintain approval of CI therapy durability because tumor escape is reduced by combinational therapy with DCVax-L.
5. Reduce competition.
The potential disadvantage:
1. Cost to patient.
2. Cut into profit margin for both companies
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