There are 7 FDA approved PD-1/L1 inhibitors
Merck holds pole position but BMS, Roche, AZ and other BP are now on the market.
Other than early stage P1 triplet combo with Roche and chemo (Insight 003) which is encouraging, there is no compelling 'competitive tension' to force Merck's arm and reach for the chequebook anytime soon (would love to be very wrong).
So a P3 registration size trial combo efti/Pembro is next?
Buys Merck another 2-3 years at little cost and time to assess the other dozens of potential combo partners.
And then what. Hopefully Efti approved with Keytruda pd-1 all comer and better QoL and durability compared to chemo combo. And then what? FDA/EMA approval.
And then what? Do we sell direct to patients based on oncologist recommendations?
In reality without Merck endorsement/ownership/licensing of efti, self marketing and selling of efti would be almost impossible for a small biotech.
To create real BP competitive tension, would it not be better to partner P2 combos with other BP and their PD-1 drugs? Then see would is serious about taking efti all the way, not only improving patient outcomes but also adding many years to their PD-1 IP in combo?
Efti has been 8 years in development and some investors are down 90% on their investment.
After recent compelling data, it is now time for Immutep to clearly articulate its commercialisation or monetisation strategy. IMO.
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