Positive feedback received from FDA on the planned TACTI-004 Ph 3 trial of eftilagimod alfa + KEYTRUDA + chemo for the treatment of 1L NSCLC
“We are pleased with the FDA’s feedback as this allows us to successfully conclude our regulatory preparation for the TACTI-004 registrational trial. This represents a key milestone in our late-stage development process for efti centred on potentially driving a new standard of care globally in the treatment of non-small cell lung cancer. We hope to achieve this through efti in combination with KEYTRUDA, which has led to strong efficacy data with a favourable safety profile in 1L NSCLC patients regardless of PD-L1 expression,” stated Christian Mueller, Immutep’s SVP, Regulatory and Strategy.
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