Immutep Announces Successful Meeting With FDA On Phase III Design In Non-Small Cell Lung Cancer; TACTI-004 Registrational Trial Will Enrol ~750 Patients Regardless Of PD-L1 Expression In Order To Address The Entire 1l NSCLC Market Eligible For anti-PD-1 Therapy
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Immutep Limited has received positive feedback from the FDA regarding the design of its Phase III TACTI-004 trial for treating first-line non-small cell lung cancer (1L NSCLC) with eftilagimod alfa in combination with KEYTRUDA and standard chemotherapy. The trial will enroll approximately 750 patients regardless of PD-L1 expression.
July 22, 2024 | 12:03 pm
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Immutep Limited has received positive feedback from the FDA for its Phase III TACTI-004 trial design, which will enroll approximately 750 patients for treating 1L NSCLC with eftilagimod alfa in combination with KEYTRUDA and standard chemotherapy.
The FDA's positive feedback on the Phase III trial design is a significant regulatory milestone for Immutep. This approval paves the way for the trial to proceed, potentially leading to a new treatment option for 1L NSCLC patients. The news is likely to boost investor confidence and positively impact the stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100