Innate Pharma Reports the US FDA’s Partial Clinical Hold on New Patient Enrolment of Lacutamab
Shots:
- The US FDA has placed a partial clinical hold on the enrolment of new patients in the P-II trial (TELLOMAK) for lacutamab (IPH4102-201) as monotx. or in combination with CT for CTCL and P-Ib trial of IPH4102-102 for r/r peripheral T-cell lymphoma that express KIR3DL2
- The final results from (TELLOMAK) trial are expected in Q4’23 & the P-Ib PTCL trial awaiting futility interim analysis with preliminary data expected in Q4’23
- The decision was based on 1 fatal case of hemophagocytic lymphohistiocytosis while enrolled patients may continue to receive treatment. Lacutamab, an anti-KIR3DL2 humanized cytotoxicity-inducing Ab received PRIME designation from the EMA; FTD from the US FDA for r/r Sézary syndrome; ODD in the EU & US for CTCL
Ref: Businesswire | Image: Innate Pharma
Related News:- Innate Pharma Presents Preliminary P-II (TELLOMAK) Trial Results of Lacutamab for the Treatment of Advanced Mycosis Fungoides
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