LTRN Lantern Pharma

Lantern Pharma amends HARMONIC trial to focus on L858R NSCLC

FDA reviewed and raised no objections to key protocol amendments for the Phase 2 HARMONIC trial of LP-300. Enrollment will now concentrate on EGFR exon 21 L858R patients, switch to a single-arm design, and extend maximum LP-300 treatment from six to eight cycles. The amendments are based on emerging data showing deeper PFS benefit with longer treatment duration in the L858R subgroup.

Lantern Pharma: FDA Type C OKs HARMONIC Phase 2 amendments for LP-300

FDA raised no objections to three protocol amendments: (1) enrichment for EGFR exon 21 L858R patients, (2) extension of LP-300 dosing to eight cycles, and (3) transition to a single-arm design. These changes sharpen the regulatory path and partnering case for LP-300 in never-smoker NSCLC.

Lantern Pharma: FDA clears IND 179145 for STAR-001 Phase 1 pediatric CNS trial

FDA cleared the IND for a planned multicenter Phase 1 trial of STAR-001 (LP-184) in children with relapsed/refractory CNS tumors. The protocol allows monotherapy and combination with spironolactone across ATRT, DIPG, GBM, medulloblastoma, and ependymoma. The study will be run with the POETIC network of 14 academic centers.