NEW YORK – Lantern Pharma said this week that it has started treating patients in Taiwan for its Phase II HARMONIC trial evaluating LP-300 in never-smoker patients with advanced non-small cell lung cancer. In Taiwan, more than half of NSCLC cases occur in people who are classified as never-smokers, according to Lantern. The trial will include never-smoker patients who harbor mutations in MET exon 14, ALK, EGFR, or NTRK. LP-300 is a cysteine-modifying agent that can modulate multiple cellular pathways simultaneously including ALK, EGFR, MET, and ROS1. The firm began the HARMONIC trial in the US in 2022.
The US Food and Drug Administration this week granted breakthrough therapy designation to AstraZeneca's datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer who have received prior treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy. The FDA granted the designation based on pooled data from the Phase II TROPION-Lung05 and Phase III TROPION-Lung01 trials. The data showed an objective response rate of 42.7 percent, a median progression-free survival of 5.8 months, and median overall survival of 15.6 months. Breakthrough therapy designation allows the sponsor to meet with the FDA more frequently for guidance on the drug development program along with the ability to submit data on a rolling basis and apply for accelerated approval or priority review.
Swiss firm Genesupport will offer GeninCode’s ROCA ovarian cancer screening test throughout Switzerland, in a distribution deal announced this week. Genesupport will offer the test through all Sonic Switzerland diagnostic and genetic companies to women in Switzerland who are BRCA positive and have not undertaken risk-reducing surgery.
Amsterdam-based UniQure this week said it has initiated biologics license application (BLA) readiness activities after reaching agreement with the US Food and Drug Administration on components of an accelerated approval pathway for AMT-130, a gene therapy that the company is developing for Huntington's disease. The FDA during a Type B meeting in November, which UniQure earlier this year said it planned to hold to discuss potential expedited clinical development pathways, indicated that data from ongoing Phase I/II trials compared to a natural history external control may serve as a primary basis for a BLA for accelerated approval, with the composite Unified Huntington's Disease Rating Scale serving as an intermediate clinical endpoint and reductions in neurofilament light chain in cerebrospinal fluid as supportive evidence.
PanGIA Biotech said this week that it has inked a deal with Canary Oncoceutics for the distribution in India of PanGIA's liquid biopsy for early cancer detection. The PanGIA Prostate Assay is a urine-based test that incorporates an artificial intelligence-developed algorithm for the analysis of biomarkers of prostate cancer.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.