Pharmaceutical company Amgen announced Friday that its bispecific antibody treatment Imdelltra demonstrated improved survival rates in patients with previously treated small cell lung cancer compared to standard chemotherapy. The findings came from an interim analysis of the Phase 3 DeLLphi-304 trial, which evaluated 500 participants globally, with half receiving Imdelltra and half receiving
conventional chemotherapy. While specific data points were not disclosed, Amgen reported the survival improvement was both
statistically significant and clinically meaningful. These results could help secure full FDA approval for Imdelltra, which currently holds conditional authorization in the United States.
In other industry news, the Parker Institute for Cancer Immunotherapy has strengthened its leadership team with two major appointments. Karen Knudsen, former CEO of the American Cancer Society and its Cancer Action Network, was named CEO in March. Additionally, the institute welcomed Ira Mellman as president of research on Thursday. Mellman, who previously worked at Genentech, was instrumental in developing several innovative cancer treatments including anti-TIGIT antibodies, personalized neo-antigen mRNA and DNA vaccines, and the established immunotherapy drug Tecentriq.
Johnson & Johnson shared promising results for its experimental autoimmune treatment icotrokinra, reporting that 84% of adolescent psoriasis patients achieved clear or nearly clear skin after 16 weeks of treatment, compared to 27% in the placebo group. The data, presented at the World Congress of Pediatric Dermatology, came from the ICONIC-LEAD trial studying patients aged 12 and older. The oral peptide drug, which targets IL-23, is being developed with Protagonist Therapeutics and could provide an alternative to injectable treatments like AbbVie’s Skyrizi and J&J’s Tremfya.
In less favorable news, Alzehon reported that its experimental Alzheimer’s treatment valiltramiprosate failed to show efficacy in delaying cognitive decline among patients with genetic mutations linked to early-onset disease. The Phase 3 trial, which included 325 early Alzheimer’s patients carrying two copies of the apolipoprotein E gene’s ε4 allele, showed no significant difference between the treatment and placebo groups on the primary endpoint measure ADAS-Cog13 or secondary endpoints. While researchers noted a “nominal” benefit in patients with mild cognitive impairment, this finding did not meet pre-specified statistical thresholds and would likely require additional studies for regulatory consideration.
Amylyx Pharmaceuticals has initiated a Phase 1 trial for a new ALS treatment, marking its return to the field after previously
withdrawing its ALS drug Relyvrio from the market. The study, named Lumina, will evaluate an antisense oligonucleotide targeting the protease calpain-2. The trial design includes 48 ALS patients in the United States, with participants randomized in a 3:1 ratio to receive either the experimental drug or placebo. The study will assess the drug’s tolerability, safety, pharmacokinetics, and pharmacodynamics, with initial results expected before year-end. This development represents Amylyx’s renewed commitment to advancing treatments for neurodegenerative conditions after shifting its research focus following the Relyvrio withdrawal.
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