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. While specific data points were not disclosed, the company reported a statistically significant and clinically meaningful increase in survival among patients receiving Imdelltra versus those on conventional chemotherapy. These results could potentially support converting Imdelltra’s current conditional approval in the U.S. to full regulatory clearance.
In other industry news, the Parker Institute for Cancer Immunotherapy has made two significant leadership appointments. Karen Knudsen, former CEO of the American Cancer Society and its Cancer Action Network, was named as the institute’s new CEO in March. Additionally, the organization appointed Genentech veteran Ira Mellman as president of research on Thursday. Mellman brings extensive experience in cancer drug development, having played a crucial role in advancing treatments including anti-TIGIT antibodies, personalized neo-antigen vaccines, and the established immunotherapy drug Tecentriq.
Johnson & Johnson shared promising results for its experimental autoimmune treatment icotrokinra in adolescent psoriasis patients. Data presented at the World Congress of Pediatric Dermatology showed that 84% of adolescents treated with the oral peptide drug achieved clear or nearly clear skin after 16 weeks, compared to 27% in the placebo group. The findings came from the ICONIC-LEAD trial studying patients aged 12 and older. Developed in partnership with Protagonist Therapeutics, icotrokinra targets IL-23 and could provide an oral alternative to injectable psoriasis medications like AbbVie’s Skyrizi and J&J’s Tremfya.
In less successful trial news, Alzheon reported that its experimental Alzheimer’s treatment valiltramiprosate failed to show benefits in delaying cognitive decline among patients with genetic risk factors for early-onset disease. The Phase 3 study included 325 early Alzheimer’s patients carrying two copies of the apolipoprotein E ε4 allele. Researchers found no significant differences between the treatment and placebo groups on the primary endpoint measure ADAS-Cog13 or secondary endpoints. While a “nominal” benefit was noted in participants with mild cognitive impairment, this finding did not meet pre-specified statistical thresholds and would likely require confirmation through additional studies.
Amylyx Pharmaceuticals has initiated a new clinical program in ALS, dosing the first participant in a Phase 1 trial of an antisense oligonucleotide targeting calpain-2 protease. This development follows the company’s previous withdrawal of its ALS drug Relyvrio from the market and subsequent shift in research focus. The new trial, called Lumina, will evaluate safety, tolerability, and pharmacological properties of the experimental treatment in 48 ALS patients across U.S. sites. Participants will be randomized in a 3:1 ratio to receive either the study drug or placebo, with initial data expected later this year. This marks Amylyx’s renewed efforts to develop treatments for the neurodegenerative condition.
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