Latest Developments in the Pharmaceutical Industry: Amgen's Cancer Drug Success, New Leadership at Parker Institute, and Alzheimer's Setbacks

Amgen's Imdelltra Shows Promise in Small Cell Lung Cancer

Amgen has announced positive interim results from its Phase 3 DeLLphi-304 trial, evaluating the bispecific antibody Imdelltra in previously treated small cell lung cancer patients. The study, which enrolled 500 participants worldwide, demonstrated that Imdelltra led to a "statistically significant and clinically meaningful improvement" in overall survival compared to standard-of-care chemotherapy.

While specific data were not disclosed, this outcome could potentially convert Imdelltra's conditional U.S. approval into full clearance. The trial's success marks a significant advancement in the treatment of small cell lung cancer, a particularly aggressive form of the disease.

Leadership Changes at Parker Institute for Cancer Immunotherapy

The Parker Institute for Cancer Immunotherapy has made two notable appointments to its leadership team. Karen Knudsen, former CEO of the American Cancer Society and its Cancer Action Network, has been named the institute's new CEO. Additionally, Ira Mellman, a Genentech veteran with extensive experience in cancer drug development, has been appointed as the president of research.

Mellman's background includes significant contributions to the development of anti-TIGIT antibodies, patient-specific neo-antigen mRNA and DNA vaccines, and the immunotherapy Tecentriq. These appointments are expected to bolster the institute's efforts in advancing cancer immunotherapy research and development.

Mixed Results in Alzheimer's and Autoimmune Disease Research

Johnson & Johnson's Icotrokinra Shows Promise in Adolescent Psoriasis

Johnson & Johnson's experimental autoimmune drug icotrokinra has shown positive results in treating adolescents with psoriasis. In the ICONIC-LEAD trial, 84% of adolescents receiving icotrokinra achieved clear or nearly clear skin after 16 weeks, compared to 27% in the placebo group. This oral peptide drug, which targets IL-23, could potentially offer an alternative to injectable treatments like AbbVie's Skyrizi and J&J's own Tremfya.

Alzheon's Valiltramiprosate Fails in Early-Onset Alzheimer's Trial

In contrast to J&J's success, Alzheon reported disappointing results from its Phase 3 trial of valiltramiprosate in early-onset Alzheimer's disease patients. The study, which focused on individuals with genetic mutations leading to early onset of the disease, failed to show a delay in cognitive decline compared to placebo. While a "nominal" benefit was observed in a subgroup of participants with mild cognitive impairment, this finding did not meet pre-specified statistical analysis goals and would likely require further confirmation through additional trials.

Amylyx Pharmaceuticals Initiates New ALS Treatment Trial

Following the withdrawal of its ALS drug Relyvrio from the market, Amylyx Pharmaceuticals has shifted its focus to a new potential treatment for the neurodegenerative condition. The company has dosed the first participant in a Phase 1 trial called Lumina, which will evaluate an antisense oligonucleotide targeting the protease calpain-2. The study will enroll 48 individuals with ALS in the U.S., randomized to receive either the experimental drug or placebo. Early data from this trial is expected later this year, potentially opening new avenues for ALS treatment.