On April 18, 2024, the U.S. Food and Drug Administration (FDA) approved Alecensa (alectinib) following surgical resection for people living with early-stage ALK-positive non-small cell lung cancer (NSCLC).
The approval is based on results from the ALINA study (NCT03456076). Participants with stage 1B (IB) to 3A (IIIA), ALK-positive NSCLC received 600 mg of Alecensa (alectinib) twice daily after surgery to remove the cancer. People treated with Alecensa (alectinib) had a meaningful reduction in disease recurrence or death compared to people treated with platinum-based chemotherapy following surgical resection. Additionally, participants receiving Alecensa (alectinib) experienced a lower rate of treatment-related adverse events requiring a change in therapy than participants treated with chemotherapy.
Just like Osi it is only available for stage 1b and above - do you know why stage 1a is never included in approval for new meds? I know Adaura 2 trail underway now for Osi stage 1a.
Hi, kri312! My name is Matt Reiss, I am manager of the LungMATCH program with GO2 for Lung Cancer. Thank you for reaching out, this is an excellent question!
Strictly speaking, saying that stage 1A cancer is 'never' included in clinical trials isn't quite the case. People with stage 1A canbe included in clinical trials, but when a company is designing a clinical trial, they often choose to exclude people with stage 1A. There are a few reasons they may choose to do this:
First, clinical trials for cancer therapies are, by nature, giving an "unproven" drug to people with serious health conditions, and as such their design and the ethics of providing the treatment is considered. Often, this is a risk-benefit analysis, where the goal is to provide the most benefit to people possible while limiting any assumed risk. In the case of people with stage 1A cancer, the disease is often small and localized to a small region in the body with a low chance of recurrence or progression to other parts of the body when receiving the current standard of care (commonly surgery with curative intent). Therefore, the risk of not giving stage 1A individuals the new drug is low compared to people with more advanced disease, particularly when considering possible side effects and complications from receiving the treatment.
Second, from a practical concern, running a clinical trial requires a large amount of often limited resources, including funding, research sites, and clinical trial personnel. As such, related to the first point, researchers will often prioritize persons with more advanced stages of disease because they are expected to experience the greatest benefit from the experimental treatment with limited availability.
And third is a scientific/statistical concern. Since early stage disease is much smaller and any measurable change (say, the tumor shrinking) would be so minimal, because of how we analyze clinical trial data, it would require a much larger number of participants in the trail to identify any significant treatment effects, which would also cause clinical trials to take much more time to complete.
Because of these reasons, clinical trial designers will often exclude very early stage participants unless their trial specifically allocates resources to evaluating the treatment in early stage individuals (such as the ADAURA2 trial). However, as the clinical trail landscape continues to evolve, we will continue to see these things change and potentially include more people wit stage 1A disease - particularly in studies examining preventative or adjuvant treatments.
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