At the ASCO conference, one of the most prominent medical conferences in the world of oncology, positive results were announced from a phase III clinical study in humans, which examined the effectiveness of the drug IMDELLTRA in patients with recurrent or treatment-resistant small cell lung cancer - one of the most aggressive and deadly forms of cancer.
Small cell lung cancer (SCLC) is one of the most aggressive and deadly types of cancer. It accounts for approximately 15% of lung cancer cases and is characterized by a rapid growth rate and a high tendency to spread early to other organs.
Patients are often diagnosed at an advanced stage of the disease, when metastases have already occurred in vital organs, making treatment options very difficult. Patients suffer from severe symptoms such as chronic cough, shortness of breath, chest pain, extreme fatigue and severe weight loss – symptoms that severely affect their quality of life.
Until now, patients have mainly received chemotherapy treatments, which, while providing an initial response, often fail to significantly prolong patients' lives. In light of this, there is an urgent need for innovative, more targeted and effective treatment approaches.
IMDELLTRA is a novel drug that targets a protein called DLL3 that is expressed on the surface of this type of cancer cells. The drug recruits the patient’s immune system – via T cells – to attack the tumor cells. This mechanism allows for targeted treatment with less damage to healthy tissue.
In a phase 3 clinical trial (DeLLphi-304) of 509 patients with advanced SCLC whose disease had progressed after platinum-based chemotherapy, IMDELLTRA reduced the risk of death by 401% compared with standard chemotherapy. The median overall survival was 13.6 months in the IMDELLTRA group compared with 8.3 months in the control group. The difference was statistically significant.
Treatment with IMDELLTRA led to improvements in respiratory symptoms such as shortness of breath and cough, compared with chemotherapy. In addition, the rate of serious adverse events (grade 3 or higher) was lower: 27% in the IMDELLTRA group compared to 62% in the chemotherapy group. Cytokine release syndrome (CRS), a known side effect of this type of drug, was in most cases mild and manageable.
The study results reinforce the FDA's accelerated approval granted to IMDELLTRA in May 2024, and offer a new therapeutic horizon for patients with advanced SCLC, a disease known for its aggressiveness and limited treatment options after first-line therapy.