Several trials provide therapeutic novelties against cancer disease
The Hospital 12 de Octubre has led an investigation and has participated in another against two types of lung cancer. One of them is an international clinical trial in which a drug that acts against a subtype of an oncogne, called KRAS, which has the greatest impact on the origin of human tumors and which generates a protein that participates in the multiplication, maturation and destruction of the body’s cells. This study, published in the international scientific journal The Lancet, has focused on the most common lung cancer, non-small cell cancer. The clinical trial Codebreak 200 compare treatment with sotorasiv with standard treatment (docetaxel) in patients with non-mitrocytic (non-small cell) lung carcinoma, carriers of the KRAS G12C mutation, who had been treated with a standard line of chemotherapy/immunotherapy.
345 patients from 148 centers in 22 participating countries were included, 12 of them Spanish, including the Madrid hospitals Puerta de Hierro, Ramón y Cajal, and La Paz, as well as Hospital 12 de Octubre as research coordinator. The results have shown a 34% reduction in the rate of tumor progression throughout the study period and an increase in the response rate, all accompanied by a favorable safety profile with significantly fewer adverse effects.
Cancer research has spent more than 40 years trying to develop drugs against the KRAS oncogene. According to Luis Paz-Ares, head of the Medical Oncology Service at Hospital 12 de Octubre and principal investigator of this clinical study “we have shown in a phase 3 trial that a specific KRAS inhibitor drug works. Sotorasib already represents a new treatment opportunity for patients. Additionally, it opens a door to continue researching and trying to optimize the type of therapy against KRAS that seemed very difficult, if not impossible”.
The Medical Oncology Service of Hospital 12 de Octubre is also participating in a second investigation against lung cancer within new immune-type therapies. This second study consisted of the initial evaluation of the first molecule that activates immune cells -T cells- against small cell lung cancer, the most aggressive of these tumors. This is a phase 1 trial on 107 patients that has shown relevant remission rates of more than 23 percent in cases previously treated with other therapies, with median duration of response that exceeded 12 months, which gives it great potential to improve patient survival if these promising results are confirmed. This drug treatment called tarlatamab is given intravenously once every 1 to 2 weeks and belongs to a class of drugs called “bispecific T cell activators” -BITEs.
On the other hand, in the European Congress of Lung Cancer Taking place in Copenhagen, Denmark, Johnson & Johnson’s Janssen Pharmaceutical Companies has presented in an oral communication new long-term data from the CHRYSALIS study, which evaluates the drug amivantamab in patients with advanced non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed after prior platinum-based chemotherapy. The study data showed the clinical response and long-term safety profile in this population, according to a company statement.
After a median follow-up of 19.2 months for the 114 patients who participated in the study, the median overall survival with amivantamab treatment was 23 months (confidence interval [IC] 95%, 18.5-29.5), with a 2-year overall survival rate of 47%. The investigator-assessed overall response rate was 37% (95% CI: 28-46), with a median duration of response of 12.5 months (95% CI: 6.9-19.3 ) and a median progression-free survival of 6.9 months (IC del 95%: 5,6-8,8).
Across all subgroups, amivantamab treatment showed consistent efficacy in platinum-experienced EGFR exon 20 insertion mutation-positive patients, including elderly patients, regardless of prior therapies or response to prior chemotherapy. with platinum. Forty-eight patients (42%) had a sustained clinical response as measured by overall response rate with amivantamab for at least 12 cycles. The median duration of treatment was 7.5 months, and treatment continued in 15 patients (13%) who received amivantamab for a median of 2.6 years. Of these patients, seven remain free of progression and eight continue on treatment after progression.
“Amivantamab showed consistent long-term efficacy, regardless of prior therapies or response to prior platinum-based chemotherapy,” he said in the same statement. Pilar Garrido, associate professor of Medical Oncology at the University of Alcalá, head of the Medical Oncology Service at the Ramón y Cajal University Hospital in Madrid and principal investigator of the trial. “Due to the aggressive nature of non-small cell lung cancer with EGFR exon 20 insertion mutations, treatment with targeted therapies is an important consideration when identifying a treatment option for patients.”
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