We started the phase II PECATI clinical trial with the objective to explore a new treatment option for patients with advanced thymic tumors. The study will evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in patients with metastatic thymic carcinoma or B3 thymoma. This treatment is expected to slow the progression of these types of tumors, increasing the time in which patients with thymic epithelial tumors (TETs) can keep their disease under control.
Because of the very low number of patients with this type of cancer, TETs are considered rare tumors, with an overall incidence of 0.13 cases per 100,000 inhabitants. This low incidence greatly hinders the possibility of conducting clinical research to explore new treatment strategies. In patients with metastases, combinations of chemotherapy based on platinum salts are chosen as the standard frontline treatment; however, when the tumor stops responding to this initial therapy, subsequent treatment options are not currently defined. For this reason, we believe that it is urgent to identify new therapeutic strategies that allow oncologists to control this disease for longer, increasing the survival and quality of life of patients with TETs.
The study, designed under the scientific direction of Dr. Jordi Remon, head of the Thoracic Tumors Unit of the Clara Campal HM CIOCC Comprehensive Cancer Center in Barcelona, will last 32 months. According to Dr. Remon, “Thymic tumors are considered rare tumors due to their low incidence, which limits the ability to investigate new treatment strategies. Immunotherapy can be very promising in these patients, especially when combined with other drugs, so it is essential to find out its effectiveness in this type of tumors in order to improve the prognosis of this rare disease”.
The PECATI study will test the efficacy of pembrolizumab in combination with lenvatinib in patients diagnosed with B3 thymoma or metastatic thymic carcinoma whose tumors have progressed after receiving at least one line of chemotherapy. The researchers work with the hypothesis that this combination of drugs will slow down the expansion of these types of tumors and thus increase the percentage of patients in tumor progression-free survival 5 months after the start of treatment.
Pembrolizumab is an immunotherapeutic drug that blocks the PD-1 protein. This drug has already proven its efficacy and safety in other thoracic tumors as well as other types of cancer. On the other hand, lenvatinib is a drug that inhibits multiple protein kinases, including those responsible for vascularizing the tumor, thus reducing the supply of nutrients to the tumor. Immunotherapy treatment has already been evaluated in pre-treated TET patients, and the combination of both drugs has already shown efficacy in different solid tumors such as endometrial cancer, renal cell carcinoma, head and neck cancer, thyroid cancer, and hepatocellular carcinoma. But this is the first time that the efficacy and safety of this combination will be evaluated in patients with TET, a population with a great unmet therapeutic need.
The PECATI study will have the participation of 43 patients from 15 health centers in Spain, France and Italy, such as the La Paz University Hospital in Madrid, La Fe University and Polytechnic Hospital in Valencia, the Gustave Roussy Oncological Institute in Paris or the Turin Hospital.