The study, which Ukraine participated in, was among the top five at the ASCO-2018 International Congress in Chicago.
The annual congress of the American Society of Clinical Oncology (ASCO) in Chicago is one of the largest in the world. It is here that scientists and physicians present the results of the latest researches. This year about 30,000 oncologists gathered in Chicago. From the 6,500 scientific papers presented at ASCO-2018, the scientific organizing committee has chosen the five best ones — the results of these studies, according to experts, may in the long run change the treatment regimens of cancer.
Among the five most important is the work, which Ukraine took part in, namely one of the co-authors of the KEYNOTE-042 study is the head of the Department of Oncology and Medical Radiology of the Dnipropetrovsk Medical Academy (DMA), Doctor of Medical Sciences, Professor Igor Bondarenko.
A possible breakthrough in the treatment of lung cancer
Immunotherapy with pembrolizumab (trade name – Keytruda) for patients with non-small cell lung cancer is more effective than chemotherapy, according to the Keynote-042 study, in which experts from the USA, China, Latvia, Poland, South Korea, Brazil, Thailand and Japan also participated. Patients taking pembrolizumab lived for 4-8 months longer than those who received chemotherapy. In addition, the former were less likely to experience severe side effects – 17.8% vs. 41% among patients taking chemotherapy.
Previously, a standard care for patients with non-small cell lung cancer without driver mutations was chemotherapy. According to the results of the previous major study on the efficiency of lung cancer immunotherapy, KEYNOTE-024, pembrolizumab significantly improves progression-free survival time (PFS, duration from the start of clinical observation to progression of the disease or death) and overall survival (OS, time from the beginning of treatment or diagnosis establishing to death of the patient) compared with chemotherapy as a first-line therapy in patients with metastatic non-small cell lung cancer.
A combination of new agents, including targeted agents and immunotherapies, have helped patients live longer
KEYNOTE-042 is the most rigorous, randomized clinical study of pembrolizumab effectiveness. It involved 1,274 patients with localized and metastatic non-small cell lung cancer, including the patients from Ukraine. Some of them received pembrolizumab, while the others were on chemotherapy in various combinations.
“What we have seen over the last few years is that a combination of new agents, including targeted agents and immunotherapies, have helped patients live a little longer, but we still have a lot of effort and work to do,” said a leading co-author of the study, Dr. Gilberto Lopes, MD, a specialist from the Sylvester Cancer Center at the University of Miami (USA), when he presented the results of the study at the ASCO Plenary Session on June 3rd.
How immunotherapy works
Pembrolizumab is an active substance, based on monoclonal antibodies, approved by the US Food and Drug Administration (FDA) in 2017. It is the first drug, authorized by FDA for treatment of cancer, that affects tumor cells depending on their genetic status (mutations that occurred in them), not the type of tissue or tumor site.
Pembrolizumab, having got into the human body, binds to the protein PD-1 and blocks its effect. This protein is responsible for suppressing the immune response in cases when it is harmful to the body – for example, during pregnancy, to avoid the rejection of the fetus. In simple words, PD-1 “keeps T-lymphocytes on a leash” and prevents them from fighting “good” cells.
And cancerous cells, due to mutations, can produce PD-1 in huge amounts – hence, they can cheat the body and avoid the attacks of T-lymphocytes. Pembrolizumab allows to deactivate the protective effect of the PD-1 protein, so that the immune system begins to recognize cancer cells with mutations as “bad” ones and sets T-lymphocytes on them. Thus, the drug does not destroy the cancer itself – it rather helps the human body to fight cancer cells on its own.
ASCO’s expert, doctor of medical sciences John Heymach, in his commentary on the study’s findings, said that they could be a turning point for patients with non-small cell lung cancer. “An era when chemotherapy was the only way out for patients with non-small cell lung cancer, is coming to an end. Immunotherapy will be a first-line therapy for the vast majority of such patients. And the results of this study lead to a tremendous progress for them,” said John Heymach.
Prospects for immunotherapy of lung cancer in Ukraine
The production of monoclonal antibodies utilizing laboratory mice is a very expensive technology. Today 50 mg of pembrolizumab costs over $2,600 (in Ukrainian pharmacies, the cost of the drug varies from 110,000 to 120,000 UAH).
According to Victor Zavizion, the candidate of medical sciences, associate professor, doctor-oncologist of the highest category, the employee of the department of oncology and medical radiology of the DMA, the very high cost of pembrolizumab is a major problem. But as a colleague of the professor Igor Bondarenko from Dnipro and a co-author of KEYNOTE-042, Victor agrees with foreign experts on the significance of this study.
“This is a real breakthrough in oncology, confirmed in clinical trials. It consists in the fact that we, without chemotherapy, mobilize the immune system to unmask the tumor. It becomes recognizable for immunocompetent cells and, as a result, lymphocytes infiltrate and destroy the tumor”, – commented Victor Zavizion.
Over the past two years, 170 people received immunotherapy at the center of chemotherapy in Dnipro
As for the head of the center of chemotherapy of the Department of Oncology and Medical Radiology of the DMA, based at the 4th Clinical Hospital of Dnipro, a doctor-oncologist of the highest category, Professor Igor Bondarenko, he is more optimistic on the prospects of immunotherapy in Ukraine. According to him, since 2002, on the basis of the clinic he leads, 340 international clinical trials were conducted. And KEYNOTE-042 is the most successful of them.
The specialist is convinced that Ukrainian patients have the right to access to innovative treatments and can realize it, primarily through international clinical trials. This will allow to successfully apply innovations in clinical practice. Thus, over the past two years, 170 people received immunotherapy at the center of chemotherapy in Dnipro. According to Igor Bondarenko, today five large foreign companies are promoting the latest immune drugs, and all of them are used in clinical studies at the clinic, which he manages.
“The motto of our clinic is “Use technologies of the future already today”,” Igor Bondarenko told the “Innovation House”. “And now we have 36 international clinical trials open for 22 oncological diseases.”