The drug nivolumab (Opdivo) developed by the pharmaceutical company Bristol Myers Squibb will be financed by the National Health System in Spain to treat lung cancer in combination with platinum-based chemotherapy and improve patient survival. Specifically, the drug will be used as the first option for neoadjuvant immunotherapy treatment in patients with non-small cell lung cancer (NSCLC) with PD-L1 expression equal to or greater than 1% and a high risk of recurrence.
The Ministry of Health has approved this new indication for the drug based on the results of the phase III CheckMate 816 clinical trial, which showed that three cycles of nivolumab with chemotherapy provided a statistically and clinically relevant improvement that translated into significantly longer free survival. of events and a higher percentage of patients with a complete pathological response than chemotherapy alone when administered before surgery. Furthermore, adding nivolumab to neoadjuvant chemotherapy “did not increase the incidence of adverse events or hamper the feasibility of surgery.”
A significant improvement in the treatment of lung cancer
The efficacy of the treatment was proven in the trial where, with a minimum follow-up of 21 months, the median event-free survival was 31.6 months with nivolumab plus chemotherapy and 20.8 months with chemotherapy alone. At one year, the estimated percentage of patients surviving without disease progression or disease recurrence was 76.1% with nivolumab plus chemotherapy and 63.4% with chemotherapy alone; At 2 years, the corresponding values were 63.8% and 45.3%.
“Nivolumab in combination with platinum-based chemotherapy is currently the only financed neoadjuvant immunotherapy treatment option in Spain”
Mariano Provencio, head of the Medical Oncology Service at the Puerta de Hierro Hospital in Madrid (Spain) and president of the Spanish Group on Lung Cancer (GECP), highlighted that the GECP was a pioneer in research into this new standard of treatment. And he has pointed out that the approval of this new indication not only adds a drug to the treatment, but also constitutes a change in the therapeutic strategy that represents a significant improvement that could allow a significant number of patients to be cured after decades without progress.
For her part, Sandra Orta, general director of Bristol Myers Squibb for Spain and Portugal, stated that “surgery alone is not always enough to prevent cancer from reappearing; Nivolumab in combination with platinum-based chemotherapy is currently the only funded neoadjuvant immunotherapy treatment option in Spain and we are very proud to make available to patients a solution that can help them reduce the risk of disease recurrence, progression and death ”.