As often happens when you have to deal with an advanced stage disease, the combination of several therapies can open up new chances of survival. This is also the case for patients with unresectable, recurrent or metastatic advanced squamous cell carcinoma of the esophagus (OSCC), with tumor PD-L1 expression ≥ 1%. The European Commission recently approved it to ‘certify’ that nivolumab in combination with combination chemotherapy based on fluoropyrimidine and platinum is effective for the first-line treatment of adult patients.
The Phase 3 study
Nivolumab is a PD-1 immune checkpoint inhibitor, which has been designed to boost our immune system in order to re-establish the anti-tumor immune response. The European Commission approval was made based on the results of the Phase 3 CheckMate -648 study that were presented at the American Society of Clinical Oncology (ASCO) annual meeting in June 2021. In this study, nivolumab with chemotherapy demonstrated a statistically significant and clinically relevant overall survival (OS) benefit compared to chemotherapy alone. The safety profile of nivolumab with chemotherapy was consistent with previously reported studies.
The increase in survival
Cancer of the esophagus is the seventh most common cancer and the sixth leading cause of cancer death worldwide, with approximately 600,000 new cases and more than 540,000 deaths in 2020. The most important result is that of overall survival (OS) which it was 15.44 months for nivolumab with chemotherapy versus 9.07 months for chemotherapy alone. Progression-free survival was also improved to nearly seven months for nivolumab with chemotherapy compared to nearly five for chemotherapy. The difference is even more pronounced when looking at the overall response rate: 53.2% for nivolumab with chemotherapy compared to 19.7% for chemotherapy. This is why this approval represents an important step forward for patients in the European Union, especially due to the extremely aggressive nature of squamous cell carcinoma of the esophagus.
The association of immunotherapics
Just yesterday Bristol Myers Squibb announced the European Commission’s approval of nivolumab in combination with ipilimumab for the first-line treatment of adult patients with unresectable, recurrent or metastatic advanced squamous cell carcinoma of the esophagus (OSCC), with tumor PD-L1 expression ≥ 1%. This approval allows for the use of nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the treatment of adult patients with unresectable, recurrent or metastatic advanced OSCC, with tumor PD-L1 expression ≥ 1% in the 27 Member States. of the European Union, Iceland, Liechtenstein and Norway.