Final assessments of a Phase II trial for resectable non-small cell lung cancer found that 60% of patients who had gone on to receive the neoadjuvant nivolumab remained recurrence-free five years following surgery. Overall survival rates were also found to be higher than they were in the past.
According to an Associate Professor of Oncology, Patrick Forde, MBBCh, at Johns Hopkins’ Sidney Kimmel Comprehensive Cancer Center, the findings suggest that neoadjuvant nivolumab was effective in long-term follow-up.
Twenty patients with stage I-III resectable NSCLC were treated with two doses of neoadjuvant nivolumab in the experiment. According to the follow-up study, which was published in Clinical Cancer Research, substantial pathological responses were detected in 45% of patients with the disease, regardless of tumour PD-L1 expression. Furthermore, 73% of individuals whose tumours were surgically removed had no recurrences even 18 months later.
Forde continued, saying that as far as they know, this data analysis has been the most extensive follow-up for a PD-1/PD-L1 inhibitor in the neoadjuvant context for any solid tumor to date.
According to the data, 80% of patients were still alive post the follow-up. This, along with the five-year recurrence-free survival rate seen in the trial, outperforms the 36 to 68% survival rate for this period previously observed in stage I-III NSCLC patients, according to Dr. Samuel Rosner, co-first author of the study, medical oncology fellow at Johns Hopkins’ Sidney Kimmel Comprehensive Cancer Center, and member of Forde’s research group.
The substantial pathologic response following neoadjuvant nivolumab was also discovered by the authors as a potential predictive biomarker of recurrence-free and overall survival. Eight of the nine patients who experienced a significant pathological reaction were still alive and cancer-free even after 5 years after starting treatment. After receiving definitive chemoradiation, one patient who had a recurrence during the first 10 months of treatment now happens to be disease-free. This subgroup’s lone fatality had no connection to cancer.
On the other hand, disease recurrence occurred in six out of the 11 non-small cell lung cancer patients who did not exhibit a significant pathological response. Cancer claimed the lives of three of these patients. These findings suggest that a significant pathological response after neoadjuvant nivolumab may be linked to a decreased risk of disease progression and passing away.
The Outcomes
According to Rosner, one notable finding from the study was the difference in outcomes between individuals with and without a severe pathogenic reaction. Despite the small sample size, the inferences demonstrate the abnormal response’s potential as a predictive biomarker.
Nivolumab neoadjuvant therapy did not cause surgical delays. There was only one late-onset immune-related adverse event (AE) 16 months after treatment. The writers stated that it was successfully managed.
The US Food and Drug Administration (FDA) approved nivolumab in combination with chemotherapy for lung cancer in March 2022.
