For patients with resectable (removable by surgery) non-small cell lung cancer (NSCLC), Opdivo (nivolumab) treatment before and after surgery resulted in a nearly 40% lower risk of disease recurrence or death after surgery when compared to presurgical Opdivo plus chemotherapy, analysis of the findings of the phase 3 CheckMate 77T and phase 3 CheckMate 816 trials showed.
The analysis may help to inform of the potential benefit of postsurgical Opdivo following presurgical Opdivo plus chemotherapy treatment and surgery, further supporting its use in eligible patients, Patrick Forde noted in his presentation at the 2024 IASLC World Conference on Lung Cancer. Forde is codirector of the Division of Upper Aerodigestive Malignancies and director of the Thoracic Oncology Clinical Research Program at Johns Hopkins Medicine in Baltimore.
In the analysis, those who were included were either enrolled in the CheckMate 77T trial (presurgical Opdivo plus chemotherapy followed by definitive surgery and at least one or more doses of postsurgical Opdivo) or the CheckMate 816 trial (presurgical Opdivo plus chemotherapy followed by definitive surgery).
Learn More: Opdivo Before and After Surgery Improves Event-Free Survival in NSCLC
Study Highlights:
- Patients who received a combination of presurgical and postsurgical treatment with Opdivo experienced a nearly 40% lower risk of disease recurrence or death compared to those who received neoadjuvant Opdivo plus chemotherapy.
- Patients with pathologic complete response and those with PD-L1 expression less than 1% demonstrated even greater reductions in the risk of disease recurrence or death with perioperative Opdivo.
- Pre- and postsurgical Opdivo showed improved event-free survival outcomes compared to neoadjuvant Opdivo plus chemotherapy for patients with both stage 1B to 2 and stage 3 NSCLC.
- Pre- and postsurgical Opdivo was generally well-tolerated, with a similar rate of treatment-related side effects compared to neoadjuvant Opdivo plus chemotherapy.
“In the absence of a randomized-controlled trial, this analysis represents the only comparison of [pre- and postsurgical versus presurgical]-only immunotherapy treatments for patients with resectable NSCLC, using individual patient-level data from two randomized phase 3 trials,” Forde noted.
At median follow-ups of 29.5 months and 33.3 months in the CheckMate 816 and CheckMate 77T trials, respectively, the landmark event-free survival (EFS; the time a patient lives without experiencing complications from their cancer) showed added benefit in the weighted average treatment effect (a statistical measure to assess the overall effectiveness of a treatment) of 39% for patients who received presurgical and postsurgical Opdivo (139 patients) compared with patients who received presurgical Opdivo plus chemotherapy (147 patients).
“When we performed an unweighted analysis (an analysis where all patients are treated as having equal importance regardless of specific characteristics or conditions at the start of the study) of all patients who had surgery, and irrespective of whether they received [presurgical Opdivo] in the CheckMate 77T trial, that adds to all of the trends in favor of [pre- and postsurgical] therapy,” Forde explained.
When stratifying landmark EFS based on pathologic complete response (the disappearance of cancer), those with (40.7%) versus without (30.5%), showed more favorable reduction in the risk for EFS with pre- and postsurgical Opdivo, compared with presurgical nivolumab plus chemotherapy.
Similarly, stratification by tumor PD-L1 expression (a protein that plays a role in the immune system’s response to the disease, and can predict how well immunotherapy may work) also demonstrated improved results, regardless of status. For patients with PD-L1 status of less than 1%, compared with those of 1% or more, pre- and postsurgical Opdivo further reduced the risk for disease recurrence or death, compared with neoadjuvant nivolumab plus chemotherapy.
Lastly, stratification by clinical stage also demonstrated improved EFS outcomes with pre- and postsurgical Opdivo versus presurgival Opdivo plus chemotherapy, regardless of tumor stage.
According to Forde, pre- and postsurgical Opdivo had a generally manageable safety profile. Treatment-related side effects of any grade leading to discontinuation occurred in 16% of the pre- and postsurgical treatment group, compared with 11% in the presurgical setting. Further, surgery-related side effects occurred in 38% versus 42%, respectively.
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