7 0 BERLIN—Presentations at the most recent European Society of Medical Oncology (ESMO) annual conference and other studies underscored the durability of immune checkpoint inhibitors (ICIs), which enable the patient’s immune cells to destroy cancer cells. Since the first ICIs were approved by the U. S. Food and Drug Administration (FDA), survival rate for lung can- cer and other cancers have improved greatly. “The introduction of ICIs has been a game changer in cancer treatments,” said Roseleen Charania, MD, associate chief medical officer for oncology programs at Evernorth, the health services division of The Cigna Group. “When ICIs are prescribed and administered in an optimal manner, they can provide significant benefits, markedly improving survival rates in comparison to other therapies. ” Evernorth Research Institute reported that, by 2021, 12. 1% of oncology patients were receiving ICIs, a 47. 5% increase since 2018 that was driven primarily by expanded use in treating breast, colorectal and prostate cancer. That report looked at how ICIs and other cancer medi- cines are being used now with data from 47. 8 million people, along with examining the data of a smaller group who were treated with infusions of pembrolizumab, the ICI most commonly used for metastatic lung cancer. Pembrolizumab, marketed as Keytruda, is widely considered the most prescribed ICI, specifically for non- small cell lung cancer (NSCLC). It is considered a foun- dational, first-line treatment for advanced or metastatic NSCLC, often used either alone or in combination with chemotherapy. It is recognized as the No. 1 prescribed immunother- apy in advanced NSCLC. Some studies have suggested that it is used as the treatment in more than 80% of cases. It also is approved for a wider range of lung can- cer applications compared to other ICIs, including both early-stage (as perioperative treatment) and advanced/ metastatic disease. Led by Heather Wakelee, MD, of Stanford Medicine, the 5-year follow-up of the global, phase 3 KEYNOTE-671 study (NCT03425643), involving perioperative pembroli- zumab. The original study showed significant improved event-free survival (EFS; HR, 0. 58; 95% CI, 0. 46–0. 72; P < 0. 001) and overall survival (IA2; HR, 0. 72; 95% CI, 0. 56- 0. 93; P = 0. 0052) vs. neoadjuvant chemotherapy (chemo) in early-stage NSCLC. The results were presented at ESMO and published late last year in ESMO Annals of Oncology. 1 Eligible participants were adults with previously untreated, resectable stage II, IIIA or IIIB (N2) NSCLC per AJCC version 8 were randomized 1:1 to 4 cycles of pem- brolizumab 200 mg or placebo Q3W plus chemother- apy, followed by surgery then adjuvant pembrolizumab 200 mg or placebo Q3W for up to 13 cycles (around 9 months) or until progressive disease or unacceptable toxicity. Dual primary endpoints were event-free survival by investigator assessment and overall survival. With 797 pts randomized to pembrolizumab (n = 397) or placebo (n = 400, the median time from randomization to data cutoff (July 3, 2025) was 60. 4 (range, 42. 6-85. 8) months. The results indicated that the 5-year event-free survival (EFS) rate was 49. 9% (95% CI, 44. 6%-55. 0%) in the pembrolizumab arm and 26. 5% (95% CI, 21. 7%- 31. 5%) in the placebo arm. The EFS hazard ratio was 0. 58 (95% CI, 0. 48-0. 69). 5-year overall survival (OS) rates were 64. 6% (95% CI, 59. 5%-69. 2%) and 53. 6% (95% CI, 48. 3%-58. 6%), respectively. In addition, the OS hazard ratio (HR) was 0. 74 (95% CI, 0. 59-0. 92). “HRs for EFS and OS favored pembro, regardless of baseline disease stage and PD-L1 status,” the authors concluded. Grade 3 or greater treatment-related adverse effects occurred in 179 of 396 treated pts (45. 2%) in the pem- brolizumab arm and 151 of 399 treated patients (37. 8%) in the placebo arm. Grade 3 or greater immune-mediated adverse effects and infusion reactions occurred in 25 patients (6. 3%) and 7 patients (1. 8%), respectively. “After 5 years of follow-up, perioperative pembro plus neoadjuvant chemo continued to prolong EFS and OS vs. neoadjuvant chemo,” the study noted. “Fifty percent of patients in the pembro arm, almost twice as many as in the placebo arm, were alive and event-free at 5 years. These long-term findings support use of perioperative pembro plus neoadjuvant chemo as a standard of care for patients with resectable early-stage NSCLC. ” By Brenda L. Mooney The Introduction of Immune Checkpoint Inhibitors ‘Game Changer’ in NSCLC Longterm Follow-Ups Show Continued Success
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