The initial perception of a complex treatment landscape in the early stages of non-small cell lung cancer (NSCLC), as characterized by physicians, may be on the brink of clarity, thanks to an unprecedented achievement in overall survival linked to Merck & Co.’s Keytruda. In a phase 3 trial, the utilization of Keytruda both before and after surgery led to a significant extension of life for patients diagnosed with stage 2 to 3b NSCLC, as announced by Merck. The study compared the Keytruda regimen with presurgical chemotherapy alone, while individuals receiving Keytruda also underwent chemotherapy before surgery.
This trial marked the first instance where an immunotherapeutic approach demonstrated a statistically significant benefit in overall survival for specific early-stage NSCLC patients. The outcome was revealed ahead of the anticipated FDA decision on the perioperative use of Keytruda as continuous neoadjuvant-plus-adjuvant therapy for early-stage NSCLC. The trial had previously achieved its other dual primary endpoint by showcasing Keytruda’s ability to mitigate the risk of tumor recurrence, progression, or mortality using the event-free survival (EFS) marker.
The latest data from Keynote-671 will be presented at the European Society for Medical Oncology 2023, offering a comprehensive update. Results from the CheckMate-77T trial for Bristol Myers Squibb’s Opdivo in a closely aligned stage 2 to 3b NSCLC perioperative setting will also be shared at the ESMO meeting. Bristol Myers Squibb successfully attained its EFS goal for the trial.
These two data sets could offer crucial clarity for doctors grappling with the challenge of determining the most suitable early-stage NSCLC treatment in the surgical context. Keytruda, Opdivo, Roche’s Tecentriq, and AstraZeneca’s Imfinzi have all demonstrated positive outcomes within this setting.
A central concern among healthcare professionals has been whether a PD-1/L1 inhibitor is necessary before and after surgery. In 2022, Opdivo received FDA approval as a neoadjuvant therapy for pre-surgical use based on data from the CheckMate-816 trial. The results revealed a 37% improvement in event-free survival for stage 1b to 3a NSCLC when Opdivo was combined with chemotherapy. Subsequent analysis demonstrated a 38% reduction in the risk of death with the Opdivo regimen, although statistical significance had not been reached at that time.
During the American Society of Clinical Oncology annual meeting, Merck disclosed a 42% improvement in EFS figures for Keynote-671. Analysts and trial investigators predicted that the study would likely achieve its overall survival goal, given the observed divergence in survival rates between Keytruda and the control arm after two years.