Opdivo plus chemo reduces recurrence risk in early-stage lung cancer surgery

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In the arena of perioperative treatment for early-stage non-small cell lung cancer (NSCLC) involving PD-1/L1 inhibitors, the competition among key players is intensifying. Bristol Myers Squibb (BMS) has revealed promising results from its phase 3 CheckMate-77T trial. The study demonstrates that incorporating BMS’s Opdivo, both before and after surgery, significantly reduces the risk of tumor recurrence, progression, or death in patients with early-stage resectable NSCLC, ranging from stages 2 to 3b, compared to using chemotherapy alone. This development positions BMS for a showdown with other PD-1/L1 drug developers, such as AstraZeneca and Merck & Co., who have recently presented their own data in the perioperative NSCLC context.

The wealth of data in early-stage NSCLC has led to concerns among healthcare professionals regarding the complexity of treatment decisions in this field. Beyond the choice of which agent to use, a pivotal question revolves around whether PD-1/L1 inhibitors should be administered both before and after surgery or if a single treatment period suffices.

While CheckMate-77T doesn’t directly address this question, it may shed light on the matter. Opdivo had previously received FDA approval as a neoadjuvant therapy based on data from the CheckMate-816 trial, where its addition to chemotherapy reduced the risk of disease recurrence, progression, or death by 37%. CheckMate-77T extends the evaluation of Opdivo to the adjuvant setting, post-surgery. If the improvement in event-free survival surpasses that observed in CheckMate-816, it could suggest the benefit of adjuvant treatment in addition to neoadjuvant therapy.

However, comparing results across trials must be done cautiously due to variations in patient populations. CheckMate-816 included patients with stage 1b to 3a disease, while the 77T study enrolled those in stages 2 to 3b.

CheckMate-77T also provides an opportunity to compare Opdivo with Merck’s Keytruda and AstraZeneca’s Imfinzi in the same perioperative context. Keytruda demonstrated a 42% event-free survival benefit in the Keynote-671 trial, and Imfinzi showed a 32% improvement in the AEGEAN trial with a shorter follow-up period. All three studies enrolled patients in stages 2 to 3b. The ongoing CheckMate-77T trial will continue to assess whether the Opdivo regimen can extend patients’ lives. In an interim analysis of Keynote-671, perioperative Keytruda reduced the risk of death by 27%, although it did not reach statistical significance.

Furthermore, Roche is planning to enter the perioperative NSCLC arena with Tecentriq. The PD-L1 inhibitor secured its first adjuvant NSCLC approval in 2021 but was overshadowed by Keytruda’s broader label in January. Roche is currently testing Tecentriq in a neoadjuvant-plus-adjuvant setting in the Impower-030 trial, with results expected in 2024.

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