European Commission Grants Approval to Bristol Myers Squibb’s Perioperative Opdivo Regimen for Resectable, High-Risk NSCLC with PD-L1 Expression ≥1%
Bristol Myers Squibb has announced that the European Commission (EC) has formally approved a new perioperative treatment regimen involving its immune checkpoint inhibitor Opdivo® (nivolumab), used in combination with chemotherapy before surgery and continued as monotherapy following surgery, for adult patients with resectable non-small cell lung cancer (NSCLC) who are at high risk of recurrence and whose tumors express PD-L1 at levels of 1% or higher. This regulatory milestone marks a major advancement in the treatment landscape for patients with early-stage, yet aggressive, forms of lung cancer in Europe.
A Significant Step Forward for Early-Stage Lung Cancer Treatment
Lung cancer remains one of the leading causes of cancer-related death globally, and non-small cell lung cancer accounts for approximately 85% of all lung cancer cases. While early-stage NSCLC is often treated with surgery, recurrence remains a major challenge, especially for patients with high-risk tumor profiles. Addressing this need, Bristol Myers Squibb’s perioperative approach with Opdivo offers a potentially transformative strategy—aiming not only to shrink tumors preoperatively but also to improve long-term survival prospects by reducing the risk of post-surgical recurrence.
The approval by the EC applies to all 27 European Union member states, along with Iceland, Liechtenstein, and Norway, thereby significantly broadening patient access to this treatment across the European Economic Area. The decision reinforces Bristol Myers Squibb’s commitment to advancing immuno-oncology therapies in the early-stage setting, where the goal is to intervene before the disease progresses beyond the point of curability.
Clinical Evidence from CheckMate -77T Supports Approval
The EC’s decision was supported by robust clinical data from the Phase 3 CheckMate -77T trial, which evaluated the efficacy and safety of perioperative treatment with Opdivo plus platinum-based chemotherapy followed by surgery and continued adjuvant Opdivo monotherapy. This regimen was compared to the standard approach of neoadjuvant platinum-doublet chemotherapy followed by surgery and placebo.
The trial met its primary endpoint, demonstrating a statistically significant improvement in event-free survival (EFS). Patients receiving the Opdivo-based perioperative treatment saw a 42% reduction in the risk of disease recurrence, progression, or death compared to those treated with chemotherapy and placebo. Specifically, the EFS hazard ratio (HR) was 0.58 (95% Confidence Interval: 0.43 to 0.78; P=0.00025), signaling a meaningful clinical benefit.
After a median follow-up of 25.4 months, 65% of patients in the Opdivo group were alive and free of disease events at the 24-month mark, compared to only 44% of patients in the placebo group. These results suggest that the Opdivo-based regimen has the potential to significantly extend the period during which patients remain cancer-free following surgery—a critical metric in early-stage oncology.
Pathologic Responses Underscore Depth of Benefit
In addition to EFS, the CheckMate -77T trial evaluated key secondary endpoints, including pathologic complete response (pCR) and major pathologic response (MPR), both of which provide insights into how effectively the treatment eradicates tumor cells before surgery.
Patients treated with the perioperative Opdivo regimen achieved clinically meaningful improvements in both pCR and MPR, indicating a deeper level of anti-tumor activity prior to surgical resection. These responses are particularly important because they are associated with longer-term survival outcomes and may predict how well a patient will do following surgery.
Importantly, the clinical benefit of Opdivo-based treatment was observed consistently across all subgroups in the trial, suggesting that the strategy may be broadly applicable to a wide range of patients with resectable NSCLC and PD-L1 expression of 1% or higher.
Safety Profile Remains Manageable and Consistent
Another encouraging finding from CheckMate -77T was that the safety profile of the perioperative Opdivo regimen remained consistent with what has previously been reported for Opdivo and chemotherapy in NSCLC. There were no new safety concerns or unexpected adverse events, further validating the suitability of this approach for use in early-stage, potentially curable lung cancer.
“This approval brings another perioperative immunotherapy treatment option for select patients with resectable NSCLC in the EU, helping address an ongoing need for interventions that can meaningfully reduce the risk of cancer returning after initial therapy,” said Dr. Dana Walker, M.D., M.S.C.E., Vice President and Global Program Lead for Opdivo at Bristol Myers Squibb. “With this approval, Opdivo with chemotherapy followed by adjuvant Opdivo has the potential to change the course of certain patients’ disease by significantly reducing the risk of cancer recurrence and improving long-term outcomes earlier in the treatment journey.”
European Regulatory Path Mirrors U.S. Approval
The EC’s approval follows a similar regulatory decision by the U.S. Food and Drug Administration (FDA) in October 2024, in which the FDA approved the same perioperative regimen for adult patients with resectable NSCLC—defined as tumors measuring 4 cm or greater, or with lymph node involvement—provided they have no known mutations in the epidermal growth factor receptor (EGFR) gene or rearrangements in the anaplastic lymphoma kinase (ALK) gene. In the U.S., the approval similarly allows the use of Opdivo in combination with platinum-doublet chemotherapy before surgery, followed by Opdivo monotherapy after surgery.
This alignment between regulatory bodies in the U.S. and Europe underscores the global significance of the CheckMate -77T data and highlights the increasing emphasis on addressing early-stage disease with aggressive yet tolerable multimodal approaches.
Ongoing Research
The CheckMate -77T trial remains ongoing to evaluate overall survival (OS), a key secondary endpoint that will provide further insights into the long-term benefit of the treatment. OS data, when mature, will help clarify the full magnitude of survival benefit associated with this perioperative strategy and could influence future treatment guidelines and standard-of-care protocols across the globe.
The early data already suggest that this approach may shift the treatment paradigm in early-stage NSCLC by demonstrating that systemic immunotherapy can be effectively incorporated both before and after surgery, targeting micrometastatic disease early and sustaining immune surveillance after tumor removal.
Results from CheckMate -77T have been showcased at prominent scientific venues, including initial presentations at the 2023 European Society for Medical Oncology (ESMO) Congress and subsequent updates presented at the 2024 ESMO Congress. The study’s primary findings have also been published in The New England Journal of Medicine, lending further credibility and visibility to the data among oncologists and healthcare providers worldwide.
A Continued Commitment to Immuno-Oncology Innovation
This EC approval represents yet another step in Bristol Myers Squibb’s broader efforts to expand the reach of Opdivo across multiple tumor types and stages of disease. In Europe, Opdivo-based therapies are already approved for a variety of cancers, including melanoma, renal cell carcinoma, urothelial carcinoma, gastric cancer, and esophageal cancer. The approval for perioperative NSCLC underscores the company’s focus on addressing unmet needs in early-stage cancer, where interventions can potentially cure patients or substantially extend survival.
Bristol Myers Squibb expressed gratitude to the patients and clinical investigators who participated in the CheckMate -77T trial, acknowledging their contributions to advancing scientific understanding and improving patient care.
By offering a new standard in the management of resectable NSCLC, the Opdivo perioperative regimen stands to benefit thousands of patients across Europe who face the ongoing risk of cancer recurrence following initial treatment. As the oncology field continues to evolve toward earlier intervention and more personalized care, this approval signals a pivotal moment in the integration of immunotherapy into the curative-intent treatment of lung cancer.
