Earlier this week, Bristol Myers Squibb (BMS) announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study. This study evaluated Opdivo® (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive).

According to the American Cancer Society (ACS), the main types of lung cancer are non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC accounts for about 80% to 85% of lung cancers, with survival rates varying based on the stage and type of cancer at diagnosis. This research highlights the importance of advancements in treatment options for NSCLC patients.

The study results revealed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint, when compared to neoadjuvant chemotherapy alone. These findings complement the previously reported primary endpoints of event-free survival (EFS) and pathological complete response (pCR), both of which also achieved statistical significance. The safety profile of Opdivo in combination with chemotherapy remained consistent with previously reported studies, with no new safety signals identified.

Here is a brief overview of the study:

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

Study Details | Source

  • Sponsor: Bristol-Myers Squibb
  • The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.
  • This study has multiple primary endpoints.
  • Interventions:
    • Biological: Nivolumab
    • Drug: Cisplatin
    • Drug: Vinorelbine
    • Drug: Gemcitabine
    • Drug: Docetaxel
    • Drug: Pemetrexed
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Biological: Ipilimumab
  • Primary Outcomes Measures:
    • Event-Free Survival (EFS)
      • Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
      • Time Frame - From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
    • Pathologic Complete Response (pCR) Rate
      • Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).
      • Time Frame - From randomization up to a median of 30 months after randomization.

BMS intends to deliver a comprehensive update on the revised data after conducting an analysis in a future peer-reviewed setting.

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