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INDICATION OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO as adjuvant treatment after surgery.

CHECKMATE 77T: NEOADJUVANT OPDIVO + CHEMO FOLLOWED BY ADJUVANT OPDIVO AFTER SURGERY

Give patients the opportunity for an extended EFS*^† benefit and a high pCR^‡ rate with perioperative OPDIVO^1,2,4

EFS: Median/minimum follow-up: 33.3/23.6 months.⁴
pCR: Median/minimum follow-up: 25.4/15.7 months.²
Limitation: The pCR rate was assessed in a descriptive analysis of a pre-specified secondary endpoint; the statistical testing plan did not assign alpha control to this endpoint, so direct comparisons between the treatment arms cannot be made.

*Vs chemo with placebo.^1,2
†EFS per BICR is defined as time from randomization to disease progression that precludes surgery, disease progression/recurrence after surgery, progression for patients without surgery, or death due to any cause.^1,2,5 
‡pCR by BIPR is defined as 0% residual viable tumor cells in both the primary tumor (lung) and sampled lymph nodes.^2,5 
§Per the 8th edition American Joint Committee on Cancer (AJCC) staging criteria.^1,2
BICR=blinded independent central review; BIPR=blinded independent pathological review; NR=not reached.

Select Important Safety Information

Serious Adverse Reactions

In Checkmate 77T, serious adverse reactions occurred in 21% of patients who received OPDIVO in combination with platinum-doublet chemotherapy as neoadjuvant treatment (n=228). The most frequent (≥2%) serious adverse reactions was pneumonia. Fatal adverse reactions occurred in 2.2% of patients, due to cerebrovascular accident, COVID-19 infection, hemoptysis, pneumonia, and pneumonitis (0.4% each). In the adjuvant phase of Checkmate 77T, 22% of patients experienced serious adverse reactions (n=142). The most frequent serious adverse reaction was pneumonitis/ILD (2.8%). One fatal adverse reaction due to COVID-19 occurred.

Common Adverse Reactions

In Checkmate 77T, the most common adverse reactions (reported in ≥20%) in patients receiving OPDIVO in combination with chemotherapy (n=228) were anemia (39.5%), constipation (32.0%), nausea (28.9%), fatigue (28.1%), alopecia (25.9%), and cough (21.9%).

Surgery Related Adverse Reactions

In Checkmate 77T, 5.3% (n=12) of the OPDIVO-treated patients who received neoadjuvant treatment, did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery in OPDIVO-treated patients were cerebrovascular accident, pneumonia, and colitis/diarrhea (2 patients each).

Please see additional Important Safety Information below.

Perioperative OPDIVO: Studied in patients with stage IIA-IIIB NSCLC^1,2,6

• Primary endpoint^1,2,5: 
  • EFS (by BICR): Time from randomization to disease progression that precludes surgery, disease progression/recurrence after surgery, progression for patients without surgery, or death due to any cause 
• Select pre-specified secondary endpoint^1,2,5: 
  • pCR^II (by BIPR): 0% residual viable tumor cells in both the primary tumor (lung) and sampled lymph nodes
• The median number of adjuvant doses received was 13 (range: 1-13) in both OPDIVO and chemo/placebo arms⁷

*EGFR testing was mandatory in all patients with NSQ histology. ALK testing was done in patients with a history of ALK alterations. EGFR/ALK testing done using US FDA/local health authority–approved assays.^6 
†Determined by the PD-L1 IHC 28-8 pharmDx assay (Dako).^6 
‡NSQ: cisplatin + pemetrexed, carboplatin + pemetrexed, or carboplatin + paclitaxel; SQ: cisplatin + docetaxel or carboplatin + paclitaxel.^8 
§Until disease progression, recurrence, unacceptable toxicity or for up to 13 cycles (~1 year) post-surgery.^1,5
∥Assessed per immune-related pathologic response criteria.⁸

AJCC=American Joint Committee on Cancer; ALK=anaplastic lymphoma kinase; ECOG PS=Eastern Cooperative Oncology Group Performance Status; EGFR=epidermal growth factor receptor; IHC=immunohistochemistry; NSQ=non-squamous; OS=overall survival; pCR=pathologic complete response; PD-L1=programmed death-ligand 1; q3w=every 3 weeks; q4w=every 4 weeks; SQ=squamous. 

Checkmate 77T baseline characteristics^2,6

Percentages may not total 100 due to rounding.

*1 patient had EGFR mutation and ALK translocation.^6 
†Five patients (2.2%) in the OPDIVO + chemo/OPDIVO group and 6 patients (2.6%) in the placebo + chemo/placebo group switched from cisplatin to carboplatin. Neoadjuvant platinum chemotherapy was not reported in 2 patients (0.9%) in the OPDIVO + chemo/OPDIVO group and 4 patients (1.7%) in the placebo + chemo/placebo group.^2
‡Disease stage (per AJCC 8th edition) as reported in case report forms. 2 (1%) patients in the OPDIVO + chemo/OPDIVO arm had stage IIIC disease, and 2 (1%) patients in the placebo + chemo/placebo arm had stage IV disease.^6
§Stage IIA was reported in 7% of patients in the OPDIVO + chemo/OPDIVO arm and 8% of patients in the placebo + chemo/placebo; stage IIB disease was reported in 29% and 27% of patients, respectively.^6
IIStage IIIA was reported in 45% of patients in the OPDIVO + chemo/OPDIVO arm and 49% of patients in the placebo + chemo/placebo arm; stage IIIB disease was reported in 19% and 15% of patients, respectively.^6
¶N3 node stage was reported in 2 patients (0.9%) in each treatment group.^2
#Determined using the PD-L1 IHC 28-8 pharmDx assay (Dako).⁶
**Includes only Argentina, Australia, Brazil, and Mexico.⁶

Dosing: Up to 4 cycles of OPDIVO + chemo prior to surgery and OPDIVO every 4 weeks post surgery^1,2,5

• OPDIVO is administered as an IV infusion over 30 minutes¹
• Refer to the respective Prescribing Information for each therapeutic agent for the recommended dosage and administration information as appropriate
• Administer OPDIVO first, followed by platinum-doublet chemo on the same day¹
• No premedication required with OPDIVO¹

*Any histology: paclitaxel and carboplatin; NSQ: pemetrexed and cisplatin or carboplatin; SQ: cisplatin and docetaxel.¹

IV=intravenous; Pt=platinum.

References:

1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
2. Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769.
3. Forde PM, Spicer J, Lu S, et al. Neoadjuvant nivolumab plush chemotherapy in resectable lung cancer. N Engl J Med. 2022;386(21):1973–1985.
4. Provencio Pulla M, Awad M, Cascone T, et al. Perioperative nivolumab vs placebo in patients with resectable NSCLC; clinical update from the phase 3 CheckMate 77T study. Oral presentation at ESMO 2024. Presentation number LBA50.
5. Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769 [protocol].
6. Cascone T, Awad MM, Spicer J, et al. CheckMate 77T: Phase 3 study comparing neoadjuvant nivolumab plus chemotherapy vs neoadjuvant placebo plus chemotherapy followed by surgery and adjuvant nivolumab or placebo for previously untreated, resectable stage II–IIIB NSCLC. Oral presentation at ESMO 2023. Abstract LBA1.
7. Awad MM, Cascone T, Spicer JD, et al. Clinical outcomes with perioperative nivolumab in patients with resectable NSCLC from the phase 3 CheckMate 77T study. Oral presentation at ELCC 2024. Abstract LBA2.
8. Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769 [supplementary appendix].
9. Data on file. BMS-REF-NIVO-0293. Princeton, NJ: Bristol-Myers Squibb Company. 2024.