OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is approved as a subcutaneous injection 

Perioperative NSCLC

See the impact of pCR* in
your patients2,3

With OPDIVO®, 25% of patients achieved pCR2,3

Checkmate 77T: Perioperative treatment
with an observed trend toward higher OS rates2,4†

Chemo optionality supports your choice of either
carboplatin- or cisplatin-based doublet therapy2

CHECKMATE 816: NOW WITH STATISTICALLY SIGNIFICANT
OS DATA5

25% Graphic

Checkmate 77T limitations

*In Checkmate 77T, the pCR rate was assessed in a descriptive analysis of a prespecified secondary endpoint; the statistical testing plan did not assign alpha control to this endpoint, so direct comparisons between the treatment arms cannot be made

OS data (HR=85% [95% CI: 0.61–1.18]) in Checkmate 77T were immature at the prespecified interim analysis and did not cross the boundary for statistical significance. These results should be interpreted with caution

  • Checkmate 77T primary endpoint: Median EFS at the 15.7-month minimum follow-up (median 25.4 months) for patients receiving neoadjuvant OPDIVO + chemo with adjuvant OPDIVO was not reached (95% CI: 28.9–NR) vs 18.4 months (95% CI: 13.6–28.1) for those receiving neoadjuvant placebo + chemo with adjuvant placebo. Checkmate 77T prespecified secondary endpoint: pCR at the 15.7-month minimum follow-up (median 25.4 months) for patients receiving neoadjuvant OPDIVO + chemo with adjuvant OPDIVO was 25% (n=58/229; [95% CI: 20–31]) and 4.7% (n=11/232; [95% CI: 2.4–8]) for those receiving neoadjuvant placebo + chemo with adjuvant placebo. Checkmate 77T interim OS data (prespecified secondary endpoint): Median OS at the 31.3-month minimum follow-up (median: 41.0 months) for patients receiving neoadjuvant OPDIVO + chemo with adjuvant OPDIVO was not reached (95% CI: NR–NR) and not reached (95% CI: NR–NR) for patients receiving neoadjuvant placebo + chemo with adjuvant placebo HR=0.85 (95% CI 0.61–1.18). The 24-month OS rates were 80% and 77% for neoadjuvant OPDIVO + chemo with adjuvant OPDIVO and neoadjuvant placebo + chemo with adjuvant placebo, respectively. The 30-month OS rates were 78% and 72% for neoadjuvant OPDIVO + chemo with adjuvant OPDIVO and neoadjuvant placebo + chemo with adjuvant placebo, respectively.2-4
  • Checkmate 816 primary endpoints: At the 2-year primary analysis of EFS, mEFS was 31.6 months (n=179 [95% CI: 30.2–NR]) with neoadjuvant OPDIVO + chemo vs 20.8 months (n=179 [95% CI: 14.0–26.7]) with chemo; HR=0.63 (95% CI: 0.45–0.87); P=0.0052.‡§ At the primary analysis, pCR was 24% (95% CI: 18.0–31.0) with neoadjuvant OPDIVO + chemo vs 2.2% (95% CI: 0.6–5.6) with chemo. Estimated treatment difference: 21.6% (95% CI: 15.1–28.2); P<0.0001.||¶ Checkmate 816 OS data (secondary endpoint): Median OS at the 59.9-month minimum follow-up (median: 68.4 months) for patients receiving neoadjuvant OPDIVO + chemo was not reached (95% CI: NR–NR) and 73.7 months (95% CI: 47.3–NR) for patients receiving neoadjuvant chemo; HR=0.72 (95% CI: 0.523–0.998); P=0.04792,5,6

Per BICR.6 §Primary analysis with a median follow-up of 29.5 months.6 ||Per BIPR. Includes those not undergoing surgery who will be considered as not achieving pCR.6 Primary analysis with a minimum follow-up of 7.6 months.6,7

BICR=blinded independent central review; BIPR=blinded independent pathologic review; CI=confidence interval; EFS=event-free survival; HR=hazard ratio; mEFS=median event-free survival; NR=not reached; NSCLC=non-small cell lung cancer; OS=overall survival; pCR=pathologic complete response.

CHECKMATE 77T 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 816 INDICATION: OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC.

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

OPDIVO is the ONLY FDA-approved I-O therapy to both provide 1 in 4 patients a chance at pCR* and demonstrate a significant EFS benefit2-4†‡

EFS per BICR in patients with Stage IIA-IIIB NSCLC

EFS: Minimum/median follow-up: 31.3/41.0 months.4
pCR: Minimum/median follow-up: 15.7/25.4 months.3
Limitation: The pCR rate was assessed in a descriptive analysis of a prespecified secondary endpoint; the statistical testing plan did not assign alpha control to this endpoint, so direct comparisons between the treatment arms cannot be made.

*pCR by BIPR is defined as 0% residual viable tumor cells in both the primary tumor (lung) and sampled lymph nodes.3,8
vs chemo with placebo.2,3
EFS per BICR is defined as time from randomization to disease progression that precludes surgery, abandoned surgery owing to unresectability, disease progression or recurrence after surgery, progression or recurrence for patients without surgery, or death due to any cause.2,3,8
§In patients with stage IIA–IIIB NSCLC, as determined by the 8th edition American Joint Committee on Cancer (AJCC) staging criteria.2,3
I-O=immuno-oncology.

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

An observed trend toward higher OS rates4*

Checkmate 77T Overall Survival (OS) at 41.10 months

Minimum/median follow-up: 31.3/41.0 months4
Limitation: OS data (HR=0.85 [95% CI: 0.61–1.18]) were immature at the prespecified interim analysis and did not cross the boundary for statistical significance. These results should be interpreted with caution.

  • EFS is a primary endpoint and pCR and OS are secondary endpoints3

*vs chemo with placebo.4

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.

National Comprehensive Cancer Network® (NCCN®) recommendations for perioperative systemic therapy for NSCLC

NCCN CATEGORY 1 Recommended

Nivolumab (OPDIVO®) and platinum-doublet chemotherapy* (every 3 weeks for up to 4 cycles with the option to continue single-agent nivolumab as adjuvant treatment after surgery every 4 weeks for up to 13 cycles) is recommended as an NCCN Category 1 therapy option for eligible patients with resectable (tumor ≥4 cm or node positive) NSCLC, regardless of PD-L1 expression and no known EGFR mutations or ALK rearrangements.9

Nivolumab and hyaluronidase-nvhy subcutaneous injection may be substituted for IV nivolumab.

Only nivolumab-based regimens are NCCN-recommended9:

  • Exclusively for neoadjuvant treatment alone or neoadjuvant treatment with the option of continuing single-agent nivolumab (or nivolumab and hyaluronidase-nvhy) as adjuvant treatment after surgery
  • For use with both carboplatin- and cisplatin-based doublet therapy, providing physicians with multiple options
  • For IV (nivolumab) and SC injection (nivolumab and hyaluronidase-nvhy) use

Neoadjuvant systemic therapy: Patients with tumors ≥4 cm or node positive should be evaluated for preoperative therapy, with strong consideration for an immune checkpoint inhibitor + chemotherapy.9‡

FDA-approved indications and recommended dosage1,2:

  • Neoadjuvant treatment — Nivolumab 360 mg IV or nivolumab and hyaluronidase-nvhy 900 mg/15,000 units subcutaneous injection q3w + PDC on same day q3w for 3 cycles for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC
  • Perioperative treatment — Nivolumab 360 mg IV or nivolumab and hyaluronidase-nvhy 900 mg/15,000 units subcutaneous injection q3w + PDC on same day q3w for up to 4 cycles or until disease progression/unacceptable toxicity for the neoadjuvant treatment of resectable NSCLC and no known EGFR mutations or ALK rearrangements, followed by nivolumab 480 mg IV or nivolumab and hyaluronidase-nvhy 1,200 mg/20,000 units subcutaneous injection q4w as single agent after surgery for up to 13 cycles (~1 year) or until disease recurrence/unacceptable toxicity

Please see updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for a complete listing of all NCCN-recommended agents, including preferred options.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

*Platinum-doublet chemo q3w for up to 4 cycles: any histology: carboplatin and paclitaxel or cisplatin and paclitaxel; NSQ: cisplatin and pemetrexed; SQ: cisplatin and gemcitabine. Chemotherapy regimens for patients not candidates for cisplatin-based therapy: NSQ: carboplatin and pemetrexed; SQ: carboplatin and gemcitabine.9 Nivolumab and hyaluronidase-nvhy has different dosing and administration instructions compared with IV nivolumab.9 Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents; some oncogenic drivers (eg, EGFR exon 19 deletion or exon 21 L858R, ALK, RET, or ROS1 rearrangements) have been shown to be associated with less benefit from PD-1/PD-L1 inhibitors. Otherwise refer to the Neoadjuvant Systemic Therapy for Patients Not Candidates for Immune Checkpoint Inhibitors.9

ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; IV=intravenous; NCCN=National Comprehensive Cancer Network; NSQ=non-squamous; PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1; PDC=platinum-doublet chemotherapy; q3w=every 3 weeks; q4w=every 4 weeks; SQ=squamous.

Dosing: Up to 4 cycles of OPDIVO Qvantig + chemo prior to surgery and OPDIVO Qvantig every 4 weeks post surgery1

OPDIVO is still available as an IV infusion. View OPDIVO IV dosing schedule >

OPDIVO Qvantig™ (nivolumab+hyaluronidase-nvhy) dosing schedule

INDICATION OPDIVO Qvantig (nivolumab + hyaluronidase-nvhy), 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 OPDIVO Qvantig as monotherapy in the adjuvant setting after surgical resection.

  • OPDIVO Qvantig is administered as a 3- to 5-minute subcutaneous injection1
  • Refer to the respective Prescribing Information for each therapeutic agent for the recommended dosage and administration information as appropriate
  • Administer OPDIVO Qvantig first, followed by platinum-doublet chemo on the same day1*
  • No premedication required with OPDIVO Qvantig1

*Every 3 weeks until disease progression, unacceptable toxicity, or for up to 4 cycles.1,2
Platinum-doublet chemotherapy consisted of one of the following: Paclitaxel 175 mg/m2 or 200 mg/m2 and carboplatin AUC 5 or AUC 6 (any histology); pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC 5 or AUC 6 (nonsquamous histology); or cisplatin 75 mg/m2 and docetaxel 75 mg/m2 (squamous histology).1,2

Pt=platinum.

Perioperative OPDIVO: Studied in patients with stage IIA-IIIB NSCLC2,3,8,10

OPDIVO was studied using both carboplatin- and cisplatin-based doublet therapy2

  • Primary endpoint2,3,8:
    • EFS (by BICR): Time from randomization to disease progression that precludes surgery, abandoned surgery owing to unresectability, disease progression or recurrence after surgery, progression or recurrence for patients without surgery, progression for patients without surgery, or death due to any cause 
  • Select prespecified secondary endpoint3,8:
    • pCRII (by BIPR): 0% residual viable tumor cells in both the primary tumor (lung) and sampled lymph nodes
  • The medium number of adjuvant doses received was 13 (range: 1–13) in both OPDIVO + chemo/OPDIVO and placebo + chemo/placebo arms11

*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.10
Determined by the PD-L1 IHC 28-8 pharmDx assay (Dako).10
NSQ: cisplatin + pemetrexed, carboplatin + pemetrexed, or carboplatin + paclitaxel; SQ: cisplatin + docetaxel or carboplatin + paclitaxel.10
§Until disease progression, recurrence, unacceptable toxicity or for up to 1 year (13 cycles) post-surgery.2,8
Assessed per immune-related pathologic response criteria.10

ECOG PS=Eastern Cooperative Oncology Group performance status; IHC=immunohistochemistry.

Checkmate 77T baseline characteristics3,11

 

Characteristics OPDIVO + chemo/OPDIVO 
(n=229)
Placebo + chemo/placebo
(n=232)*
Median age, years (range) 66 (37–83) 66 (35–86)
Male, % 73 69
Platinum therapy type, %
Cisplatin
Carboplatin

24
73

18
78
ECOG PS, %
0
1

64
36

61
39

Disease Stage, (%)
IIA-B§ 
IIIA-BII

35
64
35
64
Node stage,%
N0
N1
N2
     Single-station
     Multistation

35
25
40
26
14

38
22
39
23
16
Histology, %
Squamous
Non-squamous

51
49

51
49
Smoking status, %
Current/former
Never

93
7

88
12
Tumor PD-L1 expression,# %
Not evaluable
<1%
≥1%
     1-49%
     ≥50%

4
41
56
36
20

5
40
55
33
22
Geographic region, %
North America
Europe
Asia
Rest of the world**

10
54
28
8

9
55
22
15

Percentages may not total 100 due to rounding.

*One patient had EGFR mutation and ALK translocation.11
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.3
Disease stage (per AJCC 8th edition) as reported in case report forms. Two (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.11
§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.11
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.11

N3 node stage was reported in 2 patients (0.9%) in each treatment group.3
#Determined using the PD-L1 IHC 28-8 pharmDx assay (Dako).11
**Includes only Argentina, Australia, Brazil, and Mexico.11

See pCR data for the neoadjuvant treatment of resectable NSCLC from Checkmate 816

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Safety Data

View a selected safety profile of adverse reactions seen in clinical trials.

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Dosing Schedules

Find dosing information to get patients started on therapy. 

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More NSCLC Indications

Learn how OPDIVO and OPDIVO-based combinations treat non-small cell lung cancer.

Learn more about how OPDIVO is approved for use in earlier stages of cancer

References:

  1. OPDIVO QvantigTM [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  3. Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769.
  4. Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab vs placebo in patients with resectable NSCLC: updated survival and biomarker analyses from CheckMate 77T. Oral presentation at ASCO 2025. Abstract LBA8010.
  5. Forde PM, Spicer JD, Provencio M, et al. Overall survival with neoadjuvant nivolumab plus chemotherapy in lung cancer. N Engl J Med. 2025 Jun 2. doi:10.1056/NEJMoa2502931.
  6. Forde PM, Spicer J, Lu S, et al. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N Engl J Med. 2022;386(21):1973-1985.
  7. Forde PM, Spicer J, Lu S, et al. Nivolumab + platinum doublet chemotherapy vs hemotherapy as neoadjuvant treatment for resectable (IB IIIA) non-small cell lung cancer in the phase 3 CheckMate 816 trial. Oral presentation at AACR 2021. Abstract CT003.
  8. Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769 [protocol].
  9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer. V.6.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed July 7, 2025. To view the most recent and complete version of the guideline, go toNCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  10. 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].
  11. 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.


466-US-2500115 06/25