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

Neoadjuvant NSCLC

Shifting the paradigm for resectable NSCLC*

*Prior to the 2022 approval of the Checkmate 816 regimen—as the first I-O–based treatment regimen in the neoadjuvant-only setting for resectable NSCLC—surgery was the standard of care in this treatment setting.2,3

Per the 7th edition American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging criteria.2

I-O=immuno-oncology; NSCLC=non-small cell lung cancer; PD-L1=programmed death-ligand 1.

INDICATION OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

CHECKMATE 816: FOR PATIENTS WITH RESECTABLE NSCLC, REGARDLESS OF PD-L1 EXPRESSION

OPDIVO + chemo is the only approved regimen* with the highest pCR, giving ~1 in 4 patients a chance at pCR vs chemo2,4†

pCR, ITT (PRIMARY ANALYSIS)2,4,5†

Checkmate 816 Efficacy: pCR, ITT with Neoadjuvant OPDIVO® (nivolumab) + Chemotherapy, Chart
  • Primary endpoints
    • pCR: 0% residual viable tumor cells in both the primary tumor (lung) and sampled lymph nodes4†
    • EFS: Time from randomization to disease progression that precludes surgery, disease progression/recurrence after surgery, progression for patients without surgery, or death due to any cause4‡
  • pCR and EFS are co-primary endpoints and OS is a secondary endpoint4
    • At the 2-year primary analysis of EFS, mEFS was 31.6 months (95% CI: 30.2–NR) with neoadjuvant OPDIVO + chemo vs 20.8 months (95% CI: 14.0–26.7) with chemo; HR=0.63 (95% CI: 0.45–0.87); P=0.00522,4‡§
    • At the 5-year follow-up analysis of EFS, mEFS was 59.6 months (95% CI: 31.6–NA) with OPDIVO + chemo vs 21.1 months (95% CI: 16.5–36.8) with chemo; HR=0.68 (95% CI: 0.51–0.91). EFS was 49% with OPDIVO + chemo vs 34% with chemo6‡||

*I-O plus chemotherapy as a neoadjuvant-only regimen.7
Per BIPR. Includes those not undergoing surgery, who will be considered as not achieving pCR.4
Per BICR.8
§Primary analysis with a median follow-up of 29.5 months.4
||Extended follow-up is exploratory analysis.7

BICR=blinded independent central review; BIPR=blinded independent pathological review; CI=confidence interval; EFS=event-free survival; HR=hazard ratio; ITT=intent-to-treat; mEFS=median event-free survival; NA=not applicable; NR=not reached; pCR=pathologic complete response.

Select Important Safety Information
Serious Adverse Reactions

In Checkmate 816, adverse reactions occurred in 30% of patients (n=176) who were treated with OPDIVO in combination with platinum-doublet chemotherapy. Serious adverse reactions in >2% included pneumonia and vomiting. No fatal reactions occurred in patients who received OPDIVO in combination with platinum-doublet chemotherapy.

Common Adverse Reactions

In Checkmate 816, the most common (>20%) adverse reactions in the OPDIVO plus chemotherapy arm (n=176) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%).

Please see additional Important Safety Information below.

OPDIVO + chemo: the ONLY neoadjuvant-only option to demonstrate a statistically significant improvement in overall survival vs chemo6,9

OS, ITT (FINAL ANALYSIS AT 5 YEARS)6,9

Checkmate 816 OS, ITT (Pre-Specified Interim Analysis at 5 Years), Chart

Minimum/median follow-up: 59.9/68.4 months.6

A prespecified interim analysis for OS resulted in an HR of 0.57 (95% CI: 0.38–0.87), which did not cross the boundary for statistical significance. At the final analysis, OS data crossed the boundary for statistical significance.4,6

Longest follow-up time among neoadjuvant and perioperative I-O NSCLC studies.6*

*Follow-up time for Checkmate 816 is 68.4 months (median follow-up for OS).6

OS=overall survival.

Overall survival by pCR statusa in concurrently randomized patients6,9*

OVERALL SURVIVAL BY pCR6,9*

Checkmate 816 Overall Survival by pCR, graph

Minimum/median follow-up: 59.9/68.4 months.6

aLimitation: Checkmate 816 was not powered to detect differences in treatment effect for OS by pCR status; therefore, this exploratory analysis should be interpreted with caution because of the limited patient numbers and potential imbalances in baseline characteristics within the subgroup.

*In the OPDIVO + chemo arm: 3 deaths in patients with pCR, none due to disease; 62 (46.6%) deaths in patients with no pCR, 44 (33.1%) due to disease. In the chemo arm: no deaths in patients with pCR, and 82 (47.7%) deaths in patients with no pCR, 60 (34.9%) due to disease.6
HRs were not calculated if there was an insufficient number of events (<10 per arm).6

Consistent pCR observed* with neoadjuvant OPDIVO + chemo, regardless of stage4,10†‡

pCR RATE BY STAGE OF DISEASE AT BASELINE (EXPLORATORY ANALYSIS)4,10†‡

Checkmate 816 pCR Rate by stage of disease at baseline, Chart

Minimum follow-up of 7.6 months.10

Limitation: Checkmate 816 was not powered to detect differences in treatment effect within individual stage subgroups; therefore, this exploratory analysis should be interpreted with caution because of the limited patient numbers and potential imbalances in baseline characteristics within the subgroup.

*vs chemo.4,10
Per BIPR. Includes those not undergoing surgery, who will be considered as not achieving pCR.4,10
Baseline stage of disease by CRF; TNM 7th edition used for classification.10

CRF=case report form; TNM=classification of malignant tumors. 

Superior EFS with neoadjuvant OPDIVO + chemo in the ITT population vs chemo6*

EFS, ITT (FOLLOW-UP ANALYSIS AT 5 YEARS)2,4,6*

Checkmate 816 EFS, ITT (Follow-up Analysis at 5 Years), Chart

Minimum/median follow-up: 59.9/68.4 months.6

*Per BICR.6

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.11

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

Only nivolumab-based regimens are NCCN-recommended11

  • 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.11‡

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.11 Nivolumab and hyaluronidase-nvhy has different dosing and administration instructions compared with IV nivolumab.11 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.11

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.

Neoadjuvant OPDIVO + chemo: 3 cycles of treatment studied in stage IB-IIIA resectable NSCLC patients2,4,12*

Checkmate 816 Study Design, graphic
  • 83% of patients treated with neoadjuvant OPDIVO + chemo received definitive surgery and 75% with chemo2

Neoadjuvant OPDIVO + chemo for resectable NSCLC was studied using both carboplatin- and cisplatin-based doublet therapy11

  • Primary endpoints
    • pCR (per BIPR): 0% residual viable tumor cells in both the primary tumor (lung) and sampled lymph nodes
    • EFS (per 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 cause8
  • Key secondary endpoint
    • OS2,12
  • The trial excluded patients with unresectable or metastatic NSCLC, known EGFR mutations or ALK translocations, Grade 2 or greater peripheral neuropathy, active autoimmune disease, or medical conditions requiring systemic immunosuppression2
  • Within the ITT population, 50% had tumors with PD-L1 expression ≥1%, 51% had tumors with squamous histology, and 49% had tumors with non-squamous histology2

*Platinum-doublet chemo q3w for 3 cycles; NSQ: pemetrexed and cisplatin or paclitaxel and carboplatin; SQ: gemcitabine and cisplatin or paclitaxel and carboplatin.2
Per the 7th edition American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging critera.2
Determined by the PD-L1 IHC 28-8 pharmDx assay (Dako); PD-L1 <1% stratification includes patients with PD-L1 expression status not evaluable and indeterminate.12
§
The approved recommended dosage of OPDIVO per the Prescribing Information is 360 mg q3w with platinum-doublet chemo on the same day q3w for 3 cycles.2
||
In the platinum-doublet chemo arm, two additional treatment regimen options included vinorelbine and cisplatin, or docetaxel and cisplatin (any histology).2
Per BIPR. Includes those not undergoing surgery who will be considered as not achieving pCR.4

IHC=immunohistochemistry.

OPDIVO Qvantig + chemo: 3 cycles of treatment prior to surgery1*

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

INDICATION OPDIVO Qvantig (nivolumab + hyaluronidase-nvhy), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

  • 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

*Platinum-doublet chemo consisted of 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 (non-squamous histology); or gemcitabine 1000 mg/m2 or 1250 mg/m2 and cisplatin 75 mg/m2 (squamous histology). In the platinum-doublet chemo arm, two additional treatment regimen options included vinorelbine 25 mg/m2 or 30 mg/m2 and cisplatin 75 mg/m2, or docetaxel 60 mg/m2 or 75 mg/m2 and cisplatin 75 mg/m2 (any histology).1,2

AUC=area under the curve; IV=intravenous; Pt=platinum.

See pCR data for the perioperative treatment of NSCLC from Checkmate 77T

Bar graph with magnifying glass icon
Safety Data

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

OPDIVO® (nivolumab) vial with timer icon
Dosing Schedules

Find dosing information to get patients started on therapy. 

Lung icon
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. Remon J, Soria JC, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer: an update of the ESMO Clinical Practice Guidelines focusing on diagnosis, staging, systemic and local therapy. Ann Oncol. 2021;32(12):1637-1642.
  4. 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.
  5. Forde PM, Spicer J, Lu S, et al. Nivolumab + platinum-doublet chemotherapy vs chemotherapy 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.
  6. Forde PM, Spicer JD, Provencio M, et al. Overall survival with neoadjuvant nivolumab + chemotherapy in patients with resectable NSCLC in CheckMate 816. Oral presentation at ASCO 2025. Abstract LBA8000.
  7. Spicer JD, Girard N, Provencio Pulla M, et al. Neoadjuvant nivolumab plus chemotherapy vs chemotherapy in patients with resectable NSCLC: 4-year update from CheckMate 816. Oral presentation at: ASCO 2024. Abstract LBA8010.
  8. Forde PM, Spicer J, Girard N, et al. Neoadjuvant nivolumab plus platinum-doublet chemotherapy for resectable NSCLC: 3-year update from CheckMate 816. Oral presentation at ELCC 2023. Abstract 840.
  9. 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.
  10. Spicer J, Wang C, Tanaka F, et al. Surgical outcomes from the phase 3 CheckMate 816 trial: nivolumab + platinum-doublet chemotherapy vs chemotherapy alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer. Oral presentation at ASCO 2021. Abstract 8503.
  11. 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 to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibilities for their application or use in any way.
  12. Girard N, Spicer J, Mariano P, et al. Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as neoadjuvant treatment for resectable (IB-IIIA) non-small cell lung cancer (NSCLC): Event-free survival (EFS) results from the phase 3 CheckMate 816 trial. Oral presentation at AACR 2022. Abstract CT012.


466-US-2500115 06/25