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In resectable Stage IIA to IIIB (tumors ≥4 cm and/or node positive [N1, N2]) NSCLC with no known EGFR mutations or ALK rearrangements
STAGE II:
~28%
STAGE IIIA:
~47%
STAGE IIIB:
~24%
| Characteristic† | Characteristic† | The AEGEAN Regimen (n=366) |
Neoadjuvant CT alone (n=374) |
||
|---|---|---|---|---|---|
| Age | Median (range in years) | 65 (30-88) | 65 (39-85) | ||
| ≥75 years | 12% | 9.6% | |||
| Sex | Male | 68.9% | 74.3% | ||
| Female | 31.1% | 25.7% | |||
| ECOG PS‡ | 0 | 68.6% | 68.2% | ||
| 1 | 31.4% | 31.8% | |||
| Race§ | Asian | 39.1% | 43.9% | ||
| White | 56.3% | 51.1% | |||
| Other | 4.6% | 5.1% | |||
| Ethnic group | Hispanic or Latino | 17.2% | 15% | ||
| Not Hispanic or Latino | 82.8% | 85% | |||
| Geographic region | Asia | 38.8% | 43.6% | ||
| Europe | 38.5% | 37.4% | |||
| North America | 11.7% | 11.5% | |||
| South America | 10.9% | 7.5% | |||
| Smoking status | Current | 26% | 25.4% | ||
| Former | 60.1% | 59.6% | |||
| Never | 13.9% | 15% | |||
| Characteristic† | Characteristic† | The AEGEAN Regimen
(n=366) |
Neoadjuvant CT alone
(n=374) |
||
|---|---|---|---|---|---|
| Disease stage|| | II | 28.4% | 29.4% | ||
| IIIA | 47.3% | 44.1% | |||
| IIIB | 24% | 26.2% | |||
| TNM classification,
primary tumor¶ |
T1 | 12% | 11.5% | ||
| T2 | 26.5% | 28.9% | |||
| T3 | 35% | 34.5% | |||
| T4 | 26.5% | 25.1% | |||
| TNM stage, regional
lymph nodes |
N0 | 30.1% | 27.3% | ||
| N1 | 20.5% | 23.3% | |||
| N2 | 49.5% | 49.5% | |||
| Single-station | 38.5% | 35.3% | |||
| Multistation | 9.3% | 10.7% | |||
| Histologic
classification |
Squamous | 46.2% | 51.1% | ||
| Nonsquamous | 53.6% | 47.9% | |||
| PD-L1 expression | Tumor cell <1% | 33.3% | 33.4% | ||
| Tumor cell 1% to 49% | 36.9% | 38% | |||
| Tumor cell ≥50% | 29.8% | 28.6% | |||
| Planned neoadjuvant platinum agent |
Cisplatin | 27.3% | 25.7% | ||
| Carboplatin | 72.7% | 74.3% | |||
Critical factors were evaluated by the MDT, including the resectability of the tumor and operability of the patient.2
AEGEAN was designed to identify appropriate patients for an IO-based perioperative treatment strategy2#
Full MDT evaluation is critical to determine resectability and operability for every patient before deciding on a treatment plan for resectable NSCLC3,4
*The mITT population excluded patients with documented EGFR or ALK alterations who were enrolled before a protocol amendment.2
†Characteristics for which there were missing or other responses were histologic classification (0.3% of the patients in the IMFINZI group and 1.1% of those in the placebo group had other histologic classification), disease stage (0.3% in the IMFINZI group had Stage IV disease and 0.3% in the placebo group had Stage III [not otherwise specified] disease, as reported on the electronic case-report form), and N2 lymph node station stage (1.6% in the IMFINZI group and 3.5% in the placebo group had N2 disease with missing data on single-station vs multistation classification).2
‡ECOG PS scores range from 0 to 5, with higher scores indicating greater disability.2
§Race was reported by the patients.2
||Patients with Stage IIA disease to Stage IIIB (N2 node stage) disease according to the 8th edition of the AJCC Cancer Staging Manual were enrolled.2
¶All patients had disease that was classified as M0 except for one patient in the IMFINZI group who had disease that was classified as M1 (not otherwise specified).2
#Inclusion criteria included: Previously untreated patients with documented NSCLC, no prior exposure to immune-mediated therapy, WHO/ECOG performance status of 0 or 1. Patients with active or prior autoimmune disease, or use of any immunosuppressive medication within 14 days of the first dose of IMFINZI were ineligible.2
**Investigators were allowed the choice of
platinum-based
CT regimen for neoadjuvant treatment: Carboplatin/
paclitaxel,
cisplatin/gemcitabine, pemetrexed/cisplatin,
and pemetrexed/carboplatin. In the
event of unfavorable tolerability, patients in the study were able to switch from cisplatin to
carboplatin therapy. In patients with comorbidities or who were unable to tolerate cisplatin per
investigator's judgement, carboplatin AUC 5 can be administered from Cycle 1. The platinum-based CT
regimen of cisplatin + paclitaxel may be considered; however, this therapy regimen was used outside the
per-protocol choice. Preoperative radiotherapy was not allowed in either arm.2
††These characteristics were excluded after an amendment to the study protocol.2
‡‡Surgical procedures did include unplanned pneumonectomies.2
AJCC=American Joint Committee on Cancer; ALK=anaplastic lymphoma kinase; AUC=area under
the curve; CT=chemotherapy; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor
receptor; IO=immuno-oncology; MDT=multidisciplinary team; mITT=modified intent to treat; NSCLC=non-small
cell lung cancer; PD-L1=programmed death-ligand 1; PS=performance status; TNM=tumor, node,
metastasis; WHO=World Health Organization.
This is not an actual patient. This representation was not designed to assess efficacy for an individual patient subgroup. Individual results may vary.
The MDT evaluated several factors to determine the optimal treatment for Charles:
Tumor characteristics
Biomarker testing results
Resectability factors
Operability factors
What factors do you consider when determining a treatment plan for patients like Charles?
ALK=anaplastic lymphoma kinase; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; NGS=next-generation sequencing; NSCLC=non-small cell lung cancer; PD-L1=programmed death-ligand 1; PFT=pulmonary function test; TPS=tumor proportion score.
This is not an actual patient. This representation was not designed to assess efficacy for an individual patient subgroup. Individual results may vary.
The MDT evaluated several factors to determine the optimal treatment for Beth:
Tumor characteristics
Biomarker testing results
Resectability factors
Operability factors
How do you determine when a Stage II patient is a good candidate for a perioperative treatment regimen?
ECOG=Eastern Cooperative Oncology Group; NGS=next-generation sequencing; NSCLC=non-small cell lung cancer; PD-L1=programmed death-ligand 1; PFT=pulmonary function test; TPS=tumor proportion score.
This is not an actual patient. This representation was not designed to assess efficacy for an individual patient subgroup. Individual results may vary.
The MDT evaluated several factors to determine the optimal treatment for Peter:
Tumor characteristics
Biomarker testing results
Resectability factors
Operability factors
How would you choose the treatment plan for a patient like Peter?
ALK=anaplastic lymphoma kinase; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; NGS=next-generation sequencing; NSCLC=non-small cell lung cancer; PD-L1=programmed death-ligand 1; PFT=pulmonary function test; TPS=tumor proportion score.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test.
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be
fatal.
IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea.
Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory
immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup
to exclude alternative etiologies.
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.
IMFINZI and IMJUDO can cause immune-mediated nephritis.
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test.
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.
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