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PATIENTS WITH ADVANCED SQUAMOUS NSCLC ARE IN URGENT NEED OF OPTIONS THAT MAY DELIVER TUMOR RESPONSE3

Lung cancer histology4
Lung cancer histology

~30% of lung cancers are
squamous cell carcinoma

NSCLC=non–small cell lung cancer.

Squamous cell carcinomas
Squamous cell carcinomas
  • Associated with a poorer prognosis than nonsquamous3
  • Tumors are often centrally located5
  • Have been shown to grow twice as fast as adenocarcinoma6
  • Often seen extrinsically pushing into airway structures as they grow7
  • Associated with a history of smoking5

NSCLC=non–small cell lung cancer.

RESPONSE RATES ARE HELPFUL IN ASSESSING CLINICAL BENEFIT

ORR is a clinically meaningful endpoint in NSCLC trials, which can help physicians choose an appropriate treatment8

Using ORR as an endpoint in oncology drug approval has a long history

Response criteria have been used for more than 30 years9

ORR=overall response rate.

TUMOR RESPONSE IS A RIGOROUS MEASUREMENT8

Spatial measurement of tumor shrinkage is a form of direct, real-time clinical assessment11

MEASURE OF THE GREATER UNIDIMENSIONAL DIAMETERS

Measure the greater unidimensional diameteres Measure the greater unidimensional diameteres

RECIST Criteria10

CR=complete response

PR=partial response

SD=stable disease

PD=progressive disease

CR

Disappearance of all clinical and radiological evidence of target lesions

CD: Disappearance of all clinical and radiological evidence of target lesions CD: Disappearance of all clinical and radiological evidence of target lesions
CD: Disappearance of all clinical and radiological evidence of target lesions CD: Disappearance of all clinical and radiological evidence of target lesions

PR

≥30% decrease of the greater unidimensional diameters

PR: ≥30% decrease of the greater unidimensional diameters PR: ≥30% decrease of the greater unidimensional diameters
PR: ≥30% decrease of the greater unidimensional diameters PR: ≥30% decrease of the greater unidimensional diameters

SD

Failure to observe CR or PR, but no PD

SD: Failure to observe CR or PR, but no PD SD: Failure to observe CR or PR, but no PD
SD: Failure to observe CR or PR, but no PD SD: Failure to observe CR or PR, but no PD

PD

≥20% decrease of the greater unidimensional diameters or presence of new lesion

PD: ≥20% decrease of the greater unidimensional diameters or presence of new lesion PD: ≥20% decrease of the greater unidimensional diameters or presence of new lesion
PD: ≥20% decrease of the greater unidimensional diameters or presence of new lesion PD: ≥20% decrease of the greater unidimensional diameters or presence of new lesion

Response assessment under RECIST guidelines is based on measurement of the longest single-dimension diameters of target lesions, which are identified at baseline.

RECIST=Response Evaluation Criteria In Solid Tumors.

CLOSE THE TAB

THE ABRAXANE PIVOTAL PHASE III TRIAL INCLUDED OVER 1000 PATIENTS WITH ADVANCED SQUAMOUS AND NONSQUAMOUS NSCLC

Treatment administered until disease progression or development of unacceptable toxicity

Treatment administered until disease progression or development of unacceptable toxicity

Studied in a broad range of chemonaïve patients with advanced NSCLC

Stratified by histologies and age10,11
ABRAXANE + carboplatin arm (n=521)

In the NSCLC study, 44% of patients had squamous cell carcinoma, 49% had adenocarcinoma, 2% had large cell carcinoma, and 6% had other types of NSCLC. 31% were ≥65 years of age, and 69% were <65 years of age.

Three-quarters of the patients had a history of
smoking11

ABRAXANE + carboplatin arm (n=519)a

In the Phase III study, 74% of patients had a history of smoking and 26% never smoked In the Phase III study, 74% of patients had a history of smoking and 26% never smoked

The smoking status was unknown for 2 patients in the ABRAXANE + carboplatin arm.
aNSCLC=advanced non–small cell lung cancer; AUC=area under the curve; IV=intravenously.

Chart icon

See ORR for ABRAXANE + carboplatin vs paclitaxel in aNSCLC

ABRAXANE + CARBOPLATIN DELIVERED SIGNIFICANTLY
SUPERIOR ORR VS PACLITAXEL

ORR in the ITT population of the Phase III trial for first-line advanced or metastatic NSCLC
Overall response rate in the ITT population was 33% with ABRAXANE + carboplatin (n=170/521 [95% CI: 28.6%-36.7%]) vs 25% with paclitaxel injection + carboplatin (n=132/531 [95% CI: 21.2%-28.5%]) (P=0.005) - bar chart Overall response rate in the ITT population was 33% with ABRAXANE + carboplatin (n=170/521 [95% CI: 28.6%-36.7%]) vs 25% with paclitaxel injection + carboplatin (n=132/531 [95% CI: 21.2%-28.5%]) (P=0.005) - bar chart

P=0.005 (based on chi-square test).

  • Median duration of response was 6.9 months vs 6.0 months (95% CI: 5.6-8.0 vs 5.6-7.1, respectively)
  • No statistically significant difference in OS between the 2 study arms (median OS 12.1 months vs 11.2 months, P=NS10)

ITT=intent-to-treat; NS=not significant.

41% ORR IN FIRST-LINE SQUAMOUS

Squamous advanced or metastatic NSCLC
41% ORR in first-line squamous NSCLC 41% ORR in first-line squamous NSCLC
RESPONSE RATE IN OTHER HISTOLOGIES

Carcinoma/Adenocarcinoma

  • 26% (66/254) for ABRAXANE + carboplatin vs 27% (71/264) for paclitaxel injection + carboplatin

Large cell carcinoma

  • 33% (3/9) for ABRAXANE + carboplatin vs 15% (2/13) for paclitaxel injection + carboplatin

Other forms of nonsquamous disease

  • 24% (7/29) for ABRAXANE + carboplatin vs 15% (5/33) for paclitaxel injection + carboplatin

WELL-ESTABLISHED SAFETY PROFILE

Selected ARs with a difference of ≥5% for all grades or ≥2% for Grades 3-4 toxicity between treatment groups
Selected ARs with a difference of ≥5% for all grades or ≥2% for Grades 3-4 toxicity between treatment groups Selected ARs with a difference of ≥5% for all grades or ≥2% for Grades 3-4 toxicity between treatment groups

508 patients assessed in ABRAXANE + carboplatin–treated group.

514 patients assessed in paclitaxel injection + carboplatin–treated group.

513 patients assessed in paclitaxel injection + carboplatin–treated group.

Peripheral neuropathy is defined by the MedDRA v14.0 SMQ neuropathy (broad scope).

AR=adverse reaction; MedDRA=Medical Dictionary for Regulatory Activities; Q3W=every 3 weeks; SMQ=Standardized MedDRA Query.

ESTABLISHED SAFETY PROFILE IN ADVANCED NSCLC

Common ARs (≥10%) for ABRAXANE + carboplatin observed at a similar incidence as with paclitaxel injection + carboplatin
Common ARs (≥10%) for ABRAXANE + carboplatin observed at a similar incidence as with paclitaxel injection + carboplatin Common ARs (≥10%) for ABRAXANE + carboplatin observed at a similar incidence as with paclitaxel injection + carboplatin CLOSE THE TAB
Patient and Healthcare Resources

Download the “Preparing for My Treatment” Brochure: Help Your Patients With
Advanced NSCLC Get Ready for Their Medical Appointments

GRADE 3 NEUROPATHY: MEDIAN TIME TO IMPROVEMENT WITHIN
1 MONTH AFTER DOSE
MODIFICATION11

48% of patients who received ABRAXANE + carboplatin developed any grade peripheral neuropathy compared with 64% of patients in the paclitaxel + carboplatin arm
Grade 3 peripheral neuropathy in the ABRAXANE + carboplatin arm vs paclitaxel + carboplatin
Grade 3 peripheral neuropathy in the ABRAXANE + carboplatin arm vs paclitaxel + carboplatin Grade 3 peripheral neuropathy in the ABRAXANE + carboplatin arm vs paclitaxel + carboplatin
  • 1% of patients discontinued ABRAXANE due to peripheral neuropathy
  • No patients in the ABRAXANE + carboplatin arm developed Grade 4 peripheral neuropathy
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Learn About Dose Modification for Treatment-related Neuropathy

DOSAGE & ADMINISTRATION: ABRAXANE + CARBOPLATIN

Administer ABRAXANE intravenously at a dose of 100 mg/m2 over 30 minutes on a weekly schedule on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin intravenously on Day 1 of each 21-day cycle immediately after completion of ABRAXANE administration Administer ABRAXANE intravenously at a dose of 100 mg/m2 over 30 minutes on a weekly schedule on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin intravenously on Day 1 of each 21-day cycle immediately after completion of ABRAXANE administration
  • Administer ABRAXANE intravenously at a dose of 100 mg/m2 over 30 minutes on a weekly schedule on Days 1, 8, and 15 of each 21-day cycle
  • Administer carboplatin intravenously on Day 1 of each 21-day cycle immediately after completion of ABRAXANE administration

Note: DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. ABRAXANE has different dosage and administration instructions from other paclitaxel products.

ABRAXANE is administered generally without the need for steroid pretreatment
  • Premedication may be needed in patients who have had a prior hypersensitivity reaction to ABRAXANE
  • Severe hypersensitivity reactions with fatal outcome have been reported with ABRAXANE. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
  • Patients with a previous history of hypersensitivity to other taxanes should be closely monitored during initiation of ABRAXANE therapy

MEDIAN NUMBER OF TREATMENT CYCLES IN THE PHASE III PIVOTAL TRIAL OF ABRAXANE + CARBOPLATIN

Median number of treatment cycles in the Phase III pivotal trial of ABRAXANE + carboplatin Median number of treatment cycles in the Phase III pivotal trial of ABRAXANE + carboplatin

Patients in the study were treated until disease progression or development of unacceptable toxicity.

DOSE ADJUSTMENTS OBSERVED IN THE PHASE III PIVOTAL TRIAL

Adverse reactions were assessed in 514 patients treated with ABRAXANE + carboplatin

Dose adjustments observed in the Phase III pivotal trial. Adverse reactions were assessed in 514 patients treated with ABRAXANE + carboplatin Dose adjustments observed in the Phase III pivotal trial. Adverse reactions were assessed in 514 patients treated with ABRAXANE + carboplatin
CLOSE THE TAB

PLEASE SELECT A DOSE MODIFICATION BELOW:

Recommendations for starting dose in patients with hepatic impairment

SGOT (AST) LEVELS
<10 x ULN AND BILIRUBIN LEVELS
> ULN TO ≤1.5 x ULN

SGOT (AST) LEVELS
<10 x ULN AND BILIRUBIN LEVELS
> 1.5 TO ≤3 x ULN

SGOT (AST) LEVELS
<10 x ULN AND BILIRUBIN LEVELS
> 3 TO ≤5 x ULN

SGOT (AST) LEVELS
>10 x ULN AND BILIRUBIN LEVELS
>5 x ULN

MILD

MODERATE

SEVERE

Mild

  • No dose adjustment is necessary for patients with mild hepatic impairment
  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
  • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
  • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal.

Moderate

  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
  • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
  • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal.

Severe

  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
  • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
  • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal.

Very Severe

  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
  • Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer

AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal.

ABRAXANE 100 mg/m2 dose illustration ABRAXANE 80 mg/m2 dose illustration ABRAXANE 80 mg/m2 dose illustration ABRAXANE NOT RECOMMENDED dose illustration
ABRAXANE 100 mg/m2 dose illustration ABRAXANE 80 mg/m2 dose illustration ABRAXANE 80 mg/m2 dose illustration ABRAXANE NOT RECOMMENDED dose illustration

ILLUSTRATIVE PURPOSES ONLY

A dose increase to 100 mg/m2 in subsequent courses should be considered if the patient tolerates the reduced dose for 2 cycles.

Recommendations for permanent dose modification in NSCLC patients with neutropenia

MAKE A SELECTION

FIRST
OCCURRENCE

SECOND
OCCURRENCE

THIRD
OCCURRENCE

  • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count
    (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
  • Nadir ANC <500 cells/mm3 with neutropenic fever >38 °C

    • OR

  • Delay of next cycle due to persistent neutropeniaa (nadir ANC <1500 cells/mm3)

    • OR

  • Nadir ANC <500 cells/mm3 for >1 week
  • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of the cycle
  • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
  • In the Phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 3-4 neutropenia

More than 7-day delay of scheduled Day 1 dose of next cycle.

  • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count
    (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
  • Nadir ANC <500 cells/mm3 with neutropenic fever >38 °C

    • OR

  • Delay of next cycle due to persistent neutropeniaa (nadir ANC <1500 cells/mm3)

    • OR

  • Nadir ANC <500 cells/mm3 for >1 week
  • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of the cycle
  • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
  • In the Phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 3-4 neutropenia

More than 7-day delay of scheduled Day 1 dose of next cycle.

  • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count
    (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
  • Nadir ANC <500 cells/mm3 with neutropenic fever >38 °C

    • OR

  • Delay of next cycle due to persistent neutropeniaa (nadir ANC <1500 cells/mm3)

    • OR

  • Nadir ANC <500 cells/mm3 for >1 week
  • Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of the cycle
  • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
  • In the Phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 neutropenia; 47% experienced Grades 3-4 neutropenia

More than 7-day delay of scheduled Day 1 dose of next cycle.

ABRAXANE 75 mg/m2 dose illustration + carboplatin ABRAXANE 50 mg/m2 dose illustration + carboplatin Discontinue treatment for ABRAXANE + carboplatin dose illustration
ABRAXANE 75 mg/m2 dose illustration + carboplatin ABRAXANE 50 mg/m2 dose illustration + carboplatin Discontinue treatment for ABRAXANE + carboplatin dose illustration

ILLUSTRATIVE PURPOSES ONLY

Recommendations for permanent dose modification in NSCLC patients with thrombocytopenia

MAKE A SELECTION

FIRST
OCCURRENCE

SECOND
OCCURRENCE

  • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count
    (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
  • Prior to permanent dose reduction, withhold treatment until platelet count
    recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8
    or 15 of the cycle
  • Monitor for myelotoxicity by performing complete blood cell counts frequently,
    including prior to dosing on Days 1, 8, and 15
  • In the Phase III ABRAXANE NSCLC clinical trial, 68% of patients treated with ABRAXANE (100 mg/m2 weekly)
    + carboplatin experienced Grades 1-4 thrombocytopenia; 18% experienced Grades 3-4 thrombocytopenia
  • Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count
    (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
  • Prior to permanent dose reduction, withhold treatment until platelet count
    recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8
    or 15 of the cycle
  • Monitor for myelotoxicity by performing complete blood cell counts frequently,
    including prior to dosing on Days 1, 8, and 15
  • In the Phase III ABRAXANE NSCLC clinical trial, 68% of patients treated with ABRAXANE (100 mg/m2 weekly)
    + carboplatin experienced Grades 1-4 thrombocytopenia; 18% experienced Grades 3-4 thrombocytopenia

Nadir platelets <50,000 cells/mm3

Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3 Prior to permanent dose reduction, withhold treatment until platelet count recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8 or 15 of the cycle
Do not administer ABRAXANE on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3 Prior to permanent dose reduction, withhold treatment until platelet count recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8 or 15 of the cycle

ILLUSTRATIVE PURPOSES ONLY

Recommendations for permanent dose modification in NSCLC patients with neurologic toxicity

MAKE A SELECTION

FIRST
OCCURRENCE

SECOND
OCCURRENCE

THIRD
OCCURRENCE

  • For Grades 3-4 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1
    • Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
  • In the Phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
  • For Grades 3-4 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1
    • Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
  • In the Phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
  • For Grades 3-4 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1
    • Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
  • In the Phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grades 1-4 peripheral neuropathy; 3% experienced Grades 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm

Severe sensory neuropathy
(Grade 3 or 4)

Severe sensory neuropathy (Grade 3 or 4). ABRAXANE 75 mg/m2 dose illustration + carboplatin Severe sensory neuropathy (Grade 3 or 4). ABRAXANE 50 mg/m2 dose illustration + carboplatin Severe sensory neuropathy (Grade 3 or 4). Discontinue treatment of ABRAXANE + carboplatin
Severe sensory neuropathy (Grade 3 or 4). ABRAXANE 75 mg/m2 dose illustration + carboplatin Severe sensory neuropathy (Grade 3 or 4). ABRAXANE 50 mg/m2 dose illustration + carboplatin Severe sensory neuropathy (Grade 3 or 4). Discontinue treatment of ABRAXANE + carboplatin

ILLUSTRATIVE PURPOSES ONLY

CLOSE THE TAB
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Watch the ABRAXANE Reconstitution Video

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ADVANCED OR METASTATIC NON–SMALL CELL
LUNG CANCER (mNSCLC)

NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY
(NCCN GUIDELINES®) RECOMMENDATIONS12*

Initial Systemic Therapy

All Histologies Advanced or Metastatic Non–Small Cell Lung Cancer (mNSCLC)

Albumin-bound paclitaxel (ABRAXANE) + carboplatin

NCCN

Category 1a

Albumin-bound paclitaxel (ABRAXANE) + carboplatin is a treatment option included in the NCCN Guidelines® for Non-Small Cell Lung Cancer with a Category 1 recommendation for the first-line treatment of metastatic squamous cell carcinoma and nonsquamous NSCLC (PS 0-1)b

For additional considerations and treatment options, see NCCN.org.

Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

EGFR, ALK, ROS1, BRAF, MET exon 14 skipping mutation, and RET negative, treatment option for patients with contraindications to PD-1 or PD-L1 inhibitors. Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents or presence of an oncogene, which would predict lack of benefit.

ALK=anaplastic lymphoma kinase; BRAF=B-Raf proto-oncogene; EGFR=epidermal growth factor receptor; MET=mesenchymal-epithelial transition; NCCN=National Comprehensive Cancer Network; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; PS=performance status; RET=rearranged during transfection; ROS1=c-ros oncogene 1.

Chart icon

See how ABRAXANE + carboplatin delivered a significantly superior ORR
vs paclitaxel in mNSCLC

ABRAXANE + CARBOPLATIN FOR FIRST-LINE ADVANCED OR
METASTATIC NSCLC, INCLUDING SQUAMOUS

ABRAXANE: Pivotal Phase III study

ABRAXANE + carboplatin delivered significantly superior ORR vs paclitaxel: ITT population10

ABRAXANE + carboplatin
(n=170/521); 95% CI: 28.6%-36.7%

Paclitaxel injection + carboplatin
(n=132/531); 95% CI: 21.2%-28.5%

  • Median duration of response was 6.9 months vs 6.0 months (95% CI: 5.6-8.0 vs 5.6-7.1, respectively)
  • No statistically significant difference in OS between the 2 study arms (median OS 12.1 months vs 11.2 months, P=NS10)

P=0.005 (based on chi-square test).

41% ORR in first-line squamous:
Squamous population

ABRAXANE + carboplatin
(n=94/229)

Paclitaxel injection + carboplatin
(n=54/221)

Response rate in other histologies

Response Rate in other histologies Response Rate in other histologies

Established safety profile

The most common ARs (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.

NCCN Guidelines Recommendations12*

Initial Systemic Therapy
All Histologies
Advanced or Metastatic NSCLC

Albumin-bound paclitaxel
(ABRAXANE) + carboplatin

NCCN Category 1†

Albumin-bound paclitaxel (ABRAXANE) + carboplatin is a treatment option included in the NCCN Guidelines® for Non-Small Cell Lung Cancer with a Category 1 recommendation for the first-line treatment of metastatic squamous cell carcinoma and nonsquamous NSCLC (PS 0-1)‡

For additional considerations and treatment options, see NCCN.org.

Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

EGFR, ALK, ROS1, BRAF, MET exon 14 skipping mutation, and RET negative, treatment option for patients with contraindications to PD-1 or PD-L1 inhibitors. Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents or presence of an oncogene, which would predict lack of benefit.

Study design

Multicenter, randomized 1:1, Phase III study comparing ABRAXANE (100 mg/m2 IV; Days 1, 8, and 15 of each 21-day cycle) + carboplatin (AUC=6 mg•min/mL IV, Day 1 of each 21-day cycle) with paclitaxel injection (200 mg/m2 IV, Day 1 of each 21-day cycle) + carboplatin (AUC=6 mg•min/mL IV, Day 1 of each 21-day cycle) in 1052 chemonaïve patients with advanced NSCLC. The primary efficacy endpoint was ORR.10

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FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING PATIENT
INFORMATION

IMPORTANT SAFETY INFORMATION & INDICATIONS

WARNING — SEVERE MYELOSUPPRESSION

  • Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3
  • Monitor for neutropenia, which may be severe and result in infection or sepsis. Perform frequent complete blood cell counts on all patients receiving ABRAXANE

CONTRAINDICATIONS

  • Baseline neutrophil counts of <1500 cells/mm3
  • A history of severe hypersensitivity reactions to ABRAXANE

WARNINGS AND PRECAUTIONS

Severe Myelosuppression

  • Severe myelosuppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of ABRAXANE. In clinical studies, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC), 47% of patients with non–small cell lung cancer (NSCLC), and 38% of patients with pancreatic cancer
  • Monitor for severe neutropenia and thrombocytopenia by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer)
  • Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1500 cells/mm3
  • In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with either MBC or NSCLC
  • In patients with MBC, resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level >1500 cells/mm3 and platelets recover to a level >100,000 cells/mm3
  • In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly ABRAXANE and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an ANC of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle
  • In patients with adenocarcinoma of the pancreas, withhold ABRAXANE and gemcitabine if the ANC is less than 500 cells/mm3 or platelets are less than 50,000 cells/mm3 and delay initiation of the next cycle if the ANC is less than 1500 cells/mm3 or platelet count is less than 100,000 cells/mm3 on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended

Severe Neuropathy

  • Sensory neuropathy is dose- and schedule-dependent
  • If ≥ Grade 3 sensory neuropathy develops, withhold ABRAXANE treatment until resolution to Grade 1 or 2 for MBC or until resolution to ≤ Grade 1 for NSCLC and pancreatic cancer followed by a dose reduction for all subsequent courses of ABRAXANE

Sepsis

  • Sepsis occurred in 5% of patients with or without neutropenia who received ABRAXANE in combination with gemcitabine
  • Biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis
  • If a patient becomes febrile (regardless of ANC), initiate treatment with broad-spectrum antibiotics
  • For febrile neutropenia, interrupt ABRAXANE and gemcitabine until fever resolves and ANC ≥1500 cells/mm3, then resume treatment at reduced dose levels

Pneumonitis

  • Pneumonitis, including some cases that were fatal, occurred in 4% of patients receiving ABRAXANE in combination with gemcitabine
  • Monitor patients for signs and symptoms and interrupt ABRAXANE and gemcitabine during evaluation of suspected pneumonitis
  • Permanently discontinue treatment with ABRAXANE and gemcitabine upon making a diagnosis of pneumonitis

Severe Hypersensitivity

  • Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported
  • Do not rechallenge patients who experience a severe hypersensitivity reaction to ABRAXANE with this drug
  • Cross-hypersensitivity between ABRAXANE and other taxane products has been reported and may include severe reactions such as anaphylaxis. Closely monitor patients with a previous history of hypersensitivity reaction to ABRAXANE with this drug

Use in Patients With Hepatic Impairment

  • The exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment. Closely monitor patients with hepatic impairment for severe myelosuppression
  • ABRAXANE is not recommended in patients who have a total bilirubin >5 x ULN or AST >10 x ULN
  • For MBC and NSCLC, the starting dose should be reduced for patients with moderate or severe hepatic impairment
  • For pancreatic adenocarcinoma, ABRAXANE is not recommended for patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST ≤10 x ULN)

Albumin (Human)

  • ABRAXANE contains albumin (human), a derivative of human blood

Embryo-Fetal Toxicity

  • Based on mechanism of action and findings in animals, ABRAXANE can cause fetal harm when administered to a pregnant woman
  • Advise females of reproductive potential of the potential risk to a fetus
  • Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with ABRAXANE and for at least six months after the last dose of ABRAXANE
  • Advise male patients with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with ABRAXANE and for at least three months after the last dose of ABRAXANE

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

  • The most common adverse reactions (≥20%) with single-agent use of ABRAXANE vs paclitaxel injection in the MBC study are alopecia (90%, 94%), neutropenia (all cases 80%, 82%; severe 9%, 22%), sensory neuropathy (any symptoms 71%, 56%; severe 10%, 2%), abnormal ECG (all patients 60%, 52%; patients with normal baseline 35%, 30%), fatigue/asthenia (any 47%, 39%; severe 8%, 3%), myalgia/arthralgia (any 44%, 49%; severe 8%, 4%), AST elevation (any 39%, 32%), alkaline phosphatase elevation (any 36%, 31%), anemia (any 33%, 25%; severe 1%, <1%), nausea (any 30%, 22%; severe 3%, <1%), diarrhea (any 27%, 15%; severe <1%, 1%), and infections (24%, 20%), respectively
  • Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%) patients
  • Other adverse reactions of note with the use of ABRAXANE vs paclitaxel injection included vomiting (any 18%, 10%; severe 4%, 1%), fluid retention (any 10%, 8%; severe 0%, <1%), mucositis (any 7%, 6%; severe <1%, 0%), hepatic dysfunction (elevations in bilirubin 7%, 7%), hypersensitivity reactions (any 4%, 12%; severe 0%, 2%), thrombocytopenia (any 2%, 3%; severe <1%, <1%), neutropenic sepsis (<1%, <1%), and injection site reactions (<1%, 1%), respectively. Dehydration and pyrexia were also reported
  • Renal dysfunction (any 11%, severe 1%) was reported in patients treated with ABRAXANE (n=229)
  • In all ABRAXANE-treated patients (n=366), ocular/visual disturbances were reported (any 13%; severe 1%)
  • Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients and included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension
  • Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported

Non-Small Cell Lung Cancer (NSCLC) Study

  • The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue
  • The most common serious adverse reactions of ABRAXANE in combination with carboplatin for NSCLC are anemia (4%) and pneumonia (3%)
  • The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%)
  • The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (24%), thrombocytopenia (13%), and anemia (6%)
  • The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%)
  • The following common (≥10% incidence) adverse reactions were observed at a similar incidence in ABRAXANE plus carboplatin–treated and paclitaxel injection plus carboplatin–treated patients: alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%); incidence rates are for the ABRAXANE plus carboplatin treatment group
  • Adverse reactions with a difference of ≥2%, Grade 3 or higher, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (28%, 7%), neutropenia (47%, 58%), thrombocytopenia (18%, 9%), and peripheral neuropathy (3%, 12%), respectively
  • Adverse reactions with a difference of ≥5%, Grades 1-4, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (98%, 91%), thrombocytopenia (68%, 55%), peripheral neuropathy (48%, 64%), edema peripheral (10%, 4%), epistaxis (7%, 2%), arthralgia (13%, 25%), and myalgia (10%, 19%), respectively
  • Neutropenia (all grades) was reported in 85% of patients who received ABRAXANE and carboplatin vs 83% of patients who received paclitaxel injection and carboplatin

Pancreatic Adenocarcinoma Study

  • Among the most common (≥20%) adverse reactions in the phase III study, those with a ≥5% higher incidence in the ABRAXANE/gemcitabine group compared with the gemcitabine group are neutropenia (73%, 58%), fatigue (59%, 46%), peripheral neuropathy (54%, 13%), nausea (54%, 48%), alopecia (50%, 5%), peripheral edema (46%, 30%), diarrhea (44%, 24%), pyrexia (41%, 28%), vomiting (36%, 28%), decreased appetite (36%, 26%), rash (30%, 11%), and dehydration (21%, 11%)
  • Of these most common adverse reactions, those with a ≥2% higher incidence of Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared with the gemcitabine group, respectively, are neutropenia (38%, 27%), fatigue (18%, 9%), peripheral neuropathy (17%, 1%), nausea (6%, 3%), diarrhea (6%, 1%), pyrexia (3%, 1%), vomiting (6%, 4%), decreased appetite (5%, 2%), and dehydration (7%, 2%)
  • Thrombocytopenia (all grades) was reported in 74% of patients in the ABRAXANE/gemcitabine group vs 70% of patients in the gemcitabine group
  • The most common serious adverse reactions of ABRAXANE (with a ≥1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%), and vomiting (4%)
  • The most common adverse reactions resulting in permanent discontinuation of ABRAXANE were peripheral neuropathy (8%), fatigue (4%), and thrombocytopenia (2%)
  • The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (10%) and peripheral neuropathy (6%)
  • The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%), and diarrhea (5%)
  • Other selected adverse reactions with a ≥5% higher incidence for all-grade toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group, respectively, are asthenia (19%, 13%), mucositis (10%, 4%), dysgeusia (16%, 8%), headache (14%, 9%), hypokalemia (12%, 7%), cough (17%, 7%), epistaxis (15%, 3%), urinary tract infection (11%, 5%), pain in extremity (11%, 6%), arthralgia (11%, 3%), myalgia (10%, 4%), and depression (12%, 6%)
  • Other selected adverse reactions with a ≥2% higher incidence for Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group are thrombocytopenia (13%, 9%), asthenia (7%, 4%), and hypokalemia (4%, 1%)

Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations

  • Severe and sometimes fatal hypersensitivity reactions. Cross-hypersensitivity between ABRAXANE and other taxanes has been reported
  • Congestive heart failure, left ventricular dysfunction, and atrioventricular block. Most patients were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history
  • Extravasation. Closely monitor the ABRAXANE infusion site for possible infiltration during drug administration

DRUG INTERACTIONS

  • Caution should be exercised when administering ABRAXANE concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4

USE IN SPECIFIC POPULATIONS

Pregnancy

  • Based on the mechanism of action and findings in animals, ABRAXANE can cause fetal harm when administered to a pregnant woman. Advise females of the potential risk to a fetus and to avoid becoming pregnant while receiving ABRAXANE

Lactation

  • Paclitaxel and/or its metabolites were excreted into the milk of lactating rats. Nursing must be discontinued when receiving treatment with ABRAXANE and for two weeks after the last dose

Females and Males of Reproductive Potential

  • Based on animal studies and mechanism of action, ABRAXANE can cause fetal harm when administered to a pregnant woman
  • Verify the pregnancy status of females of reproductive potential prior to starting treatment with ABRAXANE
  • Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with and for at least six months after the last dose of ABRAXANE [see Warnings and Precautions]
  • Advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with ABRAXANE and for at least three months after the last dose of ABRAXANE [see Warnings and Precautions]
  • Based on findings in animals, ABRAXANE may impair fertility in females and males of reproductive potential

Pediatric

  • The safety and effectiveness of ABRAXANE in pediatric patients have not been established

Geriatric

  • A higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years or older who received ABRAXANE for MBC in a pooled analysis of clinical studies
  • Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients ≥65 years of age treated with ABRAXANE and carboplatin in NSCLC
  • Diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old who received ABRAXANE and gemcitabine in adenocarcinoma of the pancreas

Renal Impairment

  • There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 mL/min)

DOSAGE AND ADMINISTRATION

  • DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS
  • Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicity

INDICATIONS

ABRAXANE® is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

ABRAXANE® is indicated for the first-line treatment of locally advanced or metastatic non–small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

ABRAXANE® is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Please see full Prescribing Information, including Boxed WARNING.

References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Cetin K, Ettinger OS, Hei Y-J, O’Malley CD. Survival by histologic subtype in stage IV nonsmall cell lung cancer based on data from the Surveillance, Epidemiology and End Results Program. Clin Epidemiol. 2011;3:139-148. 4. Lung Cancer Foundation of America. Types of lung cancer. Accessed September 16, 2020. https://lcfamerica.org/lung-cancer-info/ types-lung-cancer/ 5. Drilon A, Rekhtman N, Ladanyi M, et al. Squamous-cell carcinomas of the lung: emerging biology, controversies, and the promise of targeted therapy. Lancet Oncol. 2012;13(10):e418-e426. 6. Wilson DO, Ryan A, Fuhrman C, et al. Doubling times and CT screen–detected lung cancers in the Pittsburgh Lung Screening Study. Am J Respir Crit Care Med. 2012;185(1):85-89. 7. Moran CA, Suster S. Non–small cell carcinomas of the lung. In: Tumors and Tumor-like Conditions of the Lung and Pleura. Philadelphia, PA: Elsevier Health Sciences; 2010:51-110. 8. Pivot X, Thierry-Vuillemin A, Villanueva C, Bazan F. Response rates: a valuable signal of promising activity? Cancer J. 2009;15(5):361-365. 9. Blumenthal GM, Karuri SW, Zhang H, et al. Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses. J Clin Oncol. 2015;33(9):1008-1014. 10. Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non–small-cell lung cancer: final results of a phase Ill trial. J Clin Oncol. 2012;30(17):2055-2062. 11. Data on file. Bristol-Myers Squibb Company. 12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 15, 2020. To view the most recent and complete version of the guideline, go online to NCCN.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.

This website is intended for U.S. residents 18 years of age or older.

ABRAXANE® is a registered trademark of Abraxis BioScience, LLC. Abraxis BioScience, LLC is a wholly owned subsidiary of Bristol-Myers Squibb Company.

Access Support® is a registered trademark of Bristol-Myers Squibb Company.

© 2022 Bristol-Myers Squibb Company.

2013-US-2200013 10/22

2013-US-2300003 02/23

References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Cetin K, Ettinger OS, Hei Y-J, O’Malley CD. Survival by histologic subtype in stage IV nonsmall cell lung cancer based on data from the Surveillance, Epidemiology and End Results Program. Clin Epidemiol. 2011;3:139-148. 4. Lung Cancer Foundation of America. Types of lung cancer. Accessed September 16, 2020. https://lcfamerica.org/lung-cancer-info/ types-lung-cancer/ 5. Drilon A, Rekhtman N, Ladanyi M, et al. Squamous-cell carcinomas of the lung: emerging biology, controversies, and the promise of targeted therapy. Lancet Oncol. 2012;13(10):e418-e426. 6. Wilson DO, Ryan A, Fuhrman C, et al. Doubling times and CT screen–detected lung cancers in the Pittsburgh Lung Screening Study. Am J Respir Crit Care Med. 2012;185(1):85-89. 7. Moran CA, Suster S. Non–small cell carcinomas of the lung. In: Tumors and Tumor-like Conditions of the Lung and Pleura. Philadelphia, PA: Elsevier Health Sciences; 2010:51-110. 8. Pivot X, Thierry-Vuillemin A, Villanueva C, Bazan F. Response rates: a valuable signal of promising activity? Cancer J. 2009;15(5):361-365. 9. Blumenthal GM, Karuri SW, Zhang H, et al. Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses. J Clin Oncol. 2015;33(9):1008-1014. 10. Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non–small-cell lung cancer: final results of a phase Ill trial. J Clin Oncol. 2012;30(17):2055-2062. 11. Data on file. Bristol-Myers Squibb Company. 12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 15, 2020. To view the most recent and complete version of the guideline, go online to NCCN.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.