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HomeFirst-line Advanced RCCFirst-line Advanced RCCOverviewEfficacy Measures: OS, PFS, & ORRSafety & Tolerability ProfileDosingTherapy Management StrategiesMOAs – INLYTA and pembrolizumabNCCN Recommendation  PublicationsProfessional ResourcesSecond-line Advanced RCCSecond-line Advanced RCCOverviewEfficacy Measures: PFS, ORR, OS, & Subset AnalysesSafety & Tolerability ProfilePatient Characteristics & Treatment ConsiderationsOral DosingVEGFR Pathway & INLYTA® (axitinib) MOANCCN Recommendation  Patient Support and ResourcesPatient Support and ResourcesPfizer Oncology TogetherEventsMaterials
Prescribing InformationIndicationsPatient Site
Efficacy Measures: PFS, ORR, OS, & Subset AnalysesINLYTA® (axitinib) for 2nd-Line Treatment of Advanced RCCTHE AXIS TRIAL: A PHASE 3 TRIAL IN 2nd-LINE mRCC

A phase 3, multicenter, open-label, head-to-head trial vs sorafenib (N=723)

Trial description
  • Primary endpoint was progression-free survival (PFS)
  • Secondary endpoints included objective response rate (ORR), overall survival (OS), and safety and tolerability1,2
ECOG PS=Eastern Cooperative Oncology Group performance status; mRCC=metastatic RCC; RECIST=Response Evaluation Criteria in Solid Tumors.No agent other than sorafenib has been compared to INLYTA monotherapy in a head-to-head, phase 3 study.‡Based on MEDLINE® literature review for phase 3 trials in mRCC as of May 2018.SELECTED BASELINE CHARACTERISTICS The AXIS trial included patients across the risk spectrum

Distribution of patients by prognostic risk group (utilizing 2nd-line risk factors based on published MSKCC data)1§

Risk groups, based on published Memorial Sloan Kettering Cancer Center (MSKCC) data, were derived with 3 risk factors: hemoglobin (≤130 g/L vs >130 g/L for men and ≤115 g/L vs  >115  g/L for women), corrected calcium (<2.5 mmol/L vs ≥2.5 mmol/L), and ECOG PS (0 vs 1). Risk groups were defined as favorable (0 factors), intermediate (1 factor), or poor (2-3 factors).  45% of patients had an ECOG PS of 1

Distribution of patients by ECOG PS

 35% of patients were previously treated with cytokine-based immunotherapy 
(IL-2 or IFN-α)

Distribution of patients by prior systemic therapy containing

Primary endpoint: Progression-free survival (PFS)The ONLY approved treatment option to demonstrate SUPERIOR AND SIGNIFICANT PFS VS A VEGFR-TKI (sorafenib) IN A PHASE 3 TRIAL IN 2nd-LINE mRCC*Based on MEDLINE® literature review for phase 3 trials in mRCC as of May 2018. 
TKI=tyrosine kinase inhibitor.In the phase 3 AXIS trial (N=723)†From AXIS, a multicenter, open-label, phase 3 trial of 723 patients with mRCC after failure of 1st-line therapy (sunitinib-, temsirolimus-, bevacizumab-, or cytokine-containing regimen [54%, 3%, 8%, and 35% of patients in each of the treatment arms, respectively]). Patients were randomized 1:1 to either INLYTA 5 mg twice daily (n=361) or sorafenib 400 mg twice daily (n=362), with dose adjustments allowed in both groups. Primary endpoint was PFS. Secondary endpoints included ORR, OS, and safety and tolerability.1,2Secondary endpoints: Overall response rate (ORR) & overall survival (OS)In the phase 3 AXIS trial (N=723),* INLYTA® (axitinib) MORE THAN DOUBLED ORR VS A VEGFR-TKI (sorafenib) Secondary endpoint: ORR
  • All responses were partial responses per RECIST criteria1
  • Median time to tumor response for INLYTA was 2.9 months (n=70/361; range, 1.2-10.2 months) vs 2.6 months for sorafenib (n=34/362; range, 1.2-15.7 months)2
In the phase 3 AXIS trial (N=723),* INLYTA DEMONSTRATED A MEDIAN OS OF 20.1 MONTHS Secondary endpoint: OS3
  • The difference between the treatment arms was not statistically significant
From AXIS, a multicenter, open-label, phase 3 trial of 723 patients with mRCC after failure of 1st-line therapy (sunitinib-, temsirolimus-, bevacizumab-, or cytokine-containing regimen [54%, 3%, 8%, and 35% of patients in each of the treatment arms, respectively]). Patients were randomized 1:1 to either INLYTA 5 mg twice daily (n=361) or sorafenib 400 mg twice daily (n=362), with dose adjustments allowed in both groups. Primary endpoint was PFS. Secondary endpoints included ORR, OS, and safety and tolerability.1,2Subgroup analyses

From the AXIS trial: an open-label, phase 3 trial in metastatic RCC following one prior systemic therapy (N=723),* PFS WAS THE PRIMARY ENDPOINT

  • INLYTA® (axitinib) demonstrated 6.7 months median PFS vs 4.7 months with sorafenib (95% CI: 6.3, 8.6 and 4.6, 5.6, respectively)
  • HR=0.67 (95% CI: 0.54, 0.81); P<0.0001
In a prespecified subset analysis of the phase 3 AXIS trial, INLYTA NEARLY DOUBLED MEDIAN PFS AFTER PROGRESSION ON 1st-LINE CYTOKINE-BASED IMMUNOTHERAPY (IL-2 OR IFN-α) Improvement in PFS among patients previously treated with cytokine-based immunotherapy (IL-2 or IFN-α)1
  • 35% of patients in the AXIS trial had previously been treated with IL-2 or IFN-α
    • Prior therapies for other patients in the trial contained sunitinib (54%), bevacizumab (8%), or temsirolimus (3%)
  • The cytokine-based immunotherapies IL-2 and IFN-α were the most common 1st-line immunotherapies used at the time of the AXIS trial, for which registration concluded in 2010
INLYTA PROLONGED MEDIAN PFS AFTER PROGRESSION ON SUNITINIB Improvement in PFS among patients previously treated with sunitinib1
  • 54% of patients in the AXIS trial had previously been treated with sunitinib
    • Prior therapies for other patients in the trial contained cytokines (35%), bevacizumab (8%), or temsirolimus (3%)
From AXIS, a multicenter, open-label, phase 3 trial of 723 patients with mRCC after failure of 1st-line therapy (sunitinib-, temsirolimus-, bevacizumab-, or cytokine-containing regimen [54%, 3%, 8%, and 35% of patients in each of the treatment arms, respectively]). Patients were randomized 1:1 to either INLYTA 5 mg twice daily (n=361) or sorafenib 400 mg twice daily (n=362), with dose adjustments allowed in both groups. Primary endpoint was PFS. Secondary endpoints included ORR, OS, and safety and tolerability.1,2ReferencesRini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011;378(9807):1931-1939.Data on file. Pfizer Inc., New York, NY.Motzer RJ, Escudier B, Tomczak P. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013;14(6):552-562. Safety & Tolerability Profile

Including Warnings & Precautions, most common adverse events, duration of treatment, and real-world dosing data

 Examine the profile Loading Patient Characteristics & Treatment Considerations

Patient characteristics and clinical factors to consider when selecting a 2nd-line treatment for advanced RCC

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INDICATIONSINLYTA® (axitinib) in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.
Important Safety Information

Hypertension including hypertensive crisis has been observed. Ensure that blood pressure is well controlled prior to initiating INLYTA. Monitor for hypertension and treat as needed. Withhold and then dose reduce INLYTA or permanently discontinue based on severity of hypertension.

Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk for, or who have a history of, these events. Permanently discontinue INLYTA if an arterial thromboembolic event occurs during treatment. Monitor for signs and symptoms of VTE and pulmonary embolism. Withhold INLYTA and then resume at same dose or permanently discontinue based on severity of VTE.

Hemorrhagic events, including fatal events, have been reported. INLYTA has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. Withhold and then dose reduce INLYTA or discontinue based on severity and persistence of hemorrhage.

Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with INLYTA. Management of cardiac failure may require dose reduction, dose interruption or permanent discontinuation of INLYTA.

Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment.

Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment.

INLYTA has the potential to adversely affect wound healing. Withhold INLYTA for at least 2 days prior to elective surgery. Do not administer INLYTA for at least 2 weeks following major surgery and until adequate wound healing. Resume INLYTA at a reduced dose or discontinue based on severity and persistence of the impaired wound healing. The safety of resuming INLYTA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed. If signs or symptoms occur, permanently discontinue INLYTA.

Proteinuria has been observed. Monitor for proteinuria before initiation of, and periodically throughout, treatment. For moderate to severe proteinuria, withhold and then dose reduce INLYTA.

Liver enzyme elevation has occurred during treatment with INLYTA as a single agent. INLYTA in combination with pembrolizumab can cause hepatotoxicity with higher than expected frequencies of Grades 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Monitor ALT, AST, and bilirubin before initiation of, and periodically throughout, treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. Withhold INLYTA and/or pembrolizumab, initiate corticosteroid therapy as needed, and/or permanently discontinue the combination for severe or life-threatening hepatotoxicity.

For patients with moderate hepatic impairment, the starting dose of INLYTA should be decreased. INLYTA has not been studied in patients with severe hepatic impairment.

INLYTA can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception. When INLYTA is used in combination with pembrolizumab, refer to the full Prescribing Information of pembrolizumab for pregnancy and contraception information.

Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose of INLYTA. Grapefruit or grapefruit juice may also increase INLYTA plasma concentrations and should be avoided.

Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers.

Fatal adverse reactions (ARs) occurred in 3.3% of patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC. These included 3 cases of cardiac arrest, 2 cases of pulmonary embolism, and 1 case each of cardiac failure, death due to unknown cause, myasthenia gravis, myocarditis, Fournier’s gangrene, plasma cell myeloma, pleural effusion, pneumonitis, and respiratory failure.

The most common (≥20%) ARs (all grades, vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC were diarrhea (56% vs 45%), fatigue/asthenia (52% vs 51%), hypertension (48% vs 48%), hepatotoxicity (39% vs 25%), hypothyroidism (35% vs 32%), decreased appetite (30% vs 29%), palmar-plantar erythrodysesthesia (28% vs 40%), nausea (28% vs 32%), stomatitis/mucosal inflammation (27% vs 41%), dysphonia (25% vs 3.3%), rash (25% vs 21%), cough (21% vs 14%), and constipation (21% vs 15%).

The most common (≥20%) Grade 3/4 ARs (vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC were hypertension (24% vs 20%) and hepatotoxicity (20% vs 4.9%).

The most common (≥20%) lab abnormalities (all grades, vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC included hyperglycemia (62% vs 54%), increased ALT (60% vs 44%), increased AST (57% vs 56%), increased creatinine (43% vs 40%), hyponatremia (35% vs 29%), hyperkalemia (34% vs 22%), hypoalbuminemia (32% vs 34%), hypercalcemia (27% vs 15%), hypophosphatemia (26% vs 49%), increased alkaline phosphatase (26% vs 30%), hypocalcemia (22% vs 29%), increased blood bilirubin (22% vs 21%), prolonged activated partial thromboplastin time (22% vs 14%), lymphopenia (33% vs 46%), anemia (29% vs 65%), and thrombocytopenia (27% vs 78%).

The most common (≥20%) ARs (all grades, vs sorafenib) in patients receiving INLYTA as second-line treatment for advanced RCC were diarrhea (55% vs 53%), hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite (34% vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), palmar-plantar erythrodysesthesia syndrome (27% vs 51%), weight decreased (25% vs 21%), vomiting (24% vs 17%), asthenia (21% vs 14%), and constipation (20% vs 20%).

The most common (≥10%) Grade 3/4 ARs (vs sorafenib) occurring in patients receiving INLYTA as second-line treatment for advanced RCC were hypertension (16% vs 11%), diarrhea (11% vs 7%), and fatigue (11% vs 5%).

The most common (≥20%) lab abnormalities (all grades, vs sorafenib) occurring in patients receiving INLYTA as second-line treatment for advanced RCC included increased creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33% vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs 22%), and increased AST (20% vs 25%).

IndicationS

INLYTA® (axitinib) in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.

Please see full Prescribing Information for INLYTA.