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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
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Efficacy Measures: OS, PFS, & ORRINLYTA® (axitinib) + pembrolizumab for 1st-Line Treatment of Advanced RCCTrial design – KEYNOTE-426

A phase 3, randomized, multicenter, open-label trial conducted in patients who had not received systemic therapy for advanced RCC (N=861)1

North America vs Western Europe vs “Rest of the World.”1Until RECIST v1.1-defined progression of disease or unacceptable toxicity.1As assessed by BICR according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.1As measured by BICR.1aRCC=advanced renal cell carcinoma; BICR=Blinded Independent Central Review; IMDC=International Metastatic RCC Database Consortium; RECIST=Response Evaluation Criteria in Solid Tumors.Selected Baseline CharacteristicsDEMOGRAPHIC AND DISEASE CHARACTERISTICS AMONG ALL PATIENTS INCLUDED IN THE STUDY (N=861)2Favorable risk corresponds to an IMDC score of 0, intermediate risk to a score of 1 or 2, and poor risk to a score of 3 to 6. IMDC risk score is determined by the total number of the following 6 risk factors that are present: KPS score of less than 80 (on a scale from 0 to 100, with lower scores indicating greater disability), a time from initial diagnosis to randomization of less than 1 year, a hemoglobin level below the lower limit of the normal range,2 a corrected serum calcium level above the upper limit of the normal range, an absolute neutrophil count above the upper limit of the normal range, and platelet count above the upper limit of the normal range. †The percentage for sarcomatoid features was calculated from the number of patients with known sarcomatoid status (n=578).2 ‡The PD-L1 combined positive score was calculated as the number of PD-L1-positive cells (tumor cells, lymphocytes, and macrophages) divided by total number of tumor cells, multiplied by 100.2 §The percentage for PD-L1 was calculated from the number of patients with tumor samples that could be evaluated for PD-L1 expression (n=822).2 ||Information on the number of organs with target and nontarget lesions was missing for 3 patients (0.7%) in the pembrolizumab-axitinib group and for 2 patients (0.5%) in the sunitinib group.2
IMDC=International Metastatic RCC Database Consortium; ITT=intent-to-treat; KPS=Karnofsky Performance Status; PD-L1=programmed death-ligand 1.IMDC PROGNOSTIC RISK CATEGORY1,3,4IMDC risk score is determined by the total number of the following 6 risk factors that are present3:
  • KPS score <80
  • Time from initial diagnosis to randomization <1 year
  • Hemoglobin level below the lower limit of the normal range
  • Corrected serum calcium level above the upper limit of the normal range
  • Absolute neutrophil count above the upper limit of the normal range
  • Platelet count above the upper limit of the normal range
IMDC=International Metastatic RCC Database Consortium; KPS=Karnofsky Performance Status.Efficacy resultsINLYTA® (axitinib) + pembrolizumab was the first TKI/IO combination to demonstrate efficacy vs sunitinib across 3 key endpoints1

KEYNOTE-426: A phase 3, randomized, multicenter, open-label trial conducted in patients who had not received systemic therapy for advanced RCC (N=861)1
Data shown here are based on a median follow-up of 12.8 months (range: 0.1 to 22.0)2

Powerful efficacy: Overall survival (OS—primary endpoint) INLYTA® (axitinib) + pembrolizumab demonstrated superior OS compared with sunitinib1,2 Initial interim analysis Title
  • HR for OS for INLYTA + pembrolizumab vs sunitinib was 0.53 (95% CI: 0.38, 0.74); P<0.00012
  • Median OS was not reached in either group1
  • The median duration of treatment with INLYTA + pembrolizumab was 10.4 months (range: 1 day to 21.2 months)1
  • Number of events (%): 59 (14%) with INLYTA + pembrolizumab; 97 (23%) with sunitinib6
Based on the stratified Cox proportional hazard model.1Based on stratified log-rank test.1P value (1-sided) is compared with the allocated alpha of 0.0001 for this interim analysis (with 39% of the planned number of events for the extended follow-up analysis).1
IO=immuno-oncology; TKI=tyrosine kinase inhibitor.Prespecified extended follow-up analysisData shown here are based on a median follow-up of 43 months (range: 36.0 to 51.0)5,6LIMITATIONS: While the extended follow-up analysis was prespecified, no formal hypothesis testing was performed given the endpoint was met in the initial interim analysis. Data are presented for descriptive purposes only and no conclusions can be drawn. Prespecified extended follow-up analysis: OS (primary endpoint)5,6* Title
  • HR for OS for the INLYTA® (axitinib) + pembrolizumab arm vs the sunitinib arm was 0.73 (95% CI: 0.60, 0.88)5,6*
  • Median follow-up was 43 months (range: 36.0 to 51.0)5,6
  • Median OS was 46 months for the INLYTA + pembrolizumab arm (95% CI: 43.6, NR) and 40 months for the sunitinib arm (95% CI: 34.3, 44.2)5,6
  • Number of events (%): 193 (45%) with INLYTA + pembrolizumab; 225 (52%) with sunitinib6
Based on the stratified Cox proportional hazard model.1
NR=not reached.Nonprespecified extended follow-up analysis

Data shown here are based on a median follow-up of 67.2 months (range 60.0 to 75.0)6

LIMITATIONS: This extended follow-up analysis was nonprespecified and exploratory. Data are presented for descriptive purposes only and no conclusions can be drawn. OS (nonprespecified and exploratory)6* TitleAt the nonprespecified extended follow-up analysis:
  • HR for INLYTA® (axitinib) + pembrolizumab and sunitinib was 0.84 (95% CI: 0.71, 0.99)6
  • Median OS was 47.2 months for the INLYTA + pembrolizumab arm (95% CI: 43.6, 54.8) and 40.8 months for the sunitinib arm (95% CI: 34.3, 47.5)6
  • 60-month OS rate: 41.9% (95% CI: 37.2%, 46.5%) with INLYTA + pembrolizumab and 37.1% (95% CI: 32.5%, 41.7%) with sunitinib6
  • Number of events (%): 270 (62.5%) with INLYTA + pembrolizumab; 280 (65.3%) with sunitinib6
Based on a stratified Cox proportional hazard model with Efron's method of tie handling with treatment as a covariate stratified by International Metastatic RCC Database Consortium (IMDC) risk group (favorable vs intermediate vs poor) and geographic region (North America vs Western Europe vs Rest of the World).1Efficacy results

KEYNOTE-426: A phase 3, randomized, multicenter, open-label trial conducted in patients who had not received systemic therapy for advanced RCC (N=861)

Data shown here are based on a median follow-up of 12.8 months (range: 0.1 to 22.0)

Powerful efficacy: Progression-free survival (PFS—primary endpoint)* INLYTA® (axitinib) + pembrolizumab demonstrated superior PFS vs sunitinib​​​​​​1,2Title
  • ~4-month improvement in median PFS with INLYTA + pembrolizumab vs sunitinib1,2
  • Number of events (%): 183 (42%) with INLYTA + pembrolizumab; 213 (50%) with sunitinib1
As assessed by BICR according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.1Based on a stratified Cox proportional hazard model.1Based on stratified log-rank test.1P value (1-sided) is compared with the allocated alpha of 0.0013 for this interim analysis (with 81% of the planned number of events for the extended follow-up analysis).BICR=Blind Independent Central Review; mPFS=median progression-free survival.Prespecified extended follow-up analysisData shown here are based on a median follow-up of 43 months (range: 36.0 to 51.0)5LIMITATIONS: While the extended follow-up analysis was prespecified, no formal hypothesis testing was performed given the endpoint was met in the initial interim analysis. Data are presented for descriptive purposes only and no conclusions can be drawn. Prespecified extended follow-up analysis: PFS (primary endpoint)5* Title
  • HR for PFS for the INLYTA® (axitinib) + pembrolizumab arm vs the sunitinib arm was 0.68 (95% CI: 0.58, 0.80)5†
  • Median follow-up was 43 months (range: 36.0 to 51.0)5
  • Median PFS was 16 months for the INLYTA + pembrolizumab arm (95% CI: 14, 20) and 11 months for the sunitinib arm (95% CI: 8.9, 13)5
  • 12-month PFS rate: 60% (95% CI: 55.1, 64.6) and 47% (95% CI: 42.0, 52.2)6
  • 24-month PFS rate: 39% (95% CI: 33.9, 43.6) and 25% (95% CI: 21.0, 30.5)6
  • 36-month PFS rate: 29% (95% CI: 24.7, 34.1) and 15% (95% CI: 11.1, 19.5)6
  • Number of events (%): 286 (66%) with INLYTA + pembrolizumab; 301 (70%) with sunitinib6
As assessed by BICR according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.1Based on the stratified Cox proportional hazard model.1BICR=Blind Independent Central Review; mPFS=median progression-free survival.Nonprespecified extended follow-up analysis

Data shown here are based on a median follow-up of 67.2 months (range 60.0 to 75.0)6

LIMITATIONS: This extended follow-up analysis was nonprespecified and exploratory. Data are presented for descriptive purposes only and no conclusions can be drawn.

Progression-free survival (nonprespecified and exploratory)6*TitleAt the nonprespecified extended follow-up analysis:
  • HR for INLYTA® (axitinib) + pembrolizumab and sunitinib was 0.69 (95% CI: 0.59, 0.81)6
  • Median PFS was 15.7 months for the INLYTA + pembrolizumab arm (95% CI: 13.6, 20.2) and 11.1 months for the sunitinib arm (95% CI: 8.9, 12.5)6
  • Number of events (%): 306 (70.8%) with INLYTA + pembrolizumab; 311 (72.5%) with sunitinib6
Based on a stratified Cox proportional hazard model with Efron's method of tie handling with treatment as a covariate stratified by International Metastatic RCC Database Consortium (IMDC) risk group (favorable vs intermediate vs poor) and geographic region (North America vs Western Europe vs Rest of the World).Efficacy results

KEYNOTE-426: A phase 3, randomized, multicenter, open-label trial conducted in patients who had not received systemic therapy for advanced RCC (N=861)1

Data shown here are based on a median follow-up of 12.8 months (range: 0.1 to 22.0)1

Overall confirmed response rate (ORR—secondary endpoint)INLYTA® (axitinib) + pembrolizumab demonstrated significantly higher ORR vs sunitinib*Duration of response (DOR—secondary endpoint):
  • While DOR was prespecified, it is based on descriptive statistics and no conclusions can be drawn
  • Median DOR was not reached in the INLYTA + pembrolizumab arm and was 15.2 months (range: 1.1 to 15.4) in the sunitinib arm2‡
Time to response (TTR):
  • TTR was not prespecified. These are presented for descriptive purposes only and cannot be interpreted as a demonstration of efficacy
  • Median TTR was 2.8 months (range: 1.5 to 16.6) in the INLYTA + pembrolizumab arm and 2.9 months (range: 2.1 to 15.1) in the sunitinib arm2§
  • Tumor imaging was performed at baseline and Week 12 (or earlier at discretion of HCP) and then every 6 weeks through 54 and every 12 weeks thereafter2
Per RECIST v1.1 guidelines7:
  • Complete response is evaluated as the disappearance of all target lesions
  • Partial response is evaluated as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Confirmed ORR (CR + PR) is based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by BICR with 2 measurements at least 4 weeks apart.6Based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region.6DOR is the time from first documented evidence of CR or PR until PD per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.6Time to response is the time of first documented evidence of CR and PR per RECIST v1.1 based on BICR.BICR=Blinded Independent Central Review; CR=complete response; IMDC=International Metastatic RCC Database Consortium; PD=progressive disease; PR=partial response.Prespecified extended follow-up analysis

Data shown here are based on a median follow-up of 43 months (range: 36.0 to 51.0)5

LIMITATIONS: While the extended follow-up analysis was prespecified, no formal hypothesis testing was performed given the endpoint was met in the initial interim analysis. Data are presented for descriptive purposes only and no conclusions can be drawn.

Prespecified extended follow-up analysis: ORR* (secondary endpoint)5Duration of response (DOR—secondary endpoint):
  • While DOR was prespecified, it is based on descriptive statistics and no conclusions can be drawn
  • Median DOR was not reached in the INLYTA(R) (axitinib) = pembrolizumab arm and was 15.2 months (range 1.1+ to 15.4+) in the sunitinib arm.2†
Per RECIST v1.1 guidelines7:
  • Complete response is evaluated as the disappearance of all target lesions
  • Partial response is evaluated as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Confirmed ORR (CR + PR) is based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by BICR with 2 measurements at least 4 weeks apart.6DOR is the time from first documented evidence of CR or PR until PD per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.6BICR=Blinded Independent Central Review; CR=complete response; IMDC=International Metastatic RCCDatabase Consortium; PD=progressive disease; PR=partial response.Nonprespecified extended follow-up analysis: overall confirmed response rate

Data shown here are based on a median follow-up of 67.2 months (range: 60.0 to 75.0)6

LIMITATIONS: This extended follow-up analysis was nonprespecified and exploratory. Data are presented for descriptive purposes only and no conclusions can be drawn.

Overall confirmed response rate (nonprespecified and exploratory)6*Confirmed ORR (CR + PR) is based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by BICR with 2 measurements at least 4 weeks apart.6 †Includes 1.4% not evaluable (NE; postbaseline assessment available but not evaluable [ie, all postbaseline assessments with insufficient data for assessment of response per RECIST v1.1 or CR/PR/SD <6 weeks from randomization]) and 3.7% no assessment (NA; no postbaseline assessment available for response evaluation).6 ‡Includes 1.4% NE and 6.3% NA.6 Data cutoff: January 23, 2023.6BICR=Blinded Independent Central Review; CR=complete response; IMDC=International Metastatic RCC Database Consortium; PR=partial response; SD=stable disease.ReferencesINLYTA [prescribing information]. New York, NY: Pfizer Inc., 2022.Rini BI, Plimack ER, Stus V, et al; for KEYNOTE-426 Investigators. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380(12):1116-1127.Heng DY, Xie W, Regan MM, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor–targeted agents: results from a large, multicenter study. J Clin Oncol. 2009;27(34):5794-5799. International mRCC Database Consortium. IMDC criteria. Updated May 2020. Accessed March 16, 2023. https://www.imdconline.com/Plimack ER, Powles T, Stus V, et al. Pembrolizumab plus axitinib versus sunitinib as first-line treatment of advanced renal cell carcinoma: 43-month follow-up of the phase 3 KEYNOTE-426 study. Eur Urol. 2023;84(5):449-454.Data on file. Pfizer Inc., New York, NY. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. SAFETY & TOLERABILITY PROFILE

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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.