Discover the possibilities for targeting RET in mNSCLC

NCCN Recommended

Pralsetinib is an NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)–recommended treatment option for certain patients with RET+ mNSCLC and RET+ advanced or metastatic thyroid carcinoma2,3*†

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*See the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC and thyroid carcinoma for detailed recommendations, including other preferred treatment options.
†For select patients with recurrent/persistent locoregional or distantly metastatic RET mutation-positive medullary thyroid carcinoma; for structurally persistent/recurrent locoregional or distantly metastatic RET fusion-positive differentiated thyroid cancer not amenable to RAI therapy; and for metastatic RET fusion-positive anaplastic thyroid carcinoma.
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.
mNSCLC=metastatic non–small cell lung cancer; RAI=radioactive iodine; RECIST=Response Evaluation Criteria in Solid Tumors; RET=rearranged during transfection.

GAVRETO demonstrated robust and durable response with or without prior therapy in RET+ mNSCLC1

Study design in the RET+ NSCLC population1

Efficacy and safety with GAVRETO (400 mg orally once daily) were evaluated in patients with RET fusion+ mNSCLC in the ARROW study, a phase 1/2, nonrandomized, open-label, single-arm, multicohort, multicenter clinical trial. Patients with asymptomatic central nervous system metastases, including patients with stable or decreasing steroid use within 2 weeks prior to study entry, were enrolled.

The major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR), as assessed by a blinded independent central review (BICR) according to RECIST v1.1.

GAVRETO was studied in first-line and previously treated RET+ mNSCLC patient populations similar to those seen in real-world practice1,32

  Treatment-naïve patients (n=27) Previously platinum-treated patients (n=87)
Median age (range), years 65 years (30-87) 60 years (28-85)
Gender 52% female, 48% male 49% female, 51% male
Race/ethnicity 59% White, 33% Asian, 4% Hispanic/Latino 53% White, 35% Asian, 6% Hispanic/Latino
ECOG status 0-1: 96%
2: 4%		 0-1: 94%
2: 6%
RET fusion partner 70% KIF5B, 11% CCDC6 75% KIF5B, 17% CCDC6
History of or current
brain metastases
at baseline		 37% 43%
Prior therapy - 45% PD-1/PD-L1 inhibitor
25% prior kinase inhibitors
Patient identification 67% NGS
  • 41% tumor samples
  • 22% blood or plasma
  • 4% unknown
33% FISH		 77% NGS
  • 45% tumor samples
  • 26% blood or plasma
  • 6% unknown
21% FISH
2% other

ECOG=Eastern Cooperative Oncology Group; FISH=fluorescence in situ hybridization; NGS=next-generation sequencing; PD-1=programmed cell-death protein 1; PD-L1=programmed death-ligand 1.

Efficacy results in treatment-naïve patients from the USPI1,33

Overall Response Rate (n=27)

70% ORR

70% ORR

(95% CI: 50%-86%)

Duration of and Time to Response (n=19)1,33

Median DOR Chart
  • 58% of patients continued to respond to treatment at 6 months‡
  • Median time to first response was 1.9 months
    (range: 1.4 months-5.6 months)33

Patients enrolled by July 11, 2019. Data cutoff: Feb 13, 2020.
‡Based on observed duration of response.
CI=confidence interval; CR=complete response; NE=not estimable; PR=partial response.

U.S. Prescribing Information (USPI)34

Per protocol, all treatment-naïve patients were not eligible for platinum-based chemotherapy based on an investigator assessment

Exploratory Analyses34

In July 2019, the protocol was amended to expand the eligibility criteria to include patients who were eligible for standard therapy

teal arrow

Exploratory follow-up analyses33

These analyses include treatment-naïve patients enrolled by May 22, 2020, which include the patients from the pivotal analysis in the USPI. Results of these exploratory follow-up analyses are not included in GAVRETO labeling. As these were not pre-specified analyses, data must be interpreted with caution.

ALL TREATMENT-NAÏVE PATIENTS33

Overall Response Rate (n=68)

79% ORR

79% ORR

(95% CI: 68%-88%)

Duration of Response (n=54)

Median DOR Chart

POST HOC ANALYSES OF TREATMENT-NAÏVE PATIENTS33

Initially, the ARROW protocol included treatment-naïve patients who were not candidates for standard therapy. In July 2019, the protocol was amended to expand the eligibility criteria to include patients who were eligible for standard therapy.34

Pre-protocol amendment (n=43)

74% ORR bar chart

PR=65%, CR=9% (95% CI: 59%-87%)
Median DoR (n=32): 11 months (7.4 months-NR)

Select baseline characteristics

  • Median age: 65 years (30-87)
  • Gender: female 44%, male 56%
  • History of or current CNS metastases at baseline: 35%

Post-protocol amendment (n=25)

88% ORR bar chart

All responses were partial (95% CI: 69%-98%)
Median DoR (n=22): Not Reached (NR-NR)

Select baseline characteristics

  • Median age: 54 years (35-80)
  • Gender: female 56%, male 44%
  • History of or current CNS metastases at baseline: 28%

All other baseline characteristics were generally balanced between the pivotal data included in the USPI and exploratory follow-up populations.1,33
Patients enrolled by May 22, 2020. Data cutoff: Nov 6, 2020.
CNS=central nervous system; NR=not reached.

Efficacy results in previously platinum-treated patients from the USPI1,33

Overall Response Rate (n=87)

57% ORR

57% ORR

(95% CI: 46%-68%)

Duration of and Time to Response (n=50)1,33

Median DOR Chart
  • 80% of patients continued to respond to treatment at 6 months‡
  • Median time to first response was 1.8 months
    (range: 1.3 months-9.1 months)33

Patients enrolled by July 11, 2019. Data cutoff: Feb 13, 2020.
‡Based on observed duration of response.

Consistent responses were observed with GAVRETO, including CNS activity, across previously treated subgroups1

CNS Activity

Brain metastases at baseline (n=8)§

CNS Activity 50% chart

DoR at 6 months: 75%

CNS Activity brain chart

Courtesy of Dr. Kim. Image is from a patient in the ARROW trial who achieved complete CNS response. Image is for illustrative purposes only; individual results may vary. According to the protocol, images were to be performed every 8 weeks (±7 days).33
§No patients received radiation therapy (RT) to the brain within 2 months prior to study entry.

Prior PD-1/PD-L1 Inhibitor

Exploratory Analysis

59% ORR bar chart

Disease control rate in treatment-naïve and previously treated mNSCLC patients33

Disease control rate (DCR), a prespecified secondary endpoint, was assessed in the subsets of patients in the efficacy populations with sufficient evidence of a RET fusion and baseline measurable disease confirmed on blinded independent central review. DCR is defined as ORR (CR + PR) + SD.34

  • Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR or CR nor sufficient increase to qualify for progressive disease (PD), per RECIST v1.134,35
  • Importantly, SD can reflect the natural history of the disease and may not be due to a direct therapeutic effect. Therefore, please interpret these results with caution

Treatment-naïve patients (n=27)

TREATMENT NAIVE PATIENTS (n=27)

Previously platinum-treated patients (n=87)

PREVIOUSLY PLATINUM-TREATED PATIENTS (n=87)

Patients enrolled by July 11, 2019. Data cutoff: Feb 13, 2020.

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CONTACT A REPRESENTATIVE

Important Safety Information & Indications

INDICATIONS

GAVRETO® (pralsetinib) is indicated for the treatment of:

  • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 10% of patients who received GAVRETO, including 2.7% with Grade 3/4, and 0.5% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.

Hypertension occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.

Hepatotoxicity: Serious hepatic adverse reactions occurred in 2.1% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 69% of patients, including Grade 3/4 in 5% and increased alanine aminotransferase (ALT) occurred in 46% of patients, including Grade 3/4 in 6%. The median time to first onset for increased AST was 15 days (range: 5 days to 1.5 years) and increased ALT was 22 days (range: 7 days to 1.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.

Grade ≥ 3 hemorrhagic events occurred in 2.5% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.

Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.

Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the final dose. Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the final dose.

Common adverse reactions (≥25%) were constipation, hypertension, fatigue, musculoskeletal pain and diarrhea. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased AST, increased ALT, decreased platelets and increased alkaline phosphatase.

Avoid coadministration of GAVRETO with strong CYP3A inhibitors or combined P-gp and strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please click here to see the full Prescribing Information for GAVRETO.

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      GAVRETO Prescribing Information. Genentech, Inc. February 2022.

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      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 18, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

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      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Thyroid Carcinoma V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed October 18, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org.

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