Discover the possibilities for targeting RET in advanced thyroid cancers

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 regardless of prior therapy in RET+ advanced thyroid cancers1

Study design in the RET+ advanced thyroid cancer population1

Efficacy and safety with GAVRETO (400 mg orally once daily) were evaluated in patients with advanced or metastatic RET-mutant+ MTC and RET fusion+ thyroid cancer in the ARROW study, a phase 1/2, nonrandomized, open-label, single-arm, multicohort, multicenter clinical trial.1 All patients must have had a non-resectable RET-altered solid tumor or MTC per local assessment of tumor tissue and/or blood. All patients must also have had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.36

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 v1.1.1

MTC=medullary thyroid cancer.

GAVRETO was studied in various types of patients with RET+ advanced thyroid cancers1

  MTC: cabozantinib- and
vandetanib-naïve patients
(n=29)‡
 MTC: previously cabozantinib-
and/or vandetanib-treated
patients (n=55)§
 RET fusion-positive
thyroid cancer (n=9)
Median age
(range), years		 61 years (19-81) 59 years (25-83) 61 years (46-74)
Gender 28% female
72% male		 31% female
69% male		 33% female
67% male
Race/ethnicity 76% White
17% Asian
3.4% Hispanic/Latino		 78% White
5% Asian
5% Hispanic/Latino		 78% White
22% Asian
11% Hispanic/Latino
ECOG status 0-1: 100% 0-1: 95%
2: 5%		 0-1: 100%
History of CNS metastases at baseline 14% 7% 56%
Patient identification 90% NGS
  • 52% tumor sample
  • 35% plasma
  • 3.4% blood
10% PCR		 73% NGS
  • 55% tumor sample
  • 18% plasma
26% PCR
2% other		 89% NGS
11% FISH

‡97% of patients had metastatic disease. 28% had received up to 3 lines of prior systemic therapy (including 10% PD-1/PD-L1 inhibitors, 10% radioactive iodine, 3.4% kinase inhibitors).
§Patients had received a median of 2 prior therapies (range 1-7). The primary mutations in RET-mutant MTC previously treated with cabozantinib or vandetanib are described in Table 10 of the full Prescribing Information for GAVRETO.
All patients had papillary thyroid cancer. All patients had metastatic disease. Patients had received a median of 2 prior therapies (range 1-8). Prior systemic treatments included prior radioactive iodine (100%) and prior sorafenib and/or lenvatinib (56%).
CNS=central nervous system; FISH=fluorescence in situ hybridization; NGS=next-generation sequencing; PCR=polymerase chain reaction; PD-1=programmed cell-death protein 1; PD-L1=programmed death-ligand 1.

Efficacy results with GAVRETO in advanced or metastatic RET-mutant MTC1,33

Cabozantinib- and vandetanib-naïve

Overall Response Rate (n=29)

66% ORR

66% ORR

(95% CI: 46%-82%)

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

Median DOR Chart
  • 84% of patients continued to respond to treatment at 6 months#
  • Median time to first response was 3.7 months
    (range: 1.7 months-11.1 months)33

Prior cabozantinib and/or vandetanib

Overall Response Rate (n=55)

60% ORR

60% ORR

(95% CI: 46%-73%)

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

Median DOR Chart
  • 79% of patients continued to respond to treatment at 6 months#
  • Median time to first response was 3.7 months
    (range: 1.8 months-12.9 months)33,37

Patients enrolled by July 11, 2019. Data cutoff: May 22, 2020.
#Based on observed duration of response.
CI=confidence interval; CR=complete response; NE=not estimable; NR=not reached; PR=partial response.

Efficacy results with GAVRETO in advanced or metastatic RET fusion+ thyroid cancer1,33

Overall Response Rate (n=9)

89% ORR

89% ORR

(95% CI: 52%-100%)

Duration of and Time to Response (n=8)1,33

Median DOR Chart
  • 100% of patients continued to respond to treatment at 6 months#
  • Median time to first response was 1.9 months
    (range: 1.8 months-5.5 months)33,37

Patients enrolled by July 11, 2019. Data cutoff: May 22, 2020.
#Based on observed duration of response.

Disease control rates in RET+ advanced thyroid cancers33,37

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 rearrangement and baseline measurable disease confirmed on blinded independent central review. DCR is defined as ORR (CR + PR) + SD.37

  • 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 v1.135,37
  • 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

In advanced or metastatic RET-mutant MTC33,37

Cabozantinib- and vandetanib-naïve (n=29)33

97% DCR bar chart

Prior cabozantinib and/or vandetanib (n=55)37

93% DCR bar chart

In advanced or metastatic RET fusion+ thyroid cancer37

All (n=9)

100% DCR bar chart

Patients enrolled by July 11, 2019. Data cutoff: May 22, 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.

    • 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.

      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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