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Retevmo ® (selpercatinib) tablets

40 mg, 80 mg, 120 mg, 160 mg

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

How does Retevmo® (selpercatinib) compare to standard of care treatment for non-small cell lung cancer?

LIBRETTO-431 is a phase 3, head to head trial comparing selpercatinib to standard of care in RET fusion-positive non-small cell lung cancer that has shown greater efficacy in selpercatinib-treated patients compared to standard of care.

US_cFAQ_SEL206_LIBRETTO-431
US_cFAQ_SEL206_LIBRETTO-431en-US

Selpercatinib Compared to Standard of Care in Non-Small Cell Lung Cancer (LIBRETTO-431)

LIBRETTO-431 is a global, open-label, randomized, phase 3 trial comparing selpercatinib to platinum-based chemotherapy and pemetrexed with or without pembrolizumab as initial treatment in patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive nonsquamous non-small cell lung cancer (NSCLC) (NCT04194944).1,2

LIBRETTO-431 Clinical Study Sites provides patient breakdown by region.3

The primary endpoint was progression-free survival (PFS) by blinded independent committee review (BICR) assessed in 2 patient groups: the intent-to-treat-pembrolizumab (ITT-PEMBRO) population and intent-to-treat (ITT) population.2

Prior to randomization, patients were stratified per the investigator’s choice of intent to use pembrolizumab if the patient was assigned to the control arm.  The ITT-PEMBRO population includes only those patients that investigators intended to treat with pembrolizumab.2,3

LIBRETTO-431 Study Design  provides LIBRETTO-431 study design and a summary of outcome measures.

Between March 2020 and August 2022, there were 261 patients enrolled into the study. Of the 261 patients, 159 were randomly assigned to selpercatinib, and 102 to chemotherapy with or without pembrolizumab. The ITT-PEMBRO group included 212 patients (129 in the selpercatinib arm and 83 in the chemotherapy with pembrolizumab arm). The majority of patients were Asian, female, never smokers, and younger than 65 years of age.2,3

Patient Baseline Demographics for LIBRETTO-431 provides detailed information regarding patient baseline demographics.

LIBRETTO-431 Efficacy in Patients With Non-Small Cell Lung Cancer

In the ITT-PEMBRO population, PFS was significantly increased in selpercatinib-treated patients with a hazard ratio of 0.465 (95% CI: 0.309, 0.699; p<0.001). These results were consistent with the ITT population. Progression-free survival was consistent across pre-planned analyses.2,3

Summary of Outcomes in LIBRETTO-431 by Blinded Independent Review Committee provides an overview of outcomes in LIBRETTO-431.

Summary of Outcomes in LIBRETTO-431 by Blinded Independent Review Committee2-4

Outcome Measurea

ITT-PEMBRO POPULATION

ITT POPULATION

SEL
(N=129)

Control
(N=83)

SEL
(N=159)

Control
(N=102)

Progression-free survival, months (95% CI)b

Median

24.8
(16.9, NE)

11.2
(8.8, 16.8)

24.8
(17.3, NE)

11.2
(8.8, 16.8)

Median duration of follow-up

19.4
(16.7, 19.7)​

18.9 ​ 
(14.2, 22.3)

19.4 ​ 
(16.7, 19.6)

16.5 ​ 
(13.6, 21.0)

Objective response rate, % (95% CI)

83.7 
(76.2, 89.6)

65.1
(53.8, 75.2)

83.6
(77.0, 89.0)

62.7
(52.6, 72.1)

Best overall response, n (%)

Complete

9 (7.0) 

5 (6.0)

12 (7.5)

5 (4.9)​ 

Partial

99 (76.7) 

49 (59.0)

121 (76.1)​

59 (57.8)​

Stable disease

14 (10.9) 

20 (24.1)

17 (10.7)

26 (25.5)

Progressive disease

2 (1.6)

5 (6.0) 

2 (1.3)​ 

7 (6.9)

Non-evaluable

5. (3.9)

4 (4.8) 

7 (4.4)

5 (4.9)​

Duration of response

Responders, n (%)

108 (83.7)

54 (65.1)

133 (83.6)

64 (62.7)

Median DOR, months (95% CI)

24.2 (17.9, NE) 

11.5 (9.7, 23.3)

24.2 (17.9, NE)

12.0 (9.7, 23.3)

Censored, n (%)

74 (68.5)

25 (46.3)

43 (32.3)

31 (48.4)​

Median duration of   follow-up, months (95% CI)

18.0 (16.5, 19.5)

14.6 (11.2, 19.8) 

17.9 (15.7, 18.7)

12.7 (11.1, 16.6)

Abbreviations: DOR = duration of response; ITT = intent-to-treat; NE = not evaluable; SEL = selpercatinib; PEMBRO = pembrolizumab.

aEfficacy outcomes were assessed with the use of Response Evaluation Criteria in Solid Tumors version 1.1, and were confirmed by blinded independent radiologic review.

bIn the ITT-PEMBRO patients, hazard ratio 0.465 (95% CI: 0.309, 0.699 (p<0.001).

Overall survival (OS) was immature at the time of the PFS interim analysis. At the time of an updated descriptive analysis of OS (43% of prespecified OS events needed for the final analysis), a total of 49 (31%) and 26 (25%) patients died in the selpercatinib and the control arm, respectively. The OS HR was 1.26 (95% CI: 0.78, 2.04). Overall survival may be affected by the imbalance in post-progression therapies. Of 68 control arm patients who had disease progression, 50 patients (74%) received selpercatinib at progression. Of 71 selpercatinib arm patients who had disease progression, 16 (23%) received chemotherapy and/or immune checkpoint inhibitor therapy, and 44 (62%) continued receiving selpercatinib.5

Post-Progression Therapies in Patients With Investigator-Assessed Disease Progression in Selpercatinib and Control Arm4

Figure 1 description: Of the 71 patients in the selpercatinib arm who experienced disease progression, 16 patients (23%) received chemotherapy and/or immunotherapy as their next line of treatment while 44 patients (62%) continued to receive selpercatinib post-progression. Of the 68 patients in the control arm who experienced disease progression, 50 patients (74%) crossed over to selpercatinib.

Abbreviations: Chemo = chemotherapy; IO = immunotherapy; N = number of patients; PD = progressive disease; RET = rearranged during transfection; RETi = rearranged during transfection inhibitor.

Intracranial Efficacy in LIBRETTO-431

Intracranial baseline assessments were available for evaluation by neuroradiologic BICR per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for 192 patients in the ITT-PEMBRO population (selpercatinib n=120, control n=72).6 Of those patients, 42 (22%) had brain metastases, and 29 patients had measurable disease (17 in the selpercatinib group and 12 in the control).2,6 

Intracranial Responses in the CNS-PEMBRO Population With CNS Metastasis in LIBRETTO-431 presents a summary of intracranial response for the CNS-PEMBRO population of patients with CNS metastasis.6

Intracranial Responses in the CNS-PEMBRO Population With CNS Metastasis in LIBRETTO-4316

 

Selpercatnib 
(n=21)

Control
(n=21)

Measurable disease, n (%)

17 (81.0)

12 (57.1)

Nonmeasurable disease, n (%)

4 (19.0)

9 (42.9)

Intracranial BOR, n (%)

Complete response

9 (42.9)

7 (33.3)

Partial response

8 (38.1)

5 (23.8)

Stable diseasea

2 (9.5)

5 (23.8)

Progressive disease

0

2 (9.5)

Intracranial ORR, % (95% CI)

81.0 (58.1-94.6)

57.1 (34.0-78.2)

Median time to intracranial response, months (range)

1.4 (1.2-3.0)

2.2 (1.2-11.0)

Median intracranial DOR, months (95% CI)

NE (14.8-NE)

NE (8.7-NE)

Intracranial DOR rate, % (95% CI)

At 6 months

94.1 (65.0-99.1)

90.9 (50.8-98.7)

At 12 months

80.7 (51.1-93.4)

75.8 (30.5-93.7)

Abbreviations: BOR = best overall response; CNS = central nervous system; DOR = duration of response; NE = not evaluable; ORR = overall response rate; PEMBRO = pembrolizumab.

aIncludes non-complete response/non-progressive disease in patients with baseline non-measurable lesions only.

Intracranial evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) was required for all patients. The scans were obtained at baseline and then at the same frequency as other radiologic imaging. A total of 192 patients (120 patients on the selpercatinib arm and 72 on the control arm) had these serial scans. Of these 192 patients, 150 patients (99 on the selpercatinib arm and 51 on the control arm) were without baseline brain metastases.6

Twenty-nine patients with CNS metastasis had measurable disease (17 in the selpercatinib group and 12 in the control group). Among the patients with measurable disease at baseline, intracranial response occurred in 82% (95% CI: 57, 96) of patients in the selpercatinib group and 58% (95% CI: 28, 85) of patients in the control group.2

Complete responses occurred in 6 of the 17 patients (35%) in the selpercatinib group and 2 of the 12 patients (17%) in the control group. Data on the median duration of intracranial response were immature, but at 12 months, 76% of patients continued to have a response with selpercatinib, compared to 63% with control treatment.2

Intracranial responses to selpercatinib were more common in patients without previous CNS radiation therapy (93%) compared to patients with previous CNS radiation therapy (50%).6

Cumulative Incidence of CNS Progression

In the ITT-PEMBRO population, patients with intracranial baseline assessments were followed for development of new central nervous system (CNS) metastasis (N=192). Selpercatinib delayed time to CNS progression, regardless of baseline CNS metastatic status (Cumulative Incidence of CNS Progression Overall in the LIBRETTO-431 ITT-PEMBRO Population).3

Cumulative Incidence of CNS Progression Overall in the LIBRETTO-431 ITT-PEMBRO Population3

Figure 1 description: Patients with intracranial baseline assessments were followed for development of new central nervous system metastasis (N=192). Selpercatinib delayed time to CNS progression, regardless of baseline central nervous system metastatic status.

Abbreviations: CNS = central nervous system; ITT-PEMBRO = intent-to-treat-pembrolizumab; PD = progressive disease.

As of the data cutoff date of May 2023, in the 150 patients without baseline CNS metastasis in the CNS-PEMBRO population, the 12-month CIR of CNS progressive disease was 1.1% with selpercatinib compared with 14.7% with control (Cumulative Incidence Rate of CNS Progression in CNS-PEMBRO Population Without CNS Metastasis in LIBRETTO-431).6

Cumulative Incidence Rate of CNS Progression in CNS-PEMBRO Population Without CNS Metastasis in LIBRETTO-4317

Figure 2 description: The 12-month cumulative incidence rate of central nervous system disease progression was 1.1% for selpercatinib versus 14.7% for control. The cause-specific hazard ratio was 0.17. 

Abbreviations: CIR = cumulative incidence rate; CNS = central nervous system; HR = hazard ratio; PEMBRO = pembrolizumab.

Patient-Reported Outcomes in LIBRETTO-431

NSCLC-SAQ

Selpercatinib significantly delayed the time to confirmed deterioration (TTCD) of pulmonary symptoms as measured by the non-small cell lung cancer symptom assessment questionnaire (NSCLC-SAQ) total score compared to control after 1 year of treatment (p<.05).8

Median Time to Confirmed Deterioration of NSCLC-SAQ Symptoms, ITT Pembrolizumab Population provides the median TTCD for individual symptoms within the NSCLC-SAQ.8

Median Time to Confirmed Deterioration of NSCLC-SAQ Symptoms, ITT Pembrolizumab Population8


NSCLC-SAQ Symptom

Median Time, Months (95% CI)


Hazard Ratio
(95% CI)

Selpercatinib
(n=129)

Control
(n=83)a

Cough

NE

NE

0.41 (0.21, 0.81)

Pain

NE

8.8 (1.0, NE)

0.54 (0.33, 0.88)

Dyspnea

14.0 (4.9, NE)

2.6 (1.3, 7.0)

0.57 (0.36, 0.91)

Fatigue

14.0 (2.9, NE)

0.8 (0.4, 2.9)

0.54 (0.35, 0.84)

Appetite loss

16.4 (7.9, NE)

2.3 (1.0, 5.8)

0.45 (0.28, 0.72)

Abbreviation: ITT = intent-to-treat; NE = not estimable; NSCLC-SAQ = Non-Small Cell Lung Cancer Symptom Assessment Questionnaire.

aPemetrexed plus investigator's choice of carboplatin or cisplatin with pembrolizumab.

At 1 year, the mean NSCLC-SAQ total score was lower (lower scores indicate less severe symptoms) with selpercatinib compared with control (mean difference: -2.00; 95% CI: -2.94, 1.05; p<.001).8

Health-Related Quality of Life

Treatment Difference in HRQoL From Baseline to First Year as Measured by EORTC QLQ-C30 shows the treatment difference between selpercatinib and control in health-related quality of life changes from baseline.8

Treatment Difference in HRQoL From Baseline to First Year as Measured by EORTC QLQ-C308

Figure 4 description: Physical functioning with selpercatinib was clinically and statistically improved from baseline at 1 year, compared to the control group.

Abbreviations: EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire; GHS = global health status; MID = meaningful important difference; HRQoL = Health-Related Quality of Life.

aThe estimated score difference for the physical functioning score was from a growth curve model analysis at 49 weeks.

*Clinical and statistical significance.

LIBRETTO-431 Safety in Patients With Non-Small Cell Lung Cancer

Treatment-Emergent Adverse Events in the LIBRETTO-431 Safety Population provides a listing of adverse events in the LIBRETTO-431 safety population and in ≥20% of patients in either arm in the LIBRETTO-431 safety population. Five patients (1 in selpercatinib and 4 in control arm) did not receive any treatment and are not part of the safety population. Adverse events were consistent with those previously reported for selpercatinib and managed with dose modifications.2,3

Treatment-Emergent Adverse Events in the LIBRETTO-431 Safety Population2

TEAE, n (%)

Selpercatinib
(N=158)

Control
(N=98)

Any Grade

Grade ≥3

Any Grade

Grade ≥3

AST increased

97 (61)

20 (13)

39 (40)

1 (1)

ALT increased

95 (60)

35 (22)

39 (40)

3 (3)

Hypertension

76 (48)

32 (20)

7 (7)

3 (3)

Diarrhea

70 (44)

2 (1)

24 (24)

2 (2)

Edema

65 (41)

4 (3)

27 (28)

0

Dry mouth

62 (39)

0

6 (6)

0

Blood bilirubin increased

59 (37)

2 (1)

1 (1)

0

Rash

52 (33)

3 (2)

29 (30)

1 (1)

Fatigue

51 (32)

5 (3)

49 (50)

5 (5)

Thrombocytopenia

42 (27)

5 (3)

28 (29)

7 (7)

Abdominal pain

40 (25)

1 (1)

19 (19)

2 (2)

Leukopenia

40 (25)

2 (1)

32 (33)

7 (7)

Blood creatinine increased

39 (25)

2 (1)

17 (17)

1 (1)

Neutropenia

36 (23)

3 (2)

44 (45)

27 (28)

Constipation

34 (22)

0

39 (40)

1 (1)

ECG QT prolonged

32 (20)

14 (9)

1 (1)

0

Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; ECG = electrocardiogram; TEAE = treatment-emergent adverse event.

Safety Summary for the Intent-to-Treat Population in LIBRETTO-431 provides a safety summary for LIBRETTO-431 safety population.

Safety Summary for the Intent-to-Treat Population in LIBRETTO-4313

Parameter

Selpercatinib
(N=158)

Control
(N=98)

Median time on treatment, months +/- SD

16.7 ± 8.3

9.8 ± 7.2

Adverse events

Any adverse event, n (%)

158 (100)

97 (99)

Grade ≥3

111 (70.3)

56 (57)

Serious adverse event

55 (35)

23 (24)

Dose modifications due to adverse events

Leading to discontinuation

16 (10)

2 (2)

Leading to dose adjustment

123 (78)

74 (76)

Leading to dose reduction

81 (51)

28 (29)

Deaths

Death due to an adverse event, n (%)

7 (4)

0

Relateda

2 (1)

0

aMalnutrition and sudden death deemed related by investigator.

Fatal treatment-emergent adverse events that occurred on study or within 30 days of treatment discontinuation were observed in 7 (4.4%) selpercatinib-treated patients and none in the control arm (Summary of Fatal Adverse Events).2

Summary of Fatal Adverse Events2

Patient Demographics 

Study Day of Death 

BICR Best 
Overall Response 

Adverse Eventa

Comorbidities/Comment 

70-year-old Caucasian woman

5 

Not able to evaluate 

Cardiac arrest 

Cardiac risk factors, including baseline pleural effusion and pericardial effusion  

79-year-old Caucasian male 

7 

Not able to evaluate 

Myocardial infarction 

Cardiac risk factors  
Died at home with limited data  

59-year-old Caucasian man  

46 

Not able to evaluate 

Respiratory failure 

Pneumonia (ongoing at time of death), shortness of breath, hypoxemia, respiratory deterioration. Fatal outcome 6 days after selpercatinib discontinuation 

74-year-old Caucasian woman

60 

Not able to evaluate 

Respiratory failure 

Bilateral pleural effusion and suspected carcinomatous lymphangitis.  Worsening clinical condition due to progressive disease reported by investigator. Fatal outcome 26 days after last dose of selpercatinib. 

55-year-old Caucasian man 

71 

Progressive disease 

Myocardial infarction 

Metastases in the left hilar and aortopulmonary regions. 
CT showed obstruction to main pulmonary artery. 

74-year-old Asian man 

238 

Stable disease 

Sudden deathb

Chest pain, shortness of breath, asthenia, productive cough at baseline.   
Died at home with limited data. 

 

77-year-old Asian man 

579 

Stable disease 

Malnutritionc

Sore throat, poor breathing, and loss of appetite. Family members had similar respiratory symptoms, but COVID-19 could not be tested. 
Died at home with limited data. 

 

Abbreviations: BICR = blinded independent committee review; CT = computed tomography.

aMedDRA preferred term.

bRelated to selpercatinib as assessed by the investigator.

cRelated to selpercatinib as assessed by the investigator. The investigator attribution was noted to be related as drug effect could not be ruled out.

Additionally, one patient randomized to the control arm had a fatal event (respiratory failure) on study day 187 during crossover with selpercatinib treatment.4 The deaths due to malnutrition and sudden death were deemed by investigators to be selpercatinib-related.2

Fatal Event That Occurred on Study Day 187

A 56-year-old Asian woman who was originally randomized to the control group crossed over to the selpercatinib group on study day 65 once she experienced progressive disease. On study day 187, the patient died. No autopsy was performed. The investigator related the fatal event of respiratory failure to selpercatinib and not to the study treatments in the control arm as neither selpercatinib toxicity nor disease progression could be ruled out.4

LIBRETTO-431 Study Overview

LIBRETTO-431 Enrollment by Region

As seen in LIBRETTO-431 Clinical Study Sites, LIBRETTO-431 enrolled patients N (%) from

  • Eastern Asia 142 (54.4)
  • European Union 79 (30.3)
  • Other region 32 (12.3), and
  • North America 8 (3.1).4
LIBRETTO-431 Clinical Study Sites4

Figure 4 description: LIBRETTO-431 enrolled a total of 261 patients at 103 sites across 26 countries. 

*There were no countries with 41-80 patients. Countries in light gray were not included in the study. 

LIBRETTO-431 Study Design

LIBRETTO-431 Study Design3 

Figure 7 description: Patients with locally advanced or metastatic rearranged during transfection fusion-positive nonsquamous non-small cell lung cancer were randomized to either selpercatinib 160 mg twice daily (N=159) or pemetrexed 500 mg/m2 with or without pembrolizumab 200 mg (N=102), until disease progression. Patients may cross-over at progressive disease. Coprimary endpoints are progression-free survival by blinded independent review committee in the intent-to-treat population and in the patients with intent-to treat with platinum, pemetrexed and pembrolizumab.

Abbreviations: AUC = area under the curve; BID = twice daily; BICR = blinded independent committee review; CNS = central nervous system; DOR = duration of response; ECOG PS = Eastern Cooperative Oncology Group performance status; ITT = intent-to-treat; NSCLC = non-small cell lung cancer; NSCLC SAQ = Non-Small Cell Lung Cancer Symptom Assessment Questionnaire; ORR = objective response rate; OS = overall survival; PD = progressive disease; PFS = progression-free survival; PRO = patient-reported outcomes; R = randomized; RET = rearranged during transfection.

Notes: no more than 20% of patients with intent not to received pembrolizumab will be enrolled. 

a Not suitable for radical surgery/radiation therapy.

b Investigator assessed.

c The initial randomization ratio was 1:1 but amended to 2:1.

d ITT-Pembrolizumab are patients stratified with investigator intent to receive chemotherapy with pembrolizumab and per protocol had to be at least 80% of the ITT population.

e Baseline and longitudinal intracranial scans were required for all patients beginning with amendment d. Prior to amendment d, intracranial scans were required if known CNS metastases at baseline.

Exclusion Criteria in LIBRETTO-431

Key exclusion criteria include

  • additional validated oncogenic drivers in NSCLC
  • symptomatic central nervous system metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression, and
  • clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or QT interval corrected for heart rate by Fridericia's formula >470 ms.

Key exclusion criteria specific to patients receiving pembrolizumab include having a history of interstitial lung disease or interstitial pneumonitis and/or an active autoimmune disease or any illness or treatment that could compromise the immune system.1,2

LIBRETTO-431 Baseline Demographics

Most of RET fusions were identified by next generation sequencing (60%) from

  • primary tumor (56%)
  • metastatic tumor (33%), and
  • blood-based results (10%).2
Patient Baseline Demographics for LIBRETTO-4312

Characteristic

ITT-PEMBRO Population

ITT Population

SEL
(N=129)

Control
(N=83)

SEL
(N=159)

Control
(N=102)

Age, years, median (range)

60 (31-84)

62 (31-83)

61 (31-87)

62.5 (31-83)

Sex, %

Female

50

58

54

56

Male

50

42

46

44

Race, %

Asian

59

52

59

54

White

38

47

37

45

Black

2

0

1

0

Othera

2

1

1

1

Smoking status, %

Never

66

71

68

67

Current/Former

33

29

32

33

Histology, %

Adenocarcinomab

99

96

99

97

Stage of disease, %

III B/C

5

8

6

8

IV

95

92

94

92

Metastasis, %

Brain

19

22

19

21

Liver

15

20

13

20

Abbreviations: ITT = intent-to-treat; NSCLC = non-small cell lung cancer; PEMBRO = pembrolizumab; RET = rearranged during transfection; SEL = selpercatinib.

aOther races included American Indian or Alaska Native, Native Hawaiian or other Pacific Islander or multiple races.

b There were 4 patients in the ITT population that were diagnosed with NSCLC, not otherwise specified.

Baseline Genomic Findings in LIBRETTO-4312 

Genomic characteristic, %

ITT-PEMBRO Population

ITT Population

SEL
(N=129)

Control
(N=83)

SEL
(N=159)

Control
(N=102)

PD-L1 Status

Positive

43

47

42

46

Missing

33

39

35

34

RET fusion

Positivea

45

37

43

38

KIF5Bb

42

49

44

49

CCDC6

10

10

10

9

Abbreviations: CCDC6 = coiled-coil domain containing 6; ITT = intent-to-treat; KIF5B =  kinesin family member 5B; PD-L1 = programmed death-ligand 1; PEMBRO = pembrolizumab; RET = rearranged during transfection; SEL = selpercatinib.

aRET fusion was indicated by molecular analysis, but the RET fusion partner was not identified.

bOne patient had KIF5B-RET and CDKAL1-RET co-mutation.

Completion Timeline for LIBRETTO-431

The primary completion date was May 1, 2023 with an estimated study completion February 2026. LIBRETTO-431 is active, but closed to enrollment.1

Enclosed Prescribing Information

RETEVMO® (selpercatinib) capsules and tablets, for oral use, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1A study of selpercatinib (LY3527723) in participants with advanced or metastatic RET fusion-positive non-small cell lung cancer (LIBRETTO-431). ClinicalTrials.gov identifier: NCT04194944. Updated June 20, 2024. Accessed August 5, 2024. https://www.clinicaltrials.gov/ct2/show/NCT04194944

2Zhou C, Solomon BJ, Loong K, et al; LIBRETTO-431 Trial Investigators. First-line selpercatinib or chemotherapy and pembrolizumab in RET fusion–positive NSCLC. N Engl J Med. 2023;389(20):1839-1850. https://www.nejm.org/doi/10.1056/NEJMoa2309457

3Loong HH, Goto K, Solomon BJ, et al. Randomized phase III study of first-line selpercatinib versus pembrolizumab and chemotherapy in RET fusion-positive NSCLC. Abstract presented at: 48th Annual Meeting of the European Society for Medical Oncology (ESMO); October 21 2023; Madrid Spain. Accessed October 21, 2023. https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal/presentation/list?q=Herbert+Loong&r=st~3

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.

6Pérol M, Solomon BJ, Goto K, et al. CNS protective effect of selpercatinib in first-line RET fusion-positive advanced non-small cell lung cancer. J Clin Oncol. 2024. 42(21):2500-2505. https://dx.doi.org/10.1200/JCO.24.00724

7Pérol M, Solomon BJ, Goto K, et al. Intracranial outcomes of 1L selpercatinib in advanced RET fusion-positive NSCLC: LIBRETTO-431 Study. Poster Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31 - June 4, 2024; Chicago, IL. https://meetings.asco.org/abstracts-presentations/232853

8Zhou C, Novello S, Garrido P, et al. Health-related quality of life (HRQoL) and symptoms in LIBRETTO-431 patients with RET fusion-positive advanced non-small-cell lung cancer (NSCLC). Poster presented at: Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2024; Chicago, IL. https://meetings.asco.org/abstracts-presentations/233217

Date of Last Review: September 30, 2024

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