Retsevmo ® ▼ (selpercatinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

What changes in haematology values were seen with Retsevmo® ▼ (selpercatinib)?

Most of the abnormal laboratory values and haematology events were grades 1 or 2 in severity. Three patients discontinued selpercatinib due to thrombocytopenia (n=2) and febrile neutropenia (n=1).

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Haematology Abnormalities in LIBRETTO-001

Haematology Treatment-Emergent Adverse Events

Thrombocytopenia was the most common haematologic treatment-emergent adverse event (TEAE), occurring in 16% of patients.1 Haematology Treatment-Emergent Adverse Events in the LIBRETTO-001 Safety Population (N=796)  presents haematologic TEAEs by frequency and severity.

Haematology Treatment-Emergent Adverse Events in the LIBRETTO-001 Safety Population (N=796)1 


Any Causality

Related to Study Drug

TEAE, %a

Any Grade

Grade ≥3

Any Grade

Grade ≥3

Thrombocytopeniab

16

3

11

2

Lymphopenia 

14

5

7

2

Leukopenia

13

2

8

1

Anemia

12

3

4

1

Neutropenia

11

3

8

2

Polycythemia

1

0

<1

0

Thrombocytosis

1

0

<1

0

TEAE = treatment-emergent adverse event.

aJune 2021 data cutoff.

bThrombocytopenia is a composite term that includes thrombocytopenia and platelet count decreased.

As of June 2021 data cutoff, serious adverse events (SAE) that occurred were thrombocytopenia (n=4) and 1 event each of anemia, neutropenia, and lymphopenia. Related SAEs were thrombocytopenia in 2 patients and lymphopenia in 1 patient.1

There was one case of febrile neutropenia reported. It was a grade 3 SAE that was considered not related to selpercatinib 1

Haematology Laboratory Abnormalities in LIBRETTO-001

The majority of haematologic abnormalities were grade 1 or 2 in severity.1 Haematology Laboratory Abnormalities LIBRETTO-001 (N=796) provides the abnormal chemistry values in LIBRETTO-001.

Haematology Laboratory Abnormalities LIBRETTO-001 (N=796)1

Chemistry, %a

Nb

Any Grade

Grades 3-4

Lymphocyte count decreased

765

52

20

WBC count decreased

791

49

2

Platelets decreased

791

38

3

Hemoglobin decreased

791

28

4

Neutrophil count decreased

771

25

3

Abbreviations: WBC = white blood cell.

aJune 2021 data cutoff.

bNumber of patients.

Dose Modifications Due to Haematology Abnormalities in LIBRETTO-001

Two patients permanently discontinued selpercatinib due to thrombocytopenia, and 1 patient discontinued to to febrile neutropenia.1  Dose Modifications Due to TEAEs in the LIBRETTO-001 Safety Population (N=796) presents dose modifications due to haematology abnormalities in LIBRETTO-001.

Dose Modifications Due to TEAEs in the LIBRETTO-001 Safety Population (N=796)1

TEAE, n (%)a

Dose Interrupted

Dose Reduced

Thrombocytopenia

24 (3)

12 (2)

Neutropenia

12 (2)

6 (1)

Anemia

5 (1)

1 (<1) 

Leukopenia

5 (1)

N/A

Lymphopenia

3 (<1)

N/A

Thrombocytosis

1 (<1) 

N/A

Abbreviations: N/A = not applicable; TEAE = treatment-emergent adverse event.

aJune 2021 data cutoff.

LIBRETTO-001 Study Overview and Haematology Criteria

The efficacy of selpercatinib was evaluated in a phase 1/2, multicenter, open-label, single-arm clinical trial in patients with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer, RET fusion-positive thyroid cancer, and RET fusion-positive tumors other than lung or thyroid: Study LIBRETTO-001 (NCT03157128).2-5

Criteria for trial participation included adequate haematologic status for at least 7 days prior to treatment defined as

  • absolute neutrophil count ≥ 1.0 × 109/L not requiring growth factor support
  • platelet count ≥ 75 × 109/L not requiring transfusion support, and
  • haemoglobin ≥ 9 g/dL not requiring transfusion support or erythropoietin.1

Patients were not allowed to receive concomitant hematopoietic growth factors for prophylaxis in cycle 1.1

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Drilon A, Oxnard GR, Tan DSW, et al. Efficacy of selpercatinib in RET fusion–positive non–small-cell lung cancer. N Engl J Med. 2020;383(9):813-824. https://dx.doi.org/10.1056/NEJMoa2005653

3Retsevmo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

4Wirth LJ, Sherman E, Robinson B, et al. Efficacy of selpercatinib in RET-altered thyroid cancers. N Engl J Med. 2020;383(9):825-835. https://dx.doi.org/10.1056/NEJMoa2005651

5Phase 1/2 study of LOXO-292 in participants with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated August 8, 2022. Accessed August 31, 2022. https://www.clinicaltrials.gov/ct2/show/NCT03157128

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: 14 April 2022


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