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Retsevmo ® ▼ (selpercatinib)
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Does Retsevmo® (selpercatinib) cause changes in haematology values?
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).
Management of haematologic adverse events
Management of some adverse reactions may require dose interruption and/or dose reduction. Retsevmo dose modifications are summarised in Recommended dose modifications for Retsevmo for adverse reactions based on body weight and Recommended dose modifications for Retsevmo for adverse reactions based on body weight.1
Adverse drug reaction (ADR) |
Gradea |
Dose modification |
Other adverse reactions |
Grade 1 or Grade 2 |
|
Grade 3 or Grade 4 |
|
Abbreviation: CTCAE = Common Terminology Criteria for Adverse Events.
aGrade defined by CTCAE criteria.
Dose modification |
Adults and adolescents ≥ 50 Kg |
Adults and adolescents < 50 Kg |
Starting dose |
160 mg orally twice daily |
120 mg orally twice daily |
First dose reduction |
120 mg orally twice daily |
80 mg orally twice daily |
Second dose reduction |
80 mg orally twice daily |
40 mg orally twice daily |
Third dose reduction |
40 mg orally twice daily |
Not applicable |
Hematology abnormalities in clinical studies
Hematology laboratory abnormalities across selpercatinib trials
The majority of hematologic abnormalities were grade 1 or 2 in severity.2 Hematology Laboratory Abnormalities in Selpercatinib-Treated Patients provides the abnormal hematology values seen with selpercatinib in clinical trials. Hematology Laboratory Abnormalities in LIBRETTO-431 and Hematology Laboratory Abnormalities in LIBRETTO-531 provide abnormal hematology values by arm in LIBRETTO-431 and LIBRETTO-531.
Chemistry, % |
LIBRETTO-001a |
LIBRETTO-431b |
LIBRETTO-531b |
|||
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
Lymphocyte count decreased |
52 |
20 |
53 |
8 |
41 |
18 |
White blood cell count decreased |
49 |
2 |
57 |
1 |
39 |
2 |
Platelets decreased |
38 |
3 |
53 |
3 |
28 |
1 |
Hemoglobin decreasedc |
28 |
4 |
21 |
0 |
18 |
2 |
Neutrophil count decreased |
25 |
3 |
53 |
2 |
33 |
14 |
aJune 2021 data cutoff.
bMay 2023 data cutoff.
cReported as anemia in LIBRETTO-431 and LIBRETTO-531.
Chemistry, % |
LIBRETTO-431a |
|||
SELPERCATINIB |
Pemetrexed, Platinum, +/- Pembrolizumab |
|||
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
Lymphocyte count decreased |
53 |
8 |
63 |
16 |
White blood cell count decreased |
57 |
1 |
62 |
9 |
Platelets decreased |
53 |
3 |
39 |
5 |
Hemoglobin decreasedb |
21 |
0 |
91 |
5 |
Neutrophil count decreased |
53 |
2 |
58 |
11 |
aMay 2023 data cutoff.
bReported as anemia.
Chemistry, % |
LIBRETTO-531a |
|||
SELPERCATINIB |
CABOZANTINIB or VANDETANIB |
|||
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
Lymphocyte count decreased |
41 |
18 |
36 |
13 |
White blood cell count decreased |
39 |
2 |
38 |
5 |
Platelets decreased |
28 |
1 |
34 |
1 |
Hemoglobin decreasedb |
18 |
2 |
23 |
2 |
Neutrophil count decreased |
33 |
14 |
42 |
19 |
aMay 2023 data cutoff.
bReported as anemia.
Dose modifications due to hematology treatment-emergent adverse events
Few dose interruptions or reductions occurred across selpercatinib studies due to thrombocytopenia, neutropenia, anemia, leukopenia, lymphopenia, or thrombocytosis.2
In LIBRETTO-001, 2 patients permanently discontinued selpercatinib due to thrombocytopenia, and 1 patient discontinued due to febrile neutropenia.2
In LIBRETTO-431 and LIBRETTO-531, no patients discontinued due to thrombocytopenia, neutropenia, anemia, leukopenia, lymphopenia, or thrombocytosis.2
LIBRETTO-001 study overview and haematology criteria
Criteria for trial participation included adequate hematologic status for at least 7 days before 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
- hemoglobin ≥ 9 g/dL not requiring transfusion support or erythropoietin.2
Patients were not allowed to receive concomitant hematopoietic growth factors for prophylaxis in cycle 1.2
Overview of selpercatinib clinical trials
LIBRETTO-001 is a multicenter, open-label, phase 1/2 study of selpercatinib administered orally to patients with rearranged during transfection (RET) fusion-positive solid tumors, RET-mutant medullary thyroid cancer, and other tumors with RET activation (NCT03157128).3-5
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 RET fusion-positive nonsquamous non-small cell lung cancer (NCT04194944).6
LIBRETTO-531 is a multicenter, randomized, open-label, phase 3 trial comparing selpercatinib to physician's choice of cabozantinib or vandetanib in patients with metastatic, advanced, kinase inhibitor naïve, RET-mutant MTC (NCT04211337).7-9
References
1Retsevmo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Drilon A, Subbiah V, Gautschi O, et al. Durability of efficacy and safety with selpercatinib in patients with RET fusion+ non-small-cell lung cancer: LIBRETTO-001. Poster presented at European Lung Cancer Congress (ELCC Virtual) 2022; March 30-April 2, 2022.
4Wirth LJ, Subbiah V, Worden F, et al. Efficacy of selpercatinib in patients with medullary thyroid cancer (MTC): update of the LIBRETTO-001 trial. Presented at: the European Society for Medical Oncology (ESMO); Madrid, Spain; October 20-24, 2023.
5A study of selpercatinib (LOXO-292) in participants with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated October 11, 2023. Accessed October 23, 2023. https://www.clinicaltrials.gov/ct2/show/NCT03157128
6Zhou C, Solomon BJ, Loong K, et al. First-line selpercatinib or chemotherapy and pembrolizumab in RET fusion–positive NSCLC. N Engl J Med. 2023;389(20):1839-50 https://www.nejm.org/doi/10.1056/NEJMoa2309457
7Wirth LJ, Brose MS, Elisei R, et al. LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naïve RET-mutant medullary thyroid cancer. Future Oncol. 2022;18(28):3143-3150. https://doi.org/10.2217/fon-2022-0657
8A study of selpercatinib (LY3527723) in participants with RET-mutant medullary thyroid cancer (LIBRETTO-531). ClinicalTrials.gov identifier: NCT04211337. Updated October 30, 2023. Accessed November 3, 2023. https://clinicaltrials.gov/ct2/show/NCT04211337
9Hadoux J, Elisei R, Brose M, et al; LIBRETTO-531 Trial Investigators. Phase 3 trial of selpercatinib in advanced RET-mutant medullary thyroid cancer. N Engl J Med. Published online October 21, 2023. www.nejm.org/doi/full/10.1056/NEJMoa2309719
▼ 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: 21 November 2023