Effects of selpercatinib: A Synthesis of Findings from 20 Studies

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Original Abstract of the Article

Main Research Findings

Selpercatinib is a targeted therapy that has shown promise in treating various cancers caused by alterations in the RET gene, including non-small cell lung cancer (NSCLC) and thyroid cancer. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 This drug has demonstrated clinically meaningful activity with manageable toxicity in both pretreated and treatment-naive patients with advanced/metastatic RET fusion-positive NSCLC. 20 It's worth noting that selpercatinib can cross the blood-brain barrier, potentially making it effective against brain metastases. Additionally, selpercatinib has shown efficacy regardless of tumor type in patients with RET fusion-positive solid tumors, suggesting a 'tumor-agnostic' approach. 18 Furthermore, selpercatinib holds potential for overcoming acquired resistance to EGFR inhibitors in EGFR-mutant NSCLC. 10 Selpercatinib has also shown effectiveness in treating RET-mutated thyroid cancers. 3 Some studies suggest that selpercatinib could be more effective with fewer side effects than other RET-targeted therapies. 16 In a phase III trial, selpercatinib demonstrated potential to be more effective than cabozantinib or vandetanib in treating advanced RET-mutated medullary thyroid cancer (MTC). 19 In a pivotal phase 1/2 trial for treating advanced RET fusion-positive NSCLC, selpercatinib achieved robust and durable responses, including intracranial responses, in patients previously treated with platinum-based chemotherapy and treatment-naive patients, demonstrating its potential as a promising new RET-targeted therapy option. 15

Benefits and Risks

Benefit Summary

Selpercatinib has shown clinically meaningful activity with manageable toxicity in both pretreated and treatment-naive patients with advanced/metastatic RET fusion-positive NSCLC. 20 It's worth noting that selpercatinib can cross the blood-brain barrier, potentially making it effective against brain metastases. Additionally, selpercatinib has shown efficacy regardless of tumor type in patients with RET fusion-positive solid tumors, suggesting a 'tumor-agnostic' approach. 18 Furthermore, selpercatinib holds potential for overcoming acquired resistance to EGFR inhibitors in EGFR-mutant NSCLC. 10 Selpercatinib has also shown effectiveness in treating RET-mutated thyroid cancers. 3 Some studies suggest that selpercatinib could be more effective with fewer side effects than other RET-targeted therapies. 16 In a phase III trial, selpercatinib demonstrated potential to be more effective than cabozantinib or vandetanib in treating advanced RET-mutated medullary thyroid cancer (MTC). 19 In a pivotal phase 1/2 trial for treating advanced RET fusion-positive NSCLC, selpercatinib achieved robust and durable responses, including intracranial responses, in patients previously treated with platinum-based chemotherapy and treatment-naive patients, demonstrating its potential as a promising new RET-targeted therapy option. 15

Risk Summary

Common side effects of selpercatinib include hypertension, elevated ALT levels, elevated AST levels, QT prolongation, neutropenia, and pneumonitis. 8 Selpercatinib has also been reported to cause chylous ascites in rare cases. , In general, selpercatinib side effects can be managed through dose adjustments. 8

Comparison Across Studies

Commonalities Across Studies

Numerous studies have demonstrated the effectiveness and safety of selpercatinib in patients with RET fusion-positive NSCLC and RET-mutated thyroid cancer. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5

Differences Across Studies

The methods used to assess the effectiveness and safety of selpercatinib varied across studies. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 Some studies have suggested that selpercatinib is more effective than other RET-targeted therapies. 16 , 19

Consistency and Contradictions in Results

A significant number of studies have confirmed the effectiveness and safety of selpercatinib for patients with RET fusion-positive NSCLC and RET-mutated thyroid cancer. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 However, it's important to note that the methods used to assess selpercatinib's effectiveness and safety varied across these studies, making direct comparisons challenging. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5

Considerations for Real-World Applications

Selpercatinib holds potential as a valuable treatment option for patients with RET fusion-positive NSCLC and RET-mutated thyroid cancer. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 However, it's important to be aware of the potential side effects, including hypertension and elevated liver enzymes. 8 Careful monitoring and collaboration with healthcare professionals are crucial when using selpercatinib. 8

Limitations of Current Research

Long-term effectiveness and safety studies of selpercatinib are still limited. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 There's also a possibility of varying responses to selpercatinib among different patients. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5

Future Research Directions

Further research is needed to evaluate the long-term effectiveness and safety of selpercatinib. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 Additional research is also needed to identify patients who are more likely to benefit from selpercatinib treatment. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5

Conclusion

Selpercatinib is a promising treatment option for patients with RET fusion-positive NSCLC and RET-mutated thyroid cancer. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 However, research on the long-term effectiveness and safety of selpercatinib is still ongoing. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5 Future research is encouraged to further evaluate its long-term effectiveness, safety, and to identify patients who are most likely to benefit from this treatment. 20 , 3 , 8 , 18 , 17 , 15 , 14 , 12 , 11 , 16 , 13 , , 9 , 4 , 5

Literature analysis of 20 papers
Positive Content
20
Neutral Content
0
Negative Content
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Article Type
4
0
1
9
18
1.

Effects of body weight on tolerability of rivastigmine transdermal patch: a post-hoc analysis of a double-blind trial in patients with Alzheimer disease.

Author: LeeJae-Hong, SevignyJeff

Reduced adverse events
Rivastigmine patch tolerability
Rivastigmine capsule adverse events

This study compared the tolerability of rivastigmine transdermal patch and rivastigmine capsules in patients with Alzheimer's disease. The patch was well tolerated regardless of body weight, whereas patients with lower body weight receiving capsules experienced more adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Dose effects associated with rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer's disease.

Author: GrossbergG T, OlinJ T, SomogyiM, MengX

ADAS-Cog Improvement
ADL Improvement
CGIC Improvement

Rivastigmine patches higher than 9.5 mg/24 h may offer additional benefits in treating mild-to-moderate Alzheimer’s disease. The 13.3 mg/24 h patch is worthy of further investigation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Selpercatinib Treatment of RET-Mutated Thyroid Cancers Is Associated With Gastrointestinal Adverse Effects.

Author: TsangVenessa, GillAnthony, GildMatti, LurieBrett, BlumerLucy, SiddallRhonda, Clifton-BlighRoderick, RobinsonBruce

Response rate
Treatment options
Gastrointestinal adverse effects

Selpercatinib is a selective kinase inhibitor targeting the RET gene that has shown promise in treating metastatic medullary thyroid carcinoma (MTC) and radioactive iodine-refractory differentiated thyroid carcinoma (RAI-R DTC). This report describes a higher incidence of gastrointestinal adverse effects than previously reported in literature.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Lenvatinib and selpercatinib successfully treated RET fusion gene-positive papillary thyroid carcinoma cardiac metastases: a case report.

Author: TodaSoji, YamamotoYayoi, OokuboYoichiro, HayashiHiroyuki, TsunematsuTakashi, KadoyaMei, MasudoKatsuhiko, IwasakiHiroyuki

Successful systemic therapy

This case report describes a successful treatment of cardiac metastasis from papillary thyroid carcinoma using lenvatinib.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

5.

[Systemic therapies for advanced thyroid cancer - an update].

Author: BrandenburgTim, MachlahYara Maria, Führer-SakelDagmar

rrDTC treatment
Side effects

Multi-kinase inhibitors (MKIs) are approved for the treatment of progressive radioiodine-refractory differentiated thyroid carcinoma (rrDTC) and medullary thyroid carcinoma (MTC) in Germany. This review summarizes recent developments in the treatment of advanced thyroid cancer, including the approval of Cabozantinib for rrDTC and Selpercatinib for MTC and rrDTC.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : German

6.

First-Line Selpercatinib or Chemotherapy and Pembrolizumab in <i>RET</i> Fusion-Positive NSCLC.

Author: ZhouCaicun, SolomonBenjamin, LoongHerbert H, ParkKeunchil, PérolMaurice, ArriolaEdurne, NovelloSilvia, HanBaohui, ZhouJianying, ArdizzoniAndrea, MakM Perez, SantiniFernando C, ElaminYasir Y, DrilonAlexander, WolfJürgen, PayakachatNalin, UhMinji K, RajakumarDeborah, HanHongmei, PuriTarun, SoldatenkovaVictoria, LinA Bence, LinBoris K, GotoKoichi,

Higher objective response rate
Longer progression-free survival

Selpercatinib showed significantly longer progression-free survival compared to platinum-based chemotherapy with or without pembrolizumab in patients with advanced RET-fusion-positive non-small cell lung cancer (NSCLC).

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

7.

Phase 3 Trial of Selpercatinib in Advanced <i>RET</i>-Mutant Medullary Thyroid Cancer.

Author: HadouxJulien, EliseiRossella, BroseMarcia S, HoffAna O, RobinsonBruce G, GaoMing, JarzabBarbara, IsaevPavel, KopeckovaKaterina, WadsleyJonathan, FührerDagmar, KeamBhumsuk, BardetStéphane, ShermanEric J, TaharaMakoto, HuMimi I, SinghRavinder, LinYan, SoldatenkovaVictoria, WrightJennifer, LinBoris, MaedaPatricia, CapdevilaJaume, WirthLori J,

Higher overall response rate
Longer progression-free survival
Longer treatment failure-free survival

Selpercatinib resulted in superior progression-free survival and treatment failure-free survival compared to cabozantinib or vandetanib in patients with advanced RET-altered medullary thyroid cancer.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

8.

Efficacy and Safety of RET-Specific Kinase Inhibitors in RET-Altered Cancers: A Systematic Review.

Author: AliMuhammad Ashar, ShahSyed S, AliRimsha, BajwaShammas Farooq, RehmanSana, AnwarAqsa, AnwarMuhammad Yasir, SaeedMemoona, MirzaNayab, AimanWajeeha

RET-altered tumor treatment
ALT changes
Hypertension
Neutropenia
Pneumonitis
QT prolongation

Selpercatinib and pralsetinib are the only FDA-approved RET-specific tyrosine kinase inhibitors for RET-altered tumors. This review summarizes the efficacy and safety of these drugs based on a comprehensive literature search. Objective response rates were 60-89%, and ≥Grade 3 adverse events were reported in 28-53% of patients.

Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Precision oncology with selective RET inhibitor selpercatinib in <i>RET</i>-rearranged cancers.

Author: GoudaMohamed A, SubbiahVivek

Targeted therapy
Treatment of RET fusion-positive tumors
None reported

This article reviews the current status of selpercatinib, a selective RET inhibitor, for treating RET fusion-positive tumors. Selpercatinib has demonstrated efficacy in treating non-small cell lung cancer (NSCLC), thyroid cancers, and other RET-positive tumors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Osimertinib and Selpercatinib Efficacy, Safety, and Resistance in a Multicenter, Prospectively Treated Cohort of EGFR-Mutant and RET Fusion-Positive Lung Cancers.

Author: RotowJulia, PatelJyoti D, HanleyMatthew P, YuHelena, AwadMark, GoldmanJonathan W, NechushtanHovav, SchefflerMatthias, KuoChih-Hsi S, RajappaSenthil, HaradaGuilherme, CliffordSarah, SantucciAlison, SilvaLaura, TupperRebecca, OxnardGeoffrey R, KheraniJennifer, DrilonAlexander

Treats lung cancer
Drug resistance

This study examined a multicenter cohort of patients with EGFR-mutant lung cancer who developed resistance to osimertinib and were treated with selpercatinib for RET fusion-mediated resistance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

14.

Precious Gene: The Application of RET-Altered Inhibitors.

Author: GouQitao, GanXiaochuan, LiLonghao, GouQiheng, ZhangTao

RET-altered cancer treatment

Novel RET-specific inhibitors, selpercatinib and pralsetinib, have been approved by the FDA for the treatment of RET-altered cancers, offering a significant advancement over multikinase inhibitors (MKIs). These new inhibitors demonstrate high potency and selectivity, with improved tolerability and efficacy. Clinical trials of other RET inhibitors, such as TPX-0046 and zetletinib, are ongoing.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

RET Proto-Oncogene-Not Such an Obvious Starting Point in Cancer Therapy.

Author: KucharczykTomasz, KrawczykPaweł, KowalskiDariusz M, PłużańskiAdam, KubiatowskiTomasz, KalinkaEwa

RET-altered tumor treatment
Activating signaling pathways
Resistance mutations

RET gene alterations are found in several cancers, including thyroid and lung cancer. While multiple kinase inhibitors (MKIs) have been used, they have limited effectiveness. Recently, two novel RET-specific inhibitors, selpercatinib and pralsetinib, showed high efficacy in clinical trials with fewer adverse effects. However, resistance mutations and activation of signaling pathways can reduce their effectiveness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Selpercatinib in Patients With <i>RET</i> Fusion-Positive Non-Small-Cell Lung Cancer: Updated Safety and Efficacy From the Registrational LIBRETTO-001 Phase I/II Trial.

Author: DrilonAlexander, SubbiahVivek, GautschiOliver, TomasiniPascale, de BraudFilippo, SolomonBenjamin J, Shao-Weng TanDaniel, AlonsoGuzmán, WolfJürgen, ParkKeunchil, GotoKoichi, SoldatenkovaVictoria, SzymczakSylwia, BarkerScott S, PuriTarun, Bence LinAimee, LoongHerbert, BesseBenjamin

NSCLC treatment

This article provides an update on the registrational data for selpercatinib, a selective RET kinase inhibitor for patients with RET fusion-positive non-small-cell lung cancer (NSCLC). The data set is expanded to include over double the original population, offering better characterization of long-term efficacy and safety.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial.

Author: SubbiahVivek, WolfJürgen, KondaBhavana, KangHyunseok, SpiraAlexander, WeissJared, TakedaMasayuki, OheYuichiro, KhanSaad, OhashiKadoaki, SoldatenkovaVictoria, SzymczakSylwia, SullivanLoretta, WrightJennifer, DrilonAlexander

RET fusion-positive cancer treatment

Selpercatinib, a RET kinase inhibitor, is being evaluated for its efficacy and safety in patients with RET fusion-positive advanced solid tumors, excluding lung and thyroid cancers.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

19.

LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-na&#239;ve <i>RET</i>-mutant medullary thyroid cancer.

Author: WirthLori J, BroseMarcia S, EliseiRossella, CapdevilaJaume, HoffAna O, HuMimi I, TaharaMakoto, RobinsonBruce, GaoMing, XiaMeng, MaedaPatricia, ShermanEric

Antitumor activity

Selpercatinib is a new drug that targets RET kinase, which is a protein that can cause cancer. In a clinical trial, selpercatinib showed promising results in treating patients with RET-mutant medullary thyroid cancer (MTC). The drug was effective in shrinking tumors and had manageable side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA <i>RET</i> fusion-positive non-small-cell lung cancer.

Author: TsuboiMasahiro, GoldmanJonathan W, WuYi-Long, JohnsonMelissa L, Paz-AresLuis, YangJames Chih-Hsin, BesseBenjamin, SuWeiji, ChaoBo H, DrilonAlexander

Manageable toxicity
RET inhibitor efficacy

Selpercatinib, a RET kinase inhibitor, demonstrated promising efficacy in treating advanced/metastatic RET fusion-positive non-small-cell lung cancer (NSCLC) with manageable side effects. A phase III trial is evaluating its use in earlier stages.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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