Effects of belzutifan: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Main research findings

Belzutifan is a promising drug for treating kidney cancer, particularly for patients with advanced clear cell renal cell carcinoma (RCC) who have previously received immunotherapy. 2 Belzutifan is a HIF-2α inhibitor, which means it blocks the activity of a protein called HIF-2α that helps cancer cells grow and spread. 8 This drug has shown positive results in treating VHL-associated RCC, pancreatic neuroendocrine tumors (pNETs), and central nervous system (CNS) hemangioblastomas. 16 7 6 11 5

Furthermore, combining belzutifan with other drugs, such as cabozantinib or lenvatinib, could potentially enhance its effectiveness in treating RCC, particularly in cases where immunotherapy has failed. 2 13

Belzutifan has also shown potential in overcoming resistance to anti-VEGF therapies and may even be used to treat rare conditions like the Pacak-Zhuang syndrome, which involves polycythemia and multiple paragangliomas. 13 3

Benefits and Risks

Benefits Summary

Belzutifan holds promise as a treatment for various cancers associated with VHL disease, including RCC, pNETs, and CNS hemangioblastomas. 16 11 5 Its efficacy can be further enhanced by combining it with other drugs, potentially offering better treatment outcomes. 2 13

Belzutifan may also be beneficial in addressing resistance to existing treatments like anti-VEGF therapies and can be used to treat rare disorders like the Pacak-Zhuang syndrome. 13 3

Risks Summary

Common side effects of belzutifan include anemia, fatigue, headache, dizziness, increased blood glucose levels, and nausea. 16 Belzutifan can also affect the effectiveness of some hormonal contraceptives and may harm the fetus during pregnancy. 16

Comparison between studies

Commonalities

Multiple studies have shown that belzutifan is effective in treating VHL-associated RCC. 16 7 6 11

Differences

The effects and side effects of belzutifan may vary depending on the study. 16 7 6 11

Some studies have investigated the effectiveness of belzutifan when used in combination with other medications. 2

Consistency and inconsistencies in the results

Research consistently shows that belzutifan is an effective treatment option for VHL-associated RCC. 16 7 6 11

However, there are variations in the reported effects and side effects of belzutifan across different studies. 16 7 6 11

Considerations for real-life application

Belzutifan holds potential as a valuable treatment option for patients with VHL-associated RCC and other VHL-associated tumors. 16 7 6 11

However, it is crucial to avoid belzutifan use in pregnant women and those using specific hormonal contraceptives. 16

Always consult your doctor before considering belzutifan treatment. 16

Limitations of current research

Research on belzutifan is still in its early stages. There are many unanswered questions regarding its long-term effectiveness and safety. 16 7 6 11

Further research is necessary to gain a more comprehensive understanding of belzutifan's effects. 16 7 6 11

Future research directions

More research is needed to assess the long-term efficacy and safety of belzutifan. 16 7 6 11

Further research is also needed to explore the effectiveness of belzutifan in combination with other medications. 2

Research is also needed to determine if belzutifan can overcome resistance to immunotherapy. 13

Conclusion

Belzutifan shows promise as a treatment option for various cancers associated with VHL disease, including RCC. 16 7 6 11

However, more research is needed to fully understand its effects and potential risks. 16 7 6 11

If you are considering belzutifan treatment, consult your doctor. 16

Literature analysis of 16 papers
Positive Content
15
Neutral Content
0
Negative Content
1
Article Type
0
0
0
4
15
1.

HIF2 Inactivation and Tumor Suppression with a Tumor-Directed RNA-Silencing Drug in Mice and Humans.

Author: MaYuanqing, JoyceAllison, BrandenburgOlivia, SaatchiFaeze, StevensChristina, Toffessi TcheuyapVanina, ChristieAlana, DoQuyen N, FatundeOluwatomilade, MacchiaroliAlyssa, WongSo C, WoolfordLayton, YousufQurratulain, MiyataJeffrey, CarrilloDeyssy, OnaboluOreoluwa, McKenzieTiffani, MishraAkhilesh, HardyTanner, HeWei, LiDaniel, IvanishevAlexander, ZhangQing, PedrosaIvan, KapurPayal, SchluepThomas, KannerSteven B, HamiltonJames, BrugarolasJames

Kidney cancer treatment

This study evaluated the effectiveness of a tumor-directed, systemically delivered, siRNA drug (siHIF2) against wild-type and resistant-mutant HIF2α, a key driver of kidney cancer. The study suggests that siHIF2 could be a potential therapeutic strategy for clear cell renal cell carcinomas (ccRCC).

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, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Belzutifan plus cabozantinib for patients with advanced clear cell renal cell carcinoma previously treated with immunotherapy: an open-label, single-arm, phase 2 study.

Author: ChoueiriToni K, McDermottDavid F, MerchanJaime, BauerTodd M, FiglinRobert, HeathElisabeth I, MichaelsonM Dror, ArrowsmithEdward, D'SouzaAnishka, ZhaoSong, RoyAnanya, PeriniRodolfo, VickeryDonna, TykodiScott S

Antitumor activity
Improved efficacy
Safety

This study aims to investigate the antitumor activity and safety of combining belzutifan, an HIF-2α inhibitor, with cabozantinib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced clear cell renal cell carcinoma previously treated with immunotherapy.

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, 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

3.

Belzutifan, a Potent HIF2α Inhibitor, in the Pacak-Zhuang Syndrome.

Author: KamiharaJunne, HamiltonKayla V, PollardJessica A, ClintonCatherine M, MaddenJill A, LinJasmine, ImamovicAlma, WallCatherine B, WassnerAri J, WeilBrent R, HeeneyMatthew M, VargasSara O, KaelinWilliam G, JanewayKatherine A, PeriniRodolfo F, ZojwallaNaseem J, VossStephan D, DuBoisSteven G

Symptom resolution
Targeted therapy
Tumor response

Belzutifan, a potent and selective HIF2α inhibitor, successfully treated a patient with polycythemia and multiple paragangliomas caused by a somatic mutation in EPAS1, highlighting its potential as a targeted therapy for rare tumor-predisposition syndromes.

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.
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

6.

Belzutifan: A Narrative Drug Review.

Author: VisweswaranVysakh, PavithranKeechilat

VHL RCC treatment
VHL non-RCC treatment
Anemia
Fatigue
Hypertension
Hypoxia
Visual impairment
Weight gain

Belzutifan is a drug targeting the hypoxia-inducible factor (HIF)-2α pathway for the treatment of Von Hippel-Lindau disease. This review summarizes the clinical efficacy, pharmacokinetic profile, pharmacodynamic effects, and side effects of belzutifan in treating Von Hippel-Lindau disease-associated malignancies.

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

7.

Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease.

Author: JonaschEric, DonskovFrede, IliopoulosOthon, RathmellW Kimryn, NarayanVivek K, MaughanBenjamin L, OudardStephane, ElseTobias, MaranchieJodi K, WelshSarah J, ThamakeSanjay, ParkEric K, PeriniRodolfo F, LinehanW Marston, SrinivasanRamaprasad,

Response in central nervous system hemangioblastomas
Response in pancreatic lesions
Response in renal cell carcinoma
Response in retinal hemangioblastomas
Anemia
Fatigue

Belzutifan, an HIF-2α inhibitor, showed activity in patients with renal cell carcinomas and non-renal cell carcinoma neoplasms associated with VHL disease, with predominantly grade 1 and 2 adverse events.

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, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.

Language : English

8.

Belzutifan (MK-6482): Biology and Clinical Development in Solid Tumors.

Author: ChoiWonSeok W, BolandJulia L, KalolaAkshar, LinJianqing

Cancer treatment
Anemia
Hypoxia

Belzutifan is a second-generation HIF-2α inhibitor with a 14-hour half-life that has shown promising results in treating VHL-associated tumors. In a Phase I trial, belzutifan achieved an 80% disease control rate in pretreated ccRCC patients. Common side effects include anemia and hypoxia-related symptoms. Further research is ongoing to optimize therapeutic benefits and improve outcomes for HIF-2α-driven 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

9.

Structural basis for binding of the renal carcinoma target hypoxia-inducible factor 2α to prolyl hydroxylase domain 2.

Author: FiggWilliam D, FioriniGiorgia, ChowdhuryRasheduzzaman, NakashimaYu, TumberAnthony, McDonoughMichael A, SchofieldChristopher J

Anemia treatment
PHD inhibitor efficacy
ccRCC treatment

Crystal structures of PHD2 complexed with HIF2α-ODD provide insights into PHD.HIFα-ODD binding modes and the effects of mutations. These findings may enable new therapeutic avenues for ccRCC treatment.

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

10.

Delayed onset anterior uveitis and macular edema after cessation of pembrolizumab.

Author: MenMauranda, TsuiEdmund

Macular edema
Uveitis

This case report highlights the importance of recognizing the delayed immune-related effects of immune checkpoint inhibitors, as ocular immune-related adverse events can occur months after stopping the medication.

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

11.

Belzutifan in a Patient With VHL-Associated Metastatic Pancreatic Neuroendocrine Tumor.

Author: PelleEleonora, Al-ToubahTaymeyah, MorseBrian, StrosbergJonathan

HIF-2α inhibition
Tumor regression
Asymptomatic anemia

This case report describes a 43-year-old woman with von Hippel-Lindau (VHL)-associated metastatic pancreatic neuroendocrine tumor (pNET) who achieved a partial radiographic response after being treated with belzutifan, an HIF-α inhibitor. This case highlights the potential efficacy of belzutifan in treating metastatic VHL-associated pNETs, particularly in patients who have progressed on multiple systemic therapies.

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.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy.

Author: MotzerRobert J, SchmidingerManuela, EtoMasatoshi, SuarezCristina, FiglinRobert, LiuYanfang, PeriniRodolfo, ZhangYayan, HengDaniel Yc

RCC treatment

Belzutifan, a HIF-2α inhibitor, has shown promising antitumor activity in patients with clear cell renal cell carcinoma (RCC). This study describes a randomized, phase III trial evaluating the efficacy and safety of belzutifan plus lenvatinib, a tyrosine kinase inhibitor, compared to cabozantinib, another tyrosine kinase inhibitor, in patients with advanced RCC progressing after anti-PD-1/PD-L1 therapy.

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

14.

Optimization of first-line systemic therapy in patients with advanced clear cell renal cell carcinoma.

Author: TakagiToshio

Advanced RCC treatment
Symptom relief
Steroid therapy
Treatment-related adverse events

This review discusses the optimal therapy for advanced renal cell carcinoma (RCC) in Japan. Combination therapies using immune-oncologic drugs, such as ipilimumab plus nivolumab, avelumab plus axitinib, pembrolizumab plus axitinib, nivolumab plus cabozantinib, and pembrolizumab plus lenvatinib, have been approved. Further development of systemic therapies for advanced RCC is required.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.

Author: FallahJaleh, BraveMichael H, WeinstockChana, MehtaGautam U, BradfordDiana, GittlemanHaley, BloomquistErik W, CharlabRosane, HamedSalaheldin S, MillerClaudia P, DorffSarah E, ChambersWiley A, MixterBronwyn D, DininJeannette, PierceWilliam F, RicksTiffany K, TangShenghui, DonoghueMartha, PazdurRichard, Amiri-KordestaniLaleh, IbrahimAmna, BeaverJulia A

ORR improvement
Tumor regression
VHL disease treatment
Anemia
Dizziness
Fatigue
Headache
Increased creatinine
Increased glucose
Nausea

This article summarizes the data and FDA thought process supporting traditional approval of belzutifan, a first-in-class hypoxia-inducible factor (HIF) inhibitor, for adult patients with von Hippel-Lindau (VHL) disease. The approval was based on the clinically meaningful effects on overall response rate observed in patients with VHL-associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

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