Characterization and survival benefit of drugs approved for advanced renal cell carcinoma.

Authors

null

David Joseph Benjamin

Hoag Family Cancer Institute, Newport Beach, CA

David Joseph Benjamin , Arash Rezazadeh

Organizations

Hoag Family Cancer Institute, Newport Beach, CA, University of California Irvine Medical Center, Orange, CA

Research Funding

No funding received
None.

Background: The treatment landscape of advanced renal cell carcinoma (RCC) drastically changed with the approval of tyrosine kinase inhibitors (TKIs). Since then, immunotherapy (IO) and now TKI plus IO combination therapies is considered standard-of-care. Despite multiple drug approvals, it remains unclear how much improvement in survival these therapies have provided. Methods: We reviewed the US Food and Drug Administration (FDA) website to evaluate all approvals for RCC from 2005 to 2022. We collected progression-free survival (PFS) and overall survival (OS) from the approval notification or from the corresponding clinical trial cited for drug approval. Results: Between 2005 and 2022, there were 16 drug (single or combination) approvals for advanced RCC. Most therapy approvals (93.75%) were granted through accelerated approval. Eight approvals were TKIs, 6 approvals were TKI plus IO combination therapies, and 1 approval each were for immunotherapy and a VEGF inhibitor. Average PFS benefit for 1st line approvals was 5.63 months (range 1.9-14.7) and average PFS benefit for 2nd or later line approvals was 2.95 months (range 0.2-9.1). Average OS benefit in the 1st line setting was 3.6 months and average OS benefit in the 2nd or later line setting was 5.4 months. Conclusions: Despite 16 drug (single or combination) approvals for advanced RCC since 2005, the improvements in average PFS and OS were modest. As OS data matures from recent TKI plus IO combination therapies, OS benefit may improve. Nonetheless, continued drug development is urgently warranted in advanced RCC.

List of FDA approvals for treatment of advanced RCC, 2005-2022.

Drug(s) Name(s)Year of ApprovalOriginal Line of ApprovalPFS Benefit (months)OS Benefit (months)
Sorafenib20051st2.7HR 0.72 (95% CI 0.54-0.94, p = 0.02)
Sunitinib20061stNot applicable as no control armNot reported
Temsirolimus20071st1.93.6
Everolimus20092nd2.1Not reported
Bevacizumab20091st4.8None (HR 0.86, 95% CI 0.72-1.04, p =0.13)
Pazopanib20091stNo benefit (pazopanib 8.4 versus sunitinib 9.5)No benefit (pazopanib 28.4 versus sunitinib 29.3)
Axitinib20122nd2.0Not reported
Nivolumab20152nd0.25.4
Cabozantinib20162nd2.6Not reported
Lenvatinib plus everolimus20162nd9.1Not reported
Nivolumab plus ipilumumab20181st3.2Not reached versus 26.0 (HR 0.63, 95% CI 0.44-0.89, p = < 0.0001)
Axitinib plus avelumab20191st5.4Not reported
Axitinib plus pembrolizumab20191st4Not reached (HR 0.53, 95% CI 0.38-0.74, p<0.0001)
Lenvatinib plus pembrolizumab20211st14.7Not reached (HR 0.66, 95% CI 0.49-0.88, p =0.0049)
Cabozantinib plus nivolumab20211st8.3Not reached
Tivozanib20213rd1.7HR 0.91 (95% CI 0.716-1.165)

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr 633)

DOI

10.1200/JCO.2023.41.6_suppl.633

Abstract #

633

Poster Bd #

F3

Abstract Disclosures