Carcinoma uroteliale metastatico – Novità terapeutica: Sacituzumab govitecan

Il carcinoma uroteliale è il tipo più comune di cancro alla vescica e si verifica quando le cellule uroteliali che rivestono l’interno della vescica e altre parti del tratto urinario crescono in modo insolito o incontrollabile.

Si stima che a circa 83.000 americani verrà diagnosticato un cancro alla vescica nel 2023 e quasi il 90% di queste diagnosi sarà un tumore uroteliale. In totale, il 30% dei casi è considerato malattia avanzata o metastatica.

Nonostante i progressi nel trattamento del cancro uroteliale metastatico, la sopravvivenza a lungo termine rimane bassa.

Sacituzumab govitecan ha dimostrato un’efficacia positiva nel trattamento del carcinoma uroteliale metastatico post-Platino sia in pazienti non-ammissibili alla terapia con Platino sia in quelli con un tumore in rapida progressione

A) Sacituzumab govitecan: sopravvivenza globale di 13,5 mesi in pazienti con carcinoma uroteliale metastatico non-idoneo al Platino dopo terapia con inibitori del checkpoint immunitario;

B) Sacituzumab govitecan: sopravvivenza globale di 12,8 mesi in pazienti con carcinoma uroteliale metastatico la cui malattia è progredita rapidamente dopo chemioterapia a base di Platino

Nuovi dati di tre coorti dello studio di fase 2 TROPHY-U-01 su Sacituzumab govitecan ( Sacituzumab govitecan-hziy; Trodelvy ) per il trattamento del carcinoma uroteliale metastatico ( mUC ) sono stati presentati all’American Society of Clinical Oncology Genitourinary Cancers – 2023 ASCO-GU Symposium.

Questi dati hanno dimostrato che Sacituzumab govitecan ha prodotto risposte rapide e durature nei pazienti in una gamma di tipi di carcinoma uroteliale metastatico difficili da trattare, tra cui il carcinoma uroteliale metastatico in rapida progressione post-Platino, e nei pazienti ineleggibili al Platino.

Il follow-up a lungo termine nelle coorti 1, 2 e 3 di TROPHY-U-01 ha fornito un numero crescente di prove a sostegno del potenziale beneficio del trattamento del carcinoma uroteliale metastatico con Sacituzumab govitecan in popolazioni di pazienti clinicamente rilevanti e difficili da trattare.

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Metastatic Urothelial Cancer

Urothelial Cancer is the most common type of bladder cancer and occurs when the urothelial cells that line the inside of the bladder and other parts of the urinary tract grow unusually or uncontrollably. An estimated 83,000 Americans will be diagnosed with bladder cancer in 2023, and almost 90% of those diagnoses will be urothelial cancer. In total, 30% of cases are considered advanced or metastatic disease. Despite advancements in treating metastatic urothelial cancer, long-term survival remains low.

Sacituzumab govitecan has demonstrated positive efficacy treating both Platinum-ineligible and rapidly progressing post-Platinum metastatic urothelial cancer

A) Sacituzumab govitecan: 13.5 months overall survival in patients with Platinum-ineligible metastatic urothelial cancer after checkpoint inhibitor therapy

B) Sacituzumab govitecan: 12.8 months overall survival in patients with metastatic urothelial cancer whose disease progressed rapidly following Platinum-based chemotherapy

New and updated positive results from three cohorts of the phase 2 TROPHY-U-01 study of Sacituzumab govitecan ( Sacituzumab govitecan-hziy; Trodelvy ) for the treatment of metastatic urothelial cancer ( mUC ) were presented at 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium ( ASCO-GU ) Annual Meeting.

These data have demonstrated that Sacituzumab govitecan has produced both rapid and durable responses for patients across a range of hard-to-treat types of metastatic urothelial cancer including Platinum-ineligible and rapidly progressing, post-Platinum metastatic urothelial cancer.

Longer-term follow-up across Cohorts 1, 2, and 3 of TROPHY-U-01 has provided an increasing body of evidence supporting the potential benefit of treating metastatic urothelial cancer with Sacituzumab govitecan across clinically relevant, hard-to-treat patient populations. Results are summarized:

Cohort 1: patients ( n=113 ) with metastatic urothelial cancer who progressed after Platinum-based chemotherapy and checkpoint inhibitor ( CPI ) therapy -> In new long-term follow-up results, Sacituzumab govitecan has continued to demonstrate efficacy:

10.9 months median overall survival ( OS ); ( 95% CI, 8.9-13.8 );

28% overall response rate ( ORR ) ( 95% CI, 20.2-37.6); 23% partial response [ PR ] rate and 38% clinical benefit rate [ CBR ] with 1.6 months median time to response;

8.2 months median duration of response [ DOR ] ( 95% CI, 4.7-13.7, n=32 );

5.4 months median progression-free survival [ PFS ]; ( 95% CI, 3.5-6.9 )

10.5 months median follow-up ( range, 0.3-40.9 ) for treated patients

Cohort 2: Platinum-ineligible patients ( n=38 ) with metastatic urothelial cancer who progressed after CPI therapy -> In this primary analysis, Sacituzumab govitecan has demonstrated:

13.5 months median overall survival ( 95% CI, 7.6-15.6 );

32% overall response rate ( 95% CI, 17.5-48.7 ); 32% PR and 42% CBR with 1.4 months median time to response;

5.6 months median duration of response ( 95% CI, 2.8-13.3; n=12 );

5.6 months median progression-free survival ( 95% CI, 4.1-8.3 );

9.3 months median follow-up for treated patients (range, 0.5-30.6; n=38 )

Cohort 3: patients ( n=41 ) with rapidly progressing metastatic urothelial cancer who progressed after Platinum-based therapy – > In this primary analysis, Sacituzumab govitecan plus Pembrolizumab, has demonstrated:

12.8 months overall survival ( 95% CI, 10.7-NE ) at a median follow-up of 12.5 months ( range, 0.9-24.6; n=41 );

41% overall response rate ( 95% CI, 26.3-57.9 ); 22% PR and 46% CBR with 1.4 months median time to response;

1.1 months median duration of response ( 95% CI, 4.8-NE; n=17 );

46% clinical benefit rate ( 95% CI, 30.7-62.6 ) with 1.4 months median time to response;

Median progression-free survival was 5.3 months ( 95% CI, 3.4-10.2 )

In April 2021, the U.S. FDA granted accelerated approval of Trodelvy for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a Platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. This approval is based on ORR and DOR established in Cohort 1. ( Source: Gilead )

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