Tag: Metastatic Urothelial Cancer

Key Update in Oncologia & OncoEmatologia di Gilead

Biomedicina

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Le vendite dei prodotti Cell Therapy sono aumentate del 64% a 448 milioni di dollari nel primo trimestre del 2023 rispetto allo stesso periodo del 2022.

• Le vendite di Yescarta ( Axicabtagene ciloleucel ) sono aumentate del 70% a 359 milioni di dollari nel primo trimestre del 2023, trainate principalmente dall’aumento della domanda di linfoma a grandi cellule B recidivato o refrattario ( “R/R” ) ( “LBCL” ).

• Le vendite di Tecartus ( Brexucabtagene autoleucel ) sono aumentate del 40% a 89 milioni di dollari nel primo trimestre del 2023, trainate principalmente dall’aumento della domanda di linfoma mantellare R/R e leucemia linfoblastica acuta dell’adulto R/R ( “ALL” ).

Le vendite di Trodelvy ( Sacituzumab govitecan ) sono aumentate del 52% a 222 milioni di dollari nel primo trimestre del 2023 rispetto allo stesso periodo del 2022, trainate principalmente dall’aumento dell’adozione nel carcinoma mammario triplo negativo metastatico negli Stati Uniti e in Europa, nonché dal lancio dell’indicazione per carcinoma mammario metastatico HR+/HER2- pretrattato negli Stati Uniti.

Aggiornamenti chiave in Oncologia

• Approvazione della FDA per Trodelvy per il trattamento dei pazienti adulti con carcinoma mammario non-resecabile localmente avanzato o metastatico HR+/HER2- che hanno ricevuto terapia a base endocrina e almeno due terapie sistemiche aggiuntive nel setting metastatico;

• Presentati i risultati positivi di un’analisi di follow-up a 3 anni di Tecartus nello studio di fase 2 ZUMA-3 su pazienti con leucemia linfoblastica acuta R/R all’European CAR T-cell Meeting;

• Presentati i dati positivi dello studio di fase 2 TROPHY-U-01 di Trodelvy per il trattamento del carcinoma uroteliale metastatico al Simposio sui tumori genitourinari dell’American Society of Clinical Oncology ( ASCO );

• Completata l’acquisizione di Tmunity, una società biotecnologica privata in fase clinica, che fornisce programmi preclinici e clinici, inclusa una piattaforma tecnologica CAR T che può essere applicata a una varietà di CAR T per migliorare l’attività antitumorale, nonché processi di produzione rapidi;

• Annunciati i risultati della sopravvivenza globale primaria dello studio di fase 3 ZUMA-7 per il trattamento iniziale dei pazienti adulti con linfoma a grandi cellule B R/R, che ha mostrato un miglioramento statisticamente significativo per Yescarta nella sopravvivenza globale rispetto al trattamento precedente.

Fonte: Gilead, 2023
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ENGLISH VERSION

Cell Therapy product sales increased 64% to $448 million in the first quarter of 2023 compared to the same period in 2022.

• Yescarta ( Axicabtagene ciloleucel ) sales increased 70% to $359 million in the first quarter of 2023, primarily driven by increased demand in relapsed or refractory ( “R/R” ) large B-cell lymphoma ( “LBCL” ).

• Tecartus ( Brexucabtagene autoleucel ) sales increased 40% to $89 million in the first quarter of 2023, primarily driven by increased demand in R/R mantle cell lymphoma and R/R adult acute lymphoblastic leukemia ( “ALL” ).

Trodelvy sales increased by 52% to $222 million in the first quarter of 2023 compared to the same period in 2022, primarily driven by increased adoption in metastatic triple-negative breast cancer in the United States and Europe, as well as the launch of the indication for pretreated HR+/HER2- metastatic breast cancer in the United States.

Key Updates in Oncology

• Received FDA approval of Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting;

• Presented positive results from a three-year follow-up analysis of Tecartus in the phase 2 ZUMA-3 study of patients with R/R ALL at the European CAR T-cell Meeting;

• Presented positive data from the phase 2 TROPHY-U-01 study of Trodelvy for the treatment of metastatic urothelial cancer at the American Society of Clinical Oncology Genitourinary Cancers Symposium;

• Completed the acquisition of Tmunity, a clinical stage private biotech company, which provides preclinical and clinical programs, including an investigational “armored” CAR T technology platform that has the potential to be applied to a variety of CAR Ts to enhance anti-tumor activity, as well as rapid manufacturing processes;

• Announced primary overall survival results from the phase 3 ZUMA-7 study for initial treatment of adult patients with R/R LBCL, which has shown a statistically significant improvement for Yescarta in overall survival versus historical treatment.

Source: Gilead, 2023
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Novità nel trattamento del carcinoma uroteliale metastatico: Sacituzumab govitecan, un coniugato anticorpo-farmaco

Biomedicina

OncoUrologia

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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