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19 december 2025: Bron: Annals of oncology

Enfortumab vedotin plus immuuntherapie met pembrolizumab (een anti-PD medicijn) gegeven voor een eventuele operatie verbetert de mediane overleving beduidend langer bij patiënten met spierinvasieve blaaskanker, ongeacht of ze in aanmerking komen voor cisplatine.

Uit het abstract vertaalt in het Nederlands en afkortingen voluit gemaakt voor beter begrip:

170 patiënten werden gerandomiseerd naar Enfortumab vedotin + pembrolizumab en 174 patiënten naar de controlegroep. Meer dan 80% van de patiënten kwam niet in aanmerking voor een cisplatine behandeling volgens de Galsky-criteria.

Op 6 juni 2025 was de mediane follow-upduur 25,6 maanden (bereik, 11,8–53,7). 149 patiënten (87,6%) in de Enfortumab vedotin + pembrolizumab groep en 156 (89,7%) in de controlegroep ondergingen een operatie.
Enfortumab vedotin + pembrolizumab verbeterde de ziektevrij overleving (mediaan niet bereikt versus 15,7 maanden; HR 0,40; 95% CI 0,28–0,57; P<.001).
De overall overleving (OS) (Niet bereikt versus 41,7 maanden; HR 0,50; 95% CI 0,33–0,74; P<.001) en het percentage complete en gedeeltelijke remissies (57,1% versus 8,6%; geschat verschil 48,3%; 95% CI 39,5–56,5; P<.001) significant ten opzichte van de controlegroep.

Bijwerkingen die tijdens de behandeling optraden, kwamen voor bij 100% (graad ≥3, 71,3%) van de patiënten in de Enfortumab vedotin + pembrolizumab groep en bij 64,8% (graad ≥3, 45,9%) in de controlegroep. De meest voorkomende bijwerkingen van graad ≥3 van bijzonder belang (gebaseerd op afzonderlijke, vooraf vastgestelde lijsten voor elk geneesmiddel) waren ernstige huidreacties (gezamenlijke term; 11,4%) voor pembrolizumab en huidreacties (gezamenlijke term; 10,8%) voor Enfortumab vedotin.

Het abstract staat verderop in dit artikel en lees verder hieronder over eerdere publicaties:

24 oktober 2023: Bron: Annals of oncology, ESMO 2023

Uit de tussenresultaten van de open label fase III EV302 / KEYNOTE-A39 studie blijkt enfortumab vedotin (Padcev) plus immuuntherapie met pembrolizumab (een anti-PD medicijn) de overall overleving en ziektevrije tijd te verdubbelen in vergelijking met chemotherapie bij nog niet eerder behandelde patiënten met lokaal gevorderde en/of uitgezaaide blaaskanker / urineleiderkanker.

De studie vergelijkt de effectiviteit van totaal 886 patiënten (EV+P: N = 442; chemo: N = 444) tussen enfortumab vedotin (Padcev) plus immuuntherapie met pembrolizumab en na een follow-up van 17,2 maanden blijkt de mediane overall overleving zo goed als verdubbelt met 31,5 maanden vs 16,1 maanden. Ook de mediane ziekteprogressie vrije tijd verdubbelde van 6,5 naar 12,3 maanden. Wat vertaald wordt door de onderzoekers van 55 procent minder kans op overlijden aan de ziekte.

De bevestigde onafhankelijk vastgestelde complete en gedeeltelijke remissies (ORR) waren respectievelijk 67,7% in de Enfortumab vedotin + Pembrolizumab groep en 44,4% in de chemogroepen (P<0,00001).

Optredende bijwerkingen:

Bijwerkingen van graad ≥3 kwamen voor bij 55,9% van de patiënten die met enfortumab vedotin (Padcev) plus immuuntherapie met pembrolizumab waren behandeld en 69,5% bij patiënten die met chemo waren behandeld;
De meest voorkomende bijwerkingen waren maculopapulaire huiduitslag (7,7%), hyperglykemie (5,0%) en neutropenie (4,8%) voor EV+P en anemie (31,4%), neutropenie (30,0%) en trombocytopenie (19,4%) voor chemotherapie.
De meest voorkomende (≥5%) bijwerkingen van graad ≥3 die van bijzonder belang zijn voor enfortumab vedotin (Padcev) omvatten huidreacties (15,5%), perifere neuropathie (6,8%) en hyperglykemie (6,1%).
De meest voorkomende (≥5%) graad ≥3 tijdens de behandeling optredende bijwerkingen die van bijzonder belang zijn voor pembrolizumab waren ernstige huidreacties (11,8%).

Volgens Michiel van der Heijden Medisch Oncoloog in het Anthonie van Leeuwenhoek ziekenhuis en een van de mede onderzoekers van deze studie zal deze behandeling de behandeling van blaaskanker behoorlijk veranderen.

De behandeling met enfortumab vedotin (Padcev) plus immuuntherapie met pembrolizumab moet nog worden geregistreerd en goedgekeurd in Nederland voor vergoeding door de zorgverzekering. Dat kan nog wel een jaar duren. In de VS is Enfortumab Vedotin + pembrolizumab al wel beschikbaar voor een deel van de blaaskankerpatiënten, gebaseerd op een fase-2 studie.

Het volledige studie studierapport is gepubliceerd in Annals of Oncology en gepresenteerd op ESMO 2023.

ABSTRACT| VOLUME 34, SUPPLEMENT 2, S1340, OCTOBER 2023

mUC)

DOI:https://doi.org/10.1016/j.annonc.2023.10.106

Background

Platinum-based chemo is the standard of care (SOC) for la/mUC. An unmet need remains as long-term outcomes are poor. Here we present EV-302, a global, phase 3, open-label, randomized study evaluating EV+P in patients (pts) with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemo.

Methods

Pts with previously untreated la/mUC (regardless of PD-L1 expression) were randomized 1:1 to receive 3-week cycles of EV (1.25 mg/kg; IV) on Days 1 and 8 and P (200 mg; IV) on Day 1 or gemcitabine with cisplatin or carboplatin. Dual primary endpoints were PFS per RECIST v1.1 by BICR and OS. Select secondary endpoints included overall response rate (ORR) and safety.

Results

886 pts (EV+P: 442; chemo: 444) were randomized; pt characteristics were balanced between arms. At data cutoff, median follow-up was 17.2 mo. PFS was significantly prolonged with EV+P vs chemo, reducing the risk of progression or death by 55% (median PFS, 12.5 mo vs 6.3 mo, respectively; HR 0.45 [95% CI: 0.38-0.54]; P<0.00001). OS was significantly prolonged with EV+P vs chemo, reducing the risk of death by 53% (median OS, 31.5 mo vs 16.1 mo, respectively; HR 0.47 [95% CI: 0.38-0.58]; P<0.00001). Confirmed ORR was 67.7% and 44.4% in the EV+P and chemo arms, respectively (P<0.00001). Grade ≥3 TRAEs occurred in 55.9% with EV+P and 69.5% with chemo; most common were maculopapular rash (7.7%), hyperglycemia (5.0%), and neutropenia (4.8%) for EV+P and anemia (31.4%), neutropenia (30.0%), and thrombocytopenia (19.4%) for chemo. Most common (≥5% ) grade ≥3 TRAEs of special interest for EV included skin reactions (15.5%), peripheral neuropathy (6.8%), and hyperglycemia (6.1%). Most common (≥5% ) grade ≥3 treatment-emergent AEs of special interest for P included severe skin reactions (11.8%).

Conclusions

EV+P significantly improved outcomes in pts with previously untreated la/mUC, nearly doubling the median PFS and OS vs chemo. The safety profile was generally manageable with no new safety signals. These results support EV+P as a new SOC for 1L la/mUC.

Clinical trial identification

NCT04223856.

Editorial acknowledgement

Medical writing support was provided by Thien Nguyen, Pharm D. (Seagen Inc.) and Sarah Canestaro, MS, of Populus Group, Troy, MI, supported by Seagen Inc.

Legal entity responsible for the study

Astellas Pharma.

Funding

Funded by Seagen Inc., Bothell, WA, USA; Astellas Pharma, Northbrook, IL, USA; Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Disclosure

T.B. Powles: Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers-Squibb, Exelixis, Incyte, Ipsen, Merck, Novartis, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson, Eisai, Roche, MSD; Financial Interests, Personal, Other, Travel/Accommodation/Expenses: Roche, Pfizer, MSD, AstraZeneca, Ipsen; Financial Interests, Personal, Other, Sponsorship for Uromigos Podcast: Mashup Ltd; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Bristol Myers-Squibb, Exelixis, Ipsen, Merck, MSD, Seattle Genetics, Novartis, Pfizer, Merck Serono, Astellas, Johnson & Johnson, Eisai. B. Perez Valderrama: Financial Interests, Personal, Advisory Board: Pfizer, Astellas Pharma, Bristol-Myers Squibb, Ipsen, EUSA Pharma, Merck, MSD, AstraZeneca, AAA; Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb, Roche, Bayer, EUSA Pharma, MSD, Merck, Pfizer, Janssen, Astellas Pharma, AAA. S. Gupta: Financial Interests, Personal, Advisory Board: Seattle Genetics, BMS, Pfizer, Bayer, Merck, Gilead, Loxo Oncology, Guardant, Foundation one; Financial Interests, Personal, Other, Speaker's Bureau: Janssen; Financial Interests, Personal, Other, Consultant: EMD Sorono; Financial Interests, Personal, Invited Speaker: Gilead; Financial Interests, Personal, Stocks/Shares: BioNTech, Moderna; Financial Interests, Personal, Steering Committee Member: BMS, Merck, Seattle Genetics, Acrivon; Financial Interests, Institutional, Local PI: EMD Serono, Gilead, Roche, QED, Exelixis, Moderna. J. Bedke: Financial Interests, Personal, Advisory Board: AstraZeneca, Astellas, Eisai; Financial Interests, Personal, Advisory Board and Speaker´s Bureau: BMS, Ipsen, MSD, Merck Serono, Pfizer, Roche, Janssen; Financial Interests, Institutional, Advisory Board: BMS, Pfizer; Financial Interests, Institutional, Local PI: AstraZeneca, Eisai, Novartis, Nektar; Financial Interests, Institutional, Invited Speaker: Astellas, BMS, MSD, Ipsen, Pfizer, Roche, Seagen; Other, Member of the Renal Cell Carcinoma Guidelines Panel: European Association of Urology. E. Kikuchi: Financial Interests, Personal, Invited Speaker: MSD, Bristol, Janssen, Astellas, Merck Biopham, Nippon Kayaku, Pfizer; Financial Interests, Personal, Advisory Board: Astellas, MSD, Bristol; Financial Interests, Institutional, Research Grant: Takeda, Nippon Kayaku, Kyorin, Taiho, Nippon Shinyaku. C. Vulsteke: Financial Interests, Personal, Advisory Board: MSD, Janssen-Cilag, GSK, Astellas Pharma, BMS, Leo Pharma, Bayer, AstraZeneca, Pfizer, Merck; Financial Interests, Institutional, Research Grant, Funding for research project on immune related toxicities: MSD. D.E. Castellano Gauna: Financial Interests, Personal, Advisory Board: Pfizer, Roche, BMS, Janssen, Astellas, MSD, Ipsen, AstraZeneca, Novartis, GSK; Financial Interests, Institutional, Local PI: Pfizer, Roche, MSD, BMS, AstraZeneca, Janssen, Astellas, Ipsen, Exelisis, Eisai, Lilly, Bayer, GSK, Clovis, QED Therapeutics; Non-Financial Interests, Personal, Other, Executive member: SOGUG (Spanish Oncology Genito-Urinary Group) Foundation. J. Li: Financial Interests, Personal, Invited Speaker: Astellas, Janssen Pharma, Bayer Pharmaceuticals, AstraZeneca, Ono Pharmaceutical, Merck, MSD, Roche, Synmosa, Pfizer, COOK. M. Gumus: Financial Interests, Institutional, Invited Speaker: Pfizer, Gen Pharmaceuticals, Novartis, Bayer, Amgen; Financial Interests, Institutional, Advisory Board: Amgen, Roche, BMS, AstraZeneca; Financial Interests, Institutional, Local PI: Jounce Therapeutics. N. Mar: Financial Interests, Personal, Invited Speaker: Eisai, Aveo, Tempus, Seattle Genetics; Financial Interests, Personal and Institutional, Funding, Funding for investigator initiated trial: Gilead. S. Narayanan: Financial Interests, Institutional, Full or part-time Employment: Seagen Inc; Financial Interests, Institutional, Stocks/Shares: Seagen Inc. X. Yu: Financial Interests, , Full or part-time Employment: Seagen; Financial Interests, Stocks/Shares: Seagen. S. Gorla: Financial Interests, Personal, Full or part-time Employment, I have been a full time employee of Astellas since 2012 and part of my role involves review of publications and other documents regarding the clinical trials we have conducted involving our products: Astellas; Non-Financial Interests, Project Lead, I have been a full time employee of Astellas since 2012 and have a leadership role in the projects that I lead: Astellas; Non-Financial Interests, Personal, Proprietary Information, I have been a full time employee of Astellas since 2012 and therefore have access to company confidential information about our products: Astellas. B. Homet Moreno: Financial Interests, Full or part-time Employment: Merck; Financial Interests, Proprietary Information: Merck. M.S. van der Heijden: Financial Interests, Institutional, Advisory Board: AstraZeneca, BMS, Janssen, MSD, Seagen, Pfizer; Financial Interests, Institutional, Funding, Investigator-initiated trial: BMS, Roche, AstraZeneca, 4SC; Financial Interests, Institutional, Invited Speaker, Local PI + SSC member: BMS, AstraZeneca, MSD, Seagen; Financial Interests, Institutional, Invited Speaker, Local PI + study co-PI: Janssen; Financial Interests, Institutional, Local PI: GSK. All other authors have declared no conflicts of interest.

Article info

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DOI: https://doi.org/10.1016/j.annonc.2023.10.106

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PADCEV™ Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study

C. Vulsteke1 ∙ H. Kaimakliotis2 ∙ P. Danchaivijitr3 ∙ … ∙ C. Ramamurthy18 ∙ B. Homet Moreno18 ∙ A. Ullén19 … Show more

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Background

Radical cystectomy + pelvic lymph node dissection (RC + PLND) is the standard treatment for pts with MIBC who are cisplatin-ineligible. Periop therapy may improve outcomes in these pts.

Methods

The phase 3 KEYNOTE-905/EV-303 study (NCT03924895) evaluated efficacy and safety of periop EV + pembro and RC + PLND vs RC + PLND in adult pts with MIBC (T2-T4aN0M0 or T1-T4aN1M0) who were cisplatin-ineligible or declined cisplatin. Pts were randomized 1:1 to EV + pembro (3 cycles EV 1.25 mg/kg on d1 and d8 + pembro 200 mg on d1 Q3W, followed by RC + PLND, then 6 cycles EV + 14 cycles pembro) vs control (RC + PLND only). Study therapy continued until progression, unacceptable adverse events (AEs), withdrawal of consent, or completion of planned treatment. The primary endpoint was event-free survival (EFS) by blinded independent central review. Secondary endpoints were overall survival (OS; key), pathological complete response (pCR) rate (key), and safety.

Results

170 pts were randomized to EV + pembro and 174 pts to control. >80% of pts were cisplatin-ineligible per Galsky criteria. As of Jun 6, 2025, median follow-up time was 25.6 mo (range, 11.8–53.7). 149 pts (87.6%) in the EV + pembro arm and 156 (89.7%) in the control underwent surgery. EV + pembro significantly improved EFS (median not reached vs 15.7 mo; HR 0.40; 95% CI 0.28–0.57; P<.001), OS (NR vs 41.7 mo; HR 0.50; 95% CI 0.33–0.74; P<.001), and pCR rate (57.1% vs 8.6%; estimated difference 48.3%; 95% CI 39.5–56.5; P<.001) vs control. Treatment-emergent AEs occurred in 100% (gr ≥3, 71.3%) of pts in the EV + pembro arm and 64.8% (gr ≥3, 45.9%) in the control. Most frequent gr ≥3 AE of special interest (based on distinct prespecified lists for each drug) was severe skin reactions (grouped term; 11.4%) for pembro, and skin reactions (grouped term; 10.8%) for EV.

Conclusions

Adding periop EV + pembro to surgery significantly and meaningfully improved EFS, OS, and pCR rate in pts with MIBC who were predominantly cisplatin-ineligible. The safety profile of EV + pembro was manageable and consistent with prior reports. This is the first periop regimen to improve outcomes vs RC + PLND in this setting and may be a new standard of care.

Clinical trial identification

NCT03924895.

Editorial acknowledgement

Editorial assistance was provided by Ina Bremer, PhD, an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Legal entity responsible for the study

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA in collaboration with Astellas Pharma Inc., Northbrook, IL, USA and Seagen Inc., Bothell, WA, USA, which was acquired by Pfizer in Dec. 2023.

Funding

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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blaaskanker, Enfortumab Vedotin, pembrolizumab, immuuntherapie, overall overleving, ziektevrije tijd, fase III EV302 studie / KEYNOTE-A39

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Regulier - blaaskanker: actuele ontwikkelingen en belangrijke studies binnen de reguliere oncologie: een overzicht

LBA6 EV-302/KEYNOTE-A39: Open-label, randomized phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (Chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC)

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