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Senthil Kumar: Metastatic Urothelial Carcinoma – First line therapies
Jan 7, 2025, 19:33

Senthil Kumar: Metastatic Urothelial Carcinoma – First line therapies

Senthil Kumar, Medical Oncologist at Red Hills, shared a post on X:

Metastatic Urothelial Carcinoma: First line therapies

Urothelial cancer (UC) ranks as the 10th most common cancer worldwide, with advanced treatment regimens reshaping care standards. Here’s a detailed comparison of current regimens, their benefits, and challenges:

First-Line Therapies

EV-302 Regimen

Enfortumab Vedotin (EV) + Pembrolizumab:

Overall Survival (OS): 32 months (doubled vs chemo: 16 months).
Progression-Free Survival (PFS): 12 months (doubled vs chemo: 6 months).
Overall Response Rate (ORR): 68%.

Challenges:

Cost: Extremely high; EV given until progression further amplifies expense.

Toxicity: Severe and permanent neurotoxicity risk.

Standard arm concerns: Most cases lacked maintenance avelumab.

Next best regimen — concurrent chemo+immuno combo

Checkmate 901 (CM-901)

Nivolumab (Nivo) + Chemo:

OS: 22 months (vs 19 months with chemo).
Deep, durable responses: Especially in lymph-node-only metastasis.
Complete Response (CR): 22%, with some responses lasting 3 years!
Fast & durable responses: Chemotherapy ensures rapid response, while nivolumab extends durability.

Sequential chemo – immuno combo

Platinum Doublet + Maintenance Avelumab (JAVELIN Bladder 100 Trial)

JAVELIN Bladder 100 Trial:

– OS: 24 months (vs 15 months).
– PFS: 5.5 months (vs 2 months).

Sequential vs Concurrent Chemo immuno Therapy ( CM 901 VS JAVELIN BLADDER 100)

No head on comparisons available
For patients unable to afford targeted therapy / immunotherapy

Chemotherapy Regimens

MVAC (Methotrexate + Vinblastine + Doxorubicin + Cisplatin)

OS: 13 months.
PFS: 10 months.
ORR: 40%.

Dose-Dense MVAC (DD-MVAC):

– No significant OS advantage over standard MVAC.

PGC (Triplet: Cisplatin + Gemcitabine + Paclitaxel)

ORR: 56% (better than doublets).
PFS: 8 months.
OS: 16 months.

Platinum Doublet (Cisplatin + Gemcitabine)

OS: 15 months.
ORR: 40-50%.

Cisplatin ineligible patients

Carboplatin-Gemcitabine, EV-302 regimen or Gemcitabine-Paclitaxel.

Platinum-Ineligible patients :

Immunotherapy (e.g., Pembrolizumab) or single-agent chemotherapy.

Immunotherapy Insights

Only EV 302, CM 901 – positive

Other Combination chemo + immunotherapy trials – negative

Trials like KN-361, DANUBE, IMvigor 130, and IMvigor 210 did not show significant OS benefit over chemotherapy alone.

Insights & Takeaways

EV-302 is the new SOC, offering remarkable survival benefits but comes with significant cost and some neuro toxicity.

CM-901 is the next best alternative with durable and deep responses, particularly in lymph-node-only metastasis.

22% CR rate, with many responses lasting 3 years.

Platinum Doublet + Avelumab Maintenance (JAVELIN Bladder 100 Trial) is a strong option with proven survival benefits.

MVAC and PGC are still good regimens for cisplatin-eligible patients, not affordable for the latest therapies

Immunotherapy or non-platinum single agent chemo offers hope for platinum-ineligible patients.”