1L cisplatin-eligible metastatic urothelial carcinoma (mUC) — Bristol Myers Squibb + Ono Pharmaceutical
Discover KOL Sentiment on CheckMate-901 →Design - Phase 3 nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin, 1L cisplatin-eligible unresectable/metastatic urothelial carcinoma (NCT03036098).
OS (dual primary) - Median 21.7 vs 18.9 mo, HR 0.78 (95% CI 0.63-0.96), P=0.0171.
PFS - Median 7.9 vs 7.6 mo (dual primary; favoring the nivolumab arm).
Safety - Manageable and consistent with the component agents; specific Grade >=3 rates for the cisplatin-eligible cohort pending full publication.
Regulatory - FDA approved March 6, 2024 - nivolumab + cisplatin/gemcitabine, 1L unresectable/metastatic urothelial carcinoma.
Sponsor / drug - Bristol Myers Squibb + Ono Pharmaceutical; nivolumab (Opdivo).
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.
Top tweets by impressions — click to view on X
Interesting results from #CheckMate901 by @MattGalsky
⚪️ Pts with LN only mUC have higher CR with NIVO+GC (63% vs 34% w/ GC)
⚪️ Durable responses persisting after treatment were observed
⚪️…
Ab#4509 @ASCO #ASCO24 by @MattGalsky 👉https://t.co/k7XxS9NypF👉GC+NIVO vs. GC in ph 3 Checkmate 901 in pts w/ mUC #bladdercancer 👉Remarkable improvement in PFS & OS w/ GC+NIVO in pts w/ lymph-node…
@MattGalsky CheckMate 901 trial shows that NIVO+GC significantly improves overall and progression-free survival in LN-only metastatic urothelial carcinoma compared to GC alone, with higher response…
A +ve CHMP opinion for gem/cis + nivolumab (CheckMate -901 trial) today @MichvdHeijden @MattGalsky #APCCC24 Likely to result in EMA approval. This will compete with maintenance avelumab due to ⬆️ …
#AUA24 -CHECKMATE901 Phase III trial of first-line therapy for advanced #urothelialcarcinoma #bladdercancer: 1) Nivolumab + GC showed significant benefits in overall survival OS, PFS, and response…
Tnks for attending rhe session!!
Important data presented!
🔹PROs for 1st line EV+pembro for mUC @shilpaonc
🔸Biomarkers in pembro+lenva & pembro+axi trials in mRCC @DrChoueiri @brian_rini…
CheckMate 901 trial: Abstract #4509
⭕️For lymph node-only mUC, NIVO+GC resulted in durable disease control and significant OS and PFS improvements.
⭕️Proud to have played a role in this impactful…
The most striking #bladdercancer data at #ASCO24 IMO are from the CheckMate901 analysis with striking findings in Lymph-node (LN)-only metastasis patients for GC-nivolumab vs. GC: CR rate 63.0% vs.…
Excellent coverage on lymph-node only metastatic #UrothelialCancer as a distinct entity among complete responders to Nivo/GC #CheckMate901
➡️Med OS in LN-only mUC: 46.3 (Nivo+GC) vs 24.9 months with…
News from Industry:
“European Commission Approval for nivolumab in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic…
CheckMate-901 established nivolumab + cisplatin-based chemotherapy as a 1L option in cisplatin-eligible mUC. In the EV-302 era (EV+P, mOS 33.8 mo, HR 0.51), EV+P is the preferred regimen regardless of cisplatin eligibility. CheckMate-901 remains a valuable alternative for patients unsuited to EV+P or with contraindications to ADCs.
Median: 21.7 months (Nivo + gem/cis, 95% CI 18.6-26.4) vs. 18.9 months (gem/cis, 95% CI 14.7-22.4). HR 0.78 (95% CI 0.63-0.96), P=0.0171 Nivolumab + cisplatin-based chemotherapy significantly improved OS vs. chemotherapy alone in cisplatin-eligible mUC.
In the lymph-node-only disease subgroup (post-hoc analysis, 33.6-month median follow-up): ORR 81% (nivo+gem/cis) vs. 64% (gem/cis alone); CR 63% vs. 34%.
Manageable safety profile consistent with the individual component agents. Grade ≥3 TRAEs in cisplatin-ineligible NIVO+IPI cohort were 47% vs. 76% with gem/carbo. Specific Grade ≥3 TRAE rates for the cisplatin-eligible primary cohort pending full publication detail.
✅ 1L SOC option for cisplatin-eligible mUC — alongside EV+P. CheckMate-901 established nivolumab + cisplatin-based chemotherapy as a 1L option in cisplatin-eligible mUC. In the EV-302 era (EV+P, mOS 33.8 mo, HR 0.51), EV+P is the preferred regimen regardless of cisplatin eligibility. CheckMate-901 remains a valuable alternative for patients unsuited to EV+P or with contraindications to ADCs.
CheckMate-901 is a Phase 3 randomized trial (NCT03036098) evaluating first-line nivolumab (Opdivo) plus gemcitabine-cisplatin chemotherapy versus gemcitabine-cisplatin alone in cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma. Overall survival and progression-free survival were dual primary endpoints.
Adding nivolumab to cisplatin-based chemotherapy significantly improved overall survival: median OS was 21.7 versus 18.9 months (HR 0.78; 95% CI 0.63-0.96; P=0.0171). Median progression-free survival was 7.9 versus 7.6 months, also favoring the nivolumab arm, establishing this as the first checkpoint-inhibitor-plus-chemotherapy regimen to improve survival in cisplatin-eligible metastatic urothelial carcinoma.
Yes. On March 6, 2024 the FDA approved nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma, based on the CheckMate-901 overall survival benefit.
In the EV-302 era, enfortumab vedotin plus pembrolizumab (median OS 33.8 months; HR 0.51) is generally the preferred first-line regimen regardless of cisplatin eligibility. CheckMate-901's nivolumab-plus-cisplatin/gemcitabine remains a valuable alternative for patients who are not suited to EV+P or who have contraindications to antibody-drug conjugates.
Candidates are patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy. The approved regimen pairs nivolumab with cisplatin and gemcitabine, so cisplatin eligibility (adequate renal function and performance status) is required.