EV302
What were the randomization stratification factors for EV302?
What is THE only 1L NCCN Category 1 Preferred treatment for locally advanced or metastatic urothelial carcinoma?
Enfortumab vedotin + Pembrolizumab
This adjuvant MIBC trial was considered negative for its primary endpoint of DFS, but an exploratory analysis related to ctDNA has kept it in the spotlight. Bonus points: Name the sequel
IMvigor010; Atezolizumab; IMvigor011
What is the recommended dose reduction schedule for EV?
Full Approval: 1L la/mUC in combination with pembrolizumab regardless of cisplatin eligibility
EV302
What were the ORR and CR rates for EV+P compared to chemotherapy arms?
What are other 1L NCCN recommended Category 1 treatment options for la/mUC?
This MIBC trial made a splash when it showed that using perioperative immunotherapy with neoadjuvant chemotherapy demonstrated significant improvements in pCR, EFS, and OS compared to NAC alone
NIAGARA; Durvalumab
In EV302, what was the most common reason for dose holds, changes, and discontinuations? Bonus: What were the rates of those?
Accelerated Approval: 2L la/mUC as monotherapy
EV201 C1
What were the median PFS and OS for EV+P compared to the chemotherapy arms? (LTFU data)
Aside from the preferred regimen, what are the other 1L options in patients who are ineligible for cisplatin?
This la/mUC trial showed that OS could go the distance (was improved) by giving immunotherapy to patients whose disease had not progressed after receiving 1L Platinum-based chemotherapy
JAVELIN Bladder 100; Avelumab
What is the median TTO of skin reactions with EV+P and how frequently are they seen?
2 months; Seen in 70% of patients in clinical trials
Accelerated Approval: 1L la/mUC in combination with pembrolizumab in cisplatin-ineligible patients
EV103K (and 103A/D/E)
At ASCO 2025, an exploratory analysis of responders demonstrated that at two years post-randomization, what percent of CR patients had maintained their response? Also, what percent of CR patients were still alive at two years?
What biomarkers are “often” collected in patients with la/mUC and what potential 2L+ treatment options are their results tied to?
This la/mUC trial had positive results but ultimately lost the crown at ESMO 2023 when it showed that adding a checkpoint inhibitor to cisplatin-containing chemotherapy improved overall survival. Bonus: name another oft-mentioned facet of this study.
CheckMate901; Nivolumab; Data in LN-only
What is the median TTO of Grade 2+ PN with EV+P and how frequently is it seen?
6 months; Seen in 67% of patients in clinical trials
Full Approval: 2L la/mUC as monotherapy
EV301
The EV302 study protocol had a major amendment during the conduct of the study based on new data presented that changed the treatment landscape. Please explain what the amendment was related to and why it was relevant
Results based on Javelin Bladder 100 and patients being allowed to have avelumab added after completion of chemo
Verbalize how NCCN approaches 2L+ therapy for la/mUC
Primarily driven by what was utilized in 1L
This trial evaluating an ADC did not meet its primary endpoint of OS and ultimately led to the FDA withdrawing approval in 2L la/mUC after promising Phase 2 results
TROPiCS-04; Sacituzumab Govitecan (still in NCCN guidelines)
At what blood glucose level should EV doses be held? Bonus: What was the hyperglycemia-related cutoff for “uncontrolled diabetes” in the EV302 Exclusion Criteria?
>250 mg/dL; HbA1c ≥ 8% (or HbA1c 7%–<8% with associated diabetes symptoms [polyuria or polydipsia] that are not otherwise explained)
(Hopefully) Full Approval as perioperative therapy in cisplatin-ineligible MIBC patients
EV303