Arjun Balar, MD, prepared useful practice aids pertaining to bladder cancer for this CME/MOC activity titled "Innovative Treatments for Bladder Cancer: Thoughts From the Chair." For the full presentation, monograph, complete CME/MOC information, and to apply for credit, please visit us at https://bit.ly/37eCNCm. CME/MOC credit will be available until June 23, 2021.

1. A Snapshot of Approved and Emerging
Therapies in Urothelial Carcinoma:
Therapeutic Targets, Current
Status/Indication, and Dosing Information
Access the activity, “Evidence and Insights on Innovative Treatment for Bladder Cancer:
Clinical Breakthroughs From Targeted and Immune Options to Antibodies and Gene
Therapy,” at PeerView.com/YFM40
PRACTICE AID
BCG: Bacillus Calmette-Guerin; CIS: carcinoma in situ; CPS: combined positive score; EpCAM: epithelial cell adhesion molecule; FGFR: fibroblast growth factor receptor; IC: immune cell; IFN: interferon;
IHC: immunohistochemistry; mUC: metastatic urothelial carcinoma; NMIBC: non-muscle–invasive bladder cancer; PD-1: programmed death 1; PD-L1: programmed death ligand‐1; PO4
: phosphate in
urine; UC: urothelial cancer.
1. Tecentriq (atezolizumab) Prescribing Information. https://www.gene.com/download/pdf/tecentriq_prescribing.pdf. 2. Bavencio (avelumab) Prescribing Information.https://www.accessdata.fda.
gov/drugsatfda_docs/label/2019/761049s006lbl.pdf. 3. Imfinzi (durvalumab) Prescribing Information. https://www.azpicentral.com/imfinzi/imfinzi.pdf. 4. Opdivo (nivolumab) Prescribing Information.
https://packageinserts.bms.com/pi/pi_opdivo.pdf. 5. Keytruda (pembrolizumab) Prescribing Information. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. 6. Balversa
(erdafitinib) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212018s000lbl.pdf. 7. Padcev (enfortumab vedotin-ejfv) Prescribing Information. https://astellas.us/
docs/PADCEV_label.pdf. 8. https://clinicaltrials.gov/ct2/show/NCT02773849. 9. Dinney P et al (on behalf of SUO CTC). SUO 2019. Presentation. 10. https://clinicaltrials.gov/ct2/show/NCT02449239.
DRUG/TARGET STATUS/INDICATION DOSING
Gene tx under investigation in phase 3 trial (NCT02773849) in pts with high-grade,
BCG-unresponsive NMIBC with CIS with or without concomitant high-grade Ta or T1
papillary disease; recently met primary endpoint: 3-mo CR = 53%9
Gene Therapy
Nadofaragene
firadenovec
(rAd-IFN/Syn3)8
Study investigating
high-dose tx
Adenovirus vector–based therapy
containing active IFN alpha-2b gene
Approved for treatment of adult pts with locally advanced or mUC who have previously
received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy in the
neoadjuvant/adjuvant, locally advanced, or metastatic setting
Antibody–Drug Conjugate
Enfortumab vedotin7
Nectin-4
1.25 mg/kg (up to max of
125 mg) as IV infusion over
30 min on d 1, 8, and 15 of
a 28-d cycle until disease
progression or toxicity
Approved for the treatment of pretreated pts with locally advanced or mUC who have
FGFR2 or FGFR3 genetic alterations and who progressed on prior platinum-based tx
or relapsed within 1 y of perioperative cisplatin tx
Companion diagnostic: therascreen®
FGFR RGQ RT-PCR Kit
FGFR Inhibitor
Erdafitinib6
FGFR
8 mg daily with
an increase
to 9 mg daily based on
PO4
levels and tolerability
at 14 to 21 d
Approved for the treatment of newly diagnosed pts with cis-ineligible locally advanced
UC or mUC and PD-L1+ tumors (CPS ≥10) or who are platinum ineligible
Companion diagnostic: Dako 22C3 PD-L1 IHC 22C3PharmDX
Approved for the treatment of pretreated pts with locally advanced or mUC who
progressed on prior platinum-based tx or relapsed within 1 y of perioperative cisplatin tx
Approved for the treatment of pts with BCG-unresponsive, high-risk NMIBC with CIS with
or without papillary tumors who are ineligible for or have elected not to undergo cystectomy
Pembrolizumab5
PD-1
200 mg every 3 wk
240 mg every 2 wk
or 480 mg every 4 wk
Approved for the treatment of pretreated pts with locally advanced or mUC who
progressed on prior platinum-based tx or relapsed within 1 y of perioperative cisplatin tx
Nivolumab4
PD-1
Approved for the treatment of pretreated pts with locally advanced or mUC who
progressed on prior platinum-based tx or relapsed within 1 y of perioperative cisplatin tx
Durvalumab3
PD-L1
10 mg/kg every 2 wk
Approved for the treatment of pretreated pts with locally advanced or mUC who
progressed on prior platinum-based tx or relapsed within 1 y of perioperative cisplatin tx
Avelumab2
PD-L1
800 mg every 2 wk
Immune Checkpoint Inhibitors
Atezolizumab1
PD-L1
Approved for the treatment of pretreated pts with locally advanced or mUC who
progressed on prior platinum-based tx or relapsed within 1 y of perioperative cisplatin tx
840 mg every 2 wk,
1,200 mg every 3 wk,
or 1,680 mg every 4 wk
Approved for the treatment of newly diagnosed pts with cis-ineligible locally advanced
UC or mUC and PD-L1+ tumors (tumor-infiltrating ICs covering ≥5 % of the tumor area)
or who are platinum ineligible
Companion diagnostic: Ventana PD-L1 (SP142) Assay
EpCAM-specific antibody fragment
fused to Pseudomonas exotoxin A
30 mg in 50 mL of saline
BIW for 6 wk, then QW
for 6 wk for 12 wk
FDA Fast Track Designation based on the VISTA trial for pts with high-grade NMIBC
who are BCG-unresponsive after two prior courses of BCGVicinium10

2. Selected Ongoing Clinical Trials
of Innovative Treatment Options
in Urothelial Carcinoma1
Access the activity, “Evidence and Insights on Innovative Treatment for
Bladder Cancer: Clinical Breakthroughs From Targeted and Immune Options
to Antibodies and Gene Therapy,” at PeerView.com/YFM40
PRACTICE AID
BCG: Bacillus Calmette-Guerin; BSC: best supportive care; chemo: standard chemotherapy (methotrexate/vinblastine/doxorubicin/cisplatin or gemcitabine with either cisplatin or carboplatin);
CRT: chemoradiotherapy; FGF: fibroblast growth factor; FGFR3: fibroblast growth factor receptor 3; IDO: indolamine 2,3-dioxygenase; MIBC: muscle-invasive bladder cancer;
NMIBC: non-muscle–invasive bladder cancer; RT: radiotherapy; UC: urothelial cancer.
1. www.clinicaltrials.gov.
First-Line and Maintenance Metastatic Second-Line Metastatic
Bladder PreservationAdjuvant
CheckMate -901 (NCT03036098) Phase 3:
Nivolumab + ipilimumab vs nivolumab
+ chemo vs chemo
DANUBE (NCT02516241) Phase 3:
Durvalumab ± chemo vs chemo
IMvigor130 (NCT02807636) Phase 3:
Atezolizumab ± chemo vs chemo
JAVELIN Bladder 100 (NCT02603432)
Phase 3: Avelumab + BSC vs BSC
KEYNOTE-361 (NCT02853305) Phase 3:
Pembrolizumab ± chemo vs chemo
NILE (NCT03682068) Phase 3:
Durvalumab + chemo ± tremelimumab
vs chemo
EV-301 (NCT03474107) Phase 3:
Enfortumab vedotin vs chemo
FIERCE-21 (NCT02401542) Phase 1/2:
Vofatamab ± docetaxel vs docetaxel alone
in pts with FGFR3 mutations/fusions
FIERCE-22 (NCT03123055) Phase 1/2:
Vofatamab + pembrolizumab
FIGHT-201 (NCT02872714) Phase 2:
Pemigatinib in pts with FGF/FGFR mutations
THOR (NCT03390504) Phase 3:
Erdafitinib vs chemo vs pembrolizumab
in pts with selected FGFR mutations
TROPHY-U-01 (NCT03547973) Phase 2:
Sacituzumab govitecan (IMMU-132)
NMIBCNeoadjuvant
S1806 (NCT03775265) Phase 3:
Atezolizumab ± CRT in localized MIBC
NCT02621151 Phase 2:
Pembrolizumab + gemcitabine +
hypofractionated RT in MIBC
AMBASSADOR (NCT03244384) Phase 3:
Pembrolizumab vs observation
CheckMate -274 (NCT02632409) Phase 3:
Nivolumab vs placebo
ALBAN (NCT03799835) Phase 3:
Atezolizumab + BCG vs BCG
FIERCE-23 (Planned): Vofatamab alone
KEYNOTE-057 (NCT02625961) Phase 2:
Pembrolizumab in high-risk NMIBC
KEYNOTE-676 (NCT03711032) Phase 3:
Pembrolizumab + BCG vs BCG
POTOMAC (NCT03528694) Phase 3:
Durvalumab + BCG (induction +
maintenance) vs durvalumab + BCG
(induction only) vs BCG
NCT02773849 Phase 3:
Nadofaragene firadenovec
NCT03914794 Phase 2:
Pemigatinib in recurrent
low-/intermediate-risk NMIBC
ABASCUS (NCT02662309) Phase 2:
Atezolizumab
NIAGARA (NCT03732677) Phase 3:
Durvalumab + chemo → adjuvant durvalumab
vs chemo alone
PrECOG0807 (NCT03532451) Phase 1b:
Nivolumab ± lirilumab
PURE-01 (NCT02872714) Phase 2:
Pembrolizumab
NCT03661320 Phase 3:
Nivolumab + chemo → adjuvant nivolumab
vs nivolumab + chemo + BMS-986205
(IDO inhibitor) → adjuvant nivolumab +
BMS-986205 vs chemo
NCT02365766 Phase 1b/2:
Pembrolizumab + gemcitabine ± cisplatin
NCT04241185 Phase 3:
Pembrolizumab + CRT in MIBC

3. Tools and Resources to Share With
Bladder Cancer Patients
Access the activity, “Evidence and Insights on Innovative Treatment for Bladder Cancer: Clinical Breakthroughs
From Targeted and Immune Options to Antibodies and Gene Therapy,” at PeerView.com/YFM40
PRACTICE AID
BCAN: Bladder Cancer Advocacy Network.
1. https://bcan.org/bladder-cancer-basics-handbook. 2. https://clinicaltrials.bcan.org/.
From the Handbook: Bladder Cancer Risk Factors
Bladder cancer is twice as common in whites as African Americans,
and a family history of bladder cancer can also increase one's risk for
bladder cancer
Cigarette smoking is the most common. Smokers are diagnosed
with bladder cancer twice as often as people who don’t smoke;
however, many of those diagnosed never smoked
Workers exposed to certain industrial chemicals
have a higher risk of developing bladder cancer
Men are 3-4 times more likely to be diagnosed as women,
but women are more likely to have advanced forms
Arsenic in drinking water and other environmental toxin
exposures increase the risk of developing bladder cancer
The risk of bladder cancer increases with age
BCAN’s Bladder Cancer Basics handbook for bladder cancer
patients is available free of charge
This handbook helps patients learn about1
• Bladder cancer diagnosis
• Available treatment options
• Tests used to diagnose bladder cancer
• Guidance on disease staging … and much more
BCAN also makes many resources available to patients
interested in finding clinical trials
Designed to find a safe dose of a new cancer drug
May involve testing a new therapy in humans for the
first time or a new combination of therapies that were
previously used alone
Test how well a new therapy works in a particular group
of patients
Often include at least two groups of patients: one receiving
standard-of-care therapy, the other receiving a new therapy
that has shown promise in earlier-phase studies
Patients are often randomly assigned to one group
or the other
Defining the Three Major Phases of Cancer Clinical Trials
Phase 1:
Performed in
a small group
of patients (<40)
Phase 2:
Performed in
40-100 patients
Phase 3:
Performed in
a large group
of patients (>100)
Patients seeking to understand their disease in the aftermath of a bladder cancer
diagnosis, self-educate on modern therapy and open clinical trials, or engage with
support groups or other patients can find many resources at patient organizations
such as the Bladder Cancer Advocacy Network
Patients can visit
the Clinical Trials
Dashboard to find
a trial and location
that is right
for them2