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Hypothetical clinical case studies for 2L+ PADCEVTM monotherapy

Scenario A: PADCEV following prior 1L platinum-based chemotherapy and 2L PD-1/PD-L1 inhibitor 

Case study 1: Neeta, Female, 78, ECOG PS 0, fatigued and skeptical of further treatment based on experience to date

Neeta is deciding whether to continue active treatment for mUC

Neoadjuvant/Adjuvant Unresectable or
metastatic UC		 
 1L2LSubsequent line
 Platinum-based chemotherapyPD-1/PD-L1 inhibitorPADCEV
EV-301 patient profile: Neeta thumbnail
EV-301 patient profile: Neeta thumbnail

Disease characteristics

  • Stage at initial diagnosis: MIBC
  • Time since metastatic diagnosis: 13 months
  • Comorbidities: lingering Grade 1 peripheral neuropathy due to prior cisplatin-based chemotherapy

Treatment and disease history

  • Initial local treatment: radical cystectomy
    • Initially refused cisplatin-based chemotherapy
    • Subsequent Stage IV recurrence with metastases in the lung
    • Biopsy of metastatic site showed no PD-L1 expression
  • Initial systemic treatment: cisplatin + gemcitabine
    • Achieved a PR but progressed after 5 months
  • Subsequent systemic treatment: PD-1 inhibitor monotherapy
    • Stable disease for 3 months
    • Progressive disease developed by next assessment at 6 months with new bone metastases

Case study 2: Ashok, Male, 79, former smoker, ECOG PS 1, too fatigued to attend granddaughter’s football matches

Ashok is seeking a subsequent treatment for mUC

Neoadjuvant/Adjuvant Unresectable or
metastatic UC		 
 1L2LSubsequent line
 Platinum-based chemotherapyPD-1/PD-L1 inhibitorPADCEV
EV-301 patient profile: Ashok thumbnail
EV-301 patient profile: Ashok thumbnail

Disease characteristics

  • Stage IV UC of the ureter
  • Time since metastatic diagnosis: 9 months
  • Comorbidities: mild COPD

Treatment and disease history

  • Initial systemic treatment: cisplatin + gemcitabine
    • Achieved a PR but progressed 4 months later
  • Subsequent systemic treatment: PD-1 inhibitor monotherapy
    • Stable disease for 3 months
    • Subsequent progression with more extensive nodal and liver spread

Case study 3: Arun, Male, 71, ECOG PS 1, lower back pain prevents gardening

Arun is cisplatin ineligible and seeking a subsequent treatment for la/mUC

Neoadjuvant/Adjuvant Unresectable or
metastatic UC		 
 1L2LSubsequent line
 Platinum-based chemotherapyPD-1/PD-L1 inhibitorPADCEV
EV-301 patient profile: Arun thumbnail
EV-301 patient profile: Arun thumbnail

Disease characteristics

  • Stage IIIA UC of the bladder
  • Time since locally advanced diagnosis: 8 months
  • Comorbidities: Grade 2 hearing loss

Treatment and disease history

  • Initial systemic treatment: carboplatin + gemcitabine
    • Stable disease for 4 months
  • Subsequent systemic treatment: PD-1 inhibitor
    • Stable disease for 2 months
    • Subsequent progression to Stage IIIB disease

Scenario B: PADCEV following prior 1L platinum-based chemotherapy plus subsequent 1L PD-1/PD-L1 maintenance treatment

Case study 4: Anil, Male, 68, smoker, ECOG PS 1, no longer able to climb stairs due to pain in lungs

Anil is seeking another treatment option following PD-L1 inhibitor maintenance in the 1L setting

Neoadjuvant/Adjuvant Unresectable or

metastatic UC		 
 1L2LSubsequent line
 Platinum-based chemotherapy +
PD-1/PD-L1 inhibitor
maintenance		PADCEV 
EV-301 patient profile: Anil thumbnail
EV-301 patient profile: Anil thumbnail

Disease characteristics

  • Stage at initial diagnosis: high-grade NMIBC
  • Time since Stage IV diagnosis: 20 months
  • Comorbidities: controlled type 2 diabetes

Treatment and disease history

  • Initial systemic treatment: BCG immunotherapy
    • Refused cystectomy
  • Subsequent systemic treatment: cisplatin + gemcitabine
    • Achieved a PR and started PD-L1 inhibitor maintenance therapy 4 weeks later
    • Follow-up CT scan revealed further invasion of the abdominal wall

Scenario C: PADCEV following 1L PD-1/PD-L1 inhibitor after platinum-based chemotherapy in the (neo)adjuvant setting

Case study 5: Mohan, Male, 66, ECOG PS 1, unable to exercise due to abdominal pain

Mohan is considering his next treatment option for mUC

Neoadjuvant/Adjuvant Unresectable or

metastatic UC		 
 1L2LSubsequent line
Platinum-based chemotherapyPD-1/PD-L1 inhibitorPADCEV 
EV-301 patient profile: Mohan thumbnail
EV-301 patient profile: Mohan thumbnail

Disease characteristics

  • Stage at initial diagnosis: high-risk NMIBC
  • Time since metastatic diagnosis: 9.5 months

Treatment and disease history

  • Initial systemic treatment: BCG immunotherapy
    • Follow-up TURBT confirmed persistent high-risk NMIBC
    • Subsequent progression to MIBC
  • Subsequent treatment: Neoadjuvant cisplatin + gemcitabine followed by cystectomy
    • Progression to Stage IV disease after 11 months with pelvic bone metastases
  • Systemic treatment: PD-1 inhibitor
    • Achieved a PR and 9-month duration of response
    • Subsequently developed new liver metastases

Case study 6: Rao, Male, 55, ECOG PS 0, unable to go on bike rides due to residual Grade 1 immune-mediated colitis

Rao is younger than the typical patient with la/mUC

Neoadjuvant/Adjuvant Unresectable or

metastatic UC		 
 1L2LSubsequent line
Platinum-based chemotherapyPD-1/PD-L1 inhibitorPADCEV 
EV-301 patient profile: Rao thumbnail
EV-301 patient profile: Rao thumbnail

Disease characteristics

  • Stage II UC of the renal pelvis
  • Time since locally advanced diagnosis: 28 months
  • Residual Grade 1 immune-mediated colitis

Treatment and disease history

  • Initial treatment: nephroureterectomy followed by adjuvant cisplatin + gemcitabine
    • Disease recurrence developed by next assessment at 8 months, with a new Stage IV diagnosis
  • Initial systemic treatment: PD-L1 inhibitor: cisplatin + gemcitabine
    • Achieved PR but progressed with additional lymph node spread after 10 months

1L - first-line; 2L - second-line; BCG - Bacillus Calmette-Guérin; COPD - chronic obstructive pulmonary disease; CT - computed tomography; ECOG PS - Eastern Cooperative Oncology Group performance status; LA - locally advanced; MIBC - muscle-invasive bladder cancer; MoA - mechanism of action; mUC - metastatic urothelial cancer; NMIBC - non-muscle-invasive bladder cancer; PD-1 - programmed death receptor-1; PD-L1 - programmed death-ligand 1; PR - partial response; TURBT - transurethral resection of bladder tumour; UC - urothelial cancer

References

  1. PADCEV India prescribing information.

Efficacy outcomes

Review efficacy outcomes in 2L+ locally advanced or metastatic UC

Safety outcomes


See safety results for 2L+ locally advanced or metastatic UC

Resources and treatment support

Access resources to help navigate treatment with confidence

PADCEV, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. 

 

PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

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pv@in.astellas.com or +91-226-1557-616

 

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