Blog

Amol Akhade Discusses POTOMAC Phase 3 Results in High-Risk NMIBC

Amol Akhade/hiranandanihospital.org

May 9, 2025, 11:53

Amol Akhade Discusses POTOMAC Phase 3 Results in High-Risk NMIBC

Amol Akhade, Consultant Medical Oncologist at the Suyog Cancer Clinics, posted on LinkedIn:

“Is this the long-awaited breakthrough in high-risk NMIBC?

POTOMAC Phase 3 trial results are out—and they may reshape how we treat bladder cancer at its earliest high-risk stage.

Study Summary:

The trial tested Imfinzi (durvalumab) + BCG vs BCG alone in patients with high-risk non–muscle-invasive bladder cancer (NMIBC).
Result: Statistically and clinically meaningful improvement in Disease-Free Survival (DFS).
Patients stayed in remission longer when treated with durvalumab + BCG.
This is a big step forward—most patients with high-risk NMIBC recur even with BCG alone.

Why this matters:

NMIBC = 70% of all bladder cancer cases
50% of NMIBC = high-risk, with high recurrence or progression risk
BCG has been the mainstay for decades, but failures are common
Checkpoint inhibitors (like pembrolizumab in KEYNOTE-057) were tested in BCG-unresponsive patients.
POTOMAC brings IO upfront—not as rescue, but as first-line combination with BCG!

Caveats and Criticism:

No data on delay or avoidance of cystectomy – a critical endpoint for patients and clinicians alike
Trial not powered for OS – though no detriment was observed, long-term benefit remains uncertain
No safety or QoL outcomes in this press release – important given risks of immunotherapy
No subgroup data shared (e.g., CIS vs papillary tumors)
Access and affordability – will healthcare systems support routine use of IO in NMIBC?

What’s next?

We await full presentation to review, magnitude of DFS benefit, OS, QoL, safety, and long-term outcomes. If confirmed, this could be the first major leap in NMIBC management in decades.”

Amol Akhade reflected on the newly released POTOMAC Phase 3 trial data, where durvalumab combined with BCG showed a significant improvement in disease-free survival for high-risk NMIBC. While results are promising, critical endpoints like cystectomy delay, safety, and QoL remain pending.

Learn more about Amol Akhade on OncoDaily.