KEYTRUDA Padcev MIBC Survival: New Era in Treatment Revealed by KEYNOTE-B15 Trial Results

By HEOR Staff Writer

March 2, 2026

KEYTRUDA Padcev MIBC Survival Breakthrough in Cisplatin-Eligible Patients

KEYTRUDA Padcev MIBC Survival benefits shone in the Phase 3 KEYNOTE-B15 trial, where perioperative KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) cut event-free survival (EFS) event risk by 47% and death risk by 35% versus neoadjuvant chemotherapy followed by surgery. Detailed in Merck’s press release, these late-breaking results after 33.6 months median follow-up showed median EFS not reached (vs. 48.5 months) and two-year survival of 86.9% (vs. 81.3%), marking the first immunotherapy-ADC combo to deliver such gains in this setting—and the sixth KEYTRUDA study with overall survival (OS) wins in earlier-stage cancers.

EFS and OS Risk Reductions Redefine Outcomes

The trial reported statistically significant EFS and OS improvements, plus enhanced pathologic response. Trial primary endpoint EFS—time to progression precluding surgery, surgical failure, residual disease, recurrence, or death—hit median not reached for KEYTRUDA Padcev MIBC Survival arm (79.4% two-year progression-free) vs. 48.5 months (66.2%) for gemcitabine-cisplatin. Secondary endpoints boosted pathologic complete response (pCR) to 55.8% (vs. 32.5%; difference 23.4%, p<0.0001), with median OS not reached but HR=0.65 favoring the regimen. These align with prior approvals in advanced urothelial cancer and cisplatin-ineligible MIBC, spanning three Phase 3 trials.

KEYNOTE-B15 Design Matches Real-World Needs

The open-label randomized setup pitted four neoadjuvant KEYTRUDA-Padcev cycles, cystectomy, and 13 adjuvant KEYTRUDA + five Padcev cycles against four gemcitabine-cisplatin cycles plus surgery—challenging a standard where half recur despite benefits. Safety mirrored profiles: grade ≥3 events in 75.7% (combo) vs. 67.2% (chemo), feasible amid 600,000+ global bladder cases yearly (25% MIBC).

Paradigm Shift Sparks Regulatory Momentum

KEYTRUDA Padcev MIBC Survival data signal shifts for cisplatin-eligible patients. The 47% EFS/35% OS cuts and doubled pCR justify value via quality-adjusted life years and recurrence cuts, balancing adverse events against gains—echoing KEYTRUDA’s 14 early-cancer wins. Implications: optimized care, lower metastatic costs, broader curative access pending real-world data.

Reference url

Recent Posts

HERNEXEOS Lung Cancer Treatment: First FDA Approval for HER2-Mutant NSCLC

By HEOR Staff Writer

FDA Greenlights HERNEXEOS Lung Cancer Treatment as First-Line Option HERNEXEOS lung cancer treatment (zongertinib tablets), developed by
Novartis Drug Discovery Innovation: Advancing Global Health Through Strategic R&D

By João L. Carapinha

February 26, 2026

Novartis drug discovery innovation is transforming global health through the Biomedical Research group's shift from siloed efforts to an integrated, patient-centric model targeting high-burden diseases in low- and middle-income countries (LMICs). Under Manju Ujjini, Head of Lead Discovery, key mi...
Infarmed Regulatory Activity: January 2026 Highlights and Impacts on Market Access

By João L. Carapinha

Infarmed regulatory activity in January 2026 showcased robust performance by Portugal's National Authority for Medicines and Health Products, spanning marketing authorizations, clinical trials, public reimbursement, inspections, pharmacovigilance, and enforcement. The agency processed 45 renewals...