Pfizer/Astellas Tout Encouraging Data From Keytruda Combo Regime In Urothelial Cancer Showing 49% Reduction In Death Risk Vs. Chemo

On Monday, Pfizer Inc. PFE and Astellas Pharma Inc. ALPMF ALPMY released additional follow-up results from the Phase 3 EV-302 trial (also known as KEYNOTE-A39) of Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

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The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months).

• Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy.
• The median OS was 33.8 months for the combination versus 15.9 months for chemotherapy.
• The OS benefit was observed in all prespecified subgroups, including cisplatin eligible and ineligible subgroups.
• Enfortumab vedotin plus pembrolizumab also reduced the risk of disease progression or death by 52% versus chemotherapy.
• The median PFS was 12.5 months for the combination versus 6.3 months for chemotherapy.
• The safety profile was consistent with previous findings and no new safety concerns were identified.

In addition to longer follow-up data, an exploratory analysis evaluating treatment outcomes and safety profile in patients with confirmed complete response (cCR) will also be presented.

• Among patients evaluable for response, a confirmed objective response rate (cORR) was 67.5% for enfortumab vedotin plus pembrolizumab compared to 44.2% for chemotherapy.
• Median duration of response (DOR) was 23.3 months for the combination and 7.0 months for chemotherapy.
• A cCR was achieved in 30.4% of patients treated with enfortumab vedotin plus pembrolizumab and 14.5% of patients treated with chemotherapy.
• The median duration of cCR was not reached for the combination and 15.2 months for chemotherapy.
• In patients with cCR, grade ≥3 treatment-related adverse events occurred in 61.7% of patients in the enfortumab vedotin plus pembrolizumab arm compared to 71.9% in the chemotherapy arm. There were no treatment-related deaths in the cCR subgroup.

Price Action: PFE stock is down 1.29% at $25.54 at the last check on Tuesday.

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