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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