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Pfizer’s Bavencio shows positive effect in bladder cancer study

September 18, 2020

Pfizer (NYSE:PFE) and Merck KGaA (OTCPK:MKGAY) company EMD Serono announces the publication of detailed results from the Phase III JAVELIN Bladder 100 study at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

The study describes the efficacy of BAVENCIO (avelumab) as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma (UC) and highlight exploratory biomarkers as well as patient-reported outcomes.

In the JAVELIN Bladder 100 study, overall survival (OS) was significantly longer with BAVENCIO plus best supportive care (BSC) compared to BSC alone in the primary population of all randomized patients (n=700) whose disease had not progressed on first-line platinum-containing chemotherapy:

At one year, 71.3% of patients in the BAVENCIO arm were alive vs 58.4% of those who received BSC alone.

Median OS was 21.4 months vs 14.3 months, respectively (HR 0.69; 95% CI, 0.56 to 0.86; P<0.001).

In patients with PD-L1+ tumors (n=358), OS was also significantly longer with BAVENCIO plus BSC vs BSC alone (HR 0.56; 95% CI, 0.40 to 0.79; P<0.001).

At one year, 79.1% of patients who received BAVENCIO were alive vs 60.4% in the BSC arm.

Results of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of BAVENCIO across pre-specified subgroups.

In particular, hazard ratios for OS based on response to first-line chemotherapy were 0.69 for complete or partial response and 0.70 for stable disease.

No new safety signals were identified in the JAVELIN Bladder 100 study, and safety profile was consistent with previous studies of BAVENCIO monotherapy.

Treatment-related adverse events of grade 3 or higher occurred in 57 patients (16.6%) treated with BAVENCIO plus BSC; no grade 3 or higher treatment-related events occurred in the control arm.

https://seekingalpha.com/news/3615213-pfizers-bavencio-shows-positive-effect-in-bladder-cancer-study

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