Pfizer Inc. PFE along with Germany-based partner Merck KGaA announced positive data from interim analysis of a phase III study evaluating their PD-L1 inhibitor Bavencio (avelumab). The JAVELIN Bladder 100 study is evaluating Bavencio plus best supportive care (“BSC”) as a first-line maintenance therapy, following induction chemotherapy in patients with locally advanced/metastatic urothelial carcinoma, a form of bladder cancer, (“UC”) compared to BSC alone. The study met its primary endpoint of overall survival (“OS”).
Interim data from the study showed that patients in the Bavencio arm achieved statistically significant improvement in OS compared to patients receiving BSC alone, current standard-of-care. Pfizer stated in the press release that Bavencio becomes the first immunotherapy to significantly prolong OS as first-line maintenance treatment for advanced urothelial carcinoma. Detailed data from study will be presented at any upcoming medical congress and submitted to the FDA for approval.
In 2017, Bavnecio had received accelerated approval in the United States as a treatment for locally advanced or metastatic UC with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. Data from the JAVELIN Bladder 100 study will also support Bavencio’s continued approval in the indication.
Shares of Pfizer have decreased 10.1% in the past year against the industry’s rise of 12.2%.
Notably, Bavencio is one of the key candidates in Pfizer’s oncology pipeline. Per the company, the Bavencio development program (known as JAVELIN) involves more than 10,000 patients currently being investigated across 15 tumor types including head and neck, non-small cell lung, urothelial and others. Although Bavencio is currently approved for three relatively smaller indications, it might emerge as a key long-term growth driver for Pfizer on future label expansion approvals.
Bavencio had a mixed 2019. While the drug failed in two clinical studies evaluating it in gastric and ovarian cancer, it was approved by the FDA for treating kidney cancer in combination with Pfizer’s Inlyta.
Bavencio faces stiff competition from other approved PD-L1 inhibitors in the market, such as Merck’s MRK blockbuster drug Keytruda (pembrolizumab), Bristol-Myers’ BMY Opdivo (nivolumab) and AstraZeneca’s AZN Imfinzi (durvalumab).
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