Pfizer Inc. PFE along with Germany-based partner Merck KGaA announced top-line data from a phase III study evaluating their PD-L1 inhibitor Bavencio (avelumab). The JAVELIN Gastric 100 study evaluated Bavencio as a first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced/metastatic HER2-negative gastric cancer compared to continuation of chemotherapy or best supportive care.
Top-line results showed that treatment with Bavencio did not lead to superior overall survival when compared to the standard of care in the overall intent-to-treat population or the PD-L1-positive population, thereby failing to meet the primary endpoint of the study.
However, no new safety signals were seen and the safety profile of Bavencio witnessed in this study was similar to what was earlier observed across the JAVELIN program.
Gastric or gastroesophageal junction (GEJ) cancer study covers a hard-to-treat patient population with significant unmet medical need for additional treatments. Notably, this is the second gastric cancer study on Bavencio, which failed. In November 2017, another phase III gastric cancer study (JAVELIN Gastric 300) evaluating Bavencio monotherapy in the third-line setting missed the primary endpoint.
Bavencio is presently approved for the treatment of Merkel cell carcinoma and metastatic urothelial carcinoma. Bavencio in combination with Pfizer’s another cancer drug Inlyta (axitinib) is also approved in the United States for the first-line treatment of advanced renal cell carcinoma (RCC), the most common form of kidney cancer.
Last month, the European Commission approved this Bavencio-plus-Inlyta combo for the first-line treatment of patients with advanced RCC.
Shares of Pfizer have decreased 15.2% so far this year against the industry’s rise of 3.6%.
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.
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).
Pfizer currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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