The recent success of Pfizer and Merck KGaA’s Phase III JAVELIN Bladder 100 confirmatory study investigating Bavencio (avelumab) with best supportive care as the first-line maintenance treatment for patients with locally advanced or metastatic bladder cancer is not likely to make a significant impact on Bavencio’s future market share.

Despite the drug’s approved use in the first-line treatment of renal cell carcinoma, its position in genitourinary malignancies is hampered by the presence of other established brands. Bavencio, a late-comer into the immune checkpoint inhibitors (ICI) market, suffered greatly from previous failures in multiple studies, including Phase III trials conducted in patients with lung, ovarian, gastric cancer, and other solid tumors. Considering its fierce competition with Merck & Co’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab), both of which are well-established in the ICI market, as well as Bavencio’s comparably low overall survival (OS) and progression-free survival (PFS) benefits in the second-line treatment of bladder cancer, the future for Bavencio is unclear.

Recently, Merck KGaA / Pfizer ended some cohorts of the Phase II Javelin Medley trial studying Bavencio in combination with novel checkpoint modulators such as the OX40 agonist, PF-04518600, and an anti-4-1BB monoclonal antibody, utomilumab, both of which are immunotherapies in development. This unexpected decision raises doubts over the company’s commitment to Bavencio’s expansion and where Bavencio fits in the immuno-oncology space. Still, opportunities could remain for Bavencio in various untapped and niche oncology indications.

In 2017, the Merck KGaA / Pfizer partnership resulted in the initiation of nine clinical trial programs for Bavencio, either as a monotherapy or in combination with other agents, in various types of cancers. The initial optimism caused by its approvals in Merkel cell carcinoma (MCC) and renal cell carcinoma gradually diminished, with its first failures in the second-line treatment of non-small cell lung cancer, followed by the JAVELIN Gastric 300 and JAVELIN ovarian programs. In November 2019, Merck KGaA/Pfizer confirmed that the Phase III JAVELIN Gastric 100 trial, which had been looking into the first-line maintenance use of Bavencio in patients with unresectable locally advanced gastric or gastroesophageal junction cancer, failed to meet primary endpoints.

Aside from bladder cancer, there are other ongoing Phase III trials for Bavencio, such as the first-line treatment of non-small cell lung cancer and squamous cell carcinoma of the head and neck. However, the presence of Keytruda and Opdivo in these indications limits Bavencio’s opportunities in these spaces.

Although Merck KGaA / Pfizer has lost their initial optimism and position in the ICI market, there are still untapped niche areas open for Bavencio, including glioblastomas and cancers with brain metastasis, rare forms of blood cancers such as T-cell lymphoma, and prostate cancer. However, this will be a challenge for Merck KGaA / Pfizer since previous attempts to treat these malignancies with ICIs alone have been disappointing. Combinations with novel checkpoint modulators and other immunotherapies might provide the necessary edge for Merck KGaA / Pfizer to seize opportunities in these indications. Thus, changing Bavencio’s development plan could benefit its future chance of success, which might otherwise remain unlikely due to the other ICI giants on the market.

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