Pfizer, Inc. PFE and partner Merck KGaA MKGAF announced the discontinuation of a late-stage study evaluating a combination of its PD-L1 inhibitor, Bavencio and its new PARP inhibitor, Talzenna (talazoparib) for first-line ovarian cancer.
The phase III JAVELIN Ovarian PARP 100 study (n=998) evaluated Bavencio (avelumab) + chemotherapy followed by a maintenance treatment of avelumab + Talzenna versus an active comparator for previously untreated advanced ovarian cancer
This is the third avelumab ovarian cancer study failure for Pfizer/Merck KGaA in less than six months. In December, a phase III JAVELIN Ovarian 100 study, evaluating Bavencio in combination with and/or following platinum-based chemotherapy in previously untreated patients with advanced ovarian cancer, was discontinued. Data from a planned interim analysis showed that the study will not achieve superiority in the pre-specified primary endpoint of progression-free survival (PFS). In November, a late-stage study, evaluating avelumab + chemotherapy in a difficult-to-treat advanced ovarian cancer patient population failed to meet the primary endpoints of showing superior overall survival (OS) and PFS.
The companies said several factors led to the decision to end the JAVELIN Ovarian PARP 100 study, which did not include safety reasons. First, the degree of benefit observed with avelumab in frontline ovarian cancer in the JAVELIN Ovarian 100 study did not support continuation of the JAVELIN Ovarian PARP 100 study, the companies said or for that matter evaluating an immunotherapy in ovarian cancer itself. Also, the approval of AstraZeneca/Merck’s PARP inhibitor, Lynparza in the first-line maintenance setting for ovarian cancer in December last year has raised competitive pressure in the PARP inhibitor market. Lynparza is the first and only PARP inhibitor approved in the first-line maintenance setting for ovarian cancer. This also induced Pfizer and Merck KGaA’s decision to end the JAVELIN Ovarian PARP 100 study.
Other PARP inhibitors available in the market are Tesaro’s (now a part of GlaxoSmithKline) Zejula and Clovis Oncology, Inc.’s Rubraca. Zejula and Rubraca are also being evaluated in late-stage studies in the first-line maintenance setting in ovarian cancer patients,
Shares of Pfizer have declined 3.1% so far this year against the industry’s 3.7% increase.
Bavencio is marketed for metastatic Merkel cell carcinoma in the United States, Europe and Japan and for the second-line treatment of locally advanced or metastatic urothelial carcinoma in the United States. Though Bavencio is a relatively new drug in Pfizer’s oncology portfolio and is currently approved for two relatively smaller indications, it might emerge as a key long-term growth driver for Pfizer on future label expansion approvals.
The company is focusing on consistent growth and expansion of Bavencio into new indications and markets globally. Currently, Bavencio is being developed for more than 15 types of tumors. These studies are part of the JAVELIN development program.
Pfizer is also conducting avelumab double/triple combination studies for chemotherapy and targeted therapies and has several avelumab combination therapies with immuno-oncology agents under development.
However, several studies on Bavencio have failed in the past. In February 2018, a late-stage study evaluating avelumab monotherapy in advanced non-small cell lung cancer patients who were previously treated with platinum-containing doublet therapy, failed to meet the primary endpoint of OS. In 2017, a late-stage study evaluating avelumab for the treatment of gastric cancer in the third-line setting also failed to meet the primary endpoint.
Failures like these significantly hurt the drug’s prospects as it competes with successful PD-L1 inhibitors in the market like Merck’s MRK Keytruda, Bristol Myers’ BMY Opdivo and Roche’s Tecentriq.
Pfizer currently carries a Zacks Rank #4 (Sell).
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