Bayer hits the gas on its top cancer prospect with Phase III in sight

Bayer is plotting a pair of Phase III trials for its lead oncology treatment, hoping to crack the crowded field of new blood cancer drugs with a targeted therapy of its own.

The drug, copanlisib, works by blocking overactive PI3K signaling, cutting off a key contributor to cancer growth in leukemias and lymphomas. By the middle of the year, Bayer expects to begin enrollment for two Phase III studies: one testing copanlisib against placebo on patients with the rare non-Hodgkin's lymphoma (NHL) who have failed on Roche's ($RHHBY) Rituxan, and a second pairing the two drugs against relapsed NHL and comparing the results against Rituxan alone. The company also plans to kick off an open-label Phase II study to see how well copanlisib can combat diffuse large B-cell lymphoma, an aggressive subtype of NHL.

The plan, Bayer said, is to hustle copanlisib to regulators in hopes of providing a new therapy option for a particularly deadly disease. And the drug, an FDA-designated orphan product, has the potential to fill a big unmet need, the company said.

"Non-Hodgkin's lymphoma is a highly heterogenous disease characterized by a chronic pattern of remissions and recurrences, and for NHL patients with disease recurrence after initial treatment, there are limited treatment options," Bayer Vice President Dario Mirski said in a statement.

Meanwhile, Gilead Sciences ($GILD) is already on the market with the PI3K-blocking Zydelig, approved last year to treat chronic lymphocytic leukemia, small lymphocytic lymphoma and relapsed follicular B-cell NHL, a subtype of copanlisib's target indication. And leading the new class of blood cancer drugs is Imbruvica from Johnson & Johnson ($JNJ) and Pharmacyclics ($PCYC), a drug promising enough to convince AbbVie ($ABBV) to shell out $21 billion for the latter company.

Bayer is betting copanlisib can help maintain its momentum in oncology. In 2013, Bayer and then-partner, now-subsidiary Algeta won FDA approval for the prostate cancer drug Xofigo, for which sales could top out at around $1.5 billion, analysts say. And the year before, the drugmaker swayed regulators with the colorectal cancer treatment Stivarga.

- read the statement