Dendreon eyes real-world data boost for lagging prostate cancer med Provenge

Years after winning a hotly anticipated FDA approval for its cancer immunotherapy Provenge—and struggling to build sales of the prostate cancer med—Dendreon has racked up some real-world survival data it hopes can help.

At the American Urologic Association’s annual meeting, the company presented real-world findings showing a survival benefit especially pronounced in African American patients with metastatic castrate-resistant prostate cancer (mCPRC). African-American Provenge patients lived a median 37.3 months after treatment compared with 28 months after treatment for Caucasian patients.

The data were consistent with the clinical trials Dendreon used to win Provenge approval back in 2010, according to the company, bought out by China's Sanpower last year. With that sale, Dendreon has changed hands twice and gone through bankruptcy once since the Provenge launch stumbled badly out of the gate.

Once tipped as a certain blockbuster, the therapy ran into a delay at the FDA before its approval. A variety of operational problems hampered it further, and after the embattled Valeant Pharmaceuticals bought it out of bankruptcy in 2014, the med has grown, but still lags far behind its rivals.

Dubbed Proceed, the new study comprised info on 1,900 patients with mCRPC who received Provenge between 2011 and 2013. About 12% of patients in the registry were African-American, according to the release.

Discussing the study findings, Dendreon’s senior director of research Nadeem Sheikh told FiercePharma that differences in the immune system are "really what it comes down to." He said African Americans have higher T-cell counts, "so therefore they are likely to generate a higher immune response."

The numbers are significant: Prostate cancer is the most commonly diagnosed cancer in African-American men, representing 31% of all cancers, Dendreon said. The incidence of prostate cancer is 60% higher among African-American than Caucasian men, and the mortality rate is more than twice as high, the company said.

However, Dendreon president Jim Caggiano stressed that the findings are important to all patients because they "underscore the survival impact of Provenge regardless of race."

"Every patient can benefit by strengthening his immune system against cancer and that’s what Provenge does," Caggiano said.

The data weren’t designed to secure an FDA label change, but Dendreon says it will distribute the new information to practitioners. Part of the company’s efforts to turn the business around has been an increased focus on informing urologists about the treatment, Caggiano said.

Provenge brought in $304 million for Dendreon last year, according to Wells Fargo analyst David Maris, up from $250 million in 2015. Zytiga, by contrast, delivered $2.3 billion for J&J worldwide, $1.1 billion of that in the U.S.

Digging into the data further, Dendreon also noted greater survival benefits for patients with below-average levels of prostate specific antigen. With that in mind, Caggiano said the company will look to focus on PSA screening and will look to get Provenge to patients as early in the disease process as possible.

The company presented these real-world findings almost seven years after ushering the vaccine to the market and filing for bankruptcy in 2014 after failing to turn the drug into a commercial success. Valeant picked the assets up for $495 million in 2015, and since agreed to sell Dendreon for $820 million to China’s Sanpower. The deal is expected to close mid-year.

For the next 12 months, Caggiano said Dendreon will be pushing ahead with Provenge in the U.S. Eventually, he said, Sanpower wants to introduce the cancer vaccine in China.