Clinical Trial Success Rates Still Dismal, But Certain Sectors Outperform

High-profile failures in the drug industry can break a company. In immuno-oncology, one of the hottest areas in drug development, Aduro Biotech Inc. – a fairly young firm, founded in 2008 through the merger of Triton and Oncologic [See Deal] – had high hopes for GVAX Pancreas, a whole tumor cell vaccine that secretes granulocyte-macrophage colony stimulating factor in an effort to prompt the immune system's attack on the cancer. (Aduro licensed GVAX from BioSante [now part of ANI Pharmaceuticals Inc.] in 2011 [See Deal].) The candidate advanced to Phase IIb and was being tested in combination with CRS207 (a proprietary attenuated strain of Listeria that expresses human mesothelin, also from Aduro) in the ECLIPSE trial, but failed to meet its overall survival endpoint in the third-line setting for pancreatic cancer, actually posting a shorter median overall survival time compared with CRS207 alone or chemotherapy. Aduro's shares took a hit, dropping 20% at closing on the day of the announcement in May 2016. The company is still going to be evaluating a triple combination of GVAX, CRS207 and Bristol-Myers Squibb Co.'s Opdivo (nivolumab) in the ongoing STELLAR trial. Aduro has other GVAX vaccines in the pipeline, too, but the pancreatic cancer candidate is its lead, and potentially is closest to market. Likewise, Celldex Therapeutics Inc.'s Rintega (rindopepimut) vaccine was another high-profile casualty. In March 2016, an independent data safety and monitoring board (DSMB) stated that Rintega would not reach statistical significance for overall survival in patients with newly diagnosed EGFRvIII-positive glioblastoma with minimal residual disease in the Phase III ACT IV study. The DSMB determined that, following an interim analysis, the control arm of generic temozolomide outperformed Rintega, and Celldex terminated the study. (See[A#14160307003].) The news sent Celldex's stock value into a tailspin, dropping more than 50% after the DSMB's determination, and the share price hasn't recovered since.

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